cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Prulifloxacin Versus Placebo in Traveler's Diarrhea

The objective of this pivotal Phase III study is to investigate the safety and efficacy of prulifloxacin versus placebo in the treatment of subjects with acute bacterial gastroenteritis.

This double-blind trial will compare the safety and efficacy of prulifloxacin versus placebo in adult travelers with acute gastroenteritis characterized by diarrhea with one or more of the following signs or symptoms: nausea, vomiting, abdominal pain or cramping, fecal urgency, moderate to severe gas-related symptoms, or tenesmus of ≤72 hours duration.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Acute Bacterial Gastroenteritis;
* Traveler from Industrialized Country;
* Capable of giving Informed Consent

Exclusion Criteria:

* Fever (\>100.3 degrees);
* Pregnant or Breast Feeding or Not using adequate birth control;
* Known or Suspected (co-)Infection with non-bacterial pathogen;
* Symptoms of Gastroenteritis of \>72 hours;
* Bloody Diarrhea;
* Concomitant antibacterial with activity against enteric bacterial pathogens;
* History of IBD;
* Unable/Unwilling to comply with study protocol;
* \> 2 doses of anti-diarrheal medication within 24 hours;
* Antimicrobial Treatment within 30 days
Balance and Leg Function After Hip Replacement

Task-oriented leg exercise are commonly used after joint surgeries in various hip pathologies. Based on this theory, it was hypothesized that task-oriented exercise without conventional physiotherapy can have better result in recovery of balance and leg function than with a conventional post-hip physiotherapy program after hip replacement surgery. The aim of the study was to determine the effect of task-oriented exercise on balance and leg function after total hip replacement.

Study included 40 subjects. All subjects were randomly divided into control and intervention groups. VAS scale was used to assess the pain, hip range of motion were measured using a goniometer, strength of the muscles was assessed on the Oxford 5 point scale, leg function was evaluated with modified Harris hip scale, Abili balance analyzer was used to assess static balance and Berg balance scale was used to measure dynamic balance. Intervention duration was 18 days.

Eligibility Criteria:
Inclusion Criteria:

* BMI \< 40;
* Hip coxarthrosis;
* Hip total replacement;
* Posterior incision;
* Surgery performed no more than 1 week ago;
* Ability to comprehend and execute the tasks.

Exclusion Criteria:

* Revision surgery;
* Surgery intervention for other reasons (fracture, arthritis);
* Severe cardiovascular disease;
* Vestibular disorders;
* Vision disorders;
* Proprioception disorders;
* Neurological disorders.
PK/PD of Ceftazidime Avitbatan Sodium in Children With Severe Infection

Ceftazidime avitbatan sodium is a broad-spectrum antibiotic with an antimicrobial spectrum covering resistant gram-negative bacteria. Its use in pediatric intensive care for severe infections is not unusual. Pathophysiological changes in severe sepsis can lead to significant changes in pharmacokinetics and pharmacodynamics during continuous renal replacement therapy.This research aims to study change of pharmacokinetic and pharmacodynamic in severe infection children with extracorporeal life support, thus improve the treatment of severe sepsis and sepsis shock.

This study is an observational clinical study. Subjects were recruited from children with severe infection receiving ceftazidime avitbatan sodium under routine clinical diagnosis and treatment routine. There is no control, no double-blind randomized design, and the normal treatment schedule of patients was not interfered with, and the disease risk of patients was not increased.All subjects had received at least 5 doses of ceftazidime avitbatan Sodium before enrollment.

Blood sampling time points of ceftazidime avitbatan sodium are listed as follow:

Before administration (0 min); 5,30 min,1 h,2 h,4 h and 8 h after administration, if blood purification is received, one blood sample will be collected before and after the filter at the same time point.

The concentration of ceftazidime avitbatan sodium in whole blood will be analyzed at Huashan Hospital of Fudan University.

Eligibility Criteria:
Inclusion Criteria:

* Children who are admitted in the pediatric intensive care unit receiving ceftazidime avitbatan sodium

Exclusion Criteria:

* No Informed Consent signed
* Participate in other clinical trials
Determination of the Validity of a Questionnaire to Assess the Visual Function of Preverbal Children with Operable Bilateral Ocular Pathologies

In some symmetrical pediatric ocular pathologies, the treatment is surgical with usually satisfactory postoperative results in visual terms.

However, it is often difficult to choose the right moment to operate. The main difficulty is that the child's vision is unknown since the child is still in a preverbal age.

The investigators have developed a questionnaire with the aim of quantifying the child's vision so that the decision is most justified. The items of this questionnaire were established based on the literature and were submitted to a panel of experts in ophthalmo-pediatrics. The objective of this study is to determine the internal validity and as far as possible (since there is no equivalent tool) the external validity of the questionnaire developed.


Eligibility Criteria:
Inclusion Criteria:

Common to the three groups:

* Patient aged 0 to 36 months
* Diagnosis of known ocular pathology

For patients targeted by the questionnaire:

- Patient with operable bilateral ocular pathology

For negative controls:

- Patient without ocular pathology inducing a decrease in vision

For positive controls:

* Patient with inoperable bilateral ocular pathology
* Patient without light perception

Exclusion Criteria:

* Patient with unilateral ocular pathology
* Verbal patients (able to express themselves through speech)
Effects of Global Postural Exercises Versus Specific Therapeutic Neck Exercises in Chronic Non-specific Neck Pain

This study is a randomized, parallel, blinded, clinical trial of treatments. The general objective of this study is to analyze and compare the short-term results, during a 4-week follow-up, of two different treatments in patients with chronic nonspecific neck pain.

The treatments to be applied are Global Postural Reeducation (GPR) and specific therapeutic exercise, applied during 8 treatment sessions in 4 weeks. These treatments will be applied by a physiotherapist with clinical experience in the treatment of cervical pain.

During the study, 4 evaluations will be carried out to assess the effects of the interventions on pain, disability, standing postural control and neuromuscular behavior of the cervical muscles ((1) Baseline (pre-intervention); 2) Second pre-intervention (1 week later); 3) 1st post-intervention after four sessions (1+2 weeks later); 4) Final, 2nd post-intervention (1+4 weeks later))


Eligibility Criteria:
Inclusion Criteria:

* Non-specific chronic neck pain (neck or upper shoulder pain that is not related to a known pathology or injury, with an evolution of at least 12 weeks)

Exclusion Criteria:

* Specific cause of cervical pain (systemic, traumatic, rheumatic pathology, discal pathology,...)
* Central or peripheral neurological signs
* Cognitive impairment to follow instructions during the evaluations or interventions
* History of cervical surgery
* Treatment of physical therapy in the last 3 months
* Pharmacologic treatment during the study
DEFENDOR: A Multicenter Prospective Observational Post-registration stuDy of Extimia® (INN: empEgfilrastim) to Evaluate Efficacy and saFEty in patieNts With soliD tumORs

This study was designed to evaluate the efficacy and safety of Extimia® (INN - empegfilgrastim) in reducing the frequency, duration of neutropenia, the incidence of febrile neutropenia and infections caused by febrile neutropenia in patients with solid tumours receiving myelosuppressive therapy


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent form;
2. Histologically verified diagnosis;
3. Age between 18 and 80 years;
4. If the patient had previously received chemotherapy for these indications, then it should be completed at least 30 days before the first administration of the study drug;
5. ECOG performance 0-2;
6. Haematology:

   * ANC ≥ 1,5 х 10(9) /L;
   * Platelets ≥ 100 х 10(9) /L;
   * Hemoglobin ≥ 90 g/L;
7. Biochemistry:

   * Creatinine ≤ 1,5 ULN;
   * Total bilirubin ≤ 1,5 ULN;
   * AST/ALT ≤ 2,5 ULN;
   * Alkaline phosphatase ≤ 5 ULN;
8. Life expectancy of at least 6 months from the date of the first drug administration in the study;
9. Ability of the patient to comply with the Protocol requirements.

Exclusion Criteria:

1. Documented hypersensitivity to empegfilgrastim, filgrastim, pegfilgrastim, and / or their constituent excipients: pegylated drugs, protein recombinant drugs;
2. Systemic use of antibiotics less than 72 hours before the first drug administration in the study;
3. Concurrent or less than 30 days before the start of the study, radiation therapy (with the exception of point radiation therapy for bone metastases); study;
4. Concurrent participation in clinical trials, participation in clinical trials within the previous 30 days, previous participation in this study;
5. Surgical treatment less than 21 days (3 weeks) prior to study enrollment; taking any experimental medications less than 30 days before enrollment in this study;
6. History of bone marrow or hematopoietic stem cell transplantation;
7. Presence of acute or active chronic infections;
8. Other diseases (with the exception of the main one) that could affect the assessment of the severity of the symptoms of the underlying disease: that may mask, enhance, change the symptoms of the underlying disease or cause clinical manifestations and changes in the data of laboratory and instrumental research methods;
9. Inability to administer the drug by intravenous infusion or subcutaneous injection.
Determine the Effect of Multiple Doses of AZD7325, CYP Study

To determine the effects of repeated doses of AZD7325 on the pharmacokinetic profile of a CYP3A4 substrate (midazolam and its 1' hydroxy metabolite) and a CYP1A2 substrate (caffeine and its paraxanthine \[3-desmethyl\] metabolite).


Eligibility Criteria:
Exclusion Criteria:

* Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, hematology or urinalysis as judged by the investigator and/or sponsor.
* Enrollment in another concurrent investigational study or intake of an investigational drug within 3 months or intake of an investigational drug within a period of 5 half lives of that drug prior to the screening visit
Influence of Emotions on Decision-making in Parkinson's Disease

Parkinson's disease mainly affects the dopaminergic neurons of the Substancia nigra, which project on the striatum. Neuronal death within this structure leads to a decrease in dopamine levels. Dopamine is a neurotransmitter essential to the proper functioning of the basal ganglia highly involved in the control of voluntary and involuntary movements.

It also leads to cognitive and behavioral changes. Among these changes, the investigators will mainly remember the idea of the emergence of difficulties to make the right decisions, for example at the financial, medical .... This disruption would be the result of executive dysfunction. By definition, executive functions allow us to evaluate, plan and organize our actions to achieve a goal.

Some research shows that positive emotional states are associated with greater self-confidence, greater optimism, and better regulation of our decision-making. The goal is to test whether positive emotional induction could improve decision-making in Parkinson's disease.

Listening to music would decrease anxiety levels and increase self-esteem levels. Who says Parkinson says dopamine deficiency and so the investigators can think that the investigators can help patients by inducing a positive emotion through musical stimulation.

All participants will be subject to emotional induction. They will be divided into two different conditions: either they will be induced in a positive state, or they will be maintained in a neutral state. For this, video clips (positive or neutral) containing music will be presented. Immediately after the presentation of the video, participants will have to perform the Iowa Gambling Task test. This is a sequential task to evaluate decision-making capabilities.

Eligibility Criteria:
Inclusion Criteria for patients :

* Diagnosis of the disease carried out by a hospital doctor
* Stable treatment for two months minimum.
* Mini-Mental Parkinson \> 26
* Under dopaminergic treatment

Exclusion Criteria for patients :

* other neurological or psychiatric antecedents
* anxio-depressive symptomatology
* delusional or psychotic state

Inclusion Criteria for witnesses :

* matched in age and sex
* Vision and hearing normal or successfully corrected
* Understand the French language
* general level in the test standard

Exclusion Criteria for witnesses :

* neurological or psychiatric diseases
* anxio-depressive symptomatology
Cervicitis by Iontophoresis

The purpose of the study is to:

Investigate effect of iontophoresis on managing uterine cervicitis.


Eligibility Criteria:
Inclusion Criteria:

1. All patients have vaginal discharge.
2. All patients have irregular vaginal bleeding, especially after sexual intercourse.
3. All patients have dyspareunia.
4. All patients have Lower abdominal pain.
5. Group A: 20 women will receive oral medication (antibiotic zesrosin) and hot water with antiseptic.
6. Group B: 20 women will receive medication by iontophoresis (antibiotic ceftriaxone) and hot water with antiseptic.

Exclusion Criteria:

1. Patients with a history of hypersensitivity or adverse reactions associated with the delivered drug in (ceftriaxone).
2. Patients with prior medical histories of cardiac arrhythmias or hypercoagulability should not receive the procedure near cardiac pacemakers and superficial blood vessels.
3. In the vicinity of embedded wires, stapes, orthopedic implants, and areas of skin with lesions and impaired sensation.
4. It either should not be used or used with extreme caution during pregnancy.
Effects of Self-mobilization Techniques in Chronic Thoracic Pain

A Randomized clinical trial will be conducted at Actilife physiotherapy Rehabilitation center, Horizon Hospital Lahore through a convenient sampling technique on patients who will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Group A will be treated with the self-mobilization technique of thoracic spine and Group B will be treated with thoracic stretching exercises at a frequency of 2 sets with 6 repetitions and thrice a week. Outcome measures will be NPRS, Goniometer, and Oswestry disability index for thoracic spine after 6 weeks. Data will be analyzed during SPSS software version 21.

Chronic thoracic pain is pain that originates from the cervicothoracic junction and extends to the lower thoracic vertebrae. It is caused by strain in the thoracic spine area, sustained postures of the neck and thoracic region, sitting on the computer for a long time in slouched position, or overuse of the thoracic spine. This study aims to see the effects of the self-mobilization technique of the thoracic spine on pain, range of motion, and function in patients with chronic thoracic spine pain. A Randomized clinical trial will be conducted at Actilife physiotherapy Rehabilitation center, Horizon Hospital Lahore through a convenient sampling technique on patients who will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Group A will be treated with the self-mobilization technique of thoracic spine and Group B will be treated with thoracic stretching exercises at a frequency of 2 sets with 6 repetitions and thrice a week. Outcome measures will be NPRS, Goniometer, and Oswestry disability index for thoracic spine after 6 weeks. Data will be analyzed during SPSS software version 21. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.

Eligibility Criteria:
Inclusion Criteria:

* chronic thoracic pain minimum 3 months

Exclusion Criteria:

* Soft tissues disease
* Bony disease
* Surgical history of thoracic spine
* Fracture history of thoracic spine
* Tumor
* Psychological disorders
* Traumatic injury
Interruptions, Teamwork, Stress and Patient Outcomes in the Operating Room

The operating theatre (OR) in hospitals is a highly complex working environment and can withstand a variety of stresses and strains for the surgical team. So-called "Flow Disruption Events" (FDs) with a potential risk to patient safety occur very often.

The aim of the planned study project is to determine the effects of flow disruption events in the operating theatre on patients, the OR team and the duration of the surgery. The investigators plan an observational study at two university hospital in Southern Germany. The study population includes the entire surgical team during selected surgical procedures as well as the patients treated. The planned sample size is 82 surgical procedures. The investigators intend to collect data in two surgical specialties: Urology and traumatology.

Selected surgeries are evaluated by a trained observer and the interruptions and distractions in the course of the surgery are observed with a standardized tool. In addition, non-technical skills of the OR team are recorded: all members of the OR team will complete a short standardized questionnaire that measures mental workload and stress during the procedure. Additionally, post-operative patient outcomes are recorded.


Eligibility Criteria:
Inclusion Criteria:

* Patients: Written consent, completed case
* OR Team: Written consent, at least 3 months working experience in the clinic, present for the majority of the procedure duration

Exclusion Criteria:

- OR visitors \& students
rTMS for Auditory Hallucinations Guided by Magnetoencephalography

rTMS and MEG for auditory hallucinations via self controlled clinical trials. Repetitive transcranial magnetic stimulation (rTMS) can increase or decrease cortical excitability in patients with psychosis (such as schizophrenia). Here, we conducted an open clinical trial on 60 schizophrenics with auditory hallucinations. We searched for targets through magnetoencephalography and then intervened to prove that rTMS guided by magnetoencephalography is effective for auditory hallucinations.

Before intervention, each patient was scheduled to collect three magnetoencephalogram data sessions. Apply MEG technology to calculate possible locations and determine three intervention targets. Pseudo stimulation in the first week, 5-day intervention, 3 targets per day, each target for 23 minutes, with a 30 minute interval between each target. Evaluate the scale after the first week of pseudo stimulation. Week 2-4 real stimulation, intervention 5 days a week, 3 targets per day, each target for 23 minutes, with a 30 minute interval between each target. After the end of the fourth week, evaluate the scale. And follow-up evaluations will be conducted on the 7th, 14th, 30th, 60th, and 90th days after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia with auditory hallucinations was diagnosed by DSM-IV, AHRS \>12, Take sufficient antipsychotics for at least 1 month.

Exclusion Criteria:

* current pregnancy, major medical illness affecting the central nervous system, significant neurologic disorders, intake of drugs including supplements like essential fatty acids that influence prostaglandins or niacin skin flush flash pathway metabolism, a history of suicide risk, or alcohol or drug abuse.
A Study in Patients With Myasthenia Gravis in China

This study is a multi-center, prospective cohort study designed to characterize current clinical practice, clinical and patient-reported outcomes (PROs), disease prognosis, treatment patterns and healthcare resource utilization for Chinese patients with myasthenia gravis (MG). This study will enroll patients with MG as diagnosed by physician. Approximately 1,200 MG patients are intended to be recruited from approximately 40 sites across majority of regions in China. The clinical and PROs included MGFA class, MGFA PIS, MG-ADL (Activities of Daily Living), QMG (Quantitative MG score), MG QOL-15R, EQ-5D etc. All MG patients enrolled will be followed up every 6 months until end of 2027.


Eligibility Criteria:
Inclusion Criteria:

This study will enroll patients of all ages who are diagnosed with MG of all MGFA classifications by physicians.

1. Patients must have the following data to be enrolled in this study:

   * MGFA classification
   * MG-ADL score
2. MG patients or their legal guardians/representatives are able to sign the Informed Consent Form (ICF).

Exclusion Criteria:

1. Patients aged ≥18 years with ocular myasthenia gravis (MGFA class I) lasting for more than 2 years;
2. Patients who are currently participating in an interventional clinical trial cannot be enrolled in this study.
Evaluation of Surgisis Gold Graft for Incision Reinforcement After Open Bariatric Surgery

The primary objective is to compare the effectiveness of the Surgisis Gold Graft to suture closure alone in preventing an incisional hernia after open bariatric surgery.

This will be a prospective, randomized clinical trial comparing outcomes of use of a sublay of Surgisis Gold Graft for tissue reinforcement, as compared to suture closure alone in evaluating incidence of incisional hernias. Prior to undergoing open bariatric surgery, patients will be randomized to receive either Surgisis Gold Graft or suture closure alone. Subjects will be seen for follow-up visits at six weeks, three months, six months, one year and two years post-operatively. Patients may see their primary care physician for the one and two follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

* Planned operative approach via upper midline incision with goal of weight loss
* 18 years of age or older
* Body mass index (BMI) \>= 30 kg/m2
* Documented history of non-surgical attempts at weight loss
* Patients undergoing reoperation for a failed previous bariatric procedure are eligible provided the operation is being performed for weight loss and provided at the time of reoperation there is no incisional hernia
* Patients with small, non-incarcerated, previously unrepaired umbilical hernias are acceptable provided the hernia defect is no greater than 2.5 cm in diameter

Exclusion Criteria:

* Patients with pre-existing midline abdominal wall incisional hernia or diastasis rectus
* Patients undergoing repeat bariatric surgery for complications of a previous bariatric procedure
* Patients with a previous upper midline incision found to have an incisional hernia
* Patients with connective tissue disorders known to predispose to hernia formation
* Active infection at the time of proposed surgery
* Sensitivity or religious objections to porcine products
Using Positive Pressure Ventilation for Preoxygenation During Panendoscopy.

the aim of the study is to determine if Spontaneous Ventilation with Positive Pressure Ventilation (PPV) preoxygenation allows a longer non hypoxemic apnea time during panendoscopy compared to spontaneous breathing preoxygenation.

the hypothesis is PPV extends the residual functional capacity of lung so it provides more oxygen during apnea.


Eligibility Criteria:
Inclusion Criteria:

* patient going for scheduled panendoscopy under general anesthesia

Exclusion Criteria:

* BMI upper to 35 kg/m2
* pregnancy
* requirement of jet ventilation
* tracheostomy
* acute respiratory failure: pneumonia, pulmonary embolism
* health insurance careless