cyrilzakka/clinical-trials huggingface dataset:
12 Weeks Intensive Lifestyle Intervention Program in Primary Care Obesity Clinic for Obese Adults: Jeddah 2015

With low carbohydrate dietary approach for both arms, the investigators will examine the effectiveness of 12-weeks intensive lifestyle intervention program provided in individual sessions in primary health care obesity clinic in Jeddah with aim to achieve 5% reduction of baseline weight for experimental participants in comparison with active comparator group (only one health education session).

The study has two arms:

Active Comparator Arm:

Only health education. One session regarding diet restriction and physical activity with printed health education papers.

Experimental Arm:

Intensive lifestyle intervention Weekly individual session in obesity clinic (15 to 20 min.) for the first 4 weeks then one individual session in obesity clinic (10 to 20 min.) every two weeks (week 5 to week 12).

Total sessions in 12 weeks: 8 (including the final data collection visit).The components of the program: 1) Low carbohydrate (aim to achieve spontaneous reduction in calorie intake) 2) increased physical activity; 3) behavioral strategies to facilitate adherence to diet and activity prescriptions.

Eligibility Criteria:
Inclusion Criteria:

* 20 years old or older
* Arabic Male or female
* Body mass index in kg/m2 (BMI) ≥30

Exclusion Criteria:

* Had recent weight loss equal or more than 5% of baseline weight
* Currently take weight loss medication or enrolled in another weight loss program
* Undergone or scheduled (within study duration) weight loss surgery
* History of diabetes, thyroid dysfunction or any other endocrine abnormality, gout, coronary heart disease, stroke, malignancy or psychological condition
* Medical condition that limits ability to comply with the program's physical activity recommendations
* Pregnant or lactating women
* If one participant had recruited in the study, his family members who live with him in the same home will be ineligible (to avoid contamination from the ripple effect on weight loss)
Accelerating Newborn Survival in Ghana Through a Low-dose, High-frequency Health Worker Training Approach

This study assesses the effect of a low-dose, high-frequency training approach on long-term evidence-based skill retention among skilled birth attendants and impact on adverse birth outcomes at hospitals in Ghana.

In-service training for skilled birth attendants (SBAs) is one of the most common interventions to address lack of knowledge and skills. However, these training interventions are seldom evaluated for effectiveness in improving learning or performance.

This study study is a cluster-randomized waitlist trial implemented in 40 public and mission hospitals in Ghana. It assesses the effect of a low-dose, high-frequency (LDHF) training approach to update hospital-based SBAs in key evidence-based intrapartum and immediate newborn care practices, using current global guidelines.The LDHF approach includes two 4-day onsite sessions (low dose) with weekly practice sessions, SMS quizzes and reminders, and mentoring via mobile phone and onsite visits between trainings (high frequency). The low-dose sessions include competency acquisition through simulation, case-based learning, and small content packages spread over short time intervals.

Eligible hospitals will be stratified by geographic region and caseload, and then randomly assigned to one of four implementation waves. The pipeline randomization allows for rigorous evaluation while the program is rolled out to all facilities.

Eligibility Criteria:
INCLUSION CRITERIA - FACILITIES:

* Public or faith based hospital
* At least three skilled birth attendants on staff
* At least 30 births per month

EXCLUSION CRITERIA - FACILITIES:

* Private hospital
* Public or faith based hospital with less than three skilled birth attendants on staff
* Public or faith based hospital with less than 30 births per month

INCLUSION CRITERIA - SERVICE PROVIDERS:

\* Health providers who attend births in participating health facilities and consent to be assessed at the time of enrollment and at several points in time over the study period

EXCLUSION CRITERIA - SERVICE PROVIDERS:

\* Health providers who decline to participate
Development of Novel Strategy for Treatment of Anterior Cruciate Ligament (ACL) Injury Using Stem Cell

Purpose:Development of novel strategy for treatment of anterior cruciate ligament (ACL) injury using stem cell.

1. Purpose: Development of novel strategy for treatment of anterior cruciate ligament (ACL) injury using stem cell.
2. Subject: Anterior cruciate ligament (ACL) injury 30 patients

   * ACL reconstruction: 10
   * ACL reconstruction + Human cord blood derived mesenchymal stem cells and hyaluronic acid (Cartistem (TM)): 10
   * ACL reconstruction + hyaluronic acid: 10
3. Hypothesis: Human Cord blood derived mesenchymal stem cells can enhance healing between bone tunnel and graft in ACL reconstruction.

Eligibility Criteria:
Inclusion Criteria:

1. Age 20\~50
2. Lachman test grade II,III or Pivot shift test grade I,II,III or ACL rupture in MRI
3. prothrombin time (PT) (INR) \<1.5, activated partial thromboplastin time (aPTT) \<1.5 x control
4. Creatinine ≤2.0 ㎎/㎗, protein uria(dipstick) ≤ trace
5. Bilirubin ≤2.0 ㎎/㎗, aspartate aminotransferase (AST) /Alanine Aminotransferase (ALT) ≤100 IU/L
6. No surgery and radiation therapy in recent 6 weeks
7. No pregnancy
8. No combine ligament instability ≥ grade II in physical examination (grade 0: none, grade I: 0\~5mm, grade II: 5\~10mm, grade III: \>10mm)
9. voluntary singed a consent form

Exclusion Criteria:

1. Degenerative osteoarthritis in knee
2. Revision or other surgery history (stem cell treatment)
3. Chronic inflammatory joint disease like rheumatoid arthritis
4. Infectious disease need to administration of parenteral antibiotics
5. Autoimmune disease
6. Myocardial infarction, congestive heart failure, other serious heart disease
7. Uncontrolled hypertension
8. Serious medical disease
9. Pregnancy and breast-feeding
10. psychiatric disorder and epilepsy
11. Alcohol overuse
12. Smoking overuse
13. Administration of immunosuppressive agents like Cyclosporin A or Azathioprine in recent 6 weeks prior screening test
14. Patient participating in other clinical trials in recent 4 weeks
15. Combined ligament instability ≥ grade II in physical test.
16. No allergy history to gentamicin antibiotics
17. Hypersensitivity patient to bovine protein, hyaluronic acid, and anesthetic agent
18. Inappropriate patient judged by researcher.
Erlotinib Is Being Studied With Or Without An Investigational Drug, PF-02341066, In Patients With Lung Cancer

This is a Phase 1/2 study comparing the safety and anti-tumor activity of erlotinib alone versus erlotinib in combination with PF-02341066 in patients with advanced non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* histologically proven diagnosis of Non-Small Cell Lung Cancer (NSCLC) that is locally advanced or metastatic and of the adenocarcinoma subtype (including mixed adenosquamous histology)
* evident disease progression by Response Evaluation Criterion in Solid Tumors (RECIST) after at least one but no more than 2 chemotherapy regimens for advanced disease
* tumors must have measurable disease as per RECIST

Exclusion Criteria:

* known interstitial lung disease
* prior treatment with an agent that is known or proposed to be active by action on EGFR tyrosine kinase or c-Met/HGF (Phase 2 Portion)
Screening for Pneumonia: A Comparison of Ultra Low Dose Chest CT [ULD-CT] and Conventional Chest Radiography [CXR]

The ULTRACHEST study will be a prospective clinical diagnostic performance study with primary objective to establish device diagnostic clinical performance of Ultra Low Dose CT (ULD-CT) in order to prove it is more accurate in detecting pneumonia when comparing to standard conventional chest radiography.

* 200 subjects
* Each subject will undergo CXR and ULD-CT at the same day.
* Subjects subdivided into 3 groups \[high, moderate and low risk\], based on a laboratory finding(CRP), symptoms and physical examination.
* 3 different thoracic radiologist will judge the scans on existence of consolidation. Consolidation will be expressed as binary outcomes (Yes or No consolidation)
* Radiologist will be blinded for subjects demographic data.
* All radiologist have to score how confidence they were on the finding of consolidation\[5point likert\].
* The investigators will perform a McNemar's test for evaluation. A two sided p-value of less than 0.05 will be considered to be statistically significant.
* Inter-observer variability will be evaluated by using a Fleiss Kappa test.

Eligibility Criteria:
Inclusion Criteria:

* Suffering from pneumonia and referred by their GP

Exclusion Criteria:

* Younger than 18
* Known pregnancy
* Not able to sign the Informed Consent document
* If not willing to be informed about additional findings
Neurobiological Effects of Oxytocin in Schizophrenia

22 male patients with schizophrenia and 22 male healthy volunteers will be included in the study. Subjects who meet the inclusion and exclusion criteria for the study will be recruited. After completion of clinical assessments and neuropsychological assessments, all subjects will undergo two multi-modal imaging sessions. In one scan they will receive intranasal oxytocin and in another scan will receive intranasal saline as control. The order of administration of the medication will be counterbalanced and subjects will be blind to the medication administered. Using the simultaneous PET-MRI scanner, PET and fMRI data will be collected simultaneously. Blood will be collected for analysis of oxytocin receptor gene polymorphism and its potential effect on brain activity.


Eligibility Criteria:
Schizophrenia group

Inclusion Criteria:

1. Diagnosis of schizophrenia or schizoaffective disorder
2. Males between 18 and 45 years
3. capacity to provide informed consent

Exclusion Criteria:

1. current comorbid axis I diagnosis and no alcohol/substance abuse/dependence in the last 12 months (except nicotine)
2. Contraindication to oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma
3. Contraindication to MRI like implants/claustrophobia
4. Past history of head injury resulting in loss of consciousness or neurosurgery
5. Concomitant severe medical conditions
6. On treatment with benzodiazepine medications for at least 8 weeks
7. Contraindication to Positron emission tomography

Healthy volunteers

Inclusion Criteria:

1. Males between 18 and 45 years
2. capacity to provide informed consent

Exclusion Criteria:

1. Lifetime diagnosis of psychiatric illness including substance dependence
2. contraindication to oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma
3. contraindication to MRI like implants/claustrophobia
4. past history of head injury resulting in loss of consciousness or neurosurgery
5. concomitant severe medical conditions
6. on treatment with benzodiazepine medications for at least 8 weeks
7. contraindication to Positron emission tomography
8. Family history of schizophrenia, schizoaffective or schizophreniform disorder in family member
Animal-Assisted Therapy in Patients With Schizophrenia

Animal-assisted therapy (AAT) can be helpful to improve the psychiatric, emotional, physical,and social status in patients with physical and mental illness and the elderly.

The study aims to investigate the effects of AAT program in middle-aged and older patients with schizophrenia. The investigators will recruit 40 patients with schizophrenia in psychiatric ward randomised into AAT group and control group. AAT group will complete the 12-week program. This study contains two assessment sessions before and after intervention, including PANSS, ACIS, MoCA-T, CHI, DASS-21, CST, TUG and 5MWT.

Animal-assisted therapy (AAT) can be helpful to improve the outcomes of psychiatric and emotional symptoms, physical activeness, social skills, well-beings in patients with physical and mental illness and the elderly.

The study aims to assess the applications and outcomes of psychiatric symptoms, social skills, cognitive function, well-beings, emotional status and physical fitness of AAT program applied to middle-aged and older patients with chronic schizophrenia.

The investigators will recruit 40 patients with chronic schizophrenia who were admitted to day care ward and rehabilitation ward, and conduct a randomized, controlled study. 40 patients will be stratified by the ward into AAT group and control group. AAT group will complete the 12-week program. This study contains two assessment sessions completed within one week before and after 12-week program. Subjects will be evaluated by the PANSS, ACIS, MoCA-T, CHI, DASS-21, CST, TUG and 5MWT in both sessions. Statistical analysis is examined using paired t-test to see whether there is a significant difference (based on p-value) between the scores of two assessment sessions in the AAT and control group, and using independent t-test to see whether there is a significant difference in the change scores of two assessment sessions between the 2 groups.

Eligibility Criteria:
Inclusion Criteria:

1. Having a diagnosis of schizophrenia according to the DSM-5.
2. Adult aged 40 years or older.
3. Having stable physical and psychological health conditions based on master clinician judgment.
4. Having the will to participate in the study after thorough comprehension of the content.
5. Not receiving treatment protocol last half a year.

Exclusion Criteria:

1. Severe cognitive impairment e.g. aphasia, being unable to follow 3 or more orders.
2. Being allergic to animals.
3. History of Asthma.
4. Coagulation disorders
5. presenting symptoms of specific phobia, anxiety disorder and obsessive-compulsive disorder in context of dog, infection and contamination.
Title: Povidone-soaked Sutures Versus Ordinary Sutures for Reducing Surgical Site Infection

To determine efficacy of using 3 minutes povidone-soaked suture in reducing surgical site infection during wound closure in elective surgery.

Participant recruitment and randomisation based on eligibility based on CONSORT.

Patient will get either package A or B which determine whether they are getting povidone-soaked suture or ordinary suture during wound closure.

Postoperative, follow up on D10 and D30 of patient well being and signs and symptoms of surgical site infection

Eligibility Criteria:
Inclusion Criteria:

* Age more than 12 years old
* Clean surgery or Clean- contaminated surgery
* Elective surgery

Exclusion Criteria:

* Age less than 12 years old
* Contaminated wound
* Dirty wound
* Allergy to povidone-iodine
* Pregnant
* Laparoscopic
* Emergency surgery
Topical Tranexamic Acid (TXA) in Hip Fractures

Mechanisms by which to reduce exposure to allogeneic blood are of financial and clinical benefit in the hip fracture population. Tranexamic acid (TXA) is an inexpensive medication with low complication risk. Its use in the hip fracture population is unproven. The purpose of this study is to evaluate the efficacy and safety of topical tranexamic acid in reduction of peri-operative blood loss in hip fracture surgery.

The results of this study may dramatically alter the manner in which surgeons manage hip fracture patients in Canada. The use of topical TXA in operatively-treated hip fracture patients has the potential to reduce perioperative blood loss and consequently reduce exposure to allogeneic blood transfusion. This will positively influence post-operative morbidity and mortality, while at the same time substantially reduce hospital length of stay and overall health care costs. The proposed study is felt to have minimal risk, and is a relatively inexpensive study.

Update: An interim analysis was completed in January 2018. The Data Safety Monitoring Committee reviewed the results and recommend the trial continue as planned.

The final data analysis is in process. The abstract will be uploaded upon completion.

Eligibility Criteria:
Inclusion Criteria:

All of the following criteria must be met to be eligible:

1. 18 years of age or older
2. Diagnosis of hip fracture (Intracapsular, Intratrochanteric or Subtrochanteric) requiring surgical repair
3. Patient/surrogate decision maker provide signed informed consent

Exclusion Criteria:

Participants cannot be included in this study if any of the following criteria apply:

1. Patient has documented renal failure with glomerular filtration rate of \<30ml/min/1.73m2
2. Documented allergy to tranexamic acid
3. Current use of hormone replacement therapy
4. Acquired disturbances of colour vision
5. Refusal of blood products
6. Pre-operative use of anticoagulant therapy (Coumadin, heparin \< 5 days of surgery, fibrinolytic disorders requiring intraoperative anti-fibrinolytic treatment)
7. Coagulopathy (pre-operative platelet count \<150,000/mm3, International Normalized Ratio (INR) \>1.4, prolonged Partial Thromboplastin Time (PTT) \>1.4x normal)
8. Hematuria
9. Acute coronary syndrome within 6 weeks of fracture
10. Any history of venous thromboembolism
11. Any intraoperative surgical/medical/anesthetic complications i.e.: myocardial infarction or neurovascular injury occurring prior to application of the tranexamic acid
12. Pregnant or lactating
13. Any major medical or psychiatric disorder that in the opinion of the investigator, might prevent the subject from completely participating in the study or interfere with the interpretation of the study results
14. Unable/unwilling to provide informed consent
Sexual Function Screening in Childhood Cancer Survivors

This is a qualitative research study involving semistructured interviews and Think-Aloud methodology during completion of a clinical screening tool. All participants will undergo the same semistructured interviews.

The proposed research will explore patient-centered approaches to evaluating younger Adolescent/young adult Childhood cancer survivors for sexual dysfunction, including strategies for implementation and usability of thePatient-Reported Outcomes Measurement Information® v2.0 Brief Profile for Sexual Function and Satisfaction Brief, an existing adult screening tool. This study will include interviews with 24 patients age 15-24 who were diagnosed with cancer prior to age 18, and treated with chemotherapy, radiation and/or surgery and are now at least two years off therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to read and understand the postcard consent.
2. Stated willingness to comply with all study procedures and be available for the duration of the study.
3. Age 15-24 at time of enrollment
4. History of cancer diagnosis, diagnosed at \<18 years old
5. Off therapy (chemotherapy, surgery, radiation) for a minimum of 2 years
6. Sufficient cognitive functioning such that participants are able to complete study measures, as determined by their physician and research personnel.

Exclusion Criteria:

1. Developmental or intellectual disability, as determined by the patient's physician
2. Received neither chemotherapy nor radiation therapy
3. Non-English speaking
4. Non-English reading
Allogeneic Bone Marrow Transplant for Inherited Metabolic Disorders

Rationale: Chemotherapy administration before a donor stem cell transplant is necessary to stop the patient's immune system from rejecting the donor's stem cells. When healthy stem cells from a donor are infused into the patient, the donor white blood cells can provide the missing enzyme that causes the metabolic disease. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving a monoclonal antibody, alemtuzumab, before transplant and cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening. This may be an effective treatment for inherited metabolic disorders.

Purpose: The design of this study is to achieve donor cell engraftment in patients with standard-risk inherited metabolic diseases with limited peri-transplant morbidity and mortality. This will be achieved through the administration of the chemotherapy regimen described. The intention is to follow transplanted patient for years after transplant monitoring them for complications of their disease and assisting families with a multifaceted interdisciplinary approach.

Primary Objective:

* To estimate the proportion of patients with donor derived engraftment at day 100 post transplant as defined by 80% or greater donor cells in the CD3 (T cell) fraction

Secondary Objectives:

* To determine the incidence and severity of graft-versus-host disease (GVHD) by day 100
* To determine the incidence of peri-transplant mortality (death by day 100)
* To monitor donor cell chimerism at various time points following allogeneic transplantation with this transplant regimen as determined at day 28, 42, 100, 6 months and yearly for 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Must have diagnosis of one of the following: mucopolysaccharidosis disorder, glycoprotein metabolic disorder, sphingolipidoses or inherited leukodystrophy, peroxisomal disorder or other inherited diseases of metabolism
* Must have an acceptable graft source as defined by University of Minnesota criteria
* Adequate organ function

Exclusion Criteria:

* Pregnant - menstruating females must have a negative serum pregnancy test within 14 days of treatment start
* Evidence of human immunodeficiency virus (HIV) infection or known HIV positive serology
Efficacy of Patellar Taping and Electromyographic Biofeedback Training at Various Knee Angles on Quadriceps Strength and Functional Performance in Patellofemoral Pain Syndrome

This study compared the effects of patellar taping and electromyographic-biofeedback (EMG-BF) guided isometric quadriceps strengthening at different knee angles in patello-femoral pain syndrome (PFPS).

A total of 60 adult male athletes aged 18 to 45 years were recruited. Subjects will be included with the history of knee pain during activities such as descending and ascending stairs, squatting, and running, had positive J sign (lateral tilt of patella), and a sign of patellar malalignment on the radiograph. Individuals with a history of fracture around the knee, patella dislocation, knee deformity (e.g., genu varum), flexion contracture, ligaments/meniscal injuries, and osteoarthritis of the knee will be excluded from the study. The protocol was submitted to and approved by the ethical sub-committee of the College of applied medical science, Majmaah, Saudi Arabia (Ethics number: MUREC-Nov./COM-2O20/11-2). Participants were requested to sign a written informed consent form approved by the institution ethics committee.

Participants were randomly assigned to Group A (experimental group): electromyography biofeedback (EMG-BF) guided maximum voluntary isometric contraction exercise with patellar taping; Group B (control group): sham EMG-BF guided maximum voluntary isometric contraction without patellar taping. The outcome measure for this study will be the mean changes in maximum voluntary isometric contraction (MVIC) of the quadriceps muscle at different angles, pain intensity, single-leg triple hop test (SLTH), and functional status up to 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Knee pain during activities such as descending and ascending stairs, squatting, and running,
* Positive J sign (lateral tilt of patella),
* Sign of patellar malalignment on the radiograph

Exclusion Criteria:

* Fracture around the knee,
* Patella dislocation,
* Knee deformity (e.g., genu varum),
* Knee flexion contracture,
* Ligaments/meniscal injuries, and
* Osteoarthritis of the knee.