cyrilzakka/clinical-trials huggingface dataset:
Evolution of Symptoms After Anterior Sacrospinofixation by Autologous Tissues

Prolapse is a pathology that can cause pelvic, urinary or sexual functional disorders and impaired quality of life. Although the use of vaginal mesh is a commonly practiced technique to correct prolapse, in recent years health officials have pointed to the lack of adequate safety and tolerability assessments of these implants. Currently, surgeons are therefore moving towards techniques without implants. The standard vaginal technique for the treatment of uterine prolapse is sacrospinofixation according to Richter. This technique can be performed without an implant, using autologous tissue.

Functional discomfort of patients is the main problem linked to the presence of prolapse. However, no study has yet evaluated the feelings of patients following the use of this sacrospinofixation technique by autologous tissues by vaginal route, which led us to set up this study.

The hypothesis is that the technique of anterior sacrospinofixation by autologous tissues improves the symptoms experienced by patients with an mid-level and / or anterior genital prolapse.


Eligibility Criteria:
Inclusion Criteria:

* women over 18
* middle and / or anterior genital prolapse (hysterocele and / or cystocele) requiring surgical correction of stage ≥ II in the POP-Q classification
* patients wanting an intervention because of the discomfort caused by the prolapse
* intervention planned by anterior sacrospinofixation by autologous tissues
* person having expressed his non-opposition

Exclusion Criteria:

* prolapse of stage \< II in the POP-Q classification, or prolapse without functional impairment
* disorders involving an unacceptable risk of postoperative complications sought after questioning of the patient (blood coagulation disorders, immune system disorders, progressive diseases, etc.)
* reduced mobility of the lower limbs (not allowing positioning for surgery)
* pregnancy or any pregnancy plan for the duration of the study
* active or latent infection
* inability to understand the information given
* person deprived of liberty, under guardianship.
Prehospital Norepinephrine and Early Mortality in Traumatic Shock

The effect of early, prehospital norepinephrine use in patients with traumatic shock on mortality is unknown. Recent existing observational evidence from single system data (US, France, Japan) are conflicting. The investigators hypothesize that prehospital norepinephrine is associated with decreased mortality when used in patients with traumatic shock.

Prehospital hypotension is associated with worse clinical outcomes in patients who sustain traumatic injuries. Administration of vasoactive medications, including norepinephrine, is not advocated in North American trauma systems due to the belief that vasopressors will worsen clinical outcomes and increase mortality. However, in European trauma systems prehospital vasopressor administration is included as part of the guidelines for the management of hypotension and hemorrhagic shock. There are multiple physiologic explanations for why prehospital vasopressor administration may be useful in patients with traumatic shock, such as providing adequate blood pressure to maintain vital signs until arrival at the trauma center, allowing adequate organ perfusion in the setting of low blood flow, and supplementing decreased hormone production in the later stages of hemorrhagic shock.

The purpose of this retrospective study is to investigate if prehospital norepinephrine administration is associated with decreased mortality in patients with traumatic shock. The investigators will collect patient data from previously collected sources of information and trauma databases from three separate locations: the TRAUMABase consortium in Paris, France; TRENAU trauma database from Grenoble, France; and the R Adams Cowley Shock Trauma Center in Baltimore, MD, USA. The investigators will perform statistical modeling to propensity score match patients that received prehospital vasopressors with patients that did not receive prehospital vasopressors and assess the association with 24-hour and 28-day mortality.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-90 years
* Blunt traumatic mechanism of injury
* Admitted to the trauma center from the scene of injury
* Systolic blood pressure during prehospital transport or at admission to the trauma center \<100 mmHg

Exclusion Criteria:

* Penetrating mechanism of injury
* No vital signs at the scene of injury
* Prehospital cardiac arrest
* Transferred to the trauma center from another hospital
A Study of Pharmacokinetic Comparison of Two Recombinant Exendin-4 Formulations in Chinese Healthy Male Subjects

Evaluation of the pharmacokinetics and safety rE-4 Injection versus rE-4 Freeze-dried Powder in healthy subjects.

The study design is an Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence Study with a washout period of 7 days. During each session, the subjects will receive a subcutaneous single dose of rE-4 (rE-4 Injection 10µg or rE-4 Freeze-dried Powder 10µg) administered 30min prior to the start time of a standard breakfast.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male adult volunteers of 18-45 years old, who can be inserted needle.
* Body mass index (BMI) of 19 to 26 kg/m2, inclusive BMI = weight (kg)/\[height(m)\]2，During Screening period body weight≥50 kg.
* Subjects are fully informed and voluntarily consent to participate in this study.

Exclusion Criteria:

* A positive result in hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), anti-hepatitis C virus (HCV) antibodies, a syphilis test, or an human immunodeficiency virus (HIV) test.
* History or presence of neurological, cardiovascular, renal, hepatic, pancreatic,gastrointestinal, pulmonary, metabolic, or musculoskeletal diseases.
* History or presence neurological disorder disease.
* Abnormal laboratory profiles, routine inspection, vitl signs and ECGs results with clinical significance.
* Participation in a clinical drug study 30 days prior to present study.
* FPG≥6.1mmol/L or \<3.9mmol/L.
* SBP\<90mmHg or \>140mmHg; DBP\>90mmHg.
* Use of any other drugs,vitamine and mineral substance.
* Blood donation more than 200 mL blood within 3 months prior to the study.
* Smoker (\>5 cigarettes/day) or alcoholist (355 ml alcohol/day).
* History or Family history of hypoglycemia.
* History of allergy or hypersensitivity.
* Subjects planning to give birth or donate sperm during the study or within 3 months after the study.
* Other unfavorable factors diagnosed by investigators.
The Neuro-protective Effects of Exercise in Children with Brain Tumors

The objectives of our proposed study are to (a) evaluate the feasibility of conducting a structured exercise program in children treated with cranial radiation for brain tumors, (b) test whether exercise results in improved thinking skills and emotional function, and (c) examine potential mechanisms of improved outcome, particularly recovery of white matter and grey matter.

Brain tumors are the leading cause of death and disability from childhood disease in developed countries. With treatment advances over the last 25 years, survival rates have improved dramatically. However, survival is often achieved at considerable cost. Cranial radiation is frequently required for effective tumor control, and is associated with significant neuro-toxicity, including white matter damage and cognitive morbidity. In order to achieve the best possible outcome for survivors, and ultimately conquer the long-term consequences of this disease, new interventions must be developed to ameliorate the neuro-toxic effects experienced by children. radiation injury can now be used to guide the development of interventions designed to rescue neural tissue. Furthermore, various new agents and activities with potential to stimulate neuro-recovery are now available. The potential value of exercise for rescuing the brain from neuro-toxic effects, for instance, has recently been reported. Next, neuro-cognitive processes that are particularly sensitive to the effects of cranial radiation have been identified and can serve as behavioral assays to test the effectiveness of these new interventions. Finally, novel neuro-imaging tools are available to perform in vivo evaluations in order to delineate potential mechanisms of neuro-recovery. We intend to integrate these new research findings to develop and evaluate a physical exercise-based intervention targeted at rescuing brain tissue of children with brain tumors from the neuro-toxic impact of cranial radiation.

Eligibility Criteria:
Inclusion Criteria:

* Survivors will be included if they are between 7 and 17 years of age.
* Survivors will be included if they either declare English as their native language or have had at least two years of schooling in English at the time of their first assessment.
* Survivors must have been diagnosed with a hemispheric or posterior fossa tumor and been treated with cranial spinal radiation.
* Survivors no more than 10 years may have elapsed between diagnosis and time of study.
* Survivors with a shunt will be included in the study, but will need to be identified prior to study on-set to discuss any specific considerations for imaging and physical activity.

Exclusion Criteria:

* are younger than 7 years (the delivery of an intervention program to young children carries challenges that make it difficult to include in an initial feasibility grant) or older than 17 years
* require sedation for MRI imaging
* is claustrophobic
* have severe neurological/motor dysfunction that would preclude safe participation in an exercise program.
Rheopheresis Blood Filtration Study for the Treatment of Dry Age-Related Macular Degeneration (AMD)

AMD is a progressive disease of the retina which is nourished by a network of tiny blood vessels. There is evidence to suggest that the flow of nutrients to the retina is impaired in patients with AMD. Rheopheresis blood filtration uses blood filters that deplete excesses of large proteins, fats and other substances from the blood, improving blood flow to the macula, potentially improving vision.


Eligibility Criteria:
* Age 50-85
* Diagnosis of Dry AMD
* BCVA between 20/32 and 20/125 in at least one eye
* Numerous large plaques (soft drusen)
* No history of HIV, Hepatitis B or C
* Elevation of certain blood factors, such as total cholesterol, fibrinogen, and IgA
Once-daily Antiretroviral Therapy in HIV-1 Infected Patients With CD4+ Cell Counts Below 100 Cells/Mcl

There are few randomized clinical trials in advanced HIV patients. This is a multicenter, randomized, open clinical trial, comparing three parallel groups, to compare the immunological reconstitution and the virological efficacy and safety of three different combinations of antiretroviral therapy given once a day (QD): tenofovir plus emtricitabine plus either efavirenz, lopinavir-ritonavir or atazanavir-ritonavir during 96 weeks in advanced antiretroviral naïve HIV-1 infected patients with less than 100 CD4+ T-cells/mm3. Primary endpoint is the median increase in CD4+ T-cell count at 48 weeks after starting HAART.


Eligibility Criteria:
Inclusion Criteria:

* Chronic HIV-1 infection
* Age 18 or more
* Antiretroviral-naive
* Baseline CD4+ count \<100 cels/mcL.
* No mutations of drug resistance at baseline (M184V/I, K65R, resistance to efavirenz or 2 or more PRAMs (L33I/F/V, V82A/F/L/T, I84V, L90M)
* Written informed consent

Exclusion Criteria:

* Hypersensibility to study drugs.
* Pregnancy or breastfeeding
* Active OI requiring admission
* Active lymphoma or malignancy (Kaposi sarcoma included)
* Cl creatinine below 30 ml/min.
* Liver failure
* Treatment with nephrotoxic drugs, immunomodulators, interleukine-2, systemic steroids or investigational products.
Improving Thrombolysis Implementation Based on Electronic Monitoring in Acute Ischemic Stroke (ITEM)

A cluster randomized controlled trial will be conducted. Hospitals in Zhejiang Province, China, will be randomized into two arms (1:1): an intervention arm and a control arm.

Hospitals in the intervention arm will receive a multilevel intervention based on the AACTT theory, whereas hospitals in the control arm will receive no intervention and maintain routine care. All the hospitals will receive electronic monitoring. Hospitals with no stroke center or with \<20 cases received thrombolysis per year will be excluded from the study.


Eligibility Criteria:
Inclusion Criteria:

1. Patients presented with clinical signs of acute ischemic stroke within 4.5 hours of stroke onset
2. Patient's age is \>18 years

Exclusion Criteria:

Contraindication for intravenous thrombolysis
Effectiveness of Spot-on ™ to Prevent Inadvertent Perioperative Hypothermia and Their Consecuences

Using the spot-on device for monitoring core body temperature during colon laparoscopic surgery and prevent non-therapeutic hypothermia.

Take active measures to prevent non-therapeutic hypothermia during the laparoscopic colon surgery. We improve these measures using heat conductive air warm blankets placed under and o over the patient.

Perform monitoring core body temperature every 15 minutes by spot-on device compared with standard nasopharyngeal probe.

Eligibility Criteria:
Inclusion Criteria:

* All patients that need a colorrectal laparoscopic surgery

Exclusion Criteria:

* Use of antagonist of Calcium
* Alergy to medications
* History of Malignant Hipertemia
* Laparosocopy surgery ≥ 120 min
* Temperature previous surgery over 38ºC
* Taking chronic steroids
Prevalence of Dental Caries in Preterm Birth Children Aged 2-5 Years in Primary Dentition

The purpose of the study is to determine the prevalence of dental caries in preterm birth children aged 2-5 years in primary dentition.

The purpose of the study is to determine the prevalence of dental caries in preterm birth children aged 2-5 years in primary dentition.

PICO format:- Population (P) = preterm children aged 2-5 years attending Cairo University Children's Hospital "Abo El-Rish" at El-Monira, Cairo, Egypt.

Outcome (O) =prevalence of dental caries

Eligibility Criteria:
Inclusion Criteria:

* Children aged 2-5 years old.
* Presence of primary teeth only.
* Children born preterm at gestational age of 6,7 and 8 month.

Exclusion Criteria:

* Children with disability or mental disorders.
* Children with immune compromising conditions.
* Hospitalized and chronically ill children.
Preoperative Pulmonary Systolic Pressure and Outcome After Non-cardiac Surgery:Threshold Analysis

The linear or nonlinear relationship of pulmonary systolic pressure and cardiovascular and kidney outcome after non-cardiac surgery is unknown. This study is to explore the relationship of the two and try to identify the possible threshold of pulmonary systolic pressure for major cardio-vascular events after non-cardiac surgery.

The linear or nonlinear relationship of pulmonary systolic pressure and cardiovascular and kidney outcome after non-cardiac surgery is unknown. This study is to explore the relationship of the two and try to identify the possible threshold of pulmonary systolic pressure for major cardio-vascular events after non-cardiac surgery.

Patients with preoperative cardio-echogram under going non-cardiac surgery were collected. The postoperative major cardiovascular, cerebral and kidney events were also identified and collected. Other data including peri-operative information and surgeries and anesthesia data were gathered.

Logistic regression models were built and selected. Independent risk factors relative to postoperative major cardiovascular and cerebral events were screened and identified. Odds ratio, relative risk and relative risk ratio of varies dichomitus cut points were calculated, trend breakpoint were identified, propensity score analysis were also done for causal inference.

Eligibility Criteria:
Inclusion Criteria:

non-cardiac surgery patients with preoperative echocardiography records

Exclusion Criteria:

electronic records missing or peri-operative data missing
Wound Closure Techniques in Primary Spine Surgery

The Researchers are trying to determine if there is a difference in blood flow around a wound site when comparing three different types of wound closure techniques.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Primary diagnosis of spinal stenosis
* Surgical indication for 1 or 2 level posterior spinal decompression or fusion

Exclusion Criteria:

* Pregnant or Breastfeeding
* Previous posterior spinal surgery
* Systemic corticosteroid use
* Long-term anticoagulation treatment
* Diagnosis of diabetes mellitus
* Diagnosis of peripheral arterial disease
* Current smoker
* Active infection of any kind or chronic infection with HIV, Hepatitis C, or Syphilis
* Iodine Allergy
This Study is to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of HSK47388 in Healthy Volunteers

This is a single-center, randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability and PK of HSK47388 in healthy adult participants and preliminarily evaluate the PD of HSK47388


Eligibility Criteria:
Inclusion Criteria:

1. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects.
2. Adult males and females between ≥ 18 and ≤ 55 years (inclusive) at Screening.
3. Able and willing to attend the necessary visits to the study site

Exclusion Criteria:

1. Participants with any disease history that may affect the safety evaluation or in vivo process of IP as judged by the PI or delegate, including central nervous, cardiovascular, digestive, respiratory, urinary, blood, immune and endocrine diseases. Participants with childhood asthma (resolved) can be included at the discretion of the PI.
2. Underlying physical or psychological medical condition that, in the opinion of the PI or delegate, would make the participant unlikely to comply with the protocol or complete the study per protocol.
3. Participants who may not be able to complete the study for other reasons, cannot comply with the requirements of the study, or are unsuitable to participate in the study as judged by the PI or delegate.
the Safety and Effectiveness of Protein Supplements on Cancer Patients With Nutritional Risk and Malnutrition

Nutritional risk and malnutrition is common in cancer patients, which is one of the significant factors affecting the overall survival, toxicity during anticancer treatment, and quality of life among patients with cancer. Previous studies have shown that the increased protein intake can stimulate muscle synthesis, and improve muscle mass, strength, function, overall survival, and quality of life. The current study is going to investigate the effectiveness and safety of protein supplements on patients with cancer, in order to provide a reference for further nutrition treatment.

An anticipated total of 100 participants will randomly assigned to receive either a 20-gram protein supplement per day or nutrition counseling to increase the protein intake. there will be a total of 3 study visits, and dietary assessment and blood sample collection will occur at every study visit. Intention-to-treat analysis (ITT) and per-protocol analysis (PP) will be used in statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* • Age\>=18years old;

  * Initial treatment patients with lung/gastrointestinal/esophageal cancer
  * Patients with nutritional risk (NRS-2002≥3) ;
  * Patients are able to provide written informed consent.

Exclusion Criteria:

* • People who are allergic to whey protein.

  * Participants received any drugs or supplements known to influence the outcomes, such as protein powder, anabolic steroids, or glucocorticoids before the 3 months preceding the study.
  * Participants with gastrointestinal bleeding or intestinal obstruction, or any contraindication for oral intake
  * Concurrent severe cardiac disease, liver and renal failure, which may significantly interfere with study compliance.
  * Participants with electronic or mental device.
  * Women in pregnancy or lactation period
Study of Liberty Program on Women's Health and Intimate Partner Violence

Previous studies indicated high frequency of abuse in families and its consequences. Considering the importance of interventions such as educational interventions, in order to increase women's abilities to prevent abusive behaviors, the current research aims to determine the impact of an Liberty program on prevention of violence against women and propose solutions for less damages and consequences.


Eligibility Criteria:
Inclusion Criteria:

* Be married,
* Be under the aegis of Foundation at least for a year,
* Have at least one child.

Exclusion Criteria:

* Not participating in two educational sessions,
* Not being interested in continuing the cooperation.
Virologic and Immunologic Characteristics of Severe Mpox in Persons With Advanced HIV

The purpose of this study is to examine the extent of mpox viral spread and immunologic markers in people with advanced HIV. Study findings will enhance knowledge of mpox pathogenesis in severely immunocompromised people, which can inform treatment and prevention of severe illness and deaths associated with mpox in people with advanced HIV.

Primary objective:

Describe the relationship between the systemic immunologic response and the persistence and replication competence of mpox virus at rash lesions, in blood, and at mucosal sites over the course of mpox illness among patients with advanced HIV.

Secondary objectives:

* Describe the association between clinical outcomes and virologic and immunologic parameters among patients with severe mpox and advanced HIV.
* Survey for emergence of antiviral drug resistance among MPXV isolates collected over time during mpox illness among patients with advanced HIV.
* Characterize the effects of antivirals to treat mpox and/or HIV infection on virologic and immunologic parameters among patients with mpox and advanced HIV.
* Assess persistence and replication competence of mpox virus in the oropharynx and rectum over the course of mpox illness among patients with advanced HIV.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years; AND
* HIV infection with CD4 count \< 200 cells/uL; AND
* Probable or confirmed mpox (does NOT need to be a new diagnosis); AND
* Hospitalized while symptomatic from mpox, for reasons other than (or in addition to) infection prevention and control

Exclusion Criteria:

* Inability of the individual or appropriate proxy to provide informed consent.
* In the judgment of the clinical treating team, has a medical condition or other factor that might affect their ability to participate in the evaluation.