cyrilzakka/clinical-trials huggingface dataset:
The Effects of Social Role Participation on Life Quality

The study was carried out among 100 RA patients (age from 20 to 70 years) by fulfilling the American College of Rheumatology 1987 revised criteria admitted to our outpatient clinic. RA patients were compared with 95 healthy volunteer control group. Participants were asked to complete interview based questionnaires regarding pain, life quality, and social role participation to obtain additional information during the interview to participate in the study in 20 min.

The study was carried out among 100 RA patients (age from 20 to 70 years) by fulfilling the American College of Rheumatology 1987 revised criteria admitted to our outpatient clinic. RA patients were compared with 95 healthy volunteer control group. Healthy volunteers were recruited from the partners next to the patients who came to our outpatient clinic for examination. The same physician carried out the physical examinations on all participations and conducted a interview, acquiring information on age, gender, body mass index (BMI), marriage status, living alone, working, and education. Participants were asked to complete interview based questionnaires regarding pain, life quality, and social role participation to obtain additional information during the interview to participate in the study in 20 min. Examinations took place at the our outpatient clinic. This study did not include all participants who had accompanying of other rheumatic diseases, musculoskeletal diseases, the presence of another chronic disease, cancer.

Eligibility Criteria:
Inclusion Criteria:The study was carried out among RA patients (age from 20 to 70 years) by fulfilling the American College of Rheumatology 1987 revised criteria admitted to our outpatient clinic -

Exclusion Criteria:This study did not include all participants who had accompanying of other rheumatic diseases, musculoskeletal diseases, the presence of another chronic disease, cancer.

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Effect of Bilberry (European Blueberries) and Grape Polyphenols on Cognition and Blood Parameters

The purpose of this study is to determine whether dietary intervention with blueberry and grape juice extracts in elderly men with subjective memory problems would raise performance on neuropsychological memory tests and change biomarker of muscle damage and whole blood gene expression profiles.

A number of studies have shown that increased dietary intake of fruits and vegetable extracts high in antioxidants (e.g., blueberries, strawberries and spinach) can retard and even reverse age-related decline in brain function and in cognitive and motor performance in rats. This is the first placebo-controlled human study to evaluate the effect of dietary intake of fruit polyphenols on neuropsychological test scores and whole blood gene regulation

Sixty-two non-demented, non-depressed men (age 67-77 years) with subjective memory decline, were randomly assigned to a blueberry/grape juice- and placebo-group in a 9 week double blind intervention study. Pre- and post treatment assessment were measured with a computerised neuropsychological test battery (CANTAB), including tests for motor speed, visual reaction time, and spatial memory. Dietary habits were registered before intervention and several clinical biomarkers were measured in plasma/serum before and after the intervention. Pre- and post intervention-samples for measurement of gene regulation were also collected

Eligibility Criteria:
Inclusion Criteria:

* men
* age 67-77 years
* gradual subjective memory decline
* response to advertisement

Exclusion Criteria:

* head trauma with loss of consciousness and lasting symptoms
* brain stroke within last 3 years
* dementia, clinically diagnosed
* signs of brain-degenerative disease
* Mini Mental Status Examination score less than 26
* depression (MADRS; Montgomery Asberg Depression Rating Scale score above 20)
* ongoing treatment for cancer (cytostatica)/diabetes
* reported or observed serious mental illness
* reported or observed use of narcotics (any, present or past)
* reported or observed abuse of alcohol
* visual, auditory, or motor handicaps of relevance for performance
Correlation Between Coital Activity During Pregnancy and Premature Delivery Related to Prostanoid Receptor Polymorphisms

The purpose of our study is correlate between premature delivery (between week 23-35 of the pregnancy) in women that had intercourse up to 12 hours prior to beginning of labor and polymorphisms in the gene Prostanoid receptor.

During the past years there has been a conflict between different studies regarding the correlation between intercourse during pregnancy and early labor. Brustman et al showed that women that were at a high risk for early delivery and had intercourse and then an early labor had significantly increase uterine activity compared to women at low risk. Petridou et al showed that this risk is significantly higher at week 33 of gestation. However, the Cochrane Library summary leaves the question of correlation between intercourse and early labor unanswered. In Sayle et al's study showed no correlation between early delivery and intercourse. In 2004 Oguma described 3 polymorphisms in the Prostanoid receptor gene. These polymorphisms were correlated to increased activity of smooth muscles of bronchi in asthma. Since this gene is also expressed in the uterine muscles we wanted to determine whether there is a correlation between the three polymorphisms T-549C, C-441T, T-197C, G+1044A and early delivery due to intercourse.

1. Brustman LS, Raptoulis M. Langer O, Anyaegbunam A \& Merkatz IR. Changes in the pattern of uterine contractility in relationship to coitus during pregnancies at low and high risk for preterm labor. Obstet Gynecol 1989;73:166-168
2. Petridou E, Salvnos H, Skalkidou A, Dessypris N, Moustaki M \& Trichopoulos D. Are there common triggers of preterm deliveries. British J Obst Gynecol 2001;108:598-604)
3. Kavanagh J, Kelly AJ \& Thomas J. Sexual intercourse for cervical ripening and induction of labour. The Cochrane Database of Systematic Reviews 2001, Issuse 2.Art. No.:CD003093. DOI: 10.1002/14651858.CD003093
4. Sayle AE, Savitz DA, Thorp JM, Hertz-Picciotto I \& Wilcox AJ. Sexual activity during late pregnancy and risk of preterm delivery. Obstet Gynecol 2001;97:283-9)
5. Bernal AL. Mechanisms of labour-biochemical aspects. BJOG 2003;110(Supp 20):39-45
6. Oguma T, Palmer L, Birden E, Sonna LA, Asano K\& Lilly CM. Role of prostanoid dp receptor variants in susceptibility to asthma. NEJM 2004;351:1752-63

Eligibility Criteria:
Inclusion Criteria:

* Women who start delivery in weeks 23-35 of pregnancy 12 hours after intercourese.
* Women who come for delivery after week 31 and have not had intercourse during the previous month.
* Women at term who have been sexually active during their pregnancy.

Exclusion Criteria:

* Any other women who come in for delivery.
Investigation of the Effect of Nomophobia on Musculoskeletal System and Sleep

The aim of this study; Investigation of the effects on the musculoskeletal system and sleep by determining the nomophobia levels of individuals between the ages of 18-25.

The research was planned as a quantitative research. Data collection was done online.

The scales and forms used are as follows:

1. Demographic Information Form
2. Nomophobia Scale
3. Cornell Musculoskeletal Disorder Questionnaire
4. Smart phone Addiction Scale
5. Pittsburgh Sleep Quality Index
6. International Physical Activity Survey
7. McGill Melzack Pain Questionnaire

Questionnaires will be sent to the participants online by invitation. Participants will be asked to participate in the study by reaching them through social media, mail or mobile phone applications. The data obtained will be analyzed statistically.

Eligibility Criteria:
Inclusion Criteria:

* To have accepted the voluntary consent form that requires participation in the survey study.
* Being a smart phone user

Exclusion Criteria:

* Not accepting the volunteer consent form
* Having undergone previous surgery
* Being on antidepressants.
Balloon Induction of Labor in PROM for TOLAC

A prospective randomized controlled trial to evaluate the safety and efficacy of labor induction with a double balloon catheter (Atad Ripener Device) in women desiring TOLAC (trial of labor after cesarean) with PROM (pre labor rupture of membranes).


Eligibility Criteria:
Inclusion Criteria:

Only patients who meet the following criteria will be approached.

1. Singleton Pregnancy
2. Previous single cesarean section
3. At least 12 months have elapsed since the previous caesarean delivery
4. Diagnosed with confirmed PROM at ≥ 34 weeks' gestation.
5. Ruptured membranes have occurred ≤24 hours prior to inclusion in the study.
6. Vertex presentation well applied to the cervix
7. Found to have an unripe cervix in a speculum examination (Bishop score ≤6).
8. Absence of significant and regular uterine contraction (\<3/10Min).
9. Willingness to comply with the protocol for the duration of the study.
10. Have signed an informed consent (including a TOLAC consent form).

Exclusion Criteria:

Patients having any of the following conditions will be excluded from the study:

1. Any contraindication for a vaginal delivery (i.e. placenta previa, non-vertex presentation, previous cesarean delivery \< 12 months).
2. Regular uterine contractions (\>3/10Min).
3. Diagnosis of ruptured membranes was made over 24 hours prior to study inclusion.
4. Meconium stained amniotic fluid.
5. Evidence of chorio-amnionitis (T 37.6°C with uterine tenderness and maternal or fetal tachycardia or purulent discharge or WBC20.000)
6. Suspected placental abruption or a significant hemorrhage.
7. Non-reassuring fetal status (as determined by fetal heart rate monitoring and/or bio-physical profile) necessitating immediate intervention.
A Clinical Trial Evaluating Diets for IBS

Diet and lifestyle changes are the recommended first line treatments for symptom relief in irritable bowel syndrome (IBS). Currently the only diet that is widely recommended and for which there is good evidence of efficacy in IBS is one low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (low-FODMAP). While effective, the Low-FODMAP diet is burdensome and costly to patients and in clinical practice adherence to FODMAP restriction is less than optimal. Further, patients who respond to a FODMAP restriction often are reluctant to reintroduce more FODMAPs into their diet, which may deprive them of foods, particularly fruits and vegetables with important health benefits. Therefore, there is a need for other dietary interventions for IBS that are less burdensome to patients. This clinical trial assesses the efficacy of two dietary interventions.


Eligibility Criteria:
Inclusion criteria

1. Patients with IBS-D diagnosed per Rome IV questionnaire and without any unexplained alarm features (rectal bleeding, weight loss, nocturnal symptoms, family history of inflammatory bowel disease or celiac disease)
2. Aged 18-65 years at the time of screening
3. Weekly average of worst daily (in the past 24 hours) abdominal pain score of ≥3.0 on a 0- to-10 point scale
4. At least 80% compliance in daily diary entries during the 7-day screening period

Exclusion criteria

1. Subjects adhering to a dietary IBS-treatments such as the low-fat diet, low FODMAP diet, or gluten-free diet within the past 6 months
2. Subjects with a known food allergy to eggs, peanuts, or milk (subjects with lactose intolerance who are experiencing IBS symptoms while on a lactose-free diet will not be excluded from the study).
3. Subjects with a history of insulin-dependent or non-insulin-dependent diabetes
4. Subjects with a known history of celiac disease, inflammatory bowel disease or microscopic colitis
5. Subjects with a history of an eating disorder requiring medical or behavioral treatment within the past 10 years.
6. BMI \< 18.5
A Study to Evaluate Vitamin B3 Derivative to Treat Mitochondrial Myopathy

The purpose of this study is to determine the effects of Nicotinamide Riboside (NR) supplement in adult-onset symptoms of mitochondrial myopathy.


Eligibility Criteria:
Inclusion Criteria:

* Biochemically and/or genetically confirmed or confirmed primary mitochondrial myopathy based on published diagnostic criteria.
* Biochemically confirmed mitochondrial disorder would mean that the patient meets clinical criteria and has either biopsy or biochemical testing that supports the diagnosis.
* Confirmed mitochondrial disorder means that the patient meets published clinical criteria for the diagnosis and has also had confirmatory genetic testing for the disorder type.
* Agreed to avoid vitamin supplementation or nutritional products with vitamin B3 forms 14 days prior to the enrollment and during the study in order to not exceed 200 mg/day of vitamin B3 derivatives intake.
* Female of childbearing potential agreed to use effective contraception throughout the study.
* Written, informed consent to participate in the study.

Exclusion Criteria:

* Unwilling to comply with the follow-up schedule.
* Inability or refusal to give informed consent by the patient or a legally authorized representative.
* Known pregnancy or breastfeeding.
* Concurrent participation in another investigational drug study or within washout period of treatment.
* Presence of other medical symptoms or condition, which may interfere with interpretation of outcome measures as determined by the study PI.

Clinical / Laboratory Exclusion Criteria:

* Estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min.
* Patients in permanent Renal Replacement Therapy.
* Serum alkaline phosphatase 50% above normal limit.
* Serum aspartate transaminase 50% above normal limit.
* Serum Thyroxine (T4) 50% above or below normal limit.
* Serum Thyroid Stimulating Hormone (TSH) 50% above or below normal limit.
* Severe anemia with Hb \< 7g/dL.
* Severe leukocytosis with WBC \> 15,000/mm\^3.
Understanding CARdiac Events in Breast Cancer

In Ireland, over 3,000 patients are diagnosed with breast cancer annually, and 1 in 9 Irish women will be diagnosed with breast cancer in their lifetime. There is evidence that female breast cancer survivors are more likely to die of cardiovascular disease than their age-matched counterparts.

This research is focused on evaluating pathways for identifying, managing, and overcoming side effects of cancer therapies that can negatively impact quality-of-life and overall outcomes for women during and after cancer treatment. The Cardio-oncology research team at GUH plan to capitalize on their expertise in both cancer care and cardiology to develop a care pathway for cancer patients who are at increased risk of developing heart disease.

Establishment of a Cardio-Oncology assessment and surveillance pathway for breast cancer patients undergoing adjuvant systemic chemotherapy at GUH and the assessment of the feasibility of trialing this approach for risk assessment and early detection of CTRCD in a multicenter, prospective RCT which will inform future development of clinical services for cancer patients nationally and later internationally.

Study Design:

This study is a prospective, single arm, pilot feasibility study.

Study Population:

The study will focus on adult female patients diagnosed with stage I-III breast cancer (BC).

Data Analysis and Statistics:

The PCORE Investigators have established collaboration with biostatisticians at the INSIGHT SFI centre for data analytics within University of Galway for analysis of the multi-component dataset from UCARE. Questionnaire data to assess health related QoL (quality of life) and physical activity will be collected at baseline and at 6-monthly intervals at 3, 6 and 12 months throughout the study period. Clinically important differences in physical activity levels or HR-QoL scores will be recorded as per the tool specific scoring systems. Multivariate analysis will be performed for association between HRQoL measures and predictors in patients undergoing breast cancer treatment. Baseline to 6, 12, 18 and 24 month changes in HRQoL over time will be described in subgroups defined by their treatment characteristics and tumor and host response to therapy (both oncologic and cardio-toxic).

Eligibility Criteria:
Inclusion Criteria:

* Women aged ≥ 18 years
* Ability to read and understand English
* Breast Cancer Stage I- III planned to receive systemic chemotherapy

Exclusion Criteria:

* Patients not for systemic chemotherapy with curative intent
* Patients who are unable to co-operate with the study protocol
* Patients who are unable to give informed consent
A Trial of AK117 (Anti-CD47 Antibody) in Patients With Acute Myeloid Leukemia

This is a open label, phase Ib/II study. All patients are diagnosed with AML, Eastern Cooperative Oncology Group (ECOG) performance status 0-3. The purpose of this study is to evaluate the safety and efficacy of AK117 + azacitidine in subjects with AML.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years (at the time consent is obtained).
* Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3，and 0\~2 are required for subjects ≥75 years old.
* Has a life expectancy of at least 12 weeks.
* Patient with AML diagnosed according to WHO 2016 criteria.
* Has adequate organ function.
* All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment.

Exclusion Criteria:

* Patient has acute promyelocytic leukemia.
* Patient has known active central nervous system (CNS) involvement with AML.
* Favorable risk cytogenetics such as t(8;21), inv(16) or t(16;16) or t(15;17) as per the National Comprehensive Cancer Network (NCCN) Guidelines Version 2, 2021 for AML.
* Is currently participating in a study of an investigational agent or using an investigational device.
* Has undergone major surgery within 30 days of Study Day 1.
* Has a known additional malignancy that is progressing or requires systemic treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
* Previous allogeneic hematopoietic stem cell transplant (allo-HSCT) .
* Prior treatment with any anti-CD47 or anti-SIRPα (signal regulatory protein alpha) agent.
* Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
* Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected).
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of this subject to participate, in the opinion of the treating investigator.
* Has received a live virus vaccine within 30 days of the planned first dose of study therapy.
* Is pregnant, breastfeeding, or expecting to conceive or father a child within the projected duration of the study including 120 days following the last dose of study treatment.
* Patient with known allergy or hypersensitivity to AK117, azacitidine or any of their components.
StereoTactic Ablative RadioTherapy of Cardiac Arrhythmias (START-CA)

This is a prospective, single-center, phase II trial that will be monitoring the safety and efficacy of using stereotactic ablative radiotherapy (SBRT) to treat patients with a medical condition affecting heart rate and rhythm (refractory arrhythmias) within the University Health Network (Princess Margaret Cancer Centre and Toronto General Hospital). The primary objective will be to prospectively monitor patient cardiac outcomes following SBRT.


Eligibility Criteria:
Inclusion Criteria:

* Patients with heart rate and rhythm condition (arrhythmia) who have failed standard of care treatment with medication OR at least one prior invasive catheter ablation procedure.
* Patients deemed medically fit to receive stereotactic ablative radiotherapy as determined by their Radiation Oncologist.

Exclusion Criteria:

* Patients who have previously received high dose radiotherapy to the target area and cannot safely receive further treatment OR are unable to receive radiotherapy due to other contraindications.
High Flow Nasal Cannula HFNC In Covid-19 Patients

Many non-invasive ventilatory choices are available for COVID-19 patient who are having mild to moderate respiratory distress and their use will decrease the chance of ICU admission, intubation and mechanical ventilation in severe cases of COVID-19. However, all these respiratory supports and oxygen supply devices are aerosol generating and their selection should be precised enough to control nosocomial spread.

High flow nasal cannula HFNC is a device that delivered the warmed and humid air on high flow rate through nose. It is used to treat severe respiratory distress in COVID-19 patients, a non-invasive ventilatory approach which is relative comfortable by using humidified and pre-heated air containing large concentration of oxygen. In acute respiratory failure HFNC is proven to be very effective and it also reduced the need of mechanical ventilation in severe patients. Apart from the supply of oxygen, HFNC generating positive airway pressure and decreasing the rebreathing from anatomical dead space.

Prone position is also a save therapy and has been proven to be effective for refractory hypoxia by increasing tidal volume, oxygenation and diaphragmatic functions in ARDS patients. Recent studies showed that prone positioning and HFNC might avoid the prerequisite of intubation in moderate to severe patients of ARDS and as a result it decreases the nosocomial infection in physicians who are doing these aerosol generating procedures.

This is observational single-center study, that will be done at Lahore General Hospital in which 95 beds are allocated for COVID-19 patients including ICUs and HDUs. Ethical approval will be obtained from research ethical committee of Lahore General hospital, Lahore. Informed consent will be obtained from all patients who will agree to publish their data in this research. We will protect patient's privacy and obey with the Helsinki Declaration.

Eligibility Criteria:
Inclusion Criteria:

* All patients of \> 18 years of ages, males and females who will be diagnosed COVID-19 positive by RT-PCR with moderate illness.
* Patients having classical radiological lesions of COVID-19 on X-ray chest or HRCT chest.
* Respiratory rate \> 30/ min and not responding to non-rebreather masks.
* COVID-related pneumonia requiring non-invasive ventilatory support (high-flow nasal cannula, and / or non-invasive ventilation and / or CPAP)

Exclusion Criteria:

* Inability to provide consent;
* Severe respiratory failure requiring invasive ventilatory support;
* Indication of immediate tracheal intubation
* Significant acute progressive circulatory insufficiency
* Impaired alertness, confusion, restlessness
* Chest trauma or other contraindication to prone position
* Pneumothorax
* Nasal blockade
* Unable to tolerate high flow oxygen