cyrilzakka/clinical-trials huggingface dataset:
The Nigerian Surgical Outcomes Study. This Study is Aimed at Observing for Complications Within 30 Days After Surgery

The Nigerian Surgical Outcome Study is a national 30-day observational cohort study of complications after surgery. Various institutions across Nigeria will be involved. The study aims at providing detailed data describing post-operative complications, requirement for intensive care and mortality. All patients undergoing either elective surgery during a 7-day study period with a planned overnight stay will be recruited.

It is widely known that complications after surgery are responsible for a good number of morbidity and mortality following surgery. This national cohort study will help contribute to, and allow a better computation of data on post-operative complications and mortality following elective surgery in Nigeria.

This study therefore has important public health implications for Nigeria. This study will also provide a baseline for other similar studies in future being the first of such in Nigeria.

Objectives are:

1. To determine the mortality rate on the day of surgery for patients undergoing surgery in Nigeria.
2. To determine the in-hospital mortality rate for patients undergoing surgery in Nigeria.
3. To describe the relationship between anaesthetic complications and postoperative mortality.
4. To describe the relationship between postoperative complications and postoperative mortality.
5. To describe the proportional contribution of communicable, non-communicable diseases and traumatic injuries to critical care admissions and in-hospital mortality in Nigeria. We plan to recruit a minimum of 5 centres per state, made up of federal, state and private hospitals. The national coordinating centre shall be the University College Hospital, Ibadan. Regional coordinating centres shall be in Lagos, Kwara, Enugu, Kaduna, Port-Harcourt, Maiduguri and Abuja.The plan is to recruit all eligible patients during the recruitment week.

All recruited patients would have had the routine preoperative surgical and anaesthetic review. Since the study is purely observational, all basic intraoperative procedures as it relates to surgery and anaesthesia will not be altered. Following informed written consent by the patient, the following information will be obtained.

* Results of preoperative Haemoglobin, Total white cell count, and Creatinine.
* Patient's socio-demographics.
* Co-morbid conditions
* Type of anaesthesia and surgical procedure.
* Anaesthetic and Surgical details
* Critical care admission post-operatively, and
* Postoperative complications observed till discharge or up to 30 days if on admission.

Eligibility Criteria:
Inclusion Criteria:

All consecutive patients admitted to participating centres undergoing elective surgery with a planned overnight hospital stay following surgery during a seven-day study period. The recruitment week will run between June and July 2018.

Exclusion Criteria:

Patients undergoing planned day-case surgery or procedures outside the operating theatre.
To Study the Efficacy of PEG-IFN Alpha in HBeAg Negative Chronic Hepatitis B Patients After Stopping Nucleotide Analogue Therapy.

* Study population:Person with HBeAg negative CHB on TDF/ETV for more than 1 year
* Study design:Prospective,Interventional (single arm study)
* Sample size: All the patients fulfilling the inclusion criteria will be included in first 6 months and subsequently followed up for 2 years
* Intervention: Peg IFN 2b 1.5mcg/kg once every week for 48 weeks
* Monitoring and assessment: LFT,HBV DNA and HbsAg at baseline, 4 weeks, 12 weeks,24 weeks,48 weeks ,72 weeks and 96 weeks, CBC every month and Thyroid function Test every 3rd month
* Adverse effects: The most frequently reported side effects of IFN-based therapy are flu-like symptoms, headache, fatigue, myalgia, alopecia, and local reaction at the injection site. Peg-IFN have myelosuppressive effects; however, neutropenia\\1000/mm3 and thrombocytopenia \\500,000/ mm3 are not common unless patients already have cirrhosis


Eligibility Criteria:
Inclusion Criteria:

- HBeAg negative Chronic HBV infection who are having HBV DNA-undetectable. ALT \<40 IU/ml No Advanced fibrosis\[LSM \<14 KPa\] TDF/ETV \>1 year Clinical Relapse after stopping NA will be defined as HBV DNA\>2000IU/ml and ALT \> 80IU

Exclusion Criteria:

- HBeAg+ CHB Pregnancy Cirrhosis on biopsy or LSM \>14 Co-infection- HIV/HCV/HDV Immunosuppressive therapy Renal failure S.Bilirubin\>2mg/dl Patient having neutropenia
Optimal Frequency of High-Intensity Interval Training for Centrally Obese Adults

The aim of this study is to examine the therapeutic effectiveness of two different exercise frequencies of high-intensity interval training (HIIT; once versus thrice weekly, with matched weekly exercise volume) on improving cardiometabolic risk factors in centrally obese adults.

HIIT is an emerging, popular, promising, cost-effective, and time-efficient exercise modality for managing obesity. Although lower-frequency HIIT is favorable for intervention adherence, the optimal exercise frequency of HIIT for alleviating obesity is unknown.

This study is a three-arm randomized controlled trial. Centrally obese adults will be randomly allocated to three groups: the usual care control, once and thrice-weekly HIIT groups. Led by research personnel, the usual care group will receive obesity-related health education. Led by athletic coaches, the HIIT intervention groups will receive 16 weeks of once or thrice weekly HIIT (with matched weekly exercise volume). Outcome measures of this study will be examined at baseline, 4 months (post-intervention), and 8 months (follow-up), by assessors blinded to group allocation.

Eligibility Criteria:
Inclusion Criteria:

* Aged above 18 years
* Ethnic Chinese
* Overweight (BMI ≥23 for Asian)
* Centrally obese according to IDF and NCEP with Asian-specific cut-off (waist circumference ≥90 cm for males; ≥80 cm for females)
* Males and females

Exclusion Criteria:

* Medical and somatic conditions that prevent brisk walking
* Chronic diseases affecting mobility and motor function (e.g., neurological disease, musculoskeletal disorder, spinal cord injury, autoimmune, arthritis, Parkinson's Disease)
* Chronic diseases affecting cardiorespiratory and metabolic health (e.g., cancers, cardio-/cerebrovascular diseases, heart disease, diabetes mellitus, pneumonia, chronic pulmonary diseases, nephritis, nephrosis)
* Signs of cardiac arrhythmia indicated by aberrant electrocardiography during incremental VO2max test
* Regular moderate-to-vigorous intensity exercise (≥150 min weekly) in the past 3 months, as screened by a specially designed questionnaire
* Daily smoking habit
* Excess alcohol consumption (daily ≥30g for men, ≥20g for women) in the past six months
* Claustrophobia
* Surgery, therapy or medication for obesity or weight loss in the past six months (e.g., gastric bypass, gastric band, sleeve gastrectomy, gastric reduction duodenal switch, and dietitian-prescribed dietary program)
A Pharmacokinetic and Pharmacodynamic Study of Vincristine in Children With Leukemia

The pharmacokinetic behavior of vincristine in pediatric patients has not been well characterized. The present study will obtain detailed information on vincristine pharmacokinetics in patients being treated for standard risk ALL on CCG protocols 1952/1962. A limited sampling strategy will be developed, and the interpatient and intrapatient variability of vincristine pharmacokinetics in children will be studied. A correlation between vincristine neurotoxicity and vincristine pharmacokinetics will be sought.

The pharmacokinetic behavior of vincristine in pediatric patients has not been well characterized. The present study will obtain detailed information on vincristine pharmacokinetics in patients being treated for standard risk ALL according to or on CCG protocols 1952/1962/1991. A limited sampling strategy will be developed, and the interpatient and intrapatient variability of vincristine pharmacokinetics in children will be studied. A correlation between vincristine neurotoxicity and vincristine pharmacokinetics will be sought.

Eligibility Criteria:
INCLUSION CRITERIA:

All patients 1 year and less than 10 years of age.

Patient must be diagnosed with acute lymphoblastic leukemia.

All CCG patients must be enrolled on CCG 1952, 1962 or 1991 protocols, or be treated according to a CCG standard risk ALL protocol. NCI patients must be treated according to CCG 1952 for the treatment of standard risk ALL. Enrollment onto the current trial (CCG B9802) should if possible take place concurrently with enrollment onto 1952/1962/1991 or start of treatment according to a CCG standard risk ALL protocol.

All patients or their legal guardians must sign a document of informed consent indicating their awareness of the investigational nature and the risks of this study.

EXCLUSION CRITERIA:

Previous underlying peripheral neuropathy.

Previous underlying central nervous system dysfunction.

Children with CNS toxicity attributable to other chemotherapeutic agents will not be followed with the Purdue pegboard test.
Collaboration to Reduce Disparities in Hypertension

A large number of African-American and low socioeconomic patients have poorly controlled high blood pressure because of not being able to take their high blood pressure medications. This puts these patients at higher risk of heart and kidney disease, stroke and death. This study is designed to reduce the barriers that prevent patients from taking their high blood pressure medications.

The objective of this study is to determine the effectiveness and cost-effectiveness of two interventions aimed at reducing barriers to blood pressure (BP) control in an indigent and African-American population. Specifically, we will conduct a randomized controlled trial comparing BP control using either: (1) reimbursing patients for filling prescriptions (reimbursement arm); (2) a computer-based behavioral intervention (behavioral arm); (3) both the reimbursement and behavioral arms (combined arms); or (4) neither.

The ultimate goal of this study is to reduce the incidence of HTN-related CVD among these populations thereby reducing cardiovascular health disparities. Specific aims of the study are to:

1. test whether receiving money each time the patient fills a prescription for medications improves BP control by a clinically significant amount.

   H1: Reimbursing patients for filling prescriptions will significantly improve BP control.
2. test whether a computer-based behavioral intervention improves BP control by a clinically significant amount.

   H2: A computer-based behavioral intervention will significantly improve BP control.
3. test whether the two interventions are more effective in improving BP control than either alone.

   H3: The effect of improving BP control of administering both interventions together will be greater than the sum of the individual effects of each intervention alone.
4. examine the relative cost effectiveness of reimbursement for filling prescriptions, a computer-based behavioral intervention, and the combination of the two.

H4: Both interventions will be cost-effective relative to other commonly-covered services.

Eligibility Criteria:
Inclusion Criteria:

* Patients of the Philadelphia Veterans Administration Hospital Primary Care Clinic, PinnacleHealth Adult Outpatient Clinics and the VA Pittsburgh Healthcare System who have a diagnosis of hypertension; are currently taking antihypertensive medications; and have elevated blood pressure.

Exclusion Criteria:

* Under 21 years of age
* Have a diagnosis of:

  * Atrial fibrillation;
  * Metastatic cancer;
  * End stage renal disease (ESRD) with dialysis;
  * Dementia;
  * New York Heart Association (NYHA) class IV congestive heart failure (CHF);
  * Blind or deaf;
  * Other reason for life expectancy of less than 1 year.
* Are currently participating in another experimental study
Hair Loss Prevention Study for Pancreatic Cancer

Pilot study intended for hair loss prevention in patients with pancreatic cancer who are receiving treatment containing nab-paclitaxel, gemcitabine and cisplatin.

Patients with pancreatic cancer who are receiving treatment containing nab-paclitaxel, gemcitabine and cisplatin will experience hair preservation with the use of the Paxman scalp cooling device, at the end of three, 3 week cycles of chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent/assent for the trial
* \>18 years of age on day of signing informed consent
* Diagnosis of pancreatic cancer and scheduled to receive treatment with a regimen containing nab-paclitaxel, gemcitabine and cisplatin

Exclusion Criteria:

* Grade 1 alopecia
* Existing history of scalp metastases or the presence of scalp metastases is suspected
* No history of previous cancers within the past 5 years
* CNS malignancies (either primary or metastatic)
* Cold sensitivity, cold agglutinin disease, cryoglobulinemia, cryofibrinogenemia, cold migraine, cold urticaria, post-traumatic cold dystrophy
* Imminent bone marrow ablation chemotherapy
* Imminent skull radiation
* Previously received or scheduled to undergo skull irradiation
* Severe liver or renal disease from any etiology as patient may not be able to metabolize or clear the metabolites of the chemotherapeutic agent
* Skin cancers including melanoma, squamous cell carcinoma and Merkel cell carcinoma
* Small cell carcinoma of the lung
* Solid tumors that have a high likelihood for metastasis in transit
* Squamous cell carcinoma of the lung
Management of Esophageal Atresia With Right Aortic Arch: Is the Side of Approach Important?

Esophageal atresia is associated with a right aortic arch in 2 to 13% of cases. Despite previous studies, consensus on the optimal surgical approach remains lacking. This study aims to analyze the management of esophageal atresia with a right aortic arch in France over three decades, to define the most effective surgical strategy and identify associated complications.


Eligibility Criteria:
Inclusion Criteria:

* Having been operated on for esophageal atresia and right aortic arch

Exclusion Criteria:

* NO
COVID-19 VAX Booster Dosing in Patients With Hematologic Malignancies

To determine whether protective antibody levels increase after booster dosing with the Moderna COVID-19 vaccine in patients diagnosed with Hematologic Malignancies who have low antibody levels after a prior first vaccination with any of the SARS-CoV2 vaccines that were authorized for use in the USA. Researchers will also assess whether the booster dosing with the Moderna COVID-19 vaccine is safe in patients with multiple myeloma, amyloidosis, or other blood cancers.

The specific hypothesis being tested is that it may be possible to induce a protective humoral immune response with a booster dose of the Moderna COVID-19 vaccine in patients with hematologic malignancies who did not have an adequate response to first vaccination with any of the available COVID-19 vaccines. To test this hypothesis, t a Phase II singlestage trial in which patients with a negative or weak positive anti-SARS-CoV2 IgG antibody test (defined as \<1.00 S/CO and 1.00-1.99 S/CO, respectively) will receive a single standard dose of the Moderna COVID-19 vaccine intramuscularly, and then have anti-SARS-CoV2 IgG antibody levels checked 28 days (+/-3 days) later.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 18 years of age or older
4. Previously diagnosed with MM/AL amyloidosis (Cohorts 1 or 3) or other hematologic malignancy (Cohorts 2 or 3).
5. Previously received any one of the available COVID-19 vaccines (between 4 and 36 weeks prior to enrollment)
6. Anti-SARS-CoV2 IgG antibody titer of results less than 1.0 units (Cohorts 1 and 2), or 1.0-1.99 units (Cohort 3). Antibody titers will be measured within 14 days of enrollment.
7. If currently receiving potentially immunosuppressive anti-neoplastic therapy for their underlying hematologic condition, a two-week interruption in therapy before and after the booster dose of vaccine is ENCOURAGED BUT NOT REQUIRED (physician discretion).-

Exclusion Criteria:

1. Daily corticosteroids at a dose equivalent to Prednisone 20 mg/day or greater during the period two weeks before enrollment to the trial. Intermittent steroid dosing at or above this level is permitted (i.e., weekly dexamethasone dosing as part of myeloma therapy)
2. History of previous severe reaction to any available COVID-19 vaccine (defined as any Grade 3 or higher reaction)
3. Febrile illness within 3 days of booster dosing.
4. Documented SARS-CoV2 infection within 2 weeks of enrollment.
5. Less than 3 months post-autologous or allogeneic stem cell transplant (NOTE: transplant between initial standard vaccine administration and enrollment is NOT otherwise grounds for exclusion from participation).
Study of RP-6306 with FOLFIRI in Advanced Solid Tumors

The primary purpose of this study is to assess the safety and tolerability of RP-6306 with FOLFIRI in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD), identify a recommended phase 2 dose (RP2D) and preferred schedule, and assess preliminary anti-tumor activity.

To assess the safety and tolerability of RP-6306 in combination with FOLFIRI in patients with eligible, advanced solid tumors. Incidence and severity of treatment-emergent adverse events (TEAEs), laboratory assessments, vital signs, electrocardiograms (ECGs), and use of concomitant medications.

Eligibility Criteria:
Inclusion Criteria:

* Male or female and ≥18 years-of-age at the time of signature of the informed consent
* Confirmed advanced solid tumors resistant or refractory to standard treatment
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
* All patients must have locally advanced or metastatic CRC, GI, or esophageal cancer(s) and radiographic evidence of progressing disease.
* Measurable disease as per RECIST v1.1
* Submission of available tumor tissue or willingness to have a biopsy performed if safe and feasible
* Acceptable hematologic and organ function at screening
* Negative pregnancy test for women of childbearing potential at Screening and prior to first study drug.

Exclusion Criteria:

* Inability to swallow and retain oral medications.
* Chemotherapy or small molecule antineoplastic agent given within 21 days or \<5 half- lives, whichever is shorter, prior to first dose of study treatment.
* History or current condition, therapy, or laboratory abnormality that might confound the study results, or interfere with the patient's participation for the full duration of the study treatment.
* Patients who are pregnant or breastfeeding
* Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction or other reasons which, in the investigator's opinion, could compromise the participating patient's safety.
* Major surgery within 4 weeks prior to first study treatment dose.
* Uncontrolled, symptomatic brain metastases.
* Uncontrolled high blood pressure
* Active, uncontrolled bacterial, fungal, or viral infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS) related illness.
* Moderate or severe hepatic impairment
* Cardiac diseases currently or within the last 6 months as defined by New York Heart Association (NYHA) ≥Class 2
* Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.
Neurophysiological Intraoperative or Epilepsy Monitoring

The investigators record the outcome of patients whose surgery involved intraoperative neurophysiological monitoring

* Trial with surgical intervention


Eligibility Criteria:
Inclusion criteria: Patients whose surgery involved intraoperative neurophysiological monitoring
The Effect of Acceptance and Commitment Therapy in Patients With Chronic Renal Failure

Psychological flexibility, life satisfaction and adaptation to the disease of individuals with chronic kidney disease were increased with psychoeducation based on acceptance and commitment therapy to be given to individuals with chronic kidney disease.

Chronic renal failure is a condition that affects the kidneys and has long-term consequences for physical, psychological, and social well-being. It reduces quality of life, productivity, and independence, leading to increased costs and the need for care. In order to ensure treatment compliance and maintain living standards, it is important to enhance individuals' readiness for treatment. While there are psychological intervention studies during the treatment process, there are few studies that focus on psychological readiness before dialysis. This study highlights acceptance and determination-based approaches to help individuals become aware of their feelings and thoughts and accept them, minimizing resistance to treatment and improving treatment compliance. By managing negative emotions and thoughts towards the treatment, this study aims to increase disease compliance, provide psychological support during pre-dialysis trainings, diversify the use of acceptance and commitment therapy-based approaches, and promote psychosocial support in chronic diseases in psychiatric nursing practices.

Eligibility Criteria:
Inclusion Criteria:

* Acceptance to participate in the research
* Diagnosis of CKD Stage 4-5
* GFR below 29ml/min/1.72m2
* 18 years of age and over
* Being literate
* No barriers to verbal communication
* No psychiatric treatment

Exclusion Criteria:

* Receiving haemodialysis and peritoneal dialysis treatment,
* Pregnancy
* The presence of a psychiatric disorder requiring treatment,
* Individuals with transplantation and rejection transplantation
Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy

The most common ocular disease in patients with diabetes, diabetic retinopathy, is present in approximately 40% of diabetic patients; about 8% of diabetic patients have vision threatening diabetic retinopathy. Although intensive control of blood glucose has been shown to reduce the development and progression of diabetic retinopathy, intensive control of glucose is usually not achieved in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Males and females with type 1 and type 2 diabetes mellitus
* Moderately severe or severe NPDR or mild PDR in at least one eye:

  * with an Early Treatment Diabetic Retinopathy Study (ETDRS) visual score of \> 35 letters; and
  * not previously treated with scatter photocoagulation.
* HbA1c \< 13% at study entry

Exclusion Criteria:

* Condition which could interfere with the assessment of retinopathy progression
* History of symptomatic gallstones without cholecystectomy
* Brittle diabetes or history of severe hypoglycemia unawareness
* Previous treatment with a somatostatin analogue