cyrilzakka/clinical-trials huggingface dataset:
Effect Of Functional Balance Exercise İn Elderly

The elderly population is increasing in Turkey and in the world. Many health problems, such as a decrease in physical and psychological abilities and an increase in chronic problems, occur with aging. It is important to encourage and support practices for the development of exercises to increase physical and cognitive capacity in order to early recognize and reduce the effects of problems that develop with aging. To the best of our knowledge, there is no exercise training to increase reaction time in the elderly in the literature.

The study was planned as a randomized controlled study. Volunteer participants over the age of 65 living in a nursing home in Ankara will be included in the study. The sample of the study will consist of 28 elderly individuals, as determined by power analysis. The participants will be randomly divided into two groups. One group (Group 1) will receive functional balance exercise training, and the other group (Group 2) will receive functional balance-based reaction exercise training. The participants socio-demographic information, cognitive level ( The Montreal Cognitive Assessment), executive function (Stroop Test), reaction time, physical performance (Four Step Square test, Short Physical Performance Battery, Time Up Go Test) and balance confidence (Falls Efficiency Scale) will be evaluated Evaluations will be repeated at baseline and 8 weeks later. The interventions will be carried out two days a week for 40 minutes for eight weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age of 65 or above
* Minimum of 5 years of education
* Moca score of 21 or higher
* Capability to walk a minimum of 10 meters (with or without walking assistance if needed)

Exclusion Criteria:

* Moca test score 21 and below
* Having vision and hearing problems (which cannot be corrected with glasses or hearing aids)
* Having an orthopedic or neurological disease that prevents standing
Effects of Counseling on the Continuation Rates and Compliance for Newly Prescribed Oral Contraceptives (Yasmin® or Any Other Oral Contraceptives (OC)

This study is a prospective, company-sponsored, non-interventional cohort study of up to 5000 patients in European countries and countries in Middle East who are newly prescribed any available OC. Patients will be followed up approximately 6 months after initial visit. Selection of Study Population: Women can be enrolled after decision for treatment with Yasmin or any other OC has been made. Physicians should consult the full prescribing information for the respective OC before enrolling patients and familiarize themselves with the safety information in the product package label.


Eligibility Criteria:
Inclusion Criteria:

* Women who have been found eligible for OC use and have newly been prescribed an OC in accordance with the terms of the respective marketing authorization
* Starter (first-ever user of an OC) and switcher from another OC (incl. women with a history of OC use)

Exclusion Criteria:

* The contraindications and warnings of the Summary of Product Characteristics must be followed.
Raltegravir and Atazanavir Dosing Strategy Study

To compare the steady-state pharmacokinetics and short-term efficacy and safety of two dosing strategies of raltegravir and atazanavir in virologically suppressed HIV-infected adults receiving atazanavir-containing combination antiretroviral therapy.

Current HIV treatment guidelines recommend the construction of combination regimens comprising a minimum of three agents from at least two drug classes. There are problems with the current recommendations for although treatments are effective, their success is often limited by tolerability, adverse effects and the need to take many pills. Antiretroviral adherence remains vital and regimens should be simplified wherever possible to facilitate maximal adherence. The recent availability of the potent HIV integrase inhibitor, raltegravir, provides an opportunity to explore moves away from current regimen components. Evidence to support the use of novel regimens must be generated through adequately powered randomized clinical trials. However, before such trials can be undertaken, preliminary data to define the pharmacokinetics, safety and tolerability of these regimens are needed to minimize unnecessary risk for participants. This eight week study will investigate the steady-state pharmacokinetics, and short-term safety and efficacy of two dosing strategies (once and twice daily) of raltegravir plus atazanavir in treatment experienced HIV-infected adults.

Eligibility Criteria:
Inclusion Criteria:

* aged ≥ 18 years with laboratory evidence of HIV-1 infection
* currently receiving 3 or more unchanged antiretroviral agents including atazanavir (with or without ritonavir boosting) for at least 24 weeks prior to study entry
* plasma HIV RNA less than 50 copies/mL for at least 24 weeks prior to study entry
* provide written, informed consent.

Exclusion Criteria :

* prior clinical/virological failure on a PI-containing regimen
* no clinical history of primary HIV-1 protease mutations identified in local baseline genotypic analysis of HIV with interpretation using current IAS-USA Drug Resistance Mutations in HIV-1
* women: pregnant, breastfeeding, or not willing to use adequate contraception (including barrier contraception) if of child-bearing potential
* laboratory abnormalities at screening:

  * absolute neutrophil count (ANC) \< 750 cells/mL
  * haemoglobin less than 8.5 g/dL
  * platelet count less than 50 000 cells/mL
  * AST, ALT \> 5 times the upper limit of normal
  * serum bilirubin \> 5 times the upper limit of normal
* chronic active hepatitis B infection defined by presence of serum viral hepatitis B surface antigen (HBsAg) or HBV DNA-positive
* any malabsorption syndrome likely to affect drug absorption
* concurrent therapy with human growth hormone or other immunomodulatory agents
* concomitant medication contraindicated for use with either atazanavir or raltegravir therapy
* any inter-current illness requiring hospitalisation
* current excessive alcohol or illicit substance use
* unlikely to be able to remain in follow-up for the protocol-defined period.
Non-rebreather at Flush Rate Compared to Bag Valve Mask With Assist

This crossover investigation enrolls healthy volunteers and compares the exhaled oxygen content (FeO2) between the non-rebreather mask at the flush rate and a bag-valve-mask device at the flush rate, used with active positive pressure assistance.


Eligibility Criteria:
Inclusion Criteria:

* Age \>17

Exclusion Criteria:

* Pregnant
* Any facial hair more than stubble that might impede a mask seal
Concordance Between Monitoring Systems for Organ/Space Surgical Site Infections in Rectal Surgery

The Catalan Cancer Plan (CCP) undertakes periodic audits of cancer treatment outcomes, including organ/space surgical site infections (O/S-SSI) rates, while the Catalan Healthcare-associated Infections Surveillance Programme (VINCat) carries out standardized prospective surveillance of surgical site infections (SSIs) in colorectal surgery. This cohort study aimed to assess the concordance between these two monitoring systems for O/S-SSI following primary rectal cancer surgery.

The healthcare system in Catalonia (Spain) monitors and reports SSI in cancer patients through two principal mechanisms. First of all, the Catalan Cancer Plan (CCP) is a Health Department structure that aims to improve the quality of care for cancer patients by means of periodic auditing of outcomes with real-world data and feedback to professionals. One indicator included in these compulsory audits is the occurrence of O/S-SSI.

On the other hand, the Catalan Healthcare-associated Infections Surveillance Programme (VINCat) is a nationwide network for hospital-acquired infections (HAI) which conducts surveillance in colorectal surgery.

The two systems thus operate with an important difference: the CCP audits are mandatory and cover all cancer surgeries performed in centres funded through the public healthcare system, while VINCat is a voluntary registry programme among participating centres. The selected cases and methods used to detect O/S-SSI may therefore vary substantially between auditing systems.

This retrospective population-based cohort study aims to assess the concordance between clinical audits of the CCP and the VINCat registry as a preliminary step to studies correlating local recurrence after rectal cancer surgery and O/S-SSI.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years old
* Eligible patients with tumour ≤ 13 cm from anal verge, as measured by Magnetic Resonance Imaging
* Primary adenocarcinoma
* Oncological resection with curative intent
* Cancer stages: I-II-III

Exclusion Criteria:

* Transanal local resection
* Emergency colorectal surgeries
* Presence of metastases found in the diagnostic process or during the surgical procedure
* Recurrence of the disease treated before the study period
* Non-resectable tumour or palliative surgery
* Patients operated in private centres
Improvement in Preschoolers' Participation as a Result of Occupational Therapy Intervention

This study evaluates the improvement of participation in everyday occupation among preschool children with mild developmental disabilities as a result of Occupational Therapy intervention.

Preschoolers suffering from mild developmental disabilities are being referred to Occupational Therapy (OT) clinics according to limitation in participating of daily occupations. As well these children often demonstrate behavior or emotional difficulties. The primary treatment goal is promoting participation yet many times the treatment focuses on child's performance skills and not on occupation based activities. Respectively its outcome measures are the child performance skills. This study will document the therapeutic intervention, and evaluate its impact on child participation as well on his performance skills and emotional aspects. Participants will be recruited from waiting list for Occupational Therapy at Clalit Health services, Child Development Institute, and will be evaluate four times. First time on referral to waiting list ( At the present time due to long waiting list, children are waiting about three to four months before starting OT intervention), second time before treatment, third time after three of treatments and last follow-up after three months.

Eligibility Criteria:
Inclusion Criteria:

* kindergarten students of regular education
* Hebrew speaking

Exclusion Criteria:

* Students of special education
* Attending physiotherapy or psychology treatments
* Autistic Spectrum Disorder
* Cerebral Palsy
* Spina Bifida
* Developmental Intellectual Disabilities
* Blindness
* Deafness
SBRT Plus Lenvatinib and TACE for Advanced Primary HCC: A Phase 3 Trial (SEARCH)

This is a phase 3, multicentri, randomised, open label study. The purpose is to investigate the safety and efficacy of stereotactic body radiation therapy (SBRT) combined with transarterial chemoembolization (TACE) and lenvatinib (LEN) in the treatment of advanced hepatocellular carcinoma with portal vein tumor thrombus.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years old;
2. Patients with primary advanced HCC (in accordance with AASLD2018 guidelines for the diagnosis of HCC), without any previous treatment;
3. There is at least one measurable lesion in the liver according to mRECIST criteria, single tumor ≤ 10.0 cm or multiple tumors and tumor burden ≤50% , with portal vein tumor embolus;
4. ECOG score 0-1;
5. Child-Pugh class A;
6. Expected survival time ≥ 3 months;
7. Blood, liver and kidney function meet the following conditions: Neutrophil count ≥ 1.5 × 10 9 /L; Platelet count ≥ 60 × 10 9 /L; Hemoglobin ≥ 90 g/L; Serum albumin ≥ 30 g/L; Bilirubin ≤ 50 umol/L; AST, ALT ≤ 5 times the upper limit of normal, ALP ≤ 4 times the upper limit of normal; Prolongation of prothrombin time not to exceed the upper limit of normal by 6 seconds; Creatinine ≤ 1.5 times the upper limit of normal.

Exclusion Criteria:

1. Extrahepatic metastases;
2. Previous history of liver or adjacent tissue radiation;
3. Previous history of hepatic encephalopathy, refractory ascites or gastric esophageal varices;
4. There are contraindications to TACE treatment, such as portosystemic shunt, liver flow ablation, significant atherosclerosis;
5. Hypersensitivity to intravenous contrast agents;
6. Pregnant or lactating women or subjects with family planning within two years;
7. With HIV, syphilis infection;
8. Accompanied by other malignant tumors or suffering from other malignancies within 5 years before enrollment;
9. Allogeneic organ transplant recipients;
10. Severe dysfunction of heart and kidney or other organs;
11. Active severe infection \> grade 2 (NCI-CTC version 5);
12. Suffering from mental and psychological diseases may affect informed consent;
13. Unable to take oral medication;
14. Participated in other drug clinical trials within 12 months before enrollment;
15. Active gastric or duodenal ulcers within 3 months before enrollment.
UHN Inpatient Hepatitis C & B Screening

Currently, there is a lack of literature on programs evaluating rapid screening methods to traditional venipuncture methods for sample collection during screening for viral hepatitis. Due to the relatively low diagnosis and linkage to care rate, screening programs that provide same day results for viral hepatitis infection may improve both diagnosis and enable providers to engage patients shortly after diagnosis. This stands in contrast to the multi-visit, weeks long process that normally accompanies serum testing for hepatitis C virus (HCV) and hepatitis B virus (HBV). A few American studies have examined the implementation of HCV inpatient screening programs; however, they are focused specifically on high-risk patient populations, the barriers to accessing care experienced by study participants are not relevant to the Canadian healthcare system context, and do not use rapid testing. Furthermore, there are few, if any, data on HBV inpatient screening programs and the diagnosis rate remains low. This project will provide key data on a rapid inpatient screening and linkage to care strategy as well as the prevalence of these viruses across different age bands within the population. Finally, the study will help determine whether rapid inpatient screening is a feasible and acceptable approach for screening and linkage to care.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years or older at time of consent
* Patients admitted to GIMIUs at TGH or TWH

Exclusion Criteria:

* Patients whose end of life is expected to be less than 6 months
* Patients who are unable or decline to provide informed consent
* Patients with confirmed, active COVID-19 infections
* Patients with immediate life-threatening conditions where screening for chronic HCV and HBV infection may delay urgent care
CRLX101(NLG207) in Combination With Bevacizumab for Metastatic Renal Cell Carcinoma (mRCC) Versus Standard of Care (SOC)

This study to evaluate treatment in patients with metastatic renal cell carcinoma (RCC) which has progressed through 2 to 3 prior lines of therapy, with the investigational drug CRLX101 in combination with bevacizumab compared to treatment with a standard of care therapy. The study will compare which treatment resulted in longer time before progression of the RCC. Patients will be treated and followed for progression of their disease on average for up to 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Must have histologically confirmed renal cell carcinoma of any pathologic subtype.
* Must have unresectable metastatic disease, and have tumor(s) present that is (are) evaluable by the RECIST, v1.1; may have spinal-associated metastases but must have concluded dexamethasone therapy and be evaluated by the Investigator to have stable CNS disease.
* Must have received 2 or 3 prior lines of conventional molecularly targeted therapy
* Must have full recovery from any toxicities from prior therapy CTCAE Grade 1 or less with the exception of Grade 2 alopecia) prior to randomization.
* ECOG performance status 0 or 1.
* Age 18 years and older.
* Life expectancy of at least 3 months.
* Must have normal organ and marrow function reported within 14 days prior to randomization
* Ability to understand and willingness to sign a written informed consent document.
* Able to comply with study visit schedule and assessments.

Exclusion Criteria:

* Any conventional molecularly targeted therapy within 2 weeks or, chemotherapy or radiotherapy within 2 weeks (local) or 4 weeks (systemic) prior to entering the study.
* Failure to recover to grade 1 or less all prior adverse events.
* Any major surgery within 4 weeks of study randomization.
* Any prior treatment with topoisomerase I therapy.
* Prior treatment with any drugs or therapies that will be administered during the course of this trial including CRLX101, any topoisomerase 1 inhibitor, bevacizumab or the conventional molecularly targeted agent intended for use as standard of care treatment.
* Patients receiving any other current investigational therapeutic agent.
* Other active malignancies
* Patients with brain metastasis treated or untreated, or other CNS disease
* Any clinically significant cardiac disease defined as NYHA class III or IV.
* Uncontrolled hypertension
* Uncontrolled concurrent illness
* History of non-healing wounds or ulcers.
* Pregnancy, or inadequate contraception for men or women of childbearing age, or lactating / breast-feeding
* Patients with known HIV or with solid organ transplant
Calcium and Vitamin D Malnutrition in Elderly Women

This study is designed to test whether calcium supplementation alone or calcium plus vitamin D reduces the incidence of fractures, reduces high parathyroid secretory activity, and halts bone loss in a population-based sample of women 55+ years of age.

* A calcium supplement of 1400 mg/d will significantly reduce the cumulative incidence of spine and appendicular fractures over four years for independently living, rural women 55 years of age and older compared to similar women on their usual diets.
* A calcium supplement of 1400 mg/d plus 1100 IU vitamin D/d will significantly reduce the cumulative incidence of spine and appendicular fractures compared to a calcium supplement only.

We are conducting a 4-year randomized, double-blind, placebo controlled trial of calcium or calcium with vitamin D supplementation. We randomly sampled the population of healthy, independent living women 55+ years in nine rural counties. We randomly assigned 1180 women to one of three groups: Group 1 receives calcium (1400 mg/d) and vitamin D placebo, Group 2 receives both calcium (1400 mg/d) and vitamin D (1100 IU/d) and Group 3 receives both placebos.

A full-service market research firm randomly selected telephone numbers from all households with listed numbers in the nine-county rural sample area. The firm continued calling until 1180 women were selected who met the inclusion and exclusion criteria and were willing to participate in a four year prospective study of calcium and vitamin D supplementation. The participants were enrolled into study between May 2000 and July 2001.

Participants have study visits every six months. Annually the following are performed: bone density scans, height and weight, brief medical history including medicine changes, fracture surveillance, and compliance with calcium and vitamin D. At baseline and end of study, spine x-rays and dietary recall were obtained.

Eligibility Criteria:
Inclusion Criteria: healthy women ages 55 and older who were at least four years postmenopausal living independently in a nine-county rural area of Nebraska

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Exclusion Criteria:

1) chronic kidney disease, 2) Paget's metabolic bone disease, and 3) history of cancer except for superficial basal or squamous cell carcinoma of the skin and

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PMS Study Ultravist-IMAGE, IoproMide (UltrAvist) to Gain Further Information on Tolerability and Safety in X-ray Examination

The purpose of this study is to obtain data on the safety and efficacy of Ultravist application in usual daily use.The radiologist will administer the contrast medium to the patient as he/she would have done without the study. No other examinations will be performed than would have been done routinely.


Eligibility Criteria:
Inclusion Criteria:

* Patients with indication for an X-ray examination and for whom the radiologist has decided to use the contrast medium Ultravist.

Exclusion Criteria:

* No exclusion criteria besides the contraindications for the use of Ultravist as mentioned in the product information.
An Audit on Management of Chronic Diarrhea

The study is to assess whether the staff in gastroenterology unit are sticking to the agreed up on unit's protocol in management of chronic diarrhea over the period of one year(september 2017-september 2018)

chronic diarrhea is defined as having loose or watery stools more than three times aday.Awakening at night to pass stools us often sign of an organic cause of diarrhea.In some cases chronic diarrhea is the result of intestinal infection that persists longer than expected. In other cases chronic diarrhea is apart of a systemic illness.

Etiology:

1. post enteritis diarrhea syndrome in whic small intestinal mucosal damage persists after acute gastroenteritis.Also secondary disaccharidase deficiency and reinfection may be a cause.
2. infectious causes:enteric infection is an important cause.Associated conditions may be T.B or impaired immunity as in malnutrition potentiating the likely-hood of prolonging or acquiring another infection.Viral infection like Rota virus,parasites as E.coli,Giardia lamblia as well as amebiasis have been implicated in chronic diarrhea.
3. Cytomegalovirus on the other hand may act as an opportunistic agent in immuno compromised patients.
4. Non infectious causes include cow's milk allergy,lactose intolerance and inflammatory bowel disease,all of which may cause chronic diarrhea that is often associated with abdominal pain with or without elevated levels of inflammatory markers.
5. Malabsorption syndrome e.g Celiac disease,cystic fibrosis where the stools are usually fatty in nature and bulky in amount.

Good management of chronic diarrhea must include investigations and treatment.A protocol must be followed accurately therefore.

Methodology:

measurment of the degree of sticking of staff in Gastro-enterology unit to the agreed upon unit's protocol in management of chronic diarrhea over the period of one year (September 2017-September 2018).

Eligibility Criteria:
Inclusion Criteria:

* age group from 2 months to 18 years
* cases with diarrhea lasts 2 weeks or more
* Genetically free

Exclusion Criteria:

* age group from 0-2 months
* age group above 18 years
* cases with diarrhea less than 2 weeks
* Gentic disease