cyrilzakka/clinical-trials huggingface dataset:
Immunonutrition and Psychosocial Factors in the Recovery of Patients After Gastrectomy: a Multidimensional Analysis

To conduct this research, the following guiding question was formulated: "Can immunonutrition, combined with the assessment of SOC and resilience, provide a broad view of the physical and psychological results during the treatment and recovery process of patients undergoing gastric cancer surgery?". This led to the formulation of the following hypothesis: "Patients who received immunonutrition and who have higher levels of resilience and sense of coherence will tend to exhibit more favorable clinical and laboratory outcomes for recovery after gastric cancer surgery.

In order to answer the question and test the study hypothesis, the general objective consisted of:

To evaluate the association of clinical and laboratory outcomes with the sense of coherence and resilience of patients undergoing gastric cancer surgery who received immunonutrition.

In view of this general objective, the following specific objectives were formulated:

* To evaluate the levels of resilience and sense of coherence in patients undergoing gastric cancer surgery who received immunonutrition.
* Analyze the results of blood count and C-Reactive Protein (CRP) in patients who received immunonutrition after gastric cancer surgery.
* Identify the association between resilience levels, sense of coherence, blood count and CRP values with clinical outcomes, such as length of hospital stay and wound recovery, in patients undergoing gastric cancer surgery who used immunonutrition.


Eligibility Criteria:
Inclusion Criteria:

Adult or elderly patients (age ≥ 18 years) Treated at Consultório Guararapes Underwent surgery to remove gastric cancer Used immunonutrition in the pre, post, or perioperative period Applicable to both sexes

Exclusion Criteria:

Pre-existing hematologic diseases that may affect blood count results History of drug abuse (legal and/or illegal) Presence of other neoplasms History of psychological disorders affecting ability to respond to study questionnaires
Prolonged Hypercoagulability Following Major Liver Resection for Malignancy

This clinical trial will investigate the ability of thromboelastrogrpahy (TEG®) to detect hypercoagulability after liver surgery and will examine the effect of extended thromboprophylaxis (medical treatment to prevent the development of blood clots inside blood vessels) in patients undergoing liver surgery for cancer treatment.

The liver plays a key role in regulating the process of blood clotting. As a result, blood clots are a major cause of complications and death following liver surgery. This is especially true in cancer patients who are at a higher risk of developing blood clots. Current methods for preventing clotting complications after liver surgery include conventional coagulation blood tests (CCTs) and anticoagulant drugs, such as low molecular weight heparins (LMWHs). Current LMWH treatment is prescribed for one month after surgery, but studies show that the risk of developing blood clots can last up to 3 months. Studies also show that CCTs may not be as effective in detecting clotting issues as more comprehensive testing systems, such as TEG. This study will randomize 50 participants to receive 90 days of thromboprophylaxis (using the LMWH Redesca) or the standard of care 30 days (using the LMWH Fragmin) after liver surgery. The medication will be given by injection, similar to a regular vaccine or an insulin injection. Participants will inject the medication every day, for 30 or 90 days, after surgery. Participants will also have their blood tested for clotting issues via TEG testing before surgery and on post-operative days 1,3,5,30 and 90. After surgery, participants will be monitored by their surgeon for clotting complications and 3 year disease-free survival.


Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 18 years or older at the time of enrollment.
2. Requiring major liver resection (\>2 liver sections) for any oncologic indication.
3. Requiring postoperative thromboprophylaxis will be included.
4. Willing and able to perform subcutaneous injections according to the study protocol, or receive injections form a caregiver delegated by the participant.

Exclusion Criteria:

1. Anyone below 18 years of age.
2. Patients on current anticoagulant and/or antiplatelet therapy
3. Patients with a history of thrombotic events
4. Patients with a coagulation disorder.
5. Patients with recognized thrombophilia.
6. Patients who cannot understand/speak or read in English.
Telerehabilitation for Anterior Cruciate Ligament Reconstruction - TAR Program in Adolescents

Anterior cruciate ligament (ACL) injuries are common in adolescents and its prevalence has increased over the years, especially with more adolescents engaging in physical activities and competitive sports. Standard of care for these injuries would be an ACL reconstruction (ACLR) to allow return to function and sports and reduce the risk of post-traumatic arthritis and recurrent knee injuries. Rehabilitation post-ACLR is crucial to optimise surgical outcomes and prevent re-rupture of ACL. However, good compliance to rehabilitation is often a challenge for patients and healthcare providers.

Telerehabilitation for this group of patients may help to augment rehabilitation by improving patient compliance and overcome barriers to behavioural change often observed in traditional in-person physiotherapy. It can also allow remote monitoring and provide feedback to patients during exercises. In addition, it is a useful tool during pandemic when in-person visits are not possible. Currently, very few studies have evaluated the use of telerehabilitation with remote monitoring for ACLR, especially in adolescents. The use of home-based telerehabilitation post ACLR may be key to improving patient motivation and exercise compliance in adolescents.

For this pilot study, the intervention group will undergo the TAR program in addition to standard care, which involves self-administered exercises in initial 12 weeks post ACLR using a mobile application. The mobile application will detect key landmarks on the body for human pose estimation. Participants will be able to perform their exercises with real-time feedback given, allowing for proper execution of the exercises. Exercise adherence, range of motion and pain scores will be tracked via the application and therapists are able to monitor via the online dashboard. The control group will undergo standard in-person physiotherapy.

Primary aim of this study is to examine exercise adherence in TAR program versus standard care post ACLR in adolescents. Secondary aims of this study are to examine the effects of TAR program on knee strength, range, function, quality of life, treatment satisfaction, self-determination and number of face-to-face rehabilitation sessions required after ACLR.


Eligibility Criteria:
Inclusion Criteria:

* Participants age 12 to 20 years old
* Participants undergoing ACLR surgery
* Participants willing to be included in either the intervention group (utilizing the mobile application) or control group

Exclusion Criteria:

* Participants with complications after ACLR surgery
* Participants with significant neurological or other lower limb impairments or conditions affecting mobility and function
* Participants with previous ACL surgeries of the same affected lower limb
* Participants with previous surgeries or trauma to the unaffected lower limb
ADenoVirus Initiative Study in Epidemiology in France

The objectives of this study is to assess the characteristics and frequency of adenovirus conjunctivitis in a population of male and female patients from one year of age who present signs and symptoms of acute conjunctivitis.

Epidemiological, prospective, open, multicentric trial in patients suffering from acute conjunctivitis who will undergo a rapid diagnostic test for adenoviral conjunctivitis at the time of their visit to the ophthalmologist office, at the emergency room or during hospitalization. This epidemiological study will include approximately 500 patients in France. The planned duration of the study is one year from the first patient visit to the last patient visit.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female patients of at least one year of age presenting acute (for less than 7 days) conjunctivitis signs and symptoms.
* Patient or / and legal representative (if patient below 18 years of age) must be able to provide oral consent for the collection and treatment of the questionnaire data.
* No history of hypersensitivity to corn starch, talcum powder or Dacron (sampling fleece components).

Exclusion Criteria:

* Current use or having received (within the last 7 days) local antiviral therapies such as povidone iodine or ganciclovir, or topical steroids or immunomodulators such as cyclosporine which may interfere with the test result.
* Previous enrolment in the present study.
* Any direct involvement with the study conduct at site or any family link with study site staff.
To Evaluate if Multiple Doses of Rifampicin Change the Blood Concentration of YM150 (Darexaban)

The primary objective of this study is to determine the effect of rifampicin on the way the body handles darexaban and its metabolites (drug degradation products). The secondary objective of the study is to evaluate the safety and tolerability of a single dose of darexaban alone and when administered together with rifampicin.

This is an open-label, 1-sequence study in young healthy male subjects to evaluate the effect of multiple daily doses of rifampicin on the PK of darexaban and metabolites after a single dose of darexaban. In addition, safety and tolerability of darexaban administered alone and in combination with rifampicin is evaluated. Eligible subjects are admitted to the clinical unit in the morning of Day -1.

Subjects receive a single dose of darexaban on Day 1. Subjects then receive rifampicin once daily (qd) on Days 4-14.On Day 11, the second single dose of darexaban is given in combination with rifampicin.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) between 18.5-30.0 kg/m2
* Male subjects must be non-fertile, i.e. surgically sterilized or must practice an adequate contraceptive method to prevent pregnancies

Exclusion Criteria:

* Known or suspected hypersensitivity to darexaban or rifampicin or any components of the formulation used
* Any of the liver function tests (i.e. ALT and AST) above the upper limit of normal at repeated measures
* Any clinically significant history of any other disease or disorder - gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic as judged by the medical investigator
* Any clinically significant abnormality following the investigator's review of the pre-study physical examination, ECG and clinical laboratory tests
* Use of any prescribed or OTC drugs (including vitamins, natural and herbal remedies, e.g. St. John's wort) in the 2 weeks prior to admission to the Clinical Unit, except for occasional use of paracetamol (up to 3 g/day)
* Regular use of any inducer of liver metabolism (e.g. barbiturates, rifampicin) in the 3 months prior to admission to the Clinical Unit
* Any use of drugs of abuse, or smoking of more than 10 cigarettes (or equivalent) or more than 21 units (210 g) of alcohol per week within the 3 months prior to study Donation of blood or blood products within 3 months prior to admission to the Clinical Unit
* Participation in any clinical study within 3 months or participation in more than 3 clinical studies within 12 months, prior to the expected date of enrolment into the study, provided that the clinical study did not entail a biological compound with a long terminal half life
Trial Comparing Capecitabine Plus Oxaliplatin (XELOX) and Capecitabine (X) as First-line Chemotherapy in Elderly Patients With Advanced Gastric Cancer

The objective of the trial is to compare Overall survival between capecitabine plus oxaliplatin (XELOX) and capecitabine (X) as first-line chemotherapy in elderly patients with advanced gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 70
2. Histologically or cytologically confirmed adenocarcinoma of the gastric
3. Advanced ,metastatic/recurrence gastric cancer
4. ECOG performance status of 0 to 2
5. Life expectancy≥3months
6. No history of any systemic anti-cancer chemotherapy (prior adjuvant chemoradiation or chemotherapy is allowed if the last date of drug administration is \> 6months from the study entry date)
7. No history of radiation therapy about Target lesion. (Prior radiotherapy is permitted if it was not administered to target lesions selected for this study, unless progression of the selected target lesions within the radiation portal is documented, and provided it has been completed at least 4 weeks before randomization.
8. Adequate marrow functions (ANC ≥ 1,500/uL, PLT ≥100,000/uL)
9. Adequate renal functions (Creatinine ≤1.5mg/dL or Ccr ≥ 50ml/min)
10. Adequate hepatic functions ( bilirubin ≤ 2.0mg/dL, SGOT/SGPT \< normal x 3)
11. provision of a signed written informed consent

Exclusion Criteria:

1. History of any medical or psychiatric condition
2. Active infections
3. Peripheral neuropathy with symptom(NCI-CTCAE ver. 3.0 \>=Grade 1 )
4. symptomatic brain metastases
5. Double primary cancer (physician at the discretion of the other cancer cured the purpose of early cancer cases can be registered)
6. History of other malignancy except:

   Adequately treated non-melanomatous skin cancer or cervical carcinoma in situ
7. Known hypersensitivity to Fluoropyrimidines/platinum
8. Clinical significant cardiovascular disease (myocardial infarction, symptomatic coronary artery disease, congestive heart failure, severe arrhythmias)
9. Required immunosuppressive therapy(transplant patients, severe autoimmune disease)
Intravesical Injection of Botox for Treating Therapy Refractory Overactive Bladder in Females

The neurotoxin Botox (botulinum neurotoxin type A) is shown to be effective in the treatment of therapy refractory overactive bladder syndrome. Our data suggests a longer during efficacy than known from the use in striated muscle.

The aim of our study is to analyze short- and longterm efficacy after Botox treatment and to evaluate risk factors for non-responders and side effects such as urinary retention.


Eligibility Criteria:
Inclusion Criteria:

* intravesical treatment with Botox at our clinic
U.S. Guided Erector Spinae Block for Postoperative Pain Management in Paraumbilical Hernia Repair Patients

Abdominal surgery is one of the most definitive and mainstay treatment options for abdominal pathologies in clinical practice. Acute postoperative pain is a major challenge in the postoperative period. Although opioids are commonly used for analgesia after paraumbilical hernia, they can lead to side effects, such as nausea and vomiting, constipation, pruritus, and life-threatening respiratory depression. Regional anesthetic techniques are commonly used to prevent or minimize these side effects. The objective of this study is to assess the effectiveness of erector spinae plane block (ESPB) and standard medical (no block) pain management after paraumbilical hernia.


Eligibility Criteria:
Inclusion Criteria:

* Age group : 18-60 years old
* Both genders
* Patient scheduled for paraumbilical hernia surgeries

Exclusion Criteria:

* Allergy to medications used in this study
* Patient's refusal to participate in this study
* Recurrent cases
* Any complications to local blocks
* Emergency surgical procedures
Adverse Events for Free Flap Surgery in Head and Neck Cancer

This is a cohort study collecting patients with head and neck cancer who underwent free flap surgery at a single medical center between January 2019 and January 2022.

Patient information are collected from the electronic medical records retrospectively:

Head and Neck cancer diagnosis: The International Classification of Diseases, Tenth Revision (ICD-10), which included C00-C14, C31, C32, C73, C75.0, C75.4 and C41.1.

The cancer stage, alcohol use, betel nut, and smoking, and baseline comorbidities.

Surgical characteristics including flap history, ablation time, reconstruction time, donor sites, recipient sites, neck dissection, flap size, anastomosis, artery types, vein types, intraoperative sealants used, and intravenous calcium channel blocker nicardipine to control hypertension after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age greater and equal to 20 years old
* Underwent free flap surgery
* Had head and neck cancer

Exclusion Criteria:

* HIV positive
* Pregnant, breast feeing women
* Missing surgical charts
Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma

Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven primary thoracic esophageal squamous cell carcinoma
* Not suitable for surgery or radio or chemical therapy
* Presence of at least one index lesion measurable by CT scan or MRI radiation therapy ended at least 4 weeks, but part of the radiation does not as a measurable lesions
* 18\~70 years
* PS:0-1
* Life expectancy of ≥ 3 months
* WBC≥3.5×109/L,ANC≥1.5×109/L, PLT≥100×109/L, Hb≥100g/L
* TB ≤ 1.5UNL, ALT/AST ≤ 2.5×UNL
* Scr≥60 mL/min
* Normal electrocardiogram (ecg)
* Can normal oral drugs
* Signed written informed consent

Exclusion Criteria:

* Breast-feeding or pregnant women, no effective contraception if risk of conception exists
* Chronic diarrhea, enteritis, intestine obstruction which are not under control
* Esophageal obstruction cannot eat liquid completely, esophagus have deep ulcer perforation or hematemesis; Esophageal cancer common complications such as anastomotic leakage, serious lung complications, etc.
* A second primary tumor (except skin basal cell carcinoma)
* The original serious heart disease, including: higher risk of congestive heart failure, unable to control arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension
* With uncontrol nerve, mental illness or mental disorders, compliance is poor, can't cooperate with accounts and response to treatment; Primary brain tumors or - CNS metastases illness did not get a control, has obvious cranial hypertension or nerve mental symptoms
* With bleeding tendency
* Has inherited bleeding evidence of physical or blood coagulation disorder
* With clear chemotherapy drug allergy
* Other researchers believe that patients should not participate in this testing
DSM-5 Personality Disorders in Adults with Autism

Rationale: Self-report measures are frequently used for research and clinical assessments of adults with autism spectrum disorder (ASD). However, there has been little research examining agreement between self-report and informant-report in this population. Reliable self-report measures are essential for conducting research with and providing high quality clinical services for adults with autism spectrum disorder.

Objective: This study aims to examine the usefulness of self-report of DSM-5-TR PD traits in adults with ASD compared to informant-reports by administering the self-report screening measure of the Structured Clinical Interview for DSM-5 Screening Personality Questionnaire (SCID-5-SPQ).


Eligibility Criteria:
Inclusion criteria Inclusion criteria for ASD participants: (1) primary diagnosis of ASD according to the DSM-5-TR, (2) age 18+ years, (3) no intellectual disability, and (4) at least having completed a primary and secondary education.

Inclusion criteria for informants:

Participants were asked to identify individuals who knew them well and were capable of providing accurate descriptions of their personality traits, preferably informants that cohabited with the participants. When cohabitants were unavailable, participants were asked to identify "the person who knows you best." Additionally, eligibility of informants for inclusion required that, historically, the informant and the participant talked at least monthly and interacted face-to-face at least yearly.

Exclusion criteria Exclusion criteria for ASD participants: (1) no ASD diagnosis, (2) current substance abuse, (3) psychotic disorders, (4) schizophrenia, (5) eating disorder, (6), mental retardation (IQ\<80), (7) suicidal ideations and (8) age \<18 years.

Exclusion criteria for informants: (1) age \<18 years, (2) intellectual disability, and (3) not being able to state and/or recognize psychological and problematic functioning of their participating relative with ASD.
Assessing Changes in Breastmilk Composition Over Time Among Pakistani Infants

In Pakistan, breastfeeding is widely practiced. National data suggests that 94% of infants \<2 years of age receive breastmilk at some point. However, the introduction of complementary foods often occurs early. At 3 months of age, it is suggested that only 54% of Pakistani infants are exclusively breastfed. This declines with each month of age. Because the production and release of breastmilk is influenced by the frequency and intensity of suckling, early initiation of complementary feeding can reduce breastmilk output. Given that complementary foods are introduced early within Pakistan, we hypothesize that breastmilk composition will change between 1 and 3 months postpartum among those mother-infant pairs if nutritive complementary foods are introduced early (i.e., before 6 months). In this study, we aim to better understand how breastmilk composition changes over time among infants recruited at 1 month of age who are exclusively breastfed or receive only non-nutritive feeds. This is a substudy to the Matiari emPowerment and Preconception Supplementation (MaPPS) Trial (ClinicalTrials.gov Identifier: NCT03287882).


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the MaPPS Trial
* Mothers must report practicing exclusive or predominant breastfeeding (i.e., breastmilk only or breastmilk and non-nutritive feeds only)
* The infant must be term-born (\>37 weeks gestation)
* Infant must be 1 month + 14 days old at the time of recruitment
* Mothers must be willing to provide a complete breastmilk expression from one breast (either via breast pump or hand expression)
* Able to provide informed consent

Exclusion Criteria:

* Mother reports mixed feeding of her infant with nutritive feeds (i.e., any provision of formula or animal milk)
* The infant was born preterm (earlier than 37 weeks gestation)
* Mother does not wish to provide a complete breast expression of one breast