cyrilzakka/clinical-trials huggingface dataset:
Linkage Study of Long QT Syndrome In An Amish Kindred

To screen by electrocardiography the entire population of 1,400 individuals in seven Amish Mennonite communities in order to perform genetic linkage studies of long QT syndrome (LQTS).

BACKGROUND:

LQTS is a severe heart disorder leading to sudden death due to ventricular tachycardia or ventricular fibrillation. The syndrome segregated as a Mendelian recessive in the highly inbred population under study and resulted in the sudden death of several members of the population.

DESIGN NARRATIVE:

The entire population was screened to identify cases of LQTS. In addition, 29 obligate heterozygotes were studied by 24-hour Holter monitoring to determine whether these gene carriers had any subtle phenotypes. The data were subjected to complex segregation and linkage analysis to establish the mode of inheritance and penetrance of LQTS.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Effectiveness of Menthol Chewing Gum in the Management of Thirst

The objective of this study was to compare the effectiveness of menthol chewing gum compared to maintained fasting (usual care) in reducing the intensity of the surgical patient's thirst during the preoperative period. The hypothesis of the study was that the use of menthol chewing gum in surgical patients in the preoperative period would be more effective than the maintenance of fasting with regard to the decrease in thirst and its discomforts.

There is evidence that chewing gum is effective in relieving thirst in the surgical patient in the preoperative period as it stimulates the salivary glands by means of mechano and chemoreceptors, increasing the salivary pH and flow, lubricating the oral cavity, acting in this way on peripheral thirst, which is triggered by dehydration of the oral mucosa. Furthermore, menthol gum stimulates the cold receptors, known as TRPM8, which are responsible for deactivating centers of thirst. Thus, the risk of bronchoaspiration due to gastric fullness is avoided and the discomfort of a dry mouth is reduced.Preliminary evidence indicates that the chewing gum strategy assists in the relief of a dry mouth and thirst in patients undergoing dialysis and head and neck radiotherapy. However, there is no scientific evidence of controlled studies with results that can be generalized regarding the use of chewing gum to reduce thirst and its discomforts in surgical patients in the preoperative period when they remain in a fasted state.

Eligibility Criteria:
Inclusion Criteria:

* Elective Surgeries;
* Aged between 12 and 65 years;
* Did not receive preanesthetic medication;
* Oriented in time and space;
* Present dentition (natural or artificial);
* Fasting for a minimum of three hours;
* Available for collection at least 3 hours prior to the scheduled surgical procedure;
* Verbalize thirst spontaneously or when questioned with an intensity greater than or equal to three on the Verbal Numerical Scale (VNS);

Exclusion Criteria:

* Allergy to menthol;
* Chewing restriction;
* Swallowing restriction;
* Patients who presented nausea, vomiting, or pain;
* Patients with chronic xerostomia;
* Chronic renal patients;
Stereotactic Body Radiotherapy and Microwave Ablation for Recurrent Small Hepatocellular Carcinoma

The prognosis of small liver cancer (≤5 cm) who had underwent stereotactic body radiotherapy (SBRT) is encouraging, with the 1-year local control rate has been reported to be 95-100%, 3-year local control rate about 91%, 3-year overall survival rate around 70%. Local ablation therapy has become the standard treatment for recurrent liver cancer after surgery and interventional treatment. The ablation rate of tumors with a diameter of 3.1-5.0 cm reached 90%. The 1, 2, and 3-year survival rates had been reported to be 89%, 74%, and 60%, respectively, which is similar to that of surgical resection. At present, there is no randomized controlled study of SBRT and microwave ablation (MWA) for small liver cancer. It is hoped that this study will further compare the efficacy of SBRT and MWA for recurrent small hepatocellular carcinoma.

Recurrent small hepatocellular carcinoma after surgery or local ablation therapy are chose for this study. The patients are divided into two groups randomly. Patients in group A receive MWA, group B patients receive SBRT. The 3-year progression free survival, 3-year local recurrence free survival, 3-year overall survival and other endpoints events were recorded and analyzed, to assess whether SBRT is non-inferior to MWA.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years old and above.
2. Clinical or pathological diagnosis of recurrent hepatocellular carcinoma after initial treatment (surgery, TACE, radiofrequency ablation, etc.)
3. Small hepatocellular carcinoma meeting the Milan criteria: single lesion ≤ 5cm, or tumor number ≤ 3, maximum diameter ≤ 3cm, no major vascular invasion of portal vein, hepatic vein, inferior vena cava, no bile duct invasion, no lymph node and extrahepatic metastasis
4. No serious blood system, heart, lung, liver, kidney dysfunction and immune deficiency
5. The neutrophil count is at least 1.0\*10\^9/ml, and the platelet count is at least 50\*10\^9/ml. Hemoglobin is at least 80g/L.
6. Men or women with fertility are willing to take contraceptive measures during the trial
7. Eastern Cooperative Oncology Group score 0-1 points
8. Expected survival period \> 3 months
9. Voluntary participation and signing of informed consent

Exclusion Criteria:

1. Patients who have undergone chemoradiation or targeted therapy for liver cancer
2. Obvious cirrhosis, recent hematemesis due to portal hypertension, Child-Pugh score ≥10 points
3. Total bilirubin \>70umol/L, aspartate aminotransferase (ALT), alanine aminotransferase (AST) exceed the upper limit of normal 3 times.
4. Patients undergoing major surgery within 1 month of study initiation
5. Patients with previous history of malignancy (excludes tumor-free survival after treatment of basal cell carcinoma of the skin and carcinoma of the cervix in situ for more than 3 years)
6. Researchers consider it inappropriate to participate in the test
Real World Evaluation of the Activity and Safety of Fostamatinib in Consecutive Adult Patients With ITP

This is a retrospective and prospective multicenter observational study with the aim to evaluate the real-life use of Fostamatinib in adult patients with chronic ITP, refractory to other treatments.

This is a retrospective and prospective multicenter observational study with the aim to evaluate the real-life use of Fostamatinib in adult patients with chronic ITP, refractory to other treatments.

All patients who received at least one dose of Fostamatinib between October 1st, 2021 and April 1st, 2023 outside interventional clinical trials in Italy in the participating centers will be invited to participate in the study. Every patient will be observed for at least 6 months until October 1st, 2023.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with chronic ITP who are refractory to other treatments and who received Fostamatinib according to standard clinical practice between October 1st, 2021 and April 1st, 2023
2. Age greater or equal to 18 years at the treatment start
3. Signed written informed consent document (if feasible) according to ICH/EU/GCP and national local laws

Exclusion Criteria:

1. Contraindications or hypersensitivity to Fostamatinib, its active substance or any of its excipients
2. Patients participating in an interventional clinical trial at the time of enrollment.
A Study of Capecitabine Plus Oxaliplatin in Combination With Pre-operative Pelvic Radiotherapy in Rectal Cancer

The purpose of this study is to determine the pathological complete tumor response rate.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed locally advanced T3/T4 rectal carcinoma with or without nodal involvement requiring surgery of the primary tumor
* Eastern Cooperative Oncology Group performance status 0-2
* Adequate values of laboratory parameters

Exclusion Criteria:

* Evidence of distant metastases
* Previous Chemotherapy or immunotherapy for colorectal cancer
* Previous radiotherapy to the pelvis
* Pre-existing condition which would deter radiotherapy
* Malignancy within last 5 years, except cured basal cell cancer of the skin and in situ cancer of the cervix
* Clinically significant cardiac disease or myocardial infarction within the last 12 months
* Lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome
* Organ allografts
* Concomitant treatment with brivudine, lamivudine, ribavirin or any other nucleoside analogues
* Dihydropyrimidine dehydrogenase (DPD) deficiency
* History of uncontrolled seizures, central nervous system disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for oral drug intake
Nursing Perspective on Burnout and Medical Errors in the Intensive Care Unit During Covid-19 Pandemic

The investigators plan to perform an observational study to evaluate the prevalence of burnout, depression and medical errors in a designated exclusive Covid-19 patients hospital in Malaysia, during the Covid-19 pandemic. In addition, the relationship between burnout and depression with medical errors will be assessed. The population studied will be the nurses working in the Intensive Care Unit, who are at higher risk due to the nature of their work at the frontlines of the pandemic.

During this unprecedented Covid-19 pandemic crisis in the whole world, Malaysia is also affected, with more than 5000 patients infected in the whole country as of 20th April, 2020. Many Intensive Care Unit nurses, who are at the frontlines of managing Covid-19 patients, face increased workload, in addition to psychological stress from managing these patients, with stress also coming from being exposed to the risk of cross infection. Hence, they are possibly at high risk of burnout and depression. In such a time of increased stress, the investigators also seek to find out the prevalence of medical errors made by Intensive Care Unit nurses during this pandemic, and whether the medical errors are associated with burnout. Factors associated with burnout, depression and medical errors will also be evaluated.

Eligibility Criteria:
Inclusion criteria

1. All nurses currently serving in the ICU, Sungai Buloh Hospital

Exclusion criteria

1. Subjects who refuse to participate
2. Subjects working in ICU, Sungai Buloh Hospital, for less than 1 month
Carpal Tunnel Release Using Ultrasound

The goal of the Carpal Tunnel Release Using Ultrasound registry (CiTRUS Registry) is to collect experience information from patients scheduled to undergo carpal tunnel release surgery with either the SX-One MicroKnife® with ultrasound guidance or the traditional mini-open technique without US guidance.

The CiTRUS registry is an observational study designed to better understand the overall patient experience following a carpal tunnel release surgery using either the SX-One MicroKnife with ultrasound guidance or the traditional mini-open technique without ultrasound guidance. The determination of which surgical technique to uses will be determined by the treating physician and the patient. The patient registry outcomes are intended to help direct future clinical care, educate patients with carpal tunnel syndrome, and design future research.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo carpal tunnel release surgery on the right and/or left wrist using either the SX-One MicroKnife with US guidance or the traditional mini-open technique without US guidance
* 18 years of age or older
* Agree to complete questionnaires over a 12-month period
* Valid mobile phone number and email address to receive and answer questions

Exclusion Criteria:

• Age less than 18 years
Outcome Analysis of POEM and Endoluminal Therapies

Evaluation of current and newly developed endoluminal therapies in the management of Upper and Lower GI conditions.

Over the last few years there have been numerous advances in the use of endoscopic equipment and related treatments in the identification and intervention of gastrointestinal diseases. Many of these treatments using flexible endoscopes have either complimented or replaced surgical approaches to these same benign and malignant disease processes with the potential of being the standard of care for many of these clinical conditions. The initial primary focus of this study will be the use of endoscopic myotomy for achalasia, endoscopic treatment of post bariatric weight gain, endoscopic gastro-gastric fistula treatments, and other endoluminal therapies for gastrointestinal and post-operative conditions. These treatments have been validated by prior surgery studies.

Eligibility Criteria:
Inclusion Criteria:

* Adult male and female patients 18-80 years of age
* Meet the criteria for surgery of benign and/or malignant gastrointestinal pathology(s)
* Gastrointestinal Reflux Disease
* Achalasia
* Barrett's Esophagus
* Post Bariatric Surgery conditions
* Other gastrointestinal and postsurgical disorders.

Exclusion Criteria:

* Adults unable to consent
* Individuals that do not meet inclusion criteria or qualify for endoluminal treatment paradigms and internees.
Effect of Probiotics in Treatment of Minimal Hepatic Encephalopathy (MHE) and Health Related Quality of Life

This study is a randomized, open, parallel group, active comparator, single center trial. Objectives of the study are hereby given below:

* To study the health related quality of life (HRQOL) in patients with chronic liver disease.
* To assess the prevalence of minimal hepatic encephalopathy (MHE) in patients with chronic liver disease and assessment of HRQOL in patients with MHE.
* To compare the effect of probiotics and lactulose in the treatment of MHE
* To assess the effect of probiotics and lactulose on the HRQOL in patients with MHE.

The study design would comprise of two parts

1. Part I: Cross sectional study: This part would comprise of the assessment of HRQOL in patients with CLD

   1. All the consecutive patients diagnosed as CLD would be enrolled in the study. All these patients would be enrolled from the liver clinics of the department of gastroenterology and those admitted in the gastroenterology ward at AIIMS.
   2. Alcohol would be considered to be the cause of CLD, if the patient regularly consumed ≥80g/d of alcohol for five years
   3. The staging of cirrhosis would be done according to the Child Pugh classification: A, B and C
   4. The causes of CLD would be divided into:- viral hepatitis, alcohol, viral hepatitis combining with alcohol and miscellaneous causes
2. Part II: Prospective randomized controlled trial: In this part the outcome of lactulose and probiotic therapy in the treatment of MHE and its effect on the HRQOL will be compared.

   1. All the consecutive patients with CLD without overt encephalopathy would be screened for MHE.
   2. All these patients would be enrolled from the liver clinics and the gastroenterology ward, AIIMS.
   3. The diagnosis of MHE would be based on abnormal psychometric tests (NCT-A and NCT-B or FCT-A and FCT-B) and /or abnormal P300 auditory event related potentials.

Eligibility Criteria:
Inclusion Criteria:

* All the patients with Chronic Liver Disease or Minimal Hepatic Encephalopathy (without overt hepatic encephalopathy) aged between 15 to 80 years of both the genders would be enrolled consecutively.

Exclusion Criteria:

* Patients with overt hepatic encephalopathy
* Active medical co-morbidities like CHD, chronic respiratory disease, chronic renal disease, malignancies, diabetes etc
* Malignancy
* History of taking lactulose or probiotics or antibiotics, in the past 6 weeks
* Presence of other neurological or psychiatric disorder
* Patients who underwent shunt surgery for portal hypertension
* History of taking medicines likely to interfere with psychometric performance
* History of GI hemorrhage or spontaneous bacterial peritonitis during the past 6 weeks
* Presence of mature cataracts and diabetic retinopathy
* Refused to participate in the study
Evaluation of a Family Strengthening Program Evaluation in Sierra Leone to Prevent Family Separation

In Sierra Leone, poverty and challenges with family functioning can lead to family separation, and children may go to live on the street or enter residential care institutions/orphanages. Helping Children Worldwide (HCW), a non-profit organization with over 20 years of experience in Sierra Leone, has developed a two-part Family Strengthening Program delivered by their program partners in Sierra Leone, the Child Reintegration Centre, to improve families financial literacy and attachment between caregivers and children, with the ultimate goal of preventing family separation. The hypothesis of this study is that the Family Strengthening Program program is effective at (1) changing parenting behaviors, (2) improving emotional regulation, (3) improving caregiver-child attachment, and (4) improving financial literacy in dyads consisting of children ages 9-13 and their caregivers.


Eligibility Criteria:
Inclusion criteria:

1. Dyads must consist of a principal child (the one whose situation initiated their involvement with the Child Reintegration Centre) and their primary caregiver (as defined by the Child Reintegration Centre as the person in the family primarily responsible for the health and wellbeing of the principal child and is noted as such in their case file)
2. Primary child is ages 9-13
3. Dyad is actively participating in Child Reintegration Centre services (i.e., child must have been seen by the case manager in the last month)
4. Dyad lives in the Bo area.

Exclusion criterion:

(1) Family has been assessed by the Child Reintegration Centre to be in active crisis, i.e., specific concerns about the child being at-risk or unsafe (suspicions of abuse or neglect).
Neoadjuvant Chemotherapy for Locally Advanced Gall Bladder Cancer : a Randomized Control Trial (NEOGB)

to study role of chemotherapy treatment for gall bladder cancer before surgery as compared to surgery directly

Gallbladder cancer is a highly aggressive disease with a late presentation and poor prognosis. Complete surgical excision remains the only potentially curative treatment for early-stage gallbladder cancer.

The use and benefit of chemotherapy in gallbladder cancer before surgery , that is , in the neoadjuvant setting, is not well studied and, to our knowledge, neoadjuvant chemotherapy has not been evaluated in any randomized clinical trial.

Neoadjuvant chemotherapy aims to achieve tumor downstaging, increase the radical surgical resection rate, reduce metastases. This study will compare the effectiveness of chemotherapy before surgery in locally advanced gall bladder cancer versus upfront surgery with respect to survival and completeness of resection of disease.

Eligibility Criteria:
Inclusion Criteria:

* ECOG 0-2
* Locally advanced resectable GBC defined as Clinical T3/4 disease or Regional LN involvement on imaging studies.
* Post cholecystectomy GBC with residual disease on imaging, History of bile spillage during primary surgery , history of piece-meal removal of gall bladder during simple cholecystectomy, Regional LN involvement on imaging studies.

Exclusion Criteria:

1. Early GBC ( cT1/T2) without significant lymphadenopathy or liver infiltration on radiological imaging .
2. Locally advanced disease requiring major hepatectomy or whipple's pancreatoduodenectomy.
3. Post cholecystectomy GBC without any evidence of spillage of residual disease on radiological imaging.
4. Obstructive jaundice due to involvement of biliary tree by tumour.
5. Vascular involvement such as common hepatic artery, MPV right hepatic artery or right portal vein.
6. Any distant metastasis or isolated port site metastasis
7. Involvement of non-regional LN (e.g . Celiac LN, SMA lymph node, inter-aortocaval or left para-ortic LN).
8. Poor performance status ECOG 3 or more.
9. Pregnancy.
10. Inability or unwillingness to follow study protocol
A Study to Evaluate the Single Vaccination of an Adenovirus Serotype 26 Pre-Fusion F (Ad26.preF) Based Respiratory Syncytial Virus (RSV) Vaccine in Japanese Adults Aged 60 Years and Older

The main purpose of this study is to assess the safety and reactogenicity of the Ad26.preF based RSV vaccine administered intramuscularly as a single injection versus placebo in Japanese adults aged greater than equal to 60 years.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be a Japanese participant whose parents and grandparents are Japanese as determined by the participant's verbal report
* Before randomization, a woman must be: postmenopausal (A postmenopausal state is defined as no menses for 12 months without an alternative medical cause); not intending to conceive by any methods
* A male participant must agree not to donate sperm for the purpose of reproduction for a minimum 28 days after receiving the dose of study vaccine
* In the investigator's clinical judgment, participant must be either in good or stable health. Participants may have underlying illnesses such as hypertension, type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms/signs are medically controlled. If they are on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and expected to remain stable for the duration of the study. Participants will be included on the basis of physical examination, medical history, vital signs , and 12-lead electrocardiogram (ECG) performed at screening
* From the time of vaccination through 3 months, participant agrees not to donate blood
* Participant must be willing to provide verifiable identification, have means to be contacted and to contact the investigator during the study

Exclusion Criteria:

* Participant has a serious chronic disorder, including severe chronic obstructive pulmonary disease or clinically significant congestive heart failure, end stage renal disease with or without dialysis, clinically unstable cardiac disease, Alzheimer's disease, or has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise well-being) or that could prevent, limit, or confound the protocol-specified assessments
* Participant has history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
* Participant has chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively
* Participant has had major psychiatric illness and/or drug or alcohol abuse which in the investigator's opinion would compromise the participant's safety and/or compliance with the study procedures
* Participant has a history of chronic urticaria (recurrent hives), eczema and/or atopic dermatitis
Study Evaluating Multiple Doses Of GSI-953 Within The Elderly Population

To assess the safety and tolerability of ascending, multiple, oral doses of GSI-953 in healthy elderly subjects.


Eligibility Criteria:
Inclusion Criteria:

* Men or women, greater than or equal to 65 years of age.
* Women of nonchildbearing potential (WONCP) may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for greater than or equal to 1 year (with FSH greater than or equal to 38 mIU/mL) and must have a negative pregnancy test result within 48 hours before administration of test article. Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound.
* Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight \>50 kg.

Exclusion Criteria:

n/a