cyrilzakka/clinical-trials huggingface dataset:
Effect of Topical Active Oxygen Therapy on Surgical Site Wound Healing and Microbial Colonization

To assess the antibacterial efficiency of oxygenated gel therapy on wound healing and microbiological colonization around surgical sutures

All the patients who will agree to participate in the study and who will sign the informed consent forms. Computer-generated randomization will be used to randomly divide the surgical sites into two groups. Control group: will receive no treatment. Study group: will receive active oxygen gel around suture. Patients scheduled for any oral surgical flap procedure that require suturing will be included in this study. After flap approximation, the surgical site will be sutured using 5-0 braided sutures. In the study group the gel will be applied over the suture and the patients will be instructed to apply the gel to the wound area and to the suture thread using a cotton swab, three times a day after brushing their teeth. Also, patients will be given instructions regarding their post-surgical care.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients in a healthy systemic condition who required comprehensive dental treatment
* Both genders with age group \> 18 years old
* Patients should approve to deliver a signature to a written consent after study nature explanation.

Exclusion Criteria:

* Patients with severe smoking habits \>10 cig \\ day
* Pregnant females, decisional impaired individuals and handicapped patients
* Patients having poor oral hygiene or not wanting to carry out oral hygiene measures
* Patients on any medication affecting the soft tissue health (e.g., amlodipine, Cyclosporine A, hydantoin)
Non Invasive Blood Test To Diagnose Acute Rejection After Kidney Transplantation

This is a prospective, multicenter, observational study of kidney transplant subjects where blood specimens, intended for dd-cfDNA and other future research purposes, will be drawn after transplant

This is a prospective, multicenter, observational study of kidney transplant subjects where blood specimens, intended for dd-cfDNA and other future research purposes, will be drawn after transplant periodically and also after the treatment of acute rejection up to 8 weeks post treatment. The blood samples and all relevant clinical data will be provided to CareDx scientists for laboratory assay of dd-cfDNA levels and correlation of dd-cfDNA levels with the clinical features of the subjects.

The primary objective of the study is to correlate circulating dd-cfDNA to clinical and sub-clinical acute rejection in renal allograft recipients. The secondary objective of the study is to correlate circulating dd-cfDNA to renal function, both serum creatinine and estimated glomerular filtration rate \[eGFR\]).

Eligibility Criteria:
Inclusion Criteria

1. Adult recipients (Age \> 18 years )
2. Both genders and all racial and ethnic groups
3. Kidney transplant alone
4. Both living and deceased donor transplants
5. Primary and re-transplants. A total of 30 re-transplant recipients across all study sites will be eligible for enrollment. CareDx will notify all centers when this subset of enrollment has been met. Thereafter, all enrolled patients should be primary transplant recipients.
6. Ability to come for follow-up and undergo biopsy (Performed in accordance to SOC)
7. Ability to give written informed consent prior to study enrollment

Patients can be enrolled at any time; before or after transplantation and/or at time of outpatient or inpatient visits for workup of medical problems; e.g. at the time of a renal biopsy (regardless of elapsed time since post transplant) as specified in this study protocol.

Exclusion Criteria

1. Pediatric recipients (Age \< 18 years)
2. Pregnant women
3. Patients undergoing multi-organ transplants (e.g. kidney with pancreas or liver)
4. Patients receiving donor organ from an identical twin
Retrospective and Prospective Observational Study in Patients With Advanced Basal Cell Carcinoma

Retrospective and Prospective Observational Study in Patients With Advanced Basal Cell Carcinoma.

Basal cell carcinoma (BCC) is an epithelial tumor characterized by the malignant proliferation of keratinocytes in the basal layer of the epidermis. It is part, along with squamous cell carcinoma (SCC),non-melanoma skin cancer (NMSC) and accounts for 80% of all skin cancers and the most common skin cancer in the United States and Europe. Estimates of BCC incidence, however, are inaccurate since in most countries there is no cancer register collecting data on BCC incidence and many patients are treated on a territorial outpatient basis, making data collection and epidemiological analysis complex. In recent decades, there has been an increasing trend in patients with BCC, as well as a reduction in the average age of onset, with a consequent drastic increase in the social and economic cost of healthcare facilities. From these considerations, arises the need to investigate and characterize the profile of patients with advanced BCC, the clinical characteristics and the course of such neoplasm, and the choice of therapeutic options available.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients aged ≥ 18 years
2. Patients diagnosed with advanced basal cell carcinoma of the skin, i.e. tumours included in at least one of the following categories: locally advanced carcinoma (not radically treatable by surgery and/or radiotherapy), carcinoma with lymph node and/or distant metastatic localisation
3. patients who have had at least one access (first visit or follow-up visit) at the dermatology or oncology outpatient clinic of the centres involved

   * Patients diagnosed with advanced BCC who have accessed the centre from 1 January 2016 until the date of activation of the centre will be included in the retrospective cohort;
   * Patients diagnosed with advanced BCC who have accessed the centre from the date of activation
4. Signature of informed consent

Exclusion Criteria:

Patients incapable of giving informed consent
N-acetyl Cysteine: the Effectiveness and Safety in a Cohort of Pediatric Patients With Chronic Kidney Disease

Anemia is a common comorbidity of CKD and is associated with a decreased quality of life and increased healthcare resource utilization. Anemia increases the risk of CKD progression, cardiovascular complications, and overall mortality. The current standard of care includes oral or intravenous iron supplementation, erythropoiesis-stimulating agents, and red blood cell transfusion. Treatment with high doses of erythropoiesis-stimulating agents increases rates of hospitalization, cardiovascular events, and mortality. Resistance to erythropoiesis-stimulating agents is a therapeutic challenge in many patients .

NAC reduces the risk of progression of CKD of any etiology to end stage renal disease (ESRD) but the mechanism by which it reduces the progression of CKD to ESRD is unclear. It may be because of its antioxidant and vasodilatory nature. Prolonged duration of administration and higher dosage of NAC can protect kidneys.

All patients with chronic kidney disease on regular hemodialysis will be enrolled.

- Study location: The patients will be recruited from pediatric nephrology department, Cairo University Children's Hospital and Beni Suef University.

History taking including the age, sex, primary cause of CKD, onset of hemodialysis, medications including erythropoietin dose, frequency, and duration, oral or intravenous iron therapy, and frequency of blood transfusion.

Clinical examination focusing on pallor, blood pressure, and anthropometric measurements and their percentile.

Investigations including hemoglobin level at the start of the study and every month during the study period, serum ferritin, alanine aminotransferase, total oxidative stress (TOS), total antioxidant capacity (TAC), and oxidative stress index (OSI) at the start and after 3 months of the onset of the study.

Patients will receive N-acetyl cysteine (10 mg/kg/day, orally). The duration of the study will 3 months.

Eligibility Criteria:
Inclusion Criteria:

* pediatric patients with chronic kidney diseases stage 3, 4 or 5

Exclusion Criteria:

* Unwilling to participate in the study.
* non-compliant patients on the standard care of CKD.

  * Patients with cardiac, endocrinal, and hepatic complications.
  * Asthma or known allergy to NAC.
  * Any chronic infections prior to or during the study period.
Alberta Physical Activity and Breast Cancer Prevention (ALPHA) Trial

The purpose of the ALPHA Trial is to examine the physiologic changes that occur in a woman's body when she begins exercising that may be related to a change in her risk of getting breast cancer.

The goal of this study is to examine how a one-year exercise intervention, as compared to a usual sedentary lifestyle, influences specific biologic mechanisms that are hypothesized to be operative in the association between physical activity and breast cancer risk. These biologic mechanisms include sex hormone concentrations (estrone, estradiol and sex-hormone binding globulin); measures of adiposity and obesity; mammographic density; insulin-like growth factors; and insulin resistance.

A two-centered, two-armed randomized controlled trial (RCT) of exercise and risk factors for breast cancer will be conducted. Approximately 334 postmenopausal, sedentary women will be recruited to the study. Participants will be randomized to one of two groups: an exercise intervention, or a control group. The intervention group will undertake five weekly exercise sessions of 60 minutes each; three will be facility-based and two will be home-based each week. The Edmonton and Calgary exercise oncology facilities will be working in collaboration, and each will include both the controls and exercise intervention arms of the trial. The exercise intervention will last for 12 months. The control group will be asked not to change their usual level of activity during that time.

Baseline assessments will be obtained of serum sex hormones (estrone and estradiol), measures of obesity and adiposity, mammographic density, serum insulin growth factor (IGF)-1, insulin resistance, aerobic capacity, and psychosocial health measures. At the end of the study, all baseline assessments will be repeated and compared between the two groups.

This study will specifically address identified gaps in knowledge, in terms of examining the simultaneous effect of physical activity on several biologic mechanisms in a controlled trial setting, building on evidence from the only other randomized controlled trial on this topic. Strengths of the proposal include the multi-centered setting (utilizing facilities in both Calgary and Edmonton), and the collaboration of an experienced multi-disciplinary research team from across North America.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 50-74 at baseline
* Postmenopausal
* Moderately sedentary lifestyle
* Live in Calgary or Edmonton, Alberta, Canada
* English-speaking
* Willing to be randomized
* Body-mass index 22.0-40.0
* Breast tissue density \>=0%

Exclusion Criteria:

* Previous invasive cancer in last 5 years
* Major co-morbidities
* Unable to participate in exercise program
* Current smoker
* Current excessive drinker
* Hormone replacement therapy use in previous 2 years
* Drugs that may influence one or more study outcomes
Integrating Mental Health Into a HIV Clinic to Improve Outcomes Among Tanzanian Youth

The purpose of this study is to evaluate if a group-based mental health intervention called Sauti ya Vijana (The Voice of Youth) designed to address mental health challenges faced by adolescents in Tanzania is acceptable and feasible and if it improves mental health, antiretroviral therapy (ART) adherence, and virologic outcomes among HIV-positive adolescents as compared to youth receiving treatment as usual. Mental health intervention sessions will take place three times a month for approximately four months in groups of eight to ten youth based on age and sex. Caregivers will attend two sessions to support the youth and provide the guardian perspective on caring for HIV-positive adolescents. The investigator hypothesizes the mental health intervention will be acceptable, feasible, and will improve mental health and ART adherence among participating youth and this improvement will be sustained over time.

The study will enroll up to approximately 130 participants from the established Kilimanjaro Christian Medical Centre and Mawenzi Saturday Teen Clinics. Participants will be assigned to approximately eight to ten persons per group, based on age and sex. Groups will be matched in pairs as closely as possible (ex. two groups of females 12-16 years of age) and assigned to Wave 1, 2, or 3. Randomization will occur on the individual level and will occur just before the start of mental health intervention for each wave. Individuals will be randomized at this time point to reduce potential drop out of those with delayed start (Wave 2/3). Randomization will occur by a coin flip for two individuals based on alphabetical order: heads will be intervention group (I) and tails the standard of care group (SOC).

This feasibility study is longitudinal with up to 24 month follow-up after intervention. Feasibility measures from lay counselors will be monitored weekly. Outcome measures will be obtained by blinded interviewers using a structured survey to inquire about mental health symptoms, self-report adherence, obtain an ART drug concentration level from a hair sample, and HIV-1 viral load from a blood sample and will be collected by the same research assistants at five to six potential time points: 1) baseline, 2) pre-intervention, 3) post-intervention, 4) 6-months post-intervention, 5) 12-months post-intervention and 6) 24-months post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* Youth between the ages of 12 and 24 years of age, attending the Teen Club HIV clinic at Kilimanjaro Christian Medical Centre (KCMC) and/or Mawenzi Hospital and receiving ART
* if \> or =l to 18 years, able to understand the project and provide written, informed consent
* if \< 18 years, a parent or guardian must provide written permission and participant must be able to assent
* all adolescents must also commit to attending 10 weekly CBT (SYV) sessions and 2 individual sessions.

Exclusion Criteria:

* Active psychosis, developmental delay, or cognitive disability that precludes active participation in consent process, intervention, and assessment interviews.
Comparison of Dry Needling and Manual Pressure Release for Managing Low Back Pain

This study will compare the effect of dry needling and manual pressure in patients having low back pain in terms of pain and disability. There will be two groups ; experimental and control. Half of study group will receive dry needling session along with hot pack. Half of study group will receive manual pressure technique along with hot pack.

The study is Randomized Control Trail , which is being conducted in fauji foundation hospital and Foundation University College Of Rehabilitation (oct 2022-feb 2023) . Sample size of 50 individual was calculated using epitool with 95% confidence interval (CI), and power 80%. sample will be collected through pilot study .

both groups will recieve conventional physiotherapy protocol (hot pack) Assessment will be done on baseline, and 4th week .

Eligibility Criteria:
Inclusion Criteria:-

* age between 30-60
* pateint with subacute and chronic low back pain at least last 6 months.
* pateint with active MTrps.

Exclusion Criteria:

* patient with fibromyalgia
* pregnant females
* patient with chronic diseases (osteoporosis, lungs disease and diabetes)
* patient with musculoskeletal injuries
* patient that are using any medication to relief pain like analgesic or muscle relaxants
* Any treatment for back pain in same period of research.
* patient having any radiculopathies or discogenic low back pain
Neurotoxic Health Hazards of Long-Term Low-Level Exposure to Organophosphate (OP) Compounds in in Hula Valley

During 1987-1991, WHO supported studies of exposures and short term neurobehavioral effects in a cohort (n=200) with occupational and community exposures to pesticide drift containing organophosphates from orchards and cotton fields in the Hula Valley. We aim (1) to re-examine neurobehavioral outcomes in members of the original cohort and (2) to examine cognitive effects in children with residential exposures. In adults, we will carry out assays of alkyl phosphates, PON1 (paraoxonase-1), NTE (Neuropathy Target Esterase), neurobehavioral tests of cognitive and performance skills, nerve conduction measurements and mood status. We will carry out Psycho-Didactic tests in children. The findings will advance knowledge on delayed term health effects of lengthy everyday exposure to OP pesticides and guide regulatory policy.


Eligibility Criteria:
Inclusion Criteria:

* Participants of the former study twenty years ago
Effects of Pistachios on Cardiovascular Responses to Stress in Type 2 Diabetes

This study is investigating the effects of three different diets, including a diet with pistachios, on cardiovascular disease risk markers in people with type 2 diabetes.

The study will last 12-16 weeks and requires 10-13 visits to the General Clinical Research Center on the University Park campus. All food and snacks will be provided for 10 weeks. At the end of each of three diet periods, participants will undergo a test of endothelial function, an oral glucose tolerance test, and a cardiovascular stress reactivity test.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, nonsmoking adults, aged 30-75 years (women must be post-menopausal)
* Diagnosed with Type 2 diabetes

Exclusion Criteria:

* Insulin, more than one blood pressure lowering medication, daily aspirin, NSAID therapy, oral steroids within the last 6 weeks, oral contraceptives, and hormone replacement therapy
* Chronic disease such as cardiovascular disease or any complications of diabetes (retinopathy, neuropathy, etc).
* Allergies or aversions to pistachios
* Unwillingness to consume all foods provided and no other meals or snacks for the 10 weeks of diet intervention
Pediatric ACTION3 (Identify, Treat, Control): Effectiveness of Adding Montelukast in Pediatric Subjects With Uncontrolled Asthma (0476-385)

a study to describe patient and physician satisfaction with montelukast therapy for the control of asthma used either as monotherapy or in combination with inhaled corticosteroids


Eligibility Criteria:
Inclusion Criteria:

* Patient Is Diagnosed With Asthma For At Least 6 Months
* Patient's Peak Expiratory Flow (PEF) Is 80% Of Predicted Value (Appendix 10)
* Patient Is Currently Untreated, Or Patient Is A User Of Short-Acting 2-Agonist On An As-Needed Basis, Or Patient Is A User Of Ics At Any Dosage
* Physician And/Or Patient Are Dissatisfied With Current Controller Therapy, Or Patient Is Reluctant To Take Ics Therapy, Or Patient Is Insufficiently Controlled Due To Non-Adherence With Current Therapy Through The Preceding 6 Weeks

Exclusion Criteria:

* As Per Canadian Guidelines, Patient Is On A Laba Alone (Formoterol (Oxeze), Salmeterol (Serevent)) Or A Combination Product (Advair Or Symbicort)
* Patient Is Well Controlled, Adherent And Satisfied With Current Controller Therapy
A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)-Japan Extension

This study is to assess the pharmacokinetics (PK) and safety of SC pembrolizumab (+) berahyaluronidase alfa vs intravenous (IV) pembrolizumab, administered with chemotherapy in first line treatment of adult Japanese participants with metastatic non-small cell lung cancer. The primary hypotheses of this study are pembrolizumab (+) berahyaluronidase alfa subcutaneous (SC) is noninferior to pembrolizumab IV with respect to PK parameters.

Japan extension study will require approximately six years which includes one additional year (beyond the global study's last participant last study related contact) from the time the first participant (or their legally acceptable representative) provides informed consent until the last participant's last study related contact to complete.

The Japan extension study will include participants previously enrolled in Japan in the global study for MK-3475A-D77 (NCT05722015) plus the study will continue to enroll participants in Japan until the sample size for participants in Japan reaches approximately 39.

As of Amendment 1 of the supplemental statistical analysis plan (effective date: 23 Aug 2024), patient reported outcomes will no longer be the secondary outcome measures of the study.

Eligibility Criteria:
The key inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

* Has histologically or cytologically confirmed diagnosis of squamous or non-squamous Non-small Cell Lung Cancer (NSCLC).
* Must provide archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated.
* Has a life expectancy of at least 3 months.

Exclusion Criteria:

* Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
* Has received prior systemic anticancer therapy for metastatic NSCLC.
* Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
* Has received prior radiotherapy within 2 weeks of start of study intervention or has radiation-related toxicity requiring corticosteroids.
* Has received radiation therapy to the lung (\>30 Gray) within 6 months of start of study intervention.
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
* Has an active autoimmune disease that has required systemic treatment in past 2 years.
* Has an active infection requiring systemic therapy.
* Has a history of human immunodeficiency virus (HIV) infection.
* Has a history of Hepatitis B or C.
* Has not adequately recovered from major surgery or has ongoing surgical complications.
* Has a history of allogenic tissue/solid organ transplant.
Optimum Timing for Surgery After Pre-operative Radiotherapy 6 vs 12 Weeks

The aim of this study is to determine whether greater rectal cancer downstaging and regression occurs when surgery is delayed to 12 weeks after completion of radiotherapy/chemotherapy compared to 6 weeks.

Hypothesis: Greater downstaging and tumour regression is observed when surgery is delayed to 12 weeks after completion of CRT compared to 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Aged \> 18
* Informed written consent
* Histological confirmation of adenocarcinoma of rectum
* Undergoing pre-operative radiotherapy/ chemotherapy
* Completion of pre-operative treatment

Exclusion Criteria:

* Aged \< 18
* Absence of pre-operative RT/CT
* Medical/ psychiatric conditions that compromise the patients ability to give informed consent
* Contra-indications to MRI, i.e. hip prothesis, cardiac pacemaker