cyrilzakka/clinical-trials huggingface dataset:
Effect of Resistance Training in Adults With Complex Congenital Heart Disease

Adults with complex congenital heart disease have impaired muscle function compared both to health controls and patients with lesions classified as simple. There is only one study assessing the effects of resistance training in patients palliated with Fontan procedure. The hypotheses of the present study is that home based resistance training will improve muscle function in adults with different complex congenital hear diseases.

The number of adults with complex congenital heart disease is increasing and today they outnumber the children with corresponding lesions. However, the longterm prognosis is still unknown and continuously changing as new therapeutic options are introduced.

Patients with complex congenital heart disease have reduced muscle function compared to healthy controls as well as patients with lesions classified as simple. Furthermore, men with congenital heart disease are more commonly underweight and less commonly overweight obese compared to the general population. In addition, men with complex lesions are shorter in comparison to controls. This indicates an altered body composition i.e. muscle mass, fat mass and bone density in this population. Moreover, impaired muscle metabolism has been reported in patients palliated with Fontan procedure.

Adult patients with complex congenital heart disease will be recruited based on defined inclusion and exclusion criteria. Muscle function, muscle strength, muscle metabolism and body composition will be evaluated before randomisation and at follow-up after twelve weeks. The patients will be randomised to twelve weeks of home based resistance training or to a control group. The randomisation ratio will be 1:1 ( intervention:control). The control group will be instructed to continue with their habitual physical activities. The resistance training protocol will be individualised based on the results of the muscle function and muscle strength tests.

The aim of this study is to investigate the effects of resistance training on muscle function, muscle strength, body composition and muscle metabolism in adults with complex congenital heart disease.

Eligibility Criteria:
Inclusion Criteria:

* Complex congenital heart disease ( e.g. tetralogy of Fallot, transposition of the great arteries, pulmonary atresia, patients palliated with Fontan procedure or total cavo-pulmonary connection).
* Clinically stable without significant change the last 3 months.
* Adult (\> 18 years of age).
* Informed consent.

Exclusion Criteria:

* Cognitive impairment affecting the ability of independent decision making.
* Present strategy of regularly executing resistance training \> 2times per week in purpose to increase muscle strength.
* Other comorbidity affecting physical activity.
* Other circumstance making participation unsuitable.
The Influence of Intensive Education and Coaching on Compliance for Oral Ganciclovir in the Prophylaxis of CMV: an Open Randomised Trial

21 patients were randomised to receive instructions and coaching or no intervention on the use and intake of ganciclovir. Intake of medication was measured by an electronic pill box. The duration of the study was 100 days.


Eligibility Criteria:
Inclusion Criteria:

* men and women between 18 and 65 years old
* de novo kidney transplant patients
* patients who need CMV prophylaxis with ganciclovir during 3 months
* patients who gave informed consent after an oral explanation of the study

Exclusion Criteria:

* patients who are seronegative for CMV virus and who received a kidney from a CMV negative donor
* patients with a creatinin clearance of less than 10 ml/min
Comparison Effectiveness Analysis Between ACL Reconstruction and Rehabilitation in Peripheral and Main Capital in Indonesia

The study was a prospective observational analysis of cases with complete ACL tears. A study was conducted between February 2021 to December 2024. All the patients attending those hospitals' emergency or outpatient departments (OPD) with knee injuries were evaluated for an ACL tear. Patients who meet inclusion criteria and consent to participate in the study will be observed for two years. Patients in Arifin Achmad Hospital Pekanbaru will follow rehabilitation treatment and optional delayed reconstruction after 12 weeks if needed, while patients in some hospitals in Jakarta and Bandung (Cipto Mangunkusumo Hospital, Gatot Subroto Army Hospital, Hasan Sadikin Hospital) will perform early reconstruction treatment. After receiving informed consent, all subjects received a self-administered patient questionnaire containing the International Knee Documentation Committee (IKDC) score, EQ5D3L, and Tegner Activity Level (TAL) scores. These questionnaires will be measured at 0, 12, 24, 48, and 96 weeks. Clinical value of the Lachman test and pivot shift test will be performed. One independent orthopedic surgeon will keep all records and evaluate the results. All costs for the treatment will be accounted for.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 to 40 years
2. Either sex
3. Isolated ACL tear not more than six weeks old to a previously uninjured knee or less than six months with showing acute symptoms (inflammation, swelling, knee effusion)
4. Tegner Activitiy Level of 5-9.

Exclusion criteria

1. Professional athletes or military
2. Collateral ligament rupture
3. Full-thickness cartilage lesion visualized
4. TAL below 5
5. Meniscal tear grade III on MRI.
6. Pregnancy
7. A history of deep vein thrombosis (DVT) or a disorder of the coagulative system
8. Claustrophobia
9. General systemic disease affecting physical function, any other condition or treatment interfering with the completion of the trial, including patients with metal devices or motion disorders
10. Hyperlaxity with a Beighton score of more than 4
To Determine the Safety and Immunogenicity of an Oral(Whole Cell) Euvichol Cholera Vaccine in Healthy Adult Men

To Determine the Safety and Immunogenicity of an Oral(Whole Cell) Euvichol Cholera Vaccine in Healthy Adult Men

This clinical trial is open, non-comparative phase 1 clinical studies in healthy men and has been designed to determine the safety and immunogenicity of Euvichol(Oral cholera vaccine)

Eligibility Criteria:
Inclusion Criteria:

* Adult men over 20years of age
* More than 45kg body weight and ideal body weight within ±20% of the weight
* Screening was conducted within 14 days of investigational drug administration (Vital Sign \& Physical Examination, hematology and blood coagulation tests, blood chemistry tests, urinalysis, 12-lead ECG, etc.), the results at the discretion of the investigator deemed suitable for participation in clinical trials
* Written consent person who determines to participate in a clinical trial

Exclusion Criteria:

* A person who showed hypersensitivity when other preventive vaccination in the past
* A person who have received cholera vaccine in the past
* A person who had a febrile illness or infection disease, or have received antibiotics within 2weeks before the start of the experiment
* A person who had gastrointestinal symptoms such as diarrhea, abdominal pain, or have been received prescription drug within one week before the start of the experiment
* A person who was lasted for more than two weeks of symptoms such as diarrhea, abdominal pain within 6months before the start of the experiment
* A person who donate whole blood or component of blood within one months before the start of the experiment if the donors
* A person who received other preventive vaccine within 2months before the start of the experiment
* A person who received blood products of immune globulin preparations within 3months before the start of the experiment
* A person who has immune function disorders or are receiving immunosuppressive treatment
* A person who has chronic illness in progress
* Ongoing drug and alcohol abuse(Not more than 28 units/week for drinking)
* A person who participate in clinical trials treated with the investigational drug within 2months before the start of the experiment
* A person who is difficult to participate in this clinical trials as the discretion of the investigator
Analysis of Tissues From Patients in Trial of Myo-Inositol to Prevent Lung Cancer

This study will examine tissue specimens from patients participating in a trial of high-dose myo-inositol to prevent lung cancer. The trial, conducted at the British Columbia Cancer Agency-Vancouver Cancer Center (BCCA-VCC), includes people who have pre-cancerous changes in the air passages of their lungs.

The BCCA-VCC trial was designed to determine side effects of taking large amounts of the food supplement myo-inositol for longer than a month and if the supplement can help smokers stop smoking.

The current study will look at the levels of a substance called Akt in tissue samples obtained from air passages of subjects in the BCCA-VCC trial. Akt is activated by tobacco components and can be found in lung tumor specimens and pre-cancerous lesions. Myo-inositol may affect Akt levels and help prevent progression of pre-cancerous lesions to cancer.

People participating in the BCCA-VCC phase 1 myo-inositol trial are eligible for this study. Tissue samples obtained from air passages of these patients during their participation in that study will be sent to the National Cancer Institute for analysis of Akt levels.

Human transbronchial biopsy specimens collected under protocol study numbers CDR0000302633; BCCA-U98-0411; BCCA-C02-0298 will be immunohistochemically stained for activated Akt using phospho-specific antibodies. These samples are part of a phase I chemoprevention trial of myo-inositol being conducted in Vancouver, BC by the British Columbia Cancer Agency in collaboration with the National Cancer Institute (NCI). The transbronchial specimens will be sent to the NCI for analysis of activated AKT. The study aims to determine whether myo-inositol, a putative inhibitor of the upstream kinase phosphatidylinositol 3-kinase, can alter activated Akt levels in smokers with bronchial dysplasia.

Eligibility Criteria:
* INCLUSION CRITERIA:

Any patients entered into phase 1 myo-inositol trial are eligible for inclusion, provided that they have consented to tissue analysis in the original consent form.

EXCLUSION CRITERIA:

None anticipated at this time.
Hyperbilirubinemia in Acute Appendicitis as a Predictor of Perforation

It has recently been published that hyperbilirubinemia is a reliable marker for the preoperative diagnosis of perforated acute appendicitis.

The investigators believe, based on their own previous publications, that C-reactive protein (CRP) with or without a white blood cell count and some other clinical parameters, are more specific markers for the preoperative diagnosis of perforated acute appendicitis.

The purpose of this study is to prospectively compare the specificity and sensitivity of hyperbilirubinemia CRP, white blood cell count and other clinical parameters for the preoperative diagnosis of acute appendicitis.

* Previously validated appendicitis score
* Time from onset of symptoms to diagnosis and to surgery
* Laboratory values: WBC, CRP, liver function test
* SIRS values
* Preoperative and postoperative diagnosis
* Length of hospital stay
* Postoperative complications
* Biopsy results

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for appendectomies for acute appendicitis at the emergency unit of our institution
* Patients older than 15 years of age to 100 years of age

Exclusion Criteria:

* Appendectomy performed incidentally or for other indications
* Patients younger than 15 years of age
* Alcoholism
* A history of viral hepatitis
* Gilbert's disease
* Dubin Johnson syndrome
* BRIC (benign recurrent intra-hepatic cholestasis) and other documented biliary
* Hemolytic or liver diseases associated with hyperbilirubinaemia
Impact of Care Transition on Medication Adherence in Cardiac Patients

Background:

Medication adherence following acute coronary syndrome (ACS) is often sub-optimal. Poor adherence is associated with increased risk of rehospitalisation along with higher rates of morbidity and mortality. After a cardiac event, transitioning from hospital into primary care can be problematic if it is not organised or coordinated properly. Patients can often find themselves unprepared and lacking the necessary information for self-management of their disease. The impact of care transition on medication adherence has not been studied in ACS.

Objectives:

This study will explore how an ACS patients' journey from hospital into primary care affects medicines use. Further, to understand how medicine information is communicated and how this influences patient beliefs about medicines.

Methods:

This is an interview study with recently hospitalised ACS patients discussing medication beliefs, communication of medicine information and the challenges when transitioning from specialist to primary care. Patients will be recruited from Guy's and St Thomas' NHS Foundation Trust and telephone interviews will be scheduled 3-4 weeks post-discharge. An inductive thematic analysis will be used to identify, construct and analyse patterns in the data and to develop a framework analysis. Analysis will be an iterative process conducted in parallel with data collection to highlight when data saturation has been reached.

Dissemination:

The primary objective is to develop a pharmacist-led behaviour change intervention to improve rates of medication adherence following an ACS. The in-depth patient data collected in this current study will contribute to the design and development of the intervention. Understanding the research topic from the patients' perspective is a necessity when designing an intervention targeting behaviour change.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years of age
* have a confirmed index diagnosis of ACS
* have sufficient spoken English to partake in an interview

Exclusion Criteria:

* under 18 years of age
* lack the level of spoken English required to be interviewed
uTRACT Jelmyto Registry: A Registry of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto

The purpose of this registry is to evaluate real world experience and outcomes of patients with Upper Tract Urothelial Cancer (UTUC) treated with Jelmyto in the United States.

Patients may be enrolled prospectively, at the time of receiving Jelmyto, or after receiving Jelmyto for retrospective data capture and prospective follow up. Patients will be followed until 3 years after the first dose of Jelmyto or death.

Data will be captured to address specific clinical questions and data gaps related to real world use of Jelmyto.

Example clinical questions:

1. How is Jelmyto used in the real world setting?
2. What adverse events (AEs) and at what rates and time points are they observed in the real world setting?
3. What is the disease volume before and after resection/ablation prior to treating with Jelmyto?
4. Did the use of Jelmyto impact clinical decision making and management?
5. What is the complete response (CR) rate, duration of response, and rate of progression, including subgroups of interest?
6. What are the rates of, time to, and pathology at radical nephroureterectomy (RNU) by response to treatment and number of Jelmyto doses received?
7. What are outcomes for non-responders or partial responders? What are the rates of surgical and therapeutic treatment options received following response assessment, including additional Jelmyto?
8. What was the outcome of patients with solitary kidney and/or chronic kidney disease (CKD)? Did Jelmyto prevent dialysis by avoiding nephrectomy in solitary kidney or in patients with baseline CKD?
9. What is the rate and timing of bladder cancer occurrence and/or recurrences?

Eligibility Criteria:
Inclusion Criteria:

* Adults \>18 years old and capable of giving informed consent.
* Diagnosis of UTUC.
* Receipt of at least 1 dose of JELMYTO after FDA approval (15 Apr 2020).

Exclusion Criteria:

* Incapable of giving informed consent (e.g., incarcerated individuals, individuals with dementia).
* Receipt of 1 or more doses of JELMYTO (also referred to as UGN-101 or Mitogel in clinical development) before FDA approval (on or before 15 Apr 2020).
* Pregnancy or lactation.
* Unable to comply with protocol requirements (for prospective data capture).
* Any medical or mental condition(s) that makes participation in the Registry inadvisable in the opinion of the Investigator (for prospective data capture).
The Metabolic Effects of Prebiotic Supplementation After Roux-en-Y Gastric Bypass Surgery

In this study, it is aimed to evaluate whether the addition of prebiotics to patients' post-operative diets increases Roux-en-Y Gastric Bypass surgery effects. Half of the participants were randomized prebiotic with conventional yogurt, while the other half were randomized only conventional yogurt as a snack

Following bariatric surgery, positive alterations are observed in gut microbiota, intestinal peptides, and inflammatory cytokines. Previous studies demonstrate that prebiotic use alone in a tolerable dose (which is 10 g/day) among obese, overweight, or diabetic individuals accelerated the weight loss by reducing hunger and food intake. Furthermore, it could also contribute to the improvement of glucose homeostasis by increase postprandial PYY and GLP-1 levels. Prebiotics feeds healthy intestinal bacteria and enhances their positive effects. The present positive effects appear with SCFAs that stimulates PYY and GLP-1 release and produced by fermentation of prebiotics by bacteria. From this point forth, it was hypothesized that post-operative pre-probiotic usage may enhance the effects of Roux-en-Y Gastric Bypass (RYGB). In addition, administration of pre-probiotics following RYGB may be considered as a simple and cheap treatment support, especially for protecting patients with poor medicine compliance against nutritional deficiencies, as well as for diabetic patients whose glucose regulations deteriorate in the long term, and for those who regain weight.

With the result that the effects of prebiotic supplementation on metabolic results of RYGB surgery in this prospective, randomized, controlled study with a duration of 24 weeks were tested.

Eligibility Criteria:
Inclusion Criteria:

* BMI \>40kg/m2; perform of other types of bariatric surgery except gastric bypass (i.e. sleeve gastrectomy, adjustable gastric band)

Exclusion Criteria: I

* Administration of antibiotics (other than 1 g ampicillin-sulbactam one hour before surgery), the presence of chronic gastrointestinal, liver or kidney diseases and malignancy.
Follow up of Mothers Suspected of Postpartum Depression

Postpartum depression (PD) is a serious and disabling mental health condition that affects 10-15% of women after childbirth. Low-income minority women are disproportionately affected. Untreated PD can lead to significant negative outcomes for both mother and child. Pediatricians are being asked to routinely screen for PD and while screening rates are improving, little is known about whether mothers actually adhere to pediatrician recommendations to seek additional help after a positive PD screen. The objective of this study is to describe the rate at which mothers seek treatment for suspected PD after a positive screen at the pediatrician office. Additional examination will look at factors that predict whether a mother recalls a recommendation to seek treatment.

The primary outcome of interest is whether mothers suspected of having PD seek treatment after discussion with the pediatrician. In order to evaluate whether discussion with pediatricians leads mothers to seek care, data collection efforts should focus on what information was exchanged, the level of shared decision-making about possible treatment options and whether an agreed upon plan was reached between both parties. The investigators will examine the effectiveness of these discussions by interviewing mothers who were suspected of having PD and referred for treatment. The investigators hypothesize that pediatricians who are able to engage mothers in a shared decision will result in more of those mothers seeking help and getting into appropriate treatment for PD.

The specific research aims of this proposal are to:

Aim 1: Describe the rate at which mothers suspected by pediatricians of having PD seek treatment.

Aim 2: Explore what factors predict whether mothers suspected of PD seek treatment, including maternal sociodemographic characteristics, family centeredness of pediatrician care, and extent of shared decision-making strategy used by the pediatrician.

This will be a cohort study examining the rate at which mothers suspected of having PD seek care and the relationship between shared decision-making and seeking mental health care. Data for both specific aims will be collected by a single telephone interview with mothers suspected of having PD by the pediatrician and referred. For this study, investigators will be focusing recruitment efforts in the four Wishard community health centers (now Eskenazi Health) that use CHICA. In 2007, these four clinics saw 8,528 patients between the ages of 0 and 3 years. These clinics serve a large proportion of families that are underserved, economically disadvantaged and are ethnically and racially diverse.

Eligibility Criteria:
Inclusion Criteria:

-mothers with a positive PD screen who brought their child to seek medical care at participating study clinics, who were present for a majority of the child's visits.

Exclusion Criteria:

-not biological mother, did not bring child to majority of clinic visits
Case Report of Nerve Root Sleeve Reinforcement and Reconstruction and Sacral Canal Plasty for the Treatment of Sacral Canal

A retrospective study of the changes in the VAS scores and imaging examinations after the reconstruction and reinforcement of nerve root sleeves and caudal angioplasty for the treatment of sacral cysts from August 2017 to January 2018 was used to evaluate the efficacy of the surgical prescription.

Objective: To clarify the curative effect of nerve root sleeve reconstruction and reinforcement and caudal plasty in the treatment of sacral cysts Design: A retrospective study of the changes in the VAS score and imaging examinations after the reconstruction and reinforcement of nerve root sleeves and sacral canoplasty for the treatment of sacral cysts from August 2017 to January 2018 to evaluate the efficacy of the surgical prescription.

Eligibility Criteria:
Inclusion Criteria:a) Symptomatic nerve root cyst diagnosed by MRI b) The capsule of the cyst is intact and the sacral lamina is not defective c) No other diseases of the nervous system, pelvic floor and important organs d) Reconstruction of patients with artificial dural nerve root sleeve reinforcement -

Exclusion Criteria:a) Non-radiotomy cyst or asymptomatic cyst b) The cyst causes severe bone erosion to lamina absorption c) Combined with other diseases of the nervous system, pelvic floor and important organs d) Those who have not used artificial dura mater for nerve root sleeve reinforcement and reconstruction

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Phase III Study of BAY43-9006 in Patients With Advanced Hepatocellular Carcinoma (HCC) Treated After Transcatheter Arterial Chemoembolization (TACE)

Clinical trial of BAY43-9006 in patients with hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Aged of 18 and over
* Advanced hepatocellular carcinoma

Exclusion Criteria:

* History of prior systemic chemotherapy
* Failure in vital organ