cyrilzakka/clinical-trials huggingface dataset:
Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine (CAIV-T) in Healthy Children

To perform a variety of assays on blood, nasal washes, and cells obtained from healthy children for the purposes of further investigation of immune responses generated by influenza virus vaccine, trivalent, types A and B, live, cold-adapted (liquid CAIV-T; Wyeth Lederle Vaccines, Marietta, PA).

• To assess nasal swab specimens to detect vaccine virus shedding.

This was a phase II, prospective, randomized, partially-blinded, placebo-controlled, outpatient study conducted at multiple sites throughout the US in healthy children aged 6 months to less than 36 months. Parents/guardians of subjects were asked to read and sign the informed consent before any study-related procedures were performed. Subjects at each study site were sequentially assigned to 1 of 2 separate blood sample groups referred to as "cellular immunity" or "antibody secreting cell". Subjects within each blood sample group were then randomized 1:1:1:1 to receive a single intranasal dose of CAIV-T 10\^7 FFU per dose, CAIV-T 10\^5 FFU per dose, placebo or a commercially-available injectable trivalent influenza vaccine (TIV).

Eligibility Criteria:
Inclusion Criteria:

* children at least 6 months of age and less than 36 months of age at the time of enrollment, and in good health as determined by medical history, physical examination and clinical judgement;
* whose parent/legal guardian has provided written informed consent after the nature of the study has been explained;
* who, along with their parent or guardian, will be available for the one month duration of the trial (from enrollment to study completion);

Exclusion Criteria:

* whose parents or guardians are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period;
* with any serious chronic disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease;
* with Down's syndrome or other known cytogenetic disorders;
* with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids, or cytotoxic agents (see Section 4.2.2);
* have an immunosuppressed or an immunocompromised individual living in the same household;
* with a documented history of hypersensitivity to egg or egg protein or any other component of the study vaccine, placebo or TIV;
* who, at anytime prior to study enrollment, receives any influenza vaccine (commercial or investigational);
* with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results.

Note: A pregnant household member is not considered a contraindication to enrollment.
Effect of Progressive Isolated Core Stability Training

Forty-two adolescent female volleyball athletes (16.0±1.4 years) were randomly divided into two groups. Group 1 was the training group and, in addition to the routine volleyball training programmes, underwent an 8-week (3 days/week) progressive core stability training programme. Group 2 was the control group and only did routine volleyball training, with no core stability training.

Main outcome measures: Shoulder IR and ER strength, medicine ball throw (MBT), modified push up (MPU) and closed kinetic chain (CKC) upper extremity stability tests were used to evaluate physical performance.

Most studies have focused on the effects of core stability training on injury prevention and physical performance for the lower extremities . However, little is known about its effect on upper extremity performance. Previous studies suggest that core strengthening could enhance upper extremity physical performance because it might lead to more efficient use of the extremity muscles . Core weakness in overhead athletes with shoulder pain. Insufficient power generation by the core muscles might overload the shoulder girdle to compensate for altered biomechanics during throwing, and this overload made the shoulder prone to sport injuries. A systematic review has suggested, however, that isolated core stability training cannot be the primary component of athletic performance enhancement and that the variability in exercise training protocols, testing methods, study population and sample size among the available studies leads to difficulties in understanding whether or not core stability training enhances physical performance.

There has been no study in the literature investigating the effect of progressive isolated core stability training on upper extremity performance in adolescent overhead athletes. This study therefore sought to investigate the effects of progressive isolated core stability training on shoulder internal (IR) and external rotator (ER) strength and upper extremity physical performance in female adolescent volleyball players. Hypothesized that core stability training would enhance shoulder rotator strength and upper extremity physical performance in these athletes.

Eligibility Criteria:
Inclusion Criteria:

- be between the ages of 12 and 16, enrolled in a similar training program and agree to participate in the study

Exclusion Criteria:

* Having any surgery / serious pathology of the spinal column,
* Have had a lower / upper extremity injury in the last 3 months,
* Sports age is less than 5 years,
* Severe orthopedic / systemic discomfort during training,
* Absence from training for more than 3 sessions
* Family disapproval or reluctance to study
* Minimal Q-DASH score (0-25)
Knowledge, Attitudes, and Practices of Operative Vaginal Birth Among Obstetric Providers in Egypt

The goal of this observational study is to evaluate the knowledge, attitudes, and practices of operative vaginal birth among obstetric providers in Egypt. The main questions it aims to answer are:

* What is the level of knowledge among obstetric providers regarding operative vaginal birth?
* What are the attitudes and practices of obstetric providers towards operative vaginal birth?

Participants will:

* Complete a detailed questionnaire assessing their knowledge, attitudes, and practices related to operative vaginal birth.
* Provide demographic information to contextualize their responses.


Eligibility Criteria:
Inclusion Criteria:

* Licensed Obstetricians: Only obstetricians who are currently licensed to practice in Egypt.
* Active Practice: Obstetricians who are actively practicing in hospitals or clinics in Egypt.
* Experience: Obstetricians with a minimum of one year of experience in obstetrics and gynecology.
* Consent: Willingness to participate and provide informed consent.
* Language: Ability to understand and complete the questionnaire in English.

Exclusion Criteria:

* Non-Obstetricians: Healthcare providers who are not obstetricians.
* Inactive Practice: Obstetricians who are not currently practicing in Egypt.
* Insufficient Experience: Obstetricians with less than one year of experience in the field.
* Non-Consent: Individuals who do not provide informed consent to participate in the study.
* Language Barrier: Obstetricians who are unable to understand and complete the questionnaire in English.
Respiratory Proprioceptive Neuromuscular Facilitation Technique in Chronic Pulmonary Obstructive Disease Patients.

The purpose of this study is to evaluate the impact of PNF technique combined with aerobic exercises among COPD patients in a clinical setting. Previous literature has evaluated this technique in ventilated patients but in clinical setting specifically in Pakistan, this invention therapy has not been implied in COPD patients.

Chronic Obstructive Pulmonary Disorder manifested as breathlessness, respiratory difficulties and persistent cough is one of the biggest causes of mortality around the world. 2.1% of Pakistani population has COPD. Proprioceptive neuromuscular facilitation is used as management technique in which muscle stretching promotes chest wall mobility and restores regular breathing rhythm. In previous studies, PNF technique combined with aerobic exercises has been utilized to improve Pulmonary functions in COPD patients. But the sample size of these studies was small and participants were ventilated patients, hence not targeting the diaphragm. Our study shall evaluate the impact of PNF technique combined with aerobic training on the Pulmonary function of COPD patients in the clinical setting.

Eligibility Criteria:
Inclusion Criteria:

* Both male \& female participants.
* Diagnosed COPD patients
* Age 35-60years
* Ratio of forced expiratory volume in first second \& forced vital capacity(FEV1/FVC \<0.7,30%\<FEV1\<80%
* Stable clinical condition.

Exclusion Criteria:

* Serious conditions with require supplementary oxygen or ventilator/support devices.
* COPD exacerbation within last 4weeks
* Patients with recent chest wall trauma, surgery or deformity.
* Patient with neurological, psychological, musculoskeletal, or cardiac medical history.
* Pulmonary disease with physical impairment.
* Inability to follow the pulmonary rehabilitation program.
SARS-CoV-2 Antibodies and Virus Neutralisation in a Cohort Vaccinted Against COVID-19

Analysis of SARS-CoV-2 antibodies and serum virus neutralisation in vaccinated heath care personnel. Analysis of virus neutralisation as a function of age, gender, and history of COVID-19 infection.

This study is an observational study with subsequent use of coded biological material. Sera of Universitiy Hospital of Zurich (USZ) personnel vaccinated with BNT162b2 (BioNTech/Pfizer) was analyzed for SARS-CoV-2 specific antibodies and virus neutralization.

Serum was analysed for virus-specific IgG and IgA using ELISA kits from Euroimmun (Kriens, Switzerland) according to the manufacturer's instruction. IgG was determined with the quantitative Anti-SARS-CoV-2 Quantivac kit and IgA was determined with the semi-quantitative Anti-SARS-CoV-2 kit The kits determine antibodies against the spike-1 protein. The sera were not diluted and not heat-inactivated prior to testing. The developed 96-well plates were analysed by reading absorbance at 450 nm using an ELx808 ELISA reader from BioTek Instr. Inc.

In addition, a SARS-CoV-2 neutralization assay was developed at the department. In this Tissue Culture Infection Dose (TCID) assay, Vero cells were infected with live SARS-CoV-2, and sera were added at various dilutions to test the potential to neutralize viral infection. The assay was conducted in a biosafety level 3 lab. Briefly, VERO-E6 cells were grown overnight to ca. 80-90% adherence in flat-bottom 96-well cell culture plates. The SARS-CoV-2 was then mixed in round-bottom 96 well titre plates with 2-fold serial dilutions of serum and incubated. The virus-serum mixture was then added to the VERO-E6 cell, and the cultures were incubated again. After three days, the cultures were fixed by addition of paraformaldehyde and stained with crystal violet for visualisation of cytotoxicity. The highest serum dilution preventing infections of the cells was defined as the neutralization titre.

Eligibility Criteria:
Inclusion Criteria:

* Employed at the USZ Department of Dermatology
* Vaccinated against Covid-19 at USZ
* Male and female persons of any age
* Serum samples collected in 2020 or until June 11th 2021
* The subject was informed and gave his/her consent to the research project (non-coded samples and data) and to publish data obtained from analysis of own biological samples

Exclusion Criteria:

* Known clinical relevant disease, e.g. immune suppressed by drugs or disease
* Documented objection of subsequent use and publication of biological samples and personal health data
Effect of Cefazolin and Normal Saline Irrigation on Surgical Site Infections (SSIs)

This study conducted to assess the effects of normal saline or cefazolin irrigation on the incidence of SSIs.

Hypothesis:

Normal saline or cefazolin irrigation decreases the incidence of SSIs.

All pregnant women who underwent cesarean after 6 hours passed their rupture of membrane and attended to Shariati Hospital of Bandarabbass were eligible for our study.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women
* 6 hours passed their rupture of membrane
* needed to undergo cesarean

Exclusion Criteria:

* allergy to penicillin
* allergy to cefazolin
* history of immunosuppressive drug use
* gestational diabetes mellitus
* preeclampsia
Study of CryoSpray Ablation(TM)to Determine Treatment Effect, Depth of Injury, and Side Effects in the Esophagus.

The purpose of this study is to evaluate the treatment effect, depth of injury, and side effects using technology involving the spray of liquid nitrogen through a catheter (CryoSpray AblationTM, "CSA" or "cryospray therapy") onto healthy tissue via esophagogastroduodenoscopy (EGD) using surgical resection specimens from subjects undergoing esophagectomy.

The proposed study is a single center study consisting of no more than 10 subjects who are undergoing scheduled esophagectomy for reasons unrelated to the study. Subjects will be divided into 2 Groups in a sequential fashion based on the time of enrollment (Subject 1 in Group1, Subject 2 in Group 2, Subject 3 in Group1, Subject 4 in Group 2, etc). Potential study subjects will be referred from clinical practice. After entry into the study with written informed consent, subjects will be scheduled for the EGD with cryospray ablation treatment 7 days prior to the expected esophagectomy date.

All subjects will receive narcotic analgesics to control symptoms.

Endpoints related to pathology will be assessed by two independent reviewers, one from the Institution's Department of Pathology, and one from an independent Pathology lab chosen by the sponsor. The reviewers will evaluate the pathology slides to assess maximal extent of depth of injury, side effects, and pathological changes associated with CSA. All reviewers will be blinded to the treatment conditions of the specimens.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years of age
* Esophagectomy planned based on clinical situation not related to this study.
* Deemed operable based on institutional criteria.

Exclusion Criteria:

* Pregnant
* Esophageal stricture preventing passage of endoscope or catheter.
* Known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines.
* Refusal or inability to give consent.
* Concurrent chemotherapy.
* Prior or concurrent endoscopic ablation therapy within 4 cm from the CSA treatment area including, but not limited to, cryospray therapy, laser treatment, photodynamic therapy, multi-polar electro coagulation, endoscopic mucosal resection, radiofrequency ablation, or argon plasma coagulation.
* Prior radiation therapy which involved the esophagus.
Acupuncture for QoL and Symptoms in Gastric Cancer During Adjuvant Chemotherapy

In the investigator's pilot study(NCT 03753399), a trend of improvement of quality of life, as well as release of symptoms, in gastric patients in acupuncture groups was indicated. This study will evaluate the efficacy of acupuncture on QoL in gastric cancer patients undergoing postoperative adjuvant chemotherapy with more samples. Enrolled participates will randomly receive high-dose acupuncture, low-dose acupuncture or non-acupuncture during the first 3 cycles of adjuvant chemotherapy after resection.


Eligibility Criteria:
Inclusion Criteria:

* 1.Pathologically diagnosed with gastric cancer or esophagogastric junction cancer after R0 resection and D2 lymph node dissection;
* 2.Pathological stage II or stage III
* 3.Without tumor recurrence confirmed by image examination;
* 4.No chemotherapy after surgery, planning to accept at least 3 cycles of adjuvant chemotherapy;
* 5.Age:18\~75 years old
* 6.ECOG score≤ 2
* 7. Normal organ function, including: 7.1 Bone marrow function: absolute neutrophil count (ANC)≥1.5×10e9/L, platelet (PLT)≥100×10e9/ L,hemoglobin (Hb)≥90g/L; 7.2 Kidney function: Serum creatinine (Scr)≤1.5mg/dl(133μmol/L), or creatinine clearance rate (Ccr)≥60ml/min; 7.3 Liver function: Total bilirubin (TB)≤1.5×upper limit of normal value (ULN), Alanine transaminase (ALT)≤2.5×ULN, Aspartate transaminase (AST)≤2.5×ULN;
* 8. Can understand the study well and finish the questionnaires in this study; 9. With the written informed consent.

Exclusion Criteria:

* 1. Can not finish the baseline assessment;
* 2. Needle phobia;
* 3. Currently diagnosed with psychiatric disorder (e.g., severe depression, obsessive-compulsive disorder, or schizophrenia);
* 4. History of autoimmune diseases, hematological diseases or organ transplantation, or long term use of hormones or immunosuppressors;
* 5. Implanted with heart pacemaker;
* 6. Has accepted neoadjuvant radiotherapy before surgery;
* 7. Planning to accept adjuvant radiotherapy after surgery;
* 8. With active infection;
* 9. Acupuncture treatment within the previous 6 weeks;
* 10.Pregnant or lactating women.
Drug-Drug Interaction Study to Evaluate the Effects of Ecopipam on the Pharmacokinetics of Multiple Substrates for Drug Metabolism and Transport

This is a single center, open-label, fixed sequence Phase 1, drug-drug interaction (DDI) study in healthy subjects.

Following a Screening period, eligible subjects will be enrolled sequentially to one of three cohorts to receive a single dose of probe substrate(s), followed by repeated titrated doses of ecopipam twice daily (BID) (with subjects in Cohort 3 also receiving a single dose of ecopipam and probe substrates on Day 4 prior to titration). After steady-state ecopipam dosing is reached, ecopipam will be co-administered with a single dose of probe substrate(s) (with continuation of ecopipam BID (every 12 h) dosing during the blood sampling period for the respective probe substrates), followed by an ecopipam tapering period and clinic discharge assessments.

Eligibility Criteria:
Inclusion Criteria:

* Male subjects or female subjects of non-childbearing potential
* ≥18 and \<55 years of age at the time of consent
* BMI \>18.5 and \<30 kg/m2 and a weight of ≥50 kg for males or ≥45 kg for females
* Subjects must be healthy, as determined by the Investigator, based on medical history, physical examination, ECG, and standard panel of blood and laboratory tests at Screening.
* Sexually active males must use a double barrier method of contraception during the study and for at least 90 days after the last dose of study drug
* Male subjects must be willing not to donate sperm until 90 days following the last study drug administration

Exclusion Criteria:

* Personal or family History of significant medical illness
* Clinically significant abnormalities on screening tests/exams
* History of or significant risk of committing suicide
* Donation of plasma within 7 days prior to dosing
* Donation or significant loss of blood within 30 days prior to the first dosing
* Major surgery within 3 months or minor surgery within 1 month prior to admission
* Use of prohibited prescription, over-the-counter medications or natural health products
* Alcohol-based products 24 hours prior to admission
* Female subjects who are currently pregnant or lactating
* Positive pregnancy test
* Use of tobacco or nicotine products within 3 months prior to Screening
* Significant alcohol consumption
* History of drug abuse within the previous 2 years, or a positive drug screen
* History of allergy to study medications
* Undergoing abrupt discontinuation of alcohol or sedatives
* Not suitable for study in the opinion of the Principal Investigator
Predictive Model for High-Flow Nasal Cannula Failure in COVID-19-related Acute Hypoxemic Respiratory Failure Based on Metabolomics and Clinical Data

The aim of this prospective observational cohort study is to develop a predictive model for high-flow nasal cannula (HFNC) failure in patients with acute hypoxemic respiratory failure (AHRF) caused by SARS-CoV-2. By combining clinical data and metabolomic profiles, the study seeks to answer:

- Can integrating clinical parameters with metabolomic markers enhance the prediction of HFNC failure in AHRF patients?

Participants with AHRF due to SARS-CoV-2 receiving HFNC under standard-of-care protocols will be monitored until hospital discharge or death. Blood samples for metabolomic analysis will be collected at inclusion.

This prospective observational cohort study focuses on developing and validating a predictive model for HFNC failure in patients with SARS-CoV-2-related AHRF, combining clinical parameters and metabolomic profiling. Patients received standard-of-care therapy based on hospital protocols, with clinical data and plasma samples collected at inclusion (T0) for laboratory and metabolomic analyses.

The study consists of two cohorts: a Training Cohort (March 2020 to April 2021) for model development and a Validation Cohort (May 2021 to October 2021) for model validation and external testing. HFNC outcomes were classified as success or failure, with failure defined as requiring orotracheal intubation (OTI). Advanced machine-learning techniques were employed for feature selection and model optimization, targeting precise integration of clinical and metabolomic data.

This model seeks to enhance early identification of HFNC failure risk, enabling timely interventions and personalized management in critically ill AHRF patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years old) with acute hypoxemic respiratory failure (AHRF) confirmed as secondary to SARS-CoV-2 infection via PCR testing.
* Requirement for high-flow nasal cannula (HFNC) initiated within 48 hours of hospital admission.

Exclusion Criteria:

* Patients under the age of 18
* Patients with active "do not resuscitate" (DNR) orders at the time of inclusion.
Hemodynamic Optimization During Major Urological Surgery

In this prospective observational study investigators aim to seek for any possible correlation between the venous to arterial carbon dioxide difference (pCO2 gap) at the end of surgery and the percentage of time spent above a predefined threshold of stroke volume (SV) andn mean arterial pressure (MAP).

During major urological surgery (i.e. cistectomy) investigators will use a minimally invasive hemodynamic monitoring system (Flotrac - Vigileo, Edwards ) to guide fluid therapy and vasopressors administration. More specifically stroke volume target will be defined as the maximum SV after a series of fluid boluses, with a 10% tolerance. MAP was considered adequate if above 65 mmHg. After the induction of anesthesia, then each hour during surgery until the end of surgical procedure investigators will assess the time of adherence to the hemodynamic protocol (in terms of both SV and MAP) and the correspondent pCO2 gap. Investigators expect to find an inverse proportionality between the two parameters explored.

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for major urological surgery
* ASA 1-2-3

Exclusion Criteria:

* pregnancy
* obesity with a BMI \> 35
* controindications to central venous catheter positioning
* end-stage renal disease