cyrilzakka/clinical-trials huggingface dataset:
Proportional Ventilation and Ventilatory Synchronism

Synchronism of gas flow delivered by the ventilator and muscular effort of the patient will be studied during two kinds of ventilation. The first one is the proportional assisted ventilation during which the gas flow is theoretically adapted to the patient's muscular effort within the breath. The second is the pressure support ventilation during which the gas flow is delivered to maintain the inspiratory pressure stable. The hypothesis is that the first mode allows a better synchronism.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing partial ventilatory support

Exclusion Criteria:

* Patients failing the weaning process
Early Clinical and Radiological Outcomes of a Novel Robotic TKA System

This study aimed to evaluate the early clinical and radiological outcomes of robot assisted total knee arthroplasty, and to determine the efficiency and safety of its bone resection and implant positioning of the novel robot system.

144 patients undergoing primary TKA were enrolled in this prospective, multicenter RCT conducted in 3 hospitals. The primary outcome was the rate of patients whose postoperative alignment was less than 3° deviated from the planned evaluated by full-length weight-bearing X-rays of the lower limb at 12 weeks postoperatively. Secondary outcomes will include coronal and sagittal alignment of the components, operation times, blood loss, 12-week range of motion(ROM), 12-week postoperative functional outcomes and satisfaction evaluated by the American Knee Society Score (KSS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and adverse events (AEs).


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-85 years (including 18 and 85), regardless of gender;
* Patients scheduled for unilateral primary total knee arthroplasty based on the clinical judgment of the study physician;
* The subject or their guardian has been informed of the study, agrees to all terms of the trial, signs an informed consent form approved by the ethics committee, and agrees to participate in the trial.

Exclusion Criteria:

* The side scheduled for surgery has significant hip joint disease, such as substantial bone defects or severe limitations in joint mobility;
* Patients with active infections around the knee joint or systemic infections;
* Discontinuity or severe functional loss of the knee extensor mechanism, painless knee joint fusion, Charcot joint, poor surgical tolerance, or other conditions that may adversely affect surgical prognosis;
* Patients with contraindications for traditional TKA surgery;
* Pregnant or breastfeeding women;
* Patients known to have excessive alcohol consumption or substance abuse; Body mass index (BMI) \> 35 kg/m²;
* Patients who have participated in other clinical trials within one month prior to signing the informed consent form;
* Patients with mental or intellectual disabilities that may affect clinical outcome evaluations;
* Patients deemed unsuitable for participation in this clinical trial by the investigator.
Clindamycin to Reduce Preterm Birth in a Low Resource Setting

Preterm birth has been linked to certain types of vaginal infections. The goal of this study is to determine if giving women pregnant between 13-20 weeks with an elavated vaginal pH(evidence of this type of infection)Oral Clindamycin(an antibiotic)will have a lower rate of preterm birth compared to women given a placebo(starch)

The primary study objective is to definitively test whether 300 mg oral clindamycin two times per day for 5-days administered at 13-20 weeks of gestation in women with a vaginal pH≥5 reduces the incidence of preterm delivery in Karnataka, India by at least 30%. The national incidence of gestation \<37 weeks in India is 14.5%, was 18% in the study area in 2011 and was 20% among women with vaginal pH≥5 in the recently completed Jawaharlal Nehru Medical Collage (JNMC) hospital-based study of clindamycin to reduce preterm birth. Using a two tailed test, α=0.05, 1-β=80%, a 17.5% rate of prematurity in women with vaginal pH≥5, a 2.5% refusal and a 7.5% loss to follow-up, assuming 86% of women presenting for antenatal care are 13-20 weeks gestation and 1% otherwise ineligible, and a multiple comparisons adjustment, 1,726 women, half in the clindamycin and half in the placebo group, need to be enrolled to test the primary hypothesis. The effects of clindamycin on spontaneous preterm birth, miscarriage, low birthweight (LBW), neonatal mortality (NMR), maternal and neonatal complications through 42 days postpartum, the utility of vaginal pH≥5 to identify women at risk for preterm delivery and the costs of preterm birth prevented by oral clindamycin treatment and compliance with the 5-day treatment regimen will also be assessed. This will be the first investigation to test whether oral clindamycin prevents preterm birth in a community-based, developing country setting, where most global newborn deaths occur.

Eligibility Criteria:
Inclusion Criteria:

* Women with a singleton Intrauterine pregnancy between 13-20 weeks
* Maternal age of 18 or older or if \< 18 assent of the women's parent/guardian
* Vaginal PH \> 5.0

Exclusion Criteria:

* Use of antibiotics within the 14 days prior to randomization
* Known sensitivity to antibiotics
* Uterine anomalies
* Major fetal anomalies
* Medical conditions that may result in iatrogenic prematurity(e.g.diabetes, Lupus, Hypertension)
Posterior Versus Lateral Laparoscopic Mesh Rectopexy for the Management of Complete Rectal Prolapse

Aim of the study is to evaluate the outcomes of two different methods of mesh placement during laparoscopic rectopexy for the management of complete rectal prolapse lateral versus posterior mesh rectopexy

Rectal prolapse is the full-thickness prolapse of the rectum, in which the rectum passes externally beyond the anal sphincters. It is a somewhat rare condition, estimated to occur in less than 0.5% of the population. Rectal prolapse has a 9:1 female predominance, and while it is occasionally seen in younger individuals, the incidence increases with age.

Surgical approaches for rectal prolapse can be divided into perineal and abdominal approaches. Traditionally, a perineal procedure such as Delorme or Altemeir operation was commonly used in elderly or frail patients while an abdominal procedure such as rectopexy with or without resection was reserved for younger and fitter patients. The frequency of laparoscopic abdominal repair of rectal prolapse has increased in recent years, with mesh rectopexy being the most popular procedure.

The mesh rectopexy operation was first described by Ripstein10 in 1952. Again, after mobilization of the rectum, an anterior sling of synthetic material (either absorbable or non-absorbable) is placed in front of the rectum and sutured to the sacral promontory. The rationale for this is to restore the natural curve of the rectum, which reduces the effect of downward abdominal pressure. The use of a non-elastic synthetic graft provides a firm anterior fascial support even in patients with significant pelvic floor descent, returning the rectum to a normal anatomical position.

The act of mobilization, suture, and fibrosis keeps the rectum fixed in position as adhesions form, attaching the rectum to the presacral fascia. Although SR is considered a good option for the cure of rectal prolapse/IS in both men and women, some reviews of this procedure noted a better overall clinical outcome in men. This may be due to occult sphincter defects in women, and failure to detect these defects before surgery owing to the lack of routine endoanal ultrasonography in the earlier years of prolapse surgery

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 70 years.
* Both sexes.
* Patients with complete rectal prolapse.

Exclusion Criteria:

* Unfit for surgery
* Impaired coagulation profile
* Contraindication of laparoscopy
Effect of Paracetamol on the Common Cold

The aim of this study is to subjectively assess symptoms in subjects suffering from the common cold following a single dose of paracetamol hot drink compared to paracetamol tablet


Eligibility Criteria:
Inclusion Criteria:

* Symptoms of the common cold of no more than 120 hours duration
* Self-rating congestion of at least moderate severity
* Suffering from at least four symptoms of common cold or flu
Lipid Emulsion Infusion and COVID-19 Patients

Investigators suggest that early administration of intravenous lipid emulsion (ILE) affect the inflammatory response and improve outcome in COVID-19. The aim of this trial is to study the effect of fish-oil-based intravenous lipid emulsion (FOBLE) supplementation added to enteral nutrition on shift to ICU for upgrading oxygenation \&/or ventilation in moderate cases of Covid-19 diseased patients requiring only supplemental oxygen in form of simple nasal cannula or venturi mask oxygen (during 7 days admission).

A written informed consent will be taken from the patients or their relatives. Patients will be randomly assigned to receive standard enteral nutrition plus 100 ml/day 0.9% normal saline at a rate 12.5 ml/h over 8 h for 5 days as the control group (Group C) or intravenous fish-oil-based lipid (SMOF lipid 20% which contains a unique 4-oil mix containing Soya bean, Medium-chain triglycerides, Olive oil and Fish oil) (Fresenius Kabi, Bad Homburg, Germany) emulsion supplementation to standard enteral nutrition (group L) in a dose of 100 ml/day at a rate of 12.5 ml/h over 8 h daily for 5 days.Finally, 20 mL of 0.9% normal saline was injected into the burette to flush the system. The entire apparatus was disposed of when each infusion was completed. The whole process was repeated for each infusion.

Eligibility Criteria:
Inclusion Criteria:

* Patients are with diagnosis of moderate cases of covid-19 (a person who may have lower respiratory illness, such as pneumonia. However, their blood oxygen levels remain ≥94%)
* Requiring only supplemental oxygen in form of simple nasal cannula or venturi mask oxygen admitted in the intermediate care attached to our ICU with good enteral nutrition.

Exclusion Criteria:

* Hypersensitivity (peanut,eggs and soya bean)
* Uncontrolled hyperlipidemia
* Severe primary blood coagulation diseases
* Acute pancreatitis
* Acute thromboembolic diseases
* Liver failure (bilirubin \>40 mmol/l, alanine aminotransferase \>100 U/l and aspartate aminotransferase \>100 U/l)
* RIFLE (Risk, Injury, Failure, Loss of kidney function and End-stage kidney disease) stage III and IV renal failure
* Pregnancy or lactation
* Severe neutropenia (\<500 cells/mm3)
Study of Aolanti Weikang Tablets in Healthy Volunteers

The purpose of this study is to evaluate the safety and tolerability of multiple doses escalation of Aolanti Weikang tablets to determine the MTD in healthy volunteers

This is a single-center, randomized, doule blind, placebo-controlled, multiple dose escalaction phase 1b study to evaluate the safety and tolerability of Aolanti Weikang tablets in healthy volunteers. Aolanti Weikang tablets is a Chinese patent drug designed to treat Functional dyspepsia (FD). The proposed dose escalaction levels is 3,6 and 8 tablets. If MTD is not established up to 8 tablets, the dose escalaction will be stopped. In each dose level, subjects will be randomly given orally Aolanti Weikang tablets or placebo tablets at a 3:1 ratio three times a day (tid) for 7 consecutive days, then will receive the Safety follow up for 14 days. No intrapatient dose-escalation is permitted.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) :≥19 and ≤26 kg/m2
* Signed written informed consent

Exclusion Criteria:

* With in 7 days of Screening, the average number of stool \> 2 times/day
* With in 7 days of Screening, with the presence of ≥ type 5 stool form per the Bristol Stool Form Scale
* At least one clinically significant abnormality based the comprehensive examination (including vital signs, physical examination, laboratory examination and others)
* Digestive diseases, or other diseases within 3 months that may affect the swallow, absorption, or metabolism of study drugs, and not yet fully recovered judged by the Investigator
* Smoking, alcohol abuse or drug abuse with in 3 months or drinking within 48 hours before the first administration
* History of drug or aurantium allergy
* Concomitant medication within 2 weeks prior to drug administration or any drug being used
* Participated in other clinical trials within 3 months before Screening
* Major surgery/surgical therapy for any cause within 4 weeks of Screening, or scheduled surgeries within 2 weeks after the last dose of study drug
* Subjects not agree to use adequate contraception from study entry through at least 28 days after the last dose of study drug
* Pregnancy or nursing
* Other conditions that unsuitable for enrollment considered by Investigator
The Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in Patients With Secondary Poor Graft Function After Hematopoietic Stem Cell Transplantation

This study is conducted in a prospective, single-center clinical design and is divided into two stages: dose escalation and dose extension. Patients meeting the diagnostic criteria of secondary poor graft function are selected as the study objects. The safety data of umbilical cord blood mononuclear cells in the treatment of secondary poor graft function are obtained through dose escalation stage, and then one dose is selected for dose extension stage to explore the efficacy of umbilical cord blood mononuclear cells in treating secondary poor graft function.


Eligibility Criteria:
Inclusion Criteria:

1. Age≥18 years old; gender is not limited.
2. Meet the diagnostic criteria for secondary poor graft function: After 28 days of transplantation, patients who had achieved hematopoietic reestablishment (ANC ≥ 0.5×10\^9/L for 3 consecutive days without G-CSF application, PLT ≥ 20×10\^9/L for 7 consecutive days without platelet infusion, Hb ≥ 80g/L for 2 consecutive weeks without red blood cell infusion) again developed two or three line cytopenia lasting more than 2 weeks. Bone marrow examination revealed low myelodysplasia, remission of primary disease, complete donor chimeric cells, and no severe graft-versus-host disease (GVHD) or disease recurrence.
3. Eastern Cooperative Oncology Group (ECOG) physical status score ≤ 2 points.
4. Subjects sign informed consent.

Exclusion Criteria:

1. Serious infection not controlled.
2. Active bleeding.
3. Patients with cardiac insufficiency (ejection fraction\<50%), or suffering from serious heart disease, including myocardial infarction, cardiac insufficiency, etc.
4. Patients with hepatic and renal insufficiency (total bilirubin\>35µmol/L, ALT and AST\>2 times of the upper limit of normal; serum creatinine\>130µmol/L).
5. Pregnant or lactating women.
6. Concurrent malignant tumors of other organs.
7. Failure to understand or follow the research protocol.
8. Patients participating in other clinical investigations.
9. Other conditions that the investigators consider inappropriate to participate in the study.
Gastric-type Endocervical Adenocarcinoma: a Population-based Cohort Study

This study aims to collect data of patients with Gastric-type Endocervical Adenocarcinoma from the SEER database, analyze the related prognostic factors and treatment patterns of Gastric-type Endocervical Adenocarcinoma, and explore the impact of surgical treatment on the prognosis of locally advanced Gastric-type Endocervical Adenocarcinoma.

This study aims to collect data of patients with Gastric - type Endocervical Adenocarcinoma from the SEER database, analyze the related prognostic factors and treatment patterns of patients with Gastric - type Endocervical Adenocarcinoma, and explore the impact of surgical treatment on the prognosis of locally advanced Gastric - type Endocervical Adenocarcinoma.

Study subjects: Patients diagnosed with Gastric - type Endocervical Adenocarcinoma were identified using the SEER database and SEER\*Stat 8.4.2 software. The search scope was the "SEER Research Plus Data, 17 Registries, Nov 2021 sub (2000 - 2019)" database, and the screening criteria included "Site and Morphology, Analytic Behavior Recode = Malignant" and "Site and Morphology, ICD - O - 3 / WHO 2008 Recode Site = Cervix". Patients with cervical Gastric - type Endocervical Adenocarcinoma were selected from the database.

Outcome measures: Overall survival (OS): The time from diagnosis to death of the patient.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Gastric - type Endocervical Adenocarcinoma were identified using the SEER database and SEER\*Stat 8.4.2 software. The search scope was the "SEER Research Plus Data, 17 Registries, Nov 2021 sub (2000 - 2019)" database. The screening criteria included "Site and Morphology, Analytic Behavior Recode = Malignant" and "Site and Morphology, ICD - O - 3 / WHO 2008 Recode Site = Cervix". Patients with Gastric - type Endocervical Adenocarcinoma in the database were selected.

Exclusion Criteria:

* Patients with a survival time of 0 or unknown.
Cognitive Behavioral Therapy, Self-Efficacy, and Depression in Persons With Chronic Pain

The investigators are exploring the role of Cognitive Behavioral Therapy (CBT), a treatment for depression, on self-efficacy (feeling empowered to accomplish a given task) and depression in persons with chronic pain and depression. Past research has shown that persons with chronic pain show improvement in self-efficacy and depression scores when they are using CBT. The Pain rehabilitation Center (PRC) at Mayo Clinic is adding CBT focused groups to better understand the role of CBT on self-efficacy and depression in persons with chronic pain and depression.

Subjects will need to complete two questionnaires on admission and on discharge from the PRC program to measure self-efficacy and depression. The first is the Pain Self-Efficacy Scale (PSEQ) which is a measure of self-efficacy in persons with chronic pain. The second questionnaire is the Center for Epidemiologic Studies Depression Scale (CES-D) which is a measure of depressive symptoms in persons with chronic pain. Both scales will also be used for clinical information. Persons who score 27 or higher on the CES-D will be approached for potential consent to this evidence based project. Each patient in the PRC will participate in up to 6 CBT sessions but only persons who, upon admission, score 27 or greater on the CES-D will be studied for any changes in scores from admission to discharge.

Eligibility Criteria:
Inclusion Criteria:

* 18 and over with chronic pain and
* score of 27 or higher on CES-D scale

Exclusion Criteria:

* 17 or younger, no chronic pain,
* cognitively unable to participate in programming
Comparison of Video Consent Versus Routine Consent for Participation in Research Studies

The purpose of this study is to examine a novel technique for improving the informed consent process for participation in research by the older psychiatric population.

This study will test a new method of delivering informed consent procedures to people with schizophrenia. The study has two aims. First, it will examine the impact of a multimedia DVD-based informed consent process on the ability of participants to make decisions regarding participation in research, both after the initial presentation of information and after 1 month. Second, it will examine the association between participant personal characteristics and the benefit derived from the DVD-based informed consent process.

Participants with schizophrenia and a normal comparison group will participate in either a routinely used informed consent procedure or an enhanced, DVD-based informed consent procedure. The outcome measure, comprehension of the consent materials, including understanding of the risks and benefits of participating in the study, will be assessed in each group. It is expected that the normal control group will reach the requisite level of comprehension faster than the schizophrenia group.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of schizophrenia or no current or past major neuropsychiatric disorder (normal subjects)
* Fluency in English
* Written informed consent

Exclusion Criteria:

* Known or suspected dementia
Survey Among Healthcare Professionals and MS Patients to Assess Their Understanding of RMP Materials

Survey to be completed independently by HCPs (neurologists treating patients with MS and MS specialist nurses) and patients/caregivers.

The survey- based study is conducting amongst HCPs and patients/caregivers in selected European countries including Germany, Netherlands, Nordics (Denmark, Sweden), Spain and Croatia, plus Canada, to evaluate whether HCPs and patients/caregivers receive the educational materials and to capture their knowledge of specific Mayzent (siponimod) safety measures.

Eligibility Criteria:
Inclusion Criteria:

Physicians will be considered eligible for the survey if they meet the following screening criteria:

* Care for relapsing MS (RMS) patients
* Personally prescribed disease modifying therapies to MS patients, and;
* Have prescribed Mayzent (siponimod) in at least 1 SPMS patient.

Nurses will be considered eligible for the survey if they:

* Provide supportive care for RMS patients
* Have initiated and/or managed the use of Mayzent (siponimod) in at least 1 SPMS patient.

Patient inclusion criteria include:

- Have been initiated onto Mayzent (siponimod) to treat their MS since reimbursement

Exclusion Criteria:

-
Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of Investigational Flu Vaccine Compared to Approved Flu Vaccine in Children.

Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to \<72 Months of Age. The study was conducted during the 2013/2014 and 2014/2015 northern hemisphere influenza season.


Eligibility Criteria:
Inclusion Criteria:

* Children, males and females, healthy or at high risk of complications from influenza, between ≥6 months to \<72 months of age
* Documented consent provided by the subject's parent(s)/legal guardian(s)
* Subjects and/or subject's parent(s)/legal guardian(s) able to comply with all study procedures.

Exclusion Criteria:

* Children with history of allergy to vaccine components.
* Additional eligibility criteria may be discussed by contacting the site
Visual Mind Mapping in Nursing Education

Visual Mind Mapping in Nursing Education

In this study, by using both teaching strategies in an integrated manner, it is aimed for students to grasp the information in depth and use this information effectively in a clinical environment instead of just superficial learning. The originality of the study is that it is about vital signs with first-year nursing students. It is anticipated that the study will contribute to the literature in terms of the development of knowledge-based skills such as pulse, respiration, blood pressure and body temperature.

Eligibility Criteria:
Inclusion Criteria:

* Receiving training on vital signs for the first time
* Being a first-year nursing student

Exclusion Criteria:

* Having previously received training on vital signs
* Having class absences, not taking the final and follow-up tests