cyrilzakka/clinical-trials huggingface dataset:
Irinotecan, Capecitabine and Avastin for Metastatic Colorectal Cancer as Salvage Treatment

This study will evaluate the efficacy of Irinotecan,Capecitabine and Avastin combination in patients with no response to previous treatment with 5-Fluorouracil,Leucovorin,Eloxatin and Avastin.

The aim of this phase II study is to evaluate the efficacy of the combination XELIRI/AVASTIN in patients with mCRC, who have progressed in first line treatment with FOLFOX/AVASTIN. For AVASTIN was selected the dosing schedule of the trials TREE 1 and 2 \[17\], where Avastin was combined with capecitabine and oxaliplatin in a three weeks schedule and with adaptation of the dose in the 7,5 mg/kg

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed locally advanced or metastatic colorectal cancer
* Measurable or evaluable disease according to the Response Evaluation Criteria in Solid Tumors
* ECOG performance status ≤ 2
* Age 18 - 72 years
* Patients who progress after 1st line therapy with FOLFOX/AVASTIN
* Adequate liver (Bilirubin ≤ 1.5 upper normal limit, SGOT/SGPT ≤ 4 upper normal limit, ALP ≤ 2.5 upper normal limit) renal (Creatinine ≤ 1.5 upper normal limit) and bone marrow (ANC ≥ 1,500/mm3, PLT ≥100,000/mm3) function
* Patients must be able to understand the nature of this study
* Written informed consent

Exclusion Criteria:

* History of serious cardiac disease (unstable angina, congestive heart failure,uncontrolled cardiac arrhythmias)
* History of myocardial infarction or stroke within 6 months
* Clinically significant peripheral vascular disease
* History of abdominal fistula, gastrointestinal perforation or intraabdominal abscess within 28 days prior to Day 0
* Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to Day 1
* Presence of central nervous system or brain metastasis
* Evidence of bleeding diathesis or coagulopathy
* Blood pressure \> 150/100 mmHg
* Pregnant or lactating woman
* Life expectancy \< 3 months
* Previous radiotherapy within the last 4 weeks or \> 25% of bone marrow
* Metastatic infiltration of the liver \> 50%
* Patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction or total colectomy
* Active infection requiring antibiotics on Day 1
* Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer
* Psychiatric illness or social situation that would preclude study compliance
A Study to Compare Rosuvastatin/Ezetimibe and Rosuvastatin in Patients With Diabetes Mellitus and Hypercholesterolemia

A Study to Compare Rosuvastatin/Ezetimibe Combination and Monotherapy in Patients with Diabetes Mellitus and Hypercholesterolemia.

This trial is conducted to compare the efficacy and safety between Rosuvastatin/Ezetimibe combination and Rosuvastatin monotherapy in patients with Diabetes Mellitus and Hypercholesterolemia for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Subjects ≥ 19 or ≤ 75 years of age
* Subjects undergoing treatment for type 2 diabetes
* Subjects undergoing treatment of statin for hypercholesterolemia
* Fasting LDL-C ≤ 250mg/dL at the screening visit
* Fasting LDL-C ≥70mg/dL or ≤ 160mg/dL at the randomization visit
* Fasting TG\<500mg/dL

Exclusion Criteria:

* Subjects with hypersensitivity reaction to Statin and Ezetimibe
* Subjects with severe kidney disease
* Subjects with HIV positive result at the screening
* Pregnant or breast-feeding subjects
* Subjects with taking any medication affecting level of LDL (Fenofibrate, Omega 3 fatty aicd etc.)
* Insulin-treated Subjects
* Other exclusions applied
Sunscreen: Persistence of Sun Protection Factor and the Influence on Vitamin D

The investigators want to investigate whether sunscreen is removed by clothing and to what extend when the amount of sunscreen applied varies.Does clothing reduce the SPF when clothes are put on 20, 8, or 4 minutes after sunscreen application? The investigators also want to investigate the persistence of sunscreen during eight hours indoor. How much does the SPF reduces? Furthermore, we want to investigate whether sunscreen in the layers 2, 1, and 0.5 mg/cm2 reduce the vitamin D production in the skin.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants.
* \> 18 years.
* Skin type I, II, and III.

Exclusion Criteria:

* Pregnancy.
* Medicin use.
* Skin or other diseases.
* The participants must not have been in solarium or gotten sun on their trunks in the 3 months before the study start and during the study.
* Skin types IV and above.
Generation of Haploid Stem Cells From Human Germ Cells

Human cells are diploid (contain a double set of chromosomes). The diploid genome is complex and therefore limits genetic research approaches in biomedical models. To overcome this problem experimental generation of haploid stem cells has been done in animals. The investigators aim at generating haploid stem cells from human germ cells that are a useful tool in genetic research and screening.

Human cells are diploid (contain a double set of chromosomes). The diploid genome is complex and therefore limits genetic research approaches in biomedical models. To overcome this problem experimental generation of haploid stem cells has been done in animal models. haploid cells are easier for genetic manipulations, such as knock-in and knock-out of genes, and therefore should make a better experimental model. The investigators aim at generating haploid stem cells from human haploid germ cells.

Eligibility Criteria:
Inclusion Criteria:

1. males over the age of 18 and under 50
2. no known chronic illness
3. not taking any chronic drugs

Exclusion Criteria:

1. females
2. males under 18 or over 50
3. any known chronic illness
4. taking chronic medications
Lorlatinib - PF-06463922

Lorlatinib expanded access program


Eligibility Criteria:
Inclusion Criteria:

* Adult, Senior

Exclusion Criteria:

-
A Study of [14c]-Samidorphan (Also Known as ALKS 33) in Healthy, Male Volunteers

This study will determine the pharmacokinetics (PK) of \[14c\]-samidorphan in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) of greater than/equal to 19 and less than/equal to 32 kg/m\^2 at screening (minimum weight of 50.0 kg)
* Generally good health
* Subjects must agree to reduce the risk of a female partner becoming pregnant during the study and for 30 days after the last dose of the study drug by abstinence from heterosexual relationships or use of a reliable contraceptive method
* Additional criteria may apply

Exclusion Criteria:

* Clinically significant illness within 30 days
* History of alcohol or opioid dependence, or positive urine toxicological screen for marijuana, cocaine, amphetamines, opioids, barbiturates, and benzodiazepines
* History of oral or gastrointestinal disease
* Irregular bowel or bladder function
* History of allergy or hypersensitivity to opioid medications or opioid antagonists (eg, naltrexone, naloxone)
* Current or pending legal charges or probation that would interfere with study conduct
* Use of alcohol within 24 hours prior to admission or urine positive test for alcohol at screening or admission
* Tobacco or nicotine use within 90 days
* Anticipated need for prescription medicines during the study period
* Additional criteria may apply
Pharmaceutical Follow-up of Coronary Heart Disease (CHD) Patients

Objectives To explore the impact of a clinical pharmacist-led 12 month lasting follow-up program for patients with established coronary heart disease (CHD) discharged from the North Norway University Hospital. Methods A total of 102 patients aged 18-82 years were enrolled in a non-blinded, randomized controlled trial. The intervention comprised medication reconciliation, medication review and patient education during three meetings; at discharge, after three months and after twelve months. The control group received standard care from their general practitioner. Primary outcomes were adherence to clinical guideline recommendations concerning prescription, therapy goal achievement and lifestyle education defined in the medication assessment tool for secondary prevention of CHD (MAT-CHDSP). Secondary outcomes included changes in the biomedical risk factors cholesterol, blood pressure and blood glucose. Key findings Ninety-four patients completed the trial, 48 intervention group patients and 46 controls.

Appropriate prescribing was high, but therapy goal achievement was low in both study groups throughout the study. Overall adherence to MAT-CHDSP criteria increased in both groups and was significantly higher in the intervention group at study end compared to the control group, 78.1% vs. 61.4%, P \< 0.001. The difference was mainly due to an increased documentation of lifestyle advices in intervention group patients.

No significant improvements in biomedical risk factors were observed in favor of the intervention group, possible due to an underpowered study. Conclusion The clinical pharmacist-led follow-up program significantly increased documented lifestyle advices defined in the MAT-CHDSP for the intervention group, but did not lead to significant improvements in biomedical risk factor measures in favor of the intervention group. Even if prescribing was high, therapy goal achievement was low in both study groups. Changes to the follow-up program are warranted, in addition to a larger, adequately powered study, before implementation in standard patient care can be recommended.

Find published article in Pharm Pract (Granada). 2015 Apr-Jun; 13(2): 575. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4482847/pdf/pharmpract-13-575.pdf

Eligibility Criteria:
Inclusion Criteria:

* established coronary heart disease
* age 18 - 80 years
* patients living in the three nearby communities Tromsoe, Balsfjord and Karlsoey, this because they need to see the pharmacist personally.

Exclusion Criteria:

* patients living in nursing homes
* patients included in NORstent, another trial including patients at the same department
* patients already receiving pharmaceutical follow-up elsewhere
* cancer patients
Cervix:Hypoxia, Interstitial Fluid Pressure and GSH Levels

The aim of this study is to measure the oxygen content and interstitial fluid pressure in cervix cancer patients. Tumour oxygen content and internal pressure of tumours may be an important factor that influences the effectiveness of radiotherapy and other treatments.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed patients with carcinoma of the cervix ( 3 cm in size or larger) where an examination under anesthesia is to be performed for staging purposes
* Informed consent

Exclusion Criteria:

* Patients with clinically occult cervix carcinoma
The Impact of an Arabic Educational Video on Reducing Ageism and Promoting Positive Attitudes Toward Older Adults Among Physical Therapists an Application of the PEACE Model

Brief Summary The goal of this experimental study is to determine the effectiveness of implementing an Arabic education video intervention based on the Positive Education about Aging and Contact Experiences (PEACE) model in reducing ageism and anxiety, promoting positive attitudes, and increasing knowledge toward older adults and assessing the effect over time among physical therapists.

The main hypothesis:

The investigators hypothesize that an Arabic educational video intervention based on the PEACE model will significantly reduce ageism and anxiety and increase positive attitudes and knowledge about older adults, and the effectiveness will last over time among physical therapists.

Participants will:

* Complete an initial online survey assessing demographic and professional information, as well as measures of ageism, aging knowledge, anxiety about interactions with older adults, and positive and negative age stereotypes (Time-1).
* Watch a 7-minute Arabic video that includes (1) an animated segment addressing ageism and debunking stereotypes and (2) a live-action segment featuring older adults sharing personal stories to promote intergenerational contact (Time-2).
* Complete an attention check followed by the same outcome measures as in Time-1.
* Complete the same set of outcome measures one week later (Time-3) to assess any changes.


Eligibility Criteria:
Inclusion Criteria:

* Licensed Saudi physical therapists.

Exclusion Criteria:

* Students.
* Intern physical therapists.
* Physical therapy technicians.
A Study to Compare Tivozanib Hydrochloride to Sorafenib in Participants With Refractory Advanced Renal Cell Carcinoma (RCC)

This is a Phase 3, open-label, randomized, controlled, multi-national, multi-center, parallel-arm study comparing tivozanib to sorafenib in participants with refractory advanced renal cell carcinoma (RCC).

Participants will be randomized (1:1) to treatment with tivozanib or sorafenib.

Participants will be stratified by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk category (favorable; intermediate; poor) and prior therapy (two prior vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR TKI); a prior checkpoint inhibitor \[programmed cell death -1 protein (PD-1) or PD-1 ligand (PD1-L) inhibitor\] plus a prior VEGFR TKI; a prior VEGFR TKI plus any other systemic agent).

All participants will be evaluated for progression free survival, overall survival, objective response rate, and the duration of response as well as safety and tolerability.

Pharmacokinetic (PK) analyses are also included in study.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Participants with metastatic RCC who have failed 2 or 3 prior systemic regimens, one of which includes a VEGFR TKI other than sorafenib or tivozanib.
* Histologically or cytologically confirmed RCC with a clear cell component (participants with pure papillary cell tumor or other non-clear cell histologies, including collecting duct, medullary, chromophobe, and unclassified RCC are excluded).
* Measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) criteria Version 1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Life expectancy ≥ 3 months.

Exclusion Criteria:

* Prior treatment with sorafenib or tivozanib.
* More than 3 prior regimens for metastatic RCC.
* Known central nervous system (CNS) metastases other than stable, treated brain metastases. Participants with previously treated brain metastasis will be allowed if the brain metastasis has been stable by neuroimaging without steroid treatment for at least 3 months following prior treatment (radiotherapy or surgery).
* Significant hematologic, gastrointestinal, thromboembolic, vascular, bleeding, or coagulation disorders.
* Significant serum chemistry abnormalities
* Significant cardiovascular disease, including: Active clinically symptomatic left ventricular failure, uncontrolled hypertension, myocardial infarction, severe angina, or unstable angina within 6 months prior to administration of first dose of study drug, history of serious ventricular arrhythmia, cardiac arrhythmias requiring anti-arrhythmic medications.
* Inadequate recovery from any prior surgical procedure or major surgical procedure within 4 weeks prior to administration of first dose of study drug.
* Currently active second primary malignancy.
Safety and Efficacy of High-dose Leukocytapheresis Using a Large Filter in Refractory Asthma

Extracorporeal leukocytapheresis (LCAP) or granulocytapheresis (GCAP) has been used in the treatment of patients with rheumatoid arthritis and ulcerative colitis and has shown promising safety and efficacy. LCAP and GCAP seem to be effective for steroid-resistant inflammation. The investigators have already reported safety and efficacy of GCAP in refractory asthma and expect the beneficial effect of LCAP in refractory asthma. In this study, in order to improve the therapeutic effect of LCAP by increasing the quantity of leukocytes that were removed, the investigators conducted a clinical study to investigate safety and efficacy of high-dose LCAP performed using a larger filter and an increased dose of the blood volume per body weight treated, as an possible therapy for refractory asthma.


Eligibility Criteria:
Inclusion Criteria:

* Patients fulfilled the 2001 criteria for refractory asthma in American Thoracic Society.

Exclusion Criteria:

* Pregnant women.
* Patients with severe cardiovascular diseases.
* Patients with infective diseases.
* Patients with leukocytopenia or anemia.
Daily Use of JARDIANCE® Tablets in Japanese Elderly Patients With Type 2 Diabetes Mellitus

Study to investigate the safety and efficacy of daily use of JARDIANCE® Tablets in Japanese elderly patients with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion criteria:

Male and female elderly patients (age 65 and over) with type 2 diabetes mellitus who have never been treated with JARDIANCE® Tablets before the enrolment and start taking JARDIANCE® Tablets within 3 months after launch in Japan

Exclusion criteria:

None
The INFLUENTIAL Trial- Evaluation of National Inpatient Influenza Vaccination Program

This study plans to learn more about whether a stakeholder-informed, standardized inpatient vaccination program will increase influenza vaccination rates of hospitalized children across US pediatric health systems. The first part of the study is to form a multidisciplinary team of stakeholders, including parents, providers, nurses, pharmacists, informaticists, data analysts and communication experts across three sites in synthesizing a best practice implementation guide for an inpatient influenza vaccination program, which will then be piloted at these three sites.

The overarching goal of this proposal is to determine whether a stakeholder-informed, standardized inpatient influenza vaccination program will increase influenza vaccination rates of hospitalized children across diverse U.S. pediatric health systems. Building upon preliminary data and experience with pediatric inpatient influenza vaccine delivery, the investigators will engage a multidisciplinary team of stakeholders in synthesizing a best practice implementation guide for an inpatient influenza vaccination program across three sites. The next phase of the study, using a novel adaptive trial design, will be to implement and test the program across 12 health systems. Finally, the investigators will evaluate the program's impact using an established dissemination and implementation framework.

Eligibility Criteria:
Inclusion Criteria:

* At least 6 months of age
* Admitted to an inpatient unit at a participating health system

Exclusion:

- Admission to critical care sites or hematology-oncology services

Exclusion Criteria:

* At least 6 months of age
* Admitted to an inpatient unit at a participating health system

Exclusion:

- Admission to critical care sites or hematology-oncology services
The Association of Helicobacter Pylori in the Pathogenesis of Hyperemesis Gravidarum in Pregnant Women

The purpose of this study to explore the association between Hyperemesis Gravidarum in pregnant women and Helicobacter pylori infection.

This study included 90 pregnant women during their first trimester who attended Ain Shams University Maternity Hospital antenatal clinic and admitted in the ward.

Patients were divided into two groups: 46 cases of pregnant women with H.G and 44 healthy control pregnant women with no vomiting.

Both groups were matched regarding the inclusion criteria which includes maternal age (18-40 years), gestational age (\<16 wks), and signs and symptoms of H.G for cases (vomiting affecting the general condition, ketonuria, weight loss) and excluding cases or controls with multiple gestation, hyadatiform disease or maternal disease causes vomiting such as ; pyelonephritis, gastroenteritis, cholecystitis or hepatitis.

The two groups were subjected to full history taking, clinical examination, routine laboratory investigations (urine analysis, CBC, liver, kidney function tests Na, k, PT, PTT \& INR) Abdominal ultrasound was done to assess fetal life and gestational age and to exclude gestational trophoblastic disease and multiple gestation pregnancy.H.Pylori infection was assessed by using One step H.pylori Stool Antigen Test.

(CER TEST BIOTEC) pol. Industrial Rio Gallego II,Calle J, No 1, 50840, San Mateo de Gallego, Zaragoza (SPAIN) for the detection of H. pylori antigen.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-40 years old
* Gestational age: less than 16 weeks confirmed by U/S
* Excessive pregnancy - related nausea and /or vomiting that prevent adequate intake of food and fluids.
* Measuring weight loss(\>5% of pre-pregnancy weight)
* Signs of dehydration:

  * Ketonuria (+1 or more)
  * Hemoconcentration (normal Female hematocrit value (36.1-44.3%)

Exclusion Criteria:

* Multiple gestation pregnancy
* Hydatidiform molar pregnancy
* Other causes of vomiting:

  * Gastroentritis
  * Cholecystitis
  * Pyelonephritis
  * Liver dysfunction
Effects of Manual Therapy on the Upper Cervical Spine Combined With Exercise vs Isolated Exercise in Patients With Cervicogenic Headache.

Cervicogenic headache is defined as unilateral headache associated with neck pain. Effect of manual translatoric therapy of the upper cervical spine associated with cervical exercises in these patients is currently unknown. Our aim was to determine if adding manual therapy to an exercise and home-exercise program improved effects on symptoms and function in short- and mid-term in patients with cervicogenic headache.

A randomized controlled study will be conducted with 40 subjects with cervicogenic headache. Each group will receive four 20-minute sessions weekly and a home-exercise program. Upper cervical flexion, flexion-rotation test, Impact Headache Test-6 (HIT-6), headache intensity, craniocervical flexion test, pain pressure thresholds and Global Rating of Change (GROC)-Scale will be assessed at end of the intervention, at 3- and at 6-month follow-ups.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cervicogenic headache according to Sjaastad et al. Subjects will have to fulfill both parts I and III of the major criteria for diagnosis (pain aggravated by neck movement, sustained position or external pressure, restricted cervical range of motion, and unilateral pain starting in the neck and radiating to the frontotemporal region)
* Hypomobility in one or more segments of C0-1, C1-2, C2-3 through manual evaluation.
* A positive result in the flexion-rotation test.
* A failure to pass stage 2 (24 mmHg) of the craniocervical flexion test.
* Be at least 18 years old.
* Have signed the informed consent.

Exclusion Criteria:

* Contraindications for manual therapy or exercise.
* Participation in exercise or manual therapy programs in the last three months.
* Inability to maintain supine position.
* The use of pacemakers (the magnets in the CROM device could alter their signal).
* Inability to perform the flexion-rotation test.
* Language difficulties.
* Pending litigation or lawsuits.