rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets Versus Venlafaxine Hydrochloride Sustained-release Tablets in Patients With Major Depression Disorder
Status: Not yet recruiting

The purpose of this study is to evaluate efficacy and safety of toludesvenlafaxine hydrochloride sustained-release tablets in the treatment of major depression disorder compared to venlafaxine hydrochloride sustained-release tablets, to provide evidence-based basis for clinical rational drug use.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Subjects meet the diagnostic criteria for major depression disorder in the Diagnostic and Statistical Manual of Manual Disorders, fifth Edition (DSM-5); Male or female aged ≥18 and ≤65 years; Subjects who have a 17-item Hamilton Depression Rating Scale (HAM-D17) total score ≥18 points; Subjects who have a total score of Snaith-Hamilton Pleasure Scale (SHARPS) ≥3 points; Subjects voluntarily participate in the study and sign the informed consent form.  Exclusion Criteria:  Allergic or known to be allergic to toludesvenlafaxine hydrochloride sustained-release tablets and venlafaxine hydrochloride sustained-release tablets; Subjects have a severe self-injury/clear suicide attempt or behavior; Scores on HAM-D17 items factor 3 ≥3 points; Subjects who meet the diagnostic criteria for any other psychotic disorders in DSM-5; Subjects who meet the diagnostic criteria for substance disorders or alcohol abuse in DSM-5 (except for nicotine or caffeine) within the past six months; Individuals with severe and unstable physical diseases such as cardiovascular disease, liver disease, kidney disease, blood disorders, and endocrine disorders; Hypertensive patients with poor blood pressure control (systolic blood pressure (SBP) ≥140 mmHg or diastolic blood pressure (DBP) ≥90 mmHg at screening); Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 2 times / creatinine (Cr) 1.2 times higher than the upper limit of normal at screening; Electrocardiogram (ECG) abnormalities that are clinically significant at period of screening and that the investigator considers as inappropriate conditions for inclusion, such as QTc interval >450 ms in men and QTc interval >460 ms in female; Subjects who received electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within 3 months prior to screening; Subjects who received systematic psychotherapy (interpersonal relationship therapy, dynamic therapy, cognitive behavioral therapy) within 3 months prior to screening; Pregnant or lactating women, recent planned pregnancy and unable to ensure effective contraception during the period; Other conditions that the investigator considers the participant is not suitable for the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Development and Validity of Turkish Atılım Kinesiophobia Scale Turkish Atılım Kinesiophobia Scale
Status: Recruiting

Background:

Kinesiophobia or fear of movement, is defined as an excessive and irrational fear of physical movement to avoid painful injury, harm or re-injury. The existing scales measuring kinesiophobia are thought to have some limitations (the difficulty of patients to understand and answer the questions, the presence of questions that are not suitable for the patient's condition). These questionnaires may not have specific questions enough to assess fear of movement in different patient populations.

Aim: The aim of this study is to develop and validate the Turkish Atılım Kinesiophobia Scale.

Material/method:

In the first stage of the study, research on kinesiophobia was reviewed and a total of 38 questions were created for the scale. The questions were submitted to the opinion of 11 experts working in the physiotherapy and rehabilitation field. Then A total of 100 patients with acute and chronic musculoskeletal pain completed the Turkish Atılım Kinesiophobia Scale and Tampa Scale of Kinesiophobia.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Young, middle-aged, neurologic, geriatric patients aged 18-70 years with chronic musculoskeletal pain problems after acute injury or surgery will be included.  Exclusion Criteria:  patients with cognitive and cooperation problems will not be included in the study. illiterate - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The study population consisted of male and female patients aged 18-70 years with complaints of acute and chronic pain due to musculoskeletal problems. - SamplingMethod: Non-Probability Sample
C.Difficile Observational Study
Status: Not yet recruiting

D8820C00001 is an exploratory, non-interventional, unblinded, observational study evaluating the acceptability, feasibility and performance of methods to collect, transport and test biospecimens in participants ≥ 18 years of age with an active CDI. Participants will also be monitored for recurring episodes of diarrhea and will need to complete validated PROs and study evaluation questionnaires

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Male or female participants ≥ 18 years of age at the time of signing the informed consent  Participants in the Monitoring and Discard Stool cohorts with an active treated CDI, defined as meeting all of the following:  Either diarrhea, defined as ≥ 3 unformed stools in a 24 hour period, with the stool being measured as Types 5, 6, 7 on the Bristol Stool Scale or evidence of megacolon, or severe ileus. A positive local stool test results for toxigenic C difficile collected no more than 7 days before entry to the study or evidence of pseudomembranes demonstrated by endoscopy or histopathology. Receiving SOC therapy (including but not limited to metronidazole, vancomycin, fidaxomicin) for the treatment of CDI, initiated in the prior 5 days, at the time of enrollment. Able to complete all study assessments, and to understand and comply with study requirements/procedures (if applicable, with assistance by caregiver, surrogate, or legally authorized representative, or equivalent representative as locally defined) based on the assessment of the PI Able to complete the Follow-up period through Day 42 based on the assessment of the PI. If able, signed and dated written informed consent prior to any study specific procedures, including screening evaluations for participants who consent to participate in the Monitoring cohort. Ensure that participants who are considered by the Investigator clinically unable to consent at screening and who are entered into the study by the consent of a legally acceptable representative show evidence of assent, as applicable in accordance with local regulations. Signed and dated written information consent prior to collection and testing of stool samples for participants in the Discard Stool cohort  Exclusion Criteria:  Employees of AstraZeneca, clinical study site, or any other individuals directly involved with the conduct of the study, or immediate family members of such individuals. Employees of the clinical site or immediate families of these individuals not directly involved in the clinical study will be permitted to participate. Deprived of freedom by an administrative or court order, or in emergency setting, or hospitalized involuntarily Absence of suitable venous access for serum sampling - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 130 Years - StdAgeList: Adult, Older Adult - StudyPopulation: ≥ 18 Years of Age (Adult, Older Adult ) - SamplingMethod: Non-Probability Sample
Early Diagnosis of Gastric Cancer Cachexia
Status: Recruiting

Gastric cancer is one of the most common malignancies, the morbidity and mortality of which are among the highest. In cancer patients, the incidence of cachexia is very high, and even 80% of patients will eventually develop into cachexia. However, once gastric cancer patients develop cachexia, patients are unlikely to obtain clinically significant benefits from conventional treatment. Therefore, it is important to find biomarkers for early detection of cachexia. The investigators carried out a plasma-derived exosomal microRNA(miRNA) study for early diagnosis of cachexia in gastric cancer, and the development of early diagnosis kits for gastric cancer cachexia.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with gastric cancer diagnosed by histopathology or cytopathology Complete clinical and pathological data No previous or current mental illness or disturbance of consciousness  Exclusion Criteria:  With multiple tumors or other malignant diseases Combined with other chronic wasting and metabolic diseases Past patients with non-tumor cachexia People with mental illness or unable to cooperate - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The research object is patients with confirmed gastric cancer.According to diagnostic criteria, patients are divided into cachexia group and non-cachexia group. - SamplingMethod: Non-Probability Sample
Feasibility Study of the Self-Care Immediate Stabilization Procedure (ISP) ® After a Traumatic Experience
Status: Not yet recruiting

The study aims to assess the feasibility of an online intervention platform based on the Immediate Stabilization Procedure (ISP ©), as outlined by Beatty et al., 2023. This intervention targets early trauma reactions, aiming to reduce the risk of future PTSD.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Hebrew speakers Age 18 years or older Where in Israel from October 7th 2023 (the start of the war) Where exposed to traumatic events during the war (Alarms, participated in battles, were attacked by terrorists', etcetera) Access to PC/smartphone Basic technological skills, ability to use the internet and email.  Exclusion Criteria:  Diagnosed with psychotic conditions. Diagnosed with PTSD or complex PTSD. Diagnosed with alcohol use disorder or drug abuse disorder. Suicidal inclinations - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Administration of Hyperthermic Intraperitoneal Chemotherapy in the General Ward
Status: Not yet recruiting

Ovarian cancer is the most lethal gynecologic malignancy. The majority of patients get diagnosed with advanced disease with peritoneal dissemination.It has been demonstrated that the addition of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) to interval debulking surgery can improve the prognosis. The National Comprehensive Cancer Network (NCCN) treatment guideline has recommended HIPEC as a first-line treatment for patients with advanced ovarian cancer. However, the guideline recommended the "Dutch model" of HIPEC, which is limited for routinely being performed in China. So we propose a HIPEC treatment modality, the bedside closed HIPEC in the general ward (C-HIPEC), which is suitable for the clinical characteristics of China. The aim of this study was to evaluate the safety of this model as a way to lay the foundation for subsequent efficacy evaluation and clinical promotion.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:（The following conditions must be met at the same time）  Pathologically confirmed primary epithelial ovarian, fallopian tube, and primary peritoneal cancers in FIGO stages III-IV. Previous neoadjuvant chemotherapy with platinum + vincristine and ≤ 4 courses of neoadjuvant chemotherapy. The residual tumor diameter is ≤1 cm after interval debulking surgery, and the reason for receiving IDS is that the patient cannot tolerate PDS due to the poor condition or the PDS cannot achieve optimal cytoreduction due to high tumor burden. Age from 18 to 70 years. Bone marrow reserve was well functioning. Leukocytosis ≥ 3.0×10^9/L, neutrophilic granulocyte ≥ 1.5 × 10^9/L, platelet count ≥ 100 × 10^9/L, and hemoglobin ≥ 80 g/L. Organs work well. AST ≤ 2.5 × ULN, ALT ≤ 2.5 × upper limit of normal(ULN), total serum bilirubin ≤ 1.5 × ULN, and creatinine ≤ 1.5 × ULN. ECOG score 0-1. Patients voluntarily sign an informed consent form  Exclusion Criteria: (None of which was eligible)  Patients diagnosed with other malignant tumors within 5 years (excluding skin and thyroid cancers). Patient is allergic to erythroxylanes. Patients treated with anticancer drugs in other clinical trials. High risk of anastomotic fistula or intestinal obstruction assessed during interval debulking surgery. Any situation of disease instability or potentially impact safety and adherence of patient. - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult
A Study of RGT001-075 in Adult Patients With Obesity
Status: Not yet recruiting

This study is being conducted to evaluate RGT001-075 to help people who are above a healthy weight range to lose weight. In this study participants will either get RGT001-075 or a "dummy" medicine (placebo). Which treatment participants get is decided by chance. Participants need to take RGT001-075 or placebo once every day for 12 weeks.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥ 18 and ≤ 75 years Have a BMI ≥27 kg/m² and ≤ 45 kg/m² Have had a stable body weight for the 3 months prior to randomization  Exclusion Criteria:  Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity Have a prior or planned surgical treatment for obesity Have or plan to have endoscopic and/or device-based therapy for obesity Have any prior diagnosis of diabetes Have an electrocardiogram (ECG) with abnormalities Have a history of Major Depressive Disorder (MDD) or other severe psychiatric disorders within the last 2 years Have a history of suicide attempt. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Morbidity and Mortality After Esophageal and Esophagogastric Junction Cancer Surgery
Status: Not yet recruiting

Esophageal and esophagogastric junction cancer is still one of the main health care issue and esophagectomy with lymph node dissection is the only chance to be cure.

However, esophagectomy for esophageal cancer is a complex procedure which carries high risk of morbidity rate of 24% and a mortality rate of 2% to 5.6%, respectively There is a need to study the differences of 90-day postoperative morbidity and mortality in different clinics and centers of the Russian Federation.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  All consecutive patients with clinically documented primary Esophageal or Esophagogastric Junction malignancy (including Siewert I and II) undergoing elective surgery with curative intent - via open, laparoscopic or robotic approach between 18th March 2024 and 18th September 2024  Exclusion Criteria:  Patients with clinical evidence of metastatic disease, including positive peritoneal cytology on a previous staging laparoscopy, or those with known synchronous other cancers. Esophagogastric Junction Siewert III malignancy Patients submitted to Emergency surgery or surgery without curative intent Patients undergoing any other surgery in addition to the curative surgery for primary Esophageal or Esophagogastric Junction malignancy - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: All consecutive patients with clinically documented primary Esophageal or Esophagogastric Junction malignancy (including Siewert I and II) undergoing elective surgery with curative intent - via open, laparoscopic or robotic approach - SamplingMethod: Non-Probability Sample
Postoperative Morbidity and Mortality After Gastric Cancer Surgery
Status: Not yet recruiting

Gastric cancer is still one of the main health care issue and gastrectomy with lymph node dissection is the only chance to be cure. Trials show that the postoperative course differs significantly between eastern and western centers, as well as between clinics within Russian Federation. Postoperative 30-day postoperative mortality after gastric cancer surgery ranges from 1% to 5%, and postoperative complication rates range from 10% to 40%. To improve the quality of further studies and recommendations for standardization of surgical treatment of gastric cancer and its complications, there is a need to study the differences in 90-day postoperative morbidity and mortality in different clinics and centers of the Russian Federation.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  All consecutive patients with primary gastric malignancy (including Siewert III) undergoing elective surgery with curative intent (either total or partial gastrectomy) via open, laparoscopic or robotic approach between 18th March 2024 and 18th September 2024.  Exclusion Criteria:  Patients with clinical evidence of metastatic disease, including positive peritoneal cytology on previous staging laparoscopy, Patients with known synchronous cancer; Patients with Gastrointestinal stromal tumors (GIST) Presence of gastroesophageal junction (Siewert I and II) malignancy; Patients submitted to Emergency surgery or surgery without curative intent; Patients undergoing additional surgery (except cholecystectomy) along with surgery for gastric cancer. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: All consecutive patients with primary gastric malignancy (including Siewert III) undergoing elective surgery with curative intent (either total or partial gastrectomy) via open, laparoscopic or robotic approach between 18th March 2024 and 18th September 2024. - SamplingMethod: Non-Probability Sample
VOCs in Patients With Acute Cardiogenic Chest Pain
Status: Recruiting

The goal of this observation study is to compare VOCs in cardiogenic chest pain population/health conditions, to answer：Establishment and promotion of the application system of emergency rapid detection of expiratory Volatile Organic Compounds (VOCs) in patients with acute cardiogenic chest pain

VOCs levels were measured at baseline in healthy people, and markers of VOCs that could be used to identify acute cardiogenic chest pain were sought.
The relationship between abnormal VOCs (mainly aldehydes) and prognosis of patients and the correlation with Super-score for early warning of acute heart failure.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Observation group inclusion criteria:  Over 18 years old, male or female; Patients with acute cardiogenic chest pain (see diagnostic criteria); Patient&#39;s informed consent.  Inclusion criteria of healthy control group:  Over 18 years old, male or female; Centerless cerebrovascular disease, lung disease, no abnormal liver and kidney function, no acute infection recently; Informed consent.  Exclusion Criteria:  The patient had difficulty in collecting breath; Patients with terminal illness or receiving palliative care; Have participated in other clinical studies or consider it inappropriate to participate in this study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Efficacy and Durability of Hepatitis A Vaccination in Patients With Advanced Fibrosis and Cirrhosis
Status: Not yet recruiting

The hepatitis A virus (HAV) is a significant global public health concern. The hepatitis A virus is transmitted primarily by the faecal-oral route, leading to acute hepatitis. Symptoms include low-grade fever, anorexia, jaundice, and typically resolve without complications.

However, HAV infection in patients with chronic liver disease, especially those over 50 years old, may result in more severe outcomes, including fulminant hepatitis, with a higher mortality rate compared to the general population

HAV vaccination is a cornerstone of prevention, especially in high-risk groups. Currently, there is a recommendation to vaccinate patients with chronic liver disease against HAV infection. However, these patients often have compromised immune responses, leading to lower vaccine efficacy compared to the general population.

The goal of this randomized controlled trial is to compare the efficacy and safety of the standard 2-dose (0, 6 months) hepatitis A vaccination regimen with an intensive 3-dose (0, 1, 6 months) schedule in patients with advanced fibrosis and cirrhosis.

The main questions it aims to answer are:

Compared the seroconversion rate of the standard 2-dose (0, 6 months) hepatitis A vaccination regimen versus the intensive 3-dose (0, 1, 6 months) hepatitis A vaccination regimen in patients with advanced fibrosis and cirrhosis.
Compared the antibody levels against the hepatitis A virus (Anti-HAV IgG) of the standard 2-dose (0, 6 months) hepatitis A vaccination regimen versus the intensive 3-dose (0, 1, 6 months) hepatitis A vaccination regimen in patients with advanced fibrosis and cirrhosis.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥ 18 years Confirmed advance fibrosis (F3) or cirrhotic (F4) status (radiologic finding or liver stiffness measurement or pathological report) Negative anti-HAV IgM, IgG at baseline  Exclusion Criteria:  Positive anti-HAV IgG at baseline Autoimmune hepatitis Current hepatocellular carcinoma Active other malignancies Presence of antibodies against Human Immunodeficiency Virus Received immunosuppressive drugs Pregnancy or lactation Decompensated cirrhosis with MELD ≥ 15 Chronic illness or bedridden patient who cannot travel to hospital Lack of consent to participate in the study - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult
Effectiveness Trial of Thermal Jacket
Status: Recruiting

Globally, over 15 million neonates are born preterm each year. They account for approximately 30% of global neonatal deaths and 19% of total neonatal deaths in Bangladesh. They usually die because they cannot maintain normal temperature due to their weight, immature skin and underdeveloped thermal regulatory capacity of the brain.

Maintaining continuous Kangaroo Mother Care (KMC) for at least 16-20 hours/day, is sometimes not feasible for mothers or caregivers. In addition, we also have the challenge of keeping preterm or low birthweight (LBW) neonates warm during transportation.

The scientists at icddr,b, Johns Hopkins University, and George Mason University developed the thermal jacket for keeping preterm or LBW neonate warm. We have already completed the laboratory trial on mannquins and clinical safety trial among preterm or LBW neonates. Now, we propose to build on our previous work by systematically testing the effectiveness trial of the 'thermal jacket' among preterm or LBW neonates at clinical settings.

Hypothesis: Thermal jacket can increase the rate of euthermia among the preterm or LBW neonates in the selected health facilities in Bangladesh.

Objectives: The aim of this study is to test whether the thermal jacket can attain and maintain euthermia of preterm or LBW neonates in clinical settings of Bangladesh.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  KMC eligible neonates Heart rate 100-160 per minute Capillary Refill Time ≤ 3 sec Respiratory rate 30-59 per minute Breaths comfortable Pink in room air  Exclusion Criteria:  In nasogastric tube In oxygen therapy In intravenous fluid Sign of respiratory distress Prolonged or frequent apnea Major surgical problem Gross congenital anomaly - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult