cyrilzakka/clinical-trials huggingface dataset:
Televideo Exercise and Nutrition Program for Kidney Transplant Recipients

The improvement in morbidity and mortality observed with kidney transplantation is often curtailed by post-transplant weight gain, which is common among kidney transplant recipients (KTR). Post-transplant weight gain is associated with serious health issues such as cardiovascular disease, new onset diabetes after transplantation, and graft failure. Although these adverse effects of post-transplant weight gain are well recognized, interventions that target the modifiable risk factors of diet and physical activity to address post-transplantation weight gain are lacking. The purpose of this study is to test the feasibility of an in-home, televideo health coaching to increase the healthy behaviors of KTRs who are 6 months post-transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Between 6 and 12 months post kidney transplantation
* Kidney allograft only
* Functioning allograft (not on dialysis)
* BMI ≥ 22 kg/m2
* Available to participate in assessments over 6 months
* Ability to speak and understand English
* Able to report data weekly by at least one of three alternative methods: telephone, email, or fax
* Access to wireless internet

Exclusion Criteria:

* Multi-organ transplant recipient
* Uncontrolled diabetes (Hemoglobin A1c≥8%)
* Currently pregnant or planning on becoming pregnant during the study
* Participation in a formal weight management, nutrition, or physical activity program
* Diagnosis of a major psychiatric illness
* Major dietary restrictions
* Inability to perform moderate to vigorous physical activity
* Unwillingness to be randomized
* Receiving supplemental nutrition
Validation of a Quantra Supported Hemotherapy Algorithm in Cardiac Surgery

The aim of this study is to develop a coagulation algorithm based on Quantra POCT for the treatment of coagulopathic cardiac surgery patients.

In order to perform a targeted coagulation therapy during intra- and postoperative care of cardiosurgical patients, it is necessary to know the hemostatic potential. After blood samples have been taken for coagulation diagnosis, they are usually sent to the central laboratory. After analysis and validation, the results are transmitted electronically. The loss of time due to sample transport, analysis and provision of the results prolongs the time required to derive therapeutic measures.

In recent years, point of care testing (POCT) devices for the diagnosis of coagulopathic patients have become increasingly important. In our clinic, POCT devices have been routinely used for intra- and postoperative targeted coagulation therapy for years. These include the ROTEM delta and Multiplate. For analysis, a whole blood sample is pipetted together with test reagents. Depending on the selected reagent, different parts of the coagulation cascade can be evaluated and, depending on this, an appropriate therapy can be derived. A coagulation algorithm developed in our clinic is based on these measurement results and has been used successfully for years for perioperative coagulation management. This algorithm requires additional information on the platelet function, which is also carried out as standard on the bed side using multi-plate analysis as POCT.

A new system for whole blood analysis has recently become available on the market. The Quantra from HemoSonics also allows the analysis of a whole blood sample on the bed side. Due to the cassette structure, the time-consuming and potentially error-prone pipetting of a whole blood sample is no longer necessary. The aim of this study is to develop a coagulation algorithm based on Quantra POCT for the treatment of coagulopathic cardiac surgery patients.

Eligibility Criteria:
Inclusion Criteria:

\>18 years elective operation with cardiac bypass

Exclusion Criteria:

participation on another study
Study on Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for Advanced Middle or Upper Third Gastric Cancer

The purpose of this study is to explore the short-term, long-term and oncological outcomes of laparoscopic spleen-preserving No. 10 lymph node dissection in a left-sided approach for advanced middle or upper third gastric cancer not invading greater curvature.

A prospective randomized comparison of laparoscopic spleen-preserving No. 10 lymph node dissection for gastric cancer will be performed, to evaluate the short-term, long-term and oncological outcomes. The evaluation parameters are perioperative clinical efficacy, postoperative life quality, immune function and 3-year survival and recurrence rates.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 75 years
* Primary proximal gastric adenocarcinoma not invading greater curvature (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
* cT2-4a, N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
* No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor.
* Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
* American Society of Anesthesiology score (ASA) class I, II, or III
* Written informed consent

Exclusion Criteria:

* Women during pregnancy or breast-feeding
* Severe mental disorder
* History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
* History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
* Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
* History of other malignant disease within past five years
* History of previous neoadjuvant chemotherapy or radiotherapy
* History of unstable angina or myocardial infarction within past six months
* History of cerebrovascular accident within past six months
* History of continuous systematic administration of corticosteroids within one month
* Requirement of simultaneous surgery for other disease
* Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
* FEV1\<50% of predicted values
Assessment of the Diagnostic Performance of the Detection System and Establishment of an Intelligent and Rapid Triage Model

The rapid triage of patients with acute chest pain remains an important issue in clinical practice. This study will establish a cohort of patients suspected of acute coronary syndrome (ACS) to construct a multi-marker dynamic combined intelligent triage model. This model will triage the risk of NSTEMI in patients with chest pain at their first visit. It will also stratify the risk of patients with chest pain using major adverse cardiovascular events (MACE) within 30 days as the endpoint.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years or above from China, regardless of gender;
* Presence of symptoms such as chest tightness and chest pain, with the need to determine whether they are patients with acute coronary syndrome;
* Ability to obtain informed consent.

Exclusion Criteria:

* - Patients with STEMI at the time of presentation;
* Patients with a clear diagnosis after tests such as troponin;
* Patients who have undergone major surgery or trauma within the past four weeks;
* Pregnant women or patients with tumors undergoing radiotherapy or chemotherapy;
* Patients who have previously participated in this study.
Packed Red Blood Cell Transfusion in Elective Coronary Artery Bypass Graft Surgery in A University Hospital

In Siriraj Hospital, blood consumption in Cardiac surgery is high (units per patient) and frequent (number of patients receiving blood). The incidence of side effects are unknown, as is the exact amount of blood used/provided for patients with elective CABGs.

The primary objective of this study was to demonstrate the incidence of packed red blood cell (PRBC) transfusion in elective CABGs.

Three hundred patients undergoing isolated, first time CABGs during November 2011-September 2013 were prospective enrolled in this observational study. Patients' preoperative variables and postoperative outcomes, as well as perioperative transfusion characteristics were recorded.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing first-time isolated elective coronary artery bypass graft surgery

Exclusion Criteria:

* None
Pre-approval Access Single Patient Request for Teclistamab (JNJ-64007957)

Teclistamab pre-approval access in relapsed or refractory multiple myeloma.


Eligibility Criteria:
Must have relapsed/refractory multiple myeloma (RRMM) and have evidence of disease progression after last therapy. Must have exhausted all available treatment options accessible as local standard of care (example. proteasome inhibitors \[PIs\], immunomodulatory imide drugs \[IMIDs\], anti CD38 monoclonal antibodies \[mAbs\] and therapies targeting Exportin 1 \[XPO1\] and B cell maturation antigen \[BCMA\]). Must not be eligible for a clinical trial with teclistamab or other medicines in this setting
Acute Effects of Endurance Exercise on Breastmilk Composition

The investigators will determine the acute effect of exercise on breastmilk composition. Participants will come in to the lab on three different days, out of which they will exercise on two of these days and rest in the lab on the third day. The conditions will be randomly allocated to each participant. Breastmilk samples will be obtained in the morning of each test day, as well as immediately after, one hour after and four hours after the exercise/rest condition. Dietary intake will be standardized on the test days. At the time of study commencement, the trial (including planned analyses) is not fully funded. Additional milk will be stored for future analyses (not yet specified) when funding is secured.


Eligibility Criteria:
Inclusion Criteria:

* 6 to 12 weeks postpartum
* Exclusive breastfeeding
* Term birth

Exclusion Criteria:

* Known cardiovascular disease
* Type 1 or 2 diabetes mellitus
* Limited ability to exercise
Comparative Effects of Milk Thistle Extract With Vitamin-E in Hemodialysis Patients

For end-stage renal disease (ESRD) patients, cardiovascular disease remains the single most common cause of excess morbidity and mortality. Among the examined nontraditional risk factors, an increase in oxidative stress as well as inflammation are postulated to contribute to excessive cardiovascular risk in this population.

Flavonoids are naturally occurring substances that possess various pharmacological actions and therapeutic applications. Some due to their phenolic structures have antioxidant effect and inhibit free radical-mediated processes, as well as anti-inflammatory effects. Silymarin,a mixture of three isomeric flavonolignans, is isolated from milk thistle (Silybum marianum) seeds, and is proven to have anti-oxidant, anti-inflammatory, cell regenerating, and antifibrotic action.

In this study, the effect of silymarin on oxidative stress and inflammation (2 major risk factors for cardiovascular morbidity and mortality in hemodialysis patients)is evaluated, and compared to vit E, a well known antioxidant.


Eligibility Criteria:
Inclusion Criteria:

* All hemodialysis patients age 18-60
* On hemodialysis for over 3 months, 3 times a week, and for 4 hours each time
* Signed informed consent

Exclusion Criteria:

* Heart Failure NYHA Class III or IV
* Recent MI (within 1 year)
* Use of anti-oxidant supplements: N-acetyl-cystein, Omega 3, Vit C, Vit E, green tea, soy extracts, pomegranate extract, grape extract..
* Hepatitis B or C
* Active Infection
* Psychiatric illness
* Active malignancy
Liposomal Bupivacaine vs Dexamethasone ISB

In this study, patients receiving shoulder arthroscopy will receive an interscalene block for pain management containing either liposomal bupivacaine and standard bupivacaine or standard bupivacaine and dexamethasone. Patients will be followed up with to determine postoperative pain and block duration.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-III
* Age 18 years or older
* Scheduled for elective outpatient arthroscopic shoulder surgery

Exclusion Criteria:

* History of allergy to local anesthetic, or one of the study medications
* Pre-existing neurological deficits
* Psychiatric or cognitive disorders that prohibit patients from following study protocol
* History of drug or alcohol abuse
* Chronic opioid use (longer than 3 months)
* Chronic pain syndromes
* Infection at the site of injection
* Patients with severe pulmonary disease
* Herniated cervical disc, cervical myelopathy
* Contraindication for general anesthesia and/or interscalene nerve block
* Pregnancy
* Open shoulder arthrotomies.
* Non English speakers
Photodynamic Therapy With Metil 5-aminolevulinate for Actinic Cheilitis - Phase 2 Clinical Trial

Brazil is a tropical country, with high incidence of ultraviolet radiation throughout the year. Many Europeans migrated to Brazil escaping either war or economic crisis to live in the country searching for opportunities. Low phototype combined with high incidence of UV light is a combination that not only affect the skin but also the lips. The current study was designed to use photodynamic therapy with metil 5-aminolevulinate for actinic cheilitis in a phase 2 clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis with histopathological confirmation of actinic cheilitis
* Patients will be requested to respect the timeframe of clinical consultations
* No treatment for actinic cheilitis in the last 3 months

Exclusion Criteria:

* Histopathological diagnosis of squamous cell carcinoma (SCC)
* Patient presenting any type of immunosupression
* Recurrent crust of the lip vermilion (high risk of SCC)
Clinical Efficacy of Ustekinumab in Crohn's Disease

Clinical Efficacy of Ustekinumab in Crohn's Disease: an Observational Study With Retrospective and Prospective Components.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and older;
* Patients who were first prescribed Ustekinumab between January 1 and December 31, 2024
* Patients who provided written informed consent to participate in the study

Exclusion Criteria:

* Contraindications to the use of the drug Ustekinumab per the current instructions:

  * Clinically significant active infection (active tuberculosis, active viral hepatitis);
  * Pregnancy and lactation;
  * A history of clinically significant, in the opinion of the investigator, psychiatric disorders that may interfere with the study procedures and compliance with the drug regimen;
  * Ulcerative colitis;
  * Malignant gastrointestinal diseases in history or at the time of inclusion in the study;
  * Decompensated chronic diseases of the liver, kidneys, cardiovascular system, systemic vasculitis, diabetes mellitus;
  * Abuse of alcohol or psychoactive drugs within 1 year before the start of this study (as reported by the patient);
* Participation in an interventional clinical trial.
Objective Measurement With TCM Pattern for AIDDES

To explore the association with TCM pattern and TCM tongue diagnosis for Autoimmune disease and Dry eye syndrome.

Objective: To explore the association with TCM pattern and TCM tongue diagnosis for Autoimmune disease and Dry eye syndrome.

Method:

This study wants to include the 1000 Autoimmune disease (AID) subjects as 800 Sjögren's syndrome (SJS) and 200 Systemic lupus erythematosus (SLE) for comparing with the 500 Dry eye syndrome (DES) subjects. AID and DES subjects will be enrolled to evaluate at V1 Baseline and follow-up for 6 times evaluation with one month interval during one year. And the non-AID-non-DES healthy control subjects will be also included in our study for comparison with the dry eye syndrome and healthy control. This study want to use objective measurement and questionnaires as TCM pattern, OSDI, ESSPRI, SF-36, Schirmer's test, TCM heart rate variability, and TCM tongue diagnosis to differentiate AID, DES and healthy control.

Expected Results:

1. To evaluate the difference among TCM pattern, OSDI, ESSPRI, SF-36, Schirmer's test, TCM heart rate variability, and TCM tongue diagnosis to differentiate between AID and DES.
2. To evaluate the difference among TCM pattern and TCM tongue diagnosis among the AID groups, DES group, and healthy control.

Keyword: Autoimmune disease, Sjögren's syndrome, Systemic lupus erythematosus, Dry eye syndrome, TCM pattern, TCM tongue diagnosis.

Eligibility Criteria:
Sjögren's syndrome

* Inclusion Criteria:

  1. aged between 20 and 75 years
  2. fulfilled the 2002 American-European Consensus Criteria for SS (AECG)
* Exclusion Criteria: NA

Systemic lupus erythematosus

* Inclusion Criteria:

  1. aged between 20 and 75 years
  2. fulfilled the 1982 and 1997 ACR revised Systemic lupus erythematosus criteria
* Exclusion Criteria: NA

Dry eye syndrome

* Inclusion Criteria:

  1. aged between 20 and 75 years
  2. Schirmer's test less than 10 mm/5 min
* Exclusion Criteria: NA

non AIDDES Healthy Controls

* Inclusion Criteria:

  1. aged between 20 and 75 years
  2. without any Chronic disease
* Exclusion Criteria: any Sjögren's syndrome, Systemic lupus erythematosus, or Dry eye syndrome.
Effect of Feeding Mode on Infant Growth and Cognitive Function

This study is intended to compare growth, nutritional status, and brain development in children fed an Investigational cow's milk based formula containing a nutrient-rich whey protein, a standard cow's milk based formula, or fed exclusively breast milk.


Eligibility Criteria:
Inclusion Criteria:

* Singleton, 0-120 days of age at study entry
* Term infant with birth weight of 2500 to 4500 grams
* Exclusively feed infant formula or exclusively feeding breast milk
* Signed informed consent

Exclusion Criteria:

* History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised.
* Feeding difficulties or formula intolerance
* Receiving complementary feedings
The Application of the Self Care Deficit Nursing Theory in Adolescents With Cystic Fibrosis

The present study evaluates the effect of nursing care based on the Self-Care Deficit Nursing Theory on the knowledge and skills related to self-care among adolescents with Cystic Fibrosis.

This study included 30 adolescents who were equally divided into the intervention and control groups. The data were collected by using the Sociodemographic Data Form and the Self-Care Knowledge and Skills Evaluation Forms for Adolescents with Cystic Fibrosis. A total of seven home visits were conducted with the adolescents in the intervention group, during which individualized care plans were applied based on the Self-Care Deficit Nursing Theory. The self-care needs of the adolescents in the control group were identified based on data collected during two home visits conducted at the onset of the study and after 4.5 months.

As a result of the application of nursing interventions based on the Self-Care Deficit Nursing Theory, a statistically significant increase was noted in the self-care knowledge and skills of the adolescents in the intervention group (p\<0.05). Additionally, nursing interventions and nursing diagnosis decreased significantly over time in all adolescents in the intervention group (p\<0.05).

Orem's Self-Care Deficit Nursing Theory was useful in enhancing the self-care knowledge and skills of adolescents with Cystic Fibrosis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Cystic Fibrosis determined by a positive sweat test and/or the presence of two Cystic Fibrosis mutations,
* Aged between 12 and 18 years
* Living in the same Ankara

Exclusion Criteria:

* Adolescents with mental health issues
* Adolescents with an atypical form of Cystic Fibrosis (characterized by an absence of symptoms and no medication requirement)
Efficiency of Modified Pilates Exercises in Patients With Chronic Neck Pain

The aim of this study is to investigate the effects of modified pilates exercises on neck pain, deep neck flexor muscles edurance, joint position sense and functionality in patients with chronic neck pain.

50 individuals with Chronic Neck Pain not working will be included to our study. We will evaluate pain (with visual analog scale), deep neck flexors' endurance (with cranio-cervical flexure test using the pressure stabilizing feedback device), cervical range of motion and cervical proprioception (wit cervical range of motion device). Besides we will conduct a questionnaire (neck disability index) to get further knowledge about their functionality. Participants will be randomly allocated 2 groups consisting of 25 participants and these 2 groups will receive different interventions. Modified Pilates Exercise Group (MPEG) will be involved in a modified pilates exercise training for a total of 6 weeks a day, 2 days a week in the presence of a physiotherapist. The Control Group (KG) will receive daily routine advises to prevent neck pain and they will be asked about to apply these advises and not to make other changes in their life. The evaluations will be repeated and analyzed 2 times, pre-treatment and 6 weeks after treatment , and the effectiveness of the modified pilates exercises will be examined in the chronic neck pain. Our hypothesis is ''Modified pilates exercises have a positive effect on neck pain, range of motion, deep neck flexor muscles, joint position sense and function in patients with chronic neck pain.''

Eligibility Criteria:
Inclusion Criteria:

* Having neck pain more than 3 months
* No physical therapy in last year
* No background with pilates exercises
* Being able to understand Turkish, treatment and evaluations.
* Being able to complete all the evaluations and treatment

Exclusion Criteria:

* Fracture or surgery background with shoulder, cervical area or other extremities.
* Any systemic musculoskeletal diseases
* Existing chest deformities or scoliosis
* Cervical hernia, neuropathy or whiplash.
* Pregnancy
* Having pain above 7 in VAS
* Any other pain that could prevent people from doing exercises
Chorus Sleep Trial

This pilot study will evaluate the feasibility of a 6-week intervention using Chorus Sleep's ios app to improve sleep quality, reduce stress, and reduce depression and anxiety using a randomized controlled design.

Chorus Sleep is a successful wellness company with a loyal and growing clientele, and considerable qualitative and anecdotal evidence for its efficacy at reducing stress, and improving sleep quality. It builds upon existing meditation and mindfulness practices with well documented efficacy for reducing pain, improving mental health, and reducing stress. Further its innovative approach - including the use of popular music and breathwork patterns that elicit stimulating and novel sensations and physiological activity - may removes barriers to participation and engagement of many traditional meditation and mindfulness practices. Prior research evaluating the efficacy of audio meditation using the Calm app found use of the app for eight weeks significantly decreased daytime fatigue and sleepiness and pre-sleep arousal compared to a wait-list control group. Further, use of the calm app for 8 weeks was associated with greater improvements in depression and anxiety symptoms, and those effects were mediated by lower pre-sleep arousal. This study will investigate whether Chorus Sleep's innovation in auditory app-based sleep inventions will demonstrate similar efficacy.

This study has the following objectives:

1. Pilot a randomized controlled trial on Chorus sleep to evaluate feasibility.
2. Evaluate the effect of Chorus sleep practice at improving sleep quality.
3. Evaluate the effect of Chorus sleep practice at reducing perceived stress, depression, and anxiety, both directly and indirectly through improved sleep quality.
4. Characterize habit formation of Chorus sleep practice

Eligibility Criteria:
Inclusion Criteria:

* Fluent English speakers
* Have an Apple Iphone 8 or later
* Have a bed to sleep in consistently every night

Exclusion Criteria:

* Narcolepsy
* night shift or shift work for more than 2 nights per week.
* Used the Chorus sleep app more than one time prior to the beginning of the trial.