cyrilzakka/clinical-trials huggingface dataset:
CMTS0929 for Clostridioides Difficile Infection

This is a prospective, open-label, single-arm study to explore the safety and the efficacy of CMTS0929 for patients with Clostridioides difficile infection (CDI).

At least 12 subjects who meet all the inclusion criteria but do not meet any exclusion criteria will be enrolled in this study. Data of demographic characteristics and clinical data will be collected. After treatment, they will enter the follow-up period for safety and efficacy evaluation.

Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to enter the study:

1. At the time of informed consent, the age is between 18 and 75 years old (inclusive), including both males and non - pregnant, non - lactating females.
2. At the time of screening, meet the diagnostic criteria for Clostridioides difficile infection: a)There is a medical record proving a confirmed CDI before screening (laboratory tests show positive results for Clostridioides difficile or its toxins): positive results in Clostridioides difficile toxin detection (determined by EIAs) or colonoscopy indicating pseudomembranous colitis; or positive GDH with negative toxin results, along with obvious predisposing factors and diarrhea. b)Have an episode of CDI - related diarrhea, that is, having at least 3 bowel movements per day for at least two consecutive days and the stools are unformed (Bristol Stool Form Scale score of 6 - 7).
3. The subject or their legal representative provides informed consent, fully understands the purpose of the study, can communicate well with the researcher, and can understand and comply with all the requirements of this study.

Exclusion Criteria:

Subjects meeting any of the following exclusion criteria must be excluded from the study:

1. Subjects with immunodeficiency (such as HIV infection, or absolute neutrophil count \< 0.5×10⁹/L, or total lymphocyte count \< 0.5×10⁹/L, etc.), or those using immunosuppressants, or those using medium - to high - dose steroid hormones (≥20 g/d prednisone or equivalent steroid hormones).
2. Subjects with rectal outlet obstruction (such as rectal mucosal prolapse) or significant intestinal stenosis that, as evaluated by the researcher, cannot undergo cTET.
3. Before screening, subjects are diagnosed or clinically suspected of having an infection with other pathogenic microorganisms in addition to Clostridioides difficile.
4. Within 6 months before screening, subjects have undergone major abdominal surgery (excluding laparoscopic cholecystectomy or appendectomy), or have previously undergone partial or total colectomy, or partial small intestine resection, or gastroduodenal surgery.
5. At the time of screening, the subject or legal representative refuses to use effective contraceptive measures within 3 months after the last treatment.
6. As judged by the researcher, the subject is not suitable to participate in this clinical study, or participation in this clinical study cannot guarantee the rights and interests of the subject.
Impact of Probiotics on Gut Microbiome During Antibiotic Prophylaxis in Elective Orthopedic Surgery

This study aims to evaluate whether probiotics can help maintain a healthy gut microbiome in patients receiving prophylactic antibiotics during elective orthopedic surgery. Antibiotics, while effective in preventing infections, can disrupt the balance of gut bacteria, leading to dysbiosis. The study hypothesizes that the use of probiotics during the perioperative period can prevent or reduce this disruption, supporting gut health and overall well-being. The research seeks to answer whether combining probiotics with routine antibiotic prophylaxis can preserve gut microbiome balance and improve patient outcomes.

This double-blinded, randomized controlled trial aims to evaluate the effect of probiotics on maintaining gut microbiome balance in patients undergoing elective orthopedic surgery who receive routine prophylactic antibiotics. Antibiotics, while essential for reducing the risk of surgical site infections, are known to disrupt gut microbiota, leading to dysbiosis, an imbalance in microbial composition. Dysbiosis can compromise gut health, reduce microbial diversity, and impair metabolic functions essential for recovery.

The study explores whether a dual-strain probiotic with Human Milk Oligosaccharides (HMO) can prevent or minimize dysbiosis during the perioperative period. By comparing patients receiving routine antibiotics alone with those receiving antibiotics plus probiotics, this trial seeks to identify if probiotics can preserve gut microbial diversity and function.

To assess the impact, fecal samples collected at specific time points will undergo detailed microbiome analysis, including metrics such as microbial richness, diversity, and such. Secondary measures will evaluate the broader effects on patient well-being during the recovery period.

This study is designed to provide evidence for the potential role of probiotics as an adjunct therapy to maintain gut health during antibiotic use, offering a novel approach to improving post-surgical recovery and patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged between 18 and 65 years
* Scheduled for elective low-risk orthopedic surgery (carpal tunnel release, A1 pulley release, knee arthroscopic surgery).

Exclusion Criteria:

* History of infection or antibiotic use within the last 12 weeks.
* Use of routine probiotics, vitamins, or herbal supplements in the last 4 weeks.
* Known allergy to beta-lactam or cephalosporin antibiotics.
* History of autoimmune disease, uncontrolled systemic disease, or chronic inflammatory conditions (e.g., systemic lupus erythematosus, rheumatoid arthritis).
* History of chronic intestinal diseases such as small intestine bacterial overgrowth (SIBO), irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), or celiac disease.
* Increased risk of infection due to medical comorbidities or use of immunosuppressive drugs.
Does Clomiphene Citrate Used for Induction of Ovulation Effect Levels of AMH and Inhibin B

100mg clomiphene citrate used for ovulation induction. The investigators take blood sample at 3 and 10 days of menstruation and count AMH and inhibin B.

100mg clomiphene citrate used for ovulation induction. The investigators take blood sample at 3 and 10 days of menstruation. AMH and inhibit B level will be measured in serum. We want to search relation of AMH, inhibin b and ovulation induction.

Eligibility Criteria:
Inclusion Criteria:

* Infertility treatment

Exclusion Criteria:

* Previous ovarian surgery
* Single functioning ovary
Yogurt for Prevention of Chronic Inflammation

The objective of this study is to conduct a randomized cross-over dietary intervention in adult women who are overweight or obese to compare how yogurt and a control food affect biomarkers of inflammation and intestinal health.


Eligibility Criteria:
Inclusion Criteria:

* healthy premenopausal women age 21-55
* BMI ≥ 25 kg/m2
* not taking medication to control hypertension (e.g. anti-hypertensives or diuretics)
* resting blood pressure \<140/90 mmHg
* stable body weight for past two months
* willing to maintain a normal exercise level (in general)
* willing to avoid exercise and smoking (or other forms of nicotine intake) for 24 h prior to blood collection
* willing to avoid caffeine for 12 h before study visits
* willing to fast 12 h prior to study visits
* willing to avoid dietary supplements, yogurt and probiotic-containing foods (as necessary) and consume 12 oz. of yogurt and the control food per day (as necessary) for the duration of the study

Exclusion Criteria:

* self-reported previous diagnoses of an inflammatory disease (e.g. inflammatory bowel disease, asthma, arthritis), CVD, diabetes, current cancer treatment (i.e., chemotherapy, radiation therapy)
* have used oral antibiotics in the prior 21 days before sample collection
* actively trying to lose weight
* regularly taking anti-inflammatory drugs
* vegetarian or allergic to soy or dairy
* are pregnant, lactating, or trying to become pregnant
Long Term Brain Toxicity of Chemotherapy in Patients Treated for a Bone TumorDuring Childhood or Adolescence

To assess the neurocognitive outcomes in patients treated with chemotherapy for a malignant bone tumor during childhood and adolescence and the factors associated with neurocognitive impairment and/or complaints


Eligibility Criteria:
Inclusion Criteria:

For study OSE A and B

* Patients treated for a bone sarcoma: Ewing or osteosarcoma
* Age under 19 years at initial diagnosis
* Treated in the Pediatric Oncology Department of Gustave

For patients diagnosed between 01.01.2001 and 31.12.2010: patients alive in complete remission at least 5 years after diagnosis

* Treated with at least one course of HDMTX for osteosarcoma
* Treated without HDMTX for Ewing sarcoma
* Time interval between the end of treatment and inclusion \>10 y
* Age \> 21 y at inclusion
* Patients with informed consent signed
* Patient under guardianship
* Affiliated to French health insurance or beneficiary of the same or equivalent

For study OSE- B only:

* Treated with at least 8 courses of HDMTX for osteosarcoma
* Treated without HDMTX for Ewing sarcoma
* Patients with Ewing sarcoma will have to be matched with osteosarcoma patients according to age at the time of treatment, sex, and duration of follow-up
* School level equivalent of at least the end of primary school

Exclusion Criteria:

For study OSE A and B

* Brain radiotherapy
* Previous relapse except those treated by local treatment without any chemotherapy
* Second malignancy treated with chemotherapy
* High dose chemotherapy with stem cell support
* Non-French speaking patients
* Pregnant and breastfeeding women

For study OSE- B only:

- Patient deprived of his liberty by a judicial or administrative decision
High Resolution Retina Imaging

To increase the clinical experience of using the rtx1 camera in various retinal disorders and to follow the evolution of structural alterations during retinal diseases using adaptive optics imaging with the rtx1 camera


Eligibility Criteria:
Inclusion Criteria:

* Persons over 12 years of age, of both sexes, presenting with retinal pathologies.
* Beneficiaries of the health insurance

Exclusion Criteria:

* Any abnormality preventing good quality OA imaging on both eyes
* Major under guardianship or curatorship
Study of the Iron Absorption From Capsules Containing Lactobacilli and Iron

The purpose of this study is to study the effect of a probiotic product on iron absorption in healthy females of child-bearing age.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Age ≥19 and ≤45 years
* Hb \>117g/L

Exclusion Criteria:

* Gastrointestinal diseases
* Metabolic diseases
* Use of other probiotic products during the study and 2 weeks before the study start
* Pregnant or breast-feeding
* A serum ferritin level \>60 µg/L
* Medication (oral contraceptives allowed)
* Intake of dietary supplements (incl. iron) during the study and two weeks before the study start
* No blood donation in the last 2 months
* High C-reactive protein levels
The Effect of Perineal Massage in Childbirth

Objective To examine the effects of perineal massage applied during the action of birth on the frequency of episiotomy procedures, perineal tearing and the duration of the second stage of birth.

Methods The present study was a randomized controlled experimental. Women (284 women) were informed on the study and provided their written consent. 10-minute perineal massage with glycerine was applied to the women in the test group for 4 times during the first stage and 1 time in the second stage of birth. The women in the control group received the routine care procedure at the clinic.

Results According to the study findings, 31% of the women in the test group and 69.7% of the women in the control group were made subject to episiotomy (p\<0.05). In the test and control group 9.2%, 2.4% of the women developed spontaneous perineal laceration (p\>0.05). The average duration of the action of birth was 25.33 minutes in the test group and 28.18 minutes in the control group (p\<0.05).

Conclusion The study results indicate that perineal massage applied during the action of birth decreased the rate of episiotomy procedure and shortened the duration of the second stage of birth.


Eligibility Criteria:
Inclusion Criteria:

* With no pregnancy-related complications diagnosed during pregnancy,
* No definitive indication for C-section,
* Satisfying the pregnancy week in terms of the fetal dimensions,
* At the 37th-42nd gestation week,
* Applying to have her first or second birth,
* With no systemic condition,
* With head presentation,
* At the latent phase of the first stage of birth with a dilatation under 4 cm and effacement below 50%,
* That have provided written consent specifying their voluntariness in participating in the study.

Exclusion Criteria:

* With pregnancy-related complications diagnosed during pregnancy,
* Definitive indication for C-section,
* No satisfying the pregnancy week in terms of the fetal dimensions,
* At the \<37th- \>42nd gestation week,
* With systemic condition,
* With no head presentation,
* At the latent phase of the first stage of birth with a dilatation above 4 cm
* No have provided written consent specifying their voluntariness in participating in the study.
Nadroparin Pharmacokinetics in Different Stages of COVID-19

Objective:

The risk of thrombotic complications in critical COVID-19 patients remains extremely high, and multicenter trials failed to prove the survival benefit of escalated doses of low molecular weight heparins (LMWH) in this group. The aim of this study was to develop a pharmacokinetic model of LMWH (nadroparin calcium) according to different stages of COVID-19 severity.

Design:

The investigators performed a prospective observational study.

Patients:

Blood samples were obtained from 43 COVID-19 patients that received nadroparin and were treated with conventional oxygen therapy, mechanical ventilation, and extracorporeal membrane oxygenation.

Setting:

The investigators recorded clinical, biochemical, and hemodynamic variables during 72 hours of treatment. The analyzed data comprised 782 serum nadroparin concentrations and 219 anti-factor Xa levels. The investigators conducted population nonlinear mixed-effects modeling (NONMEM) and performed Monte Carlo simulations of the probability of target attainment (PTA) for reaching 0.2-0.5 IU/ml anti-Xa levels in study groups.

Interventions: None.

Measurements and Main Results:

The investigators successfully developed a one-compartment model to describe the population pharmacokinetics of nadroparin in different stages of COVID-19.

Conclusions:

Different nadroparin dosing is required for patients undergoing mechanical ventilation and ECMO to achieve the same targets as those for non-critically ill patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated in the Department of Anesthesiology and Intensive Care and the Department of Infectious Diseases of a tertiary academic hospital with confirmed SARS-CoV-2 infection with a real-time reverse transcription polymerase chain reaction (RT-PCR) or an antigen test.

Exclusion Criteria:

* Coagulation disorders at the start of the therapy.
Status of Chronic Liver Disease in Hepatitis C Virus (HCV) Patients Coinfected With Human Immunodeficiency Virus (HIV) in Andalusia

This study evaluates the current situation and follow-up of chronic hepatitis C virus (HCV) infection in patients co-infected with human immunodeficiency virus (HIV) in Andalusia.

In subjects co-infected with HIV, treatment of chronic HCV infection is particularly complex and requires considerable resources, including a very high cost is likely to increase with new antivirals.

A precise knowledge of the situation in each hospital would facilitate adequate provision of personal and material resources needed to adequately address this disease in each center and in the Community as a whole. Because all or the vast majority of patients coinfected HIV / HCV are staffed by specialists who are part of Hepavir group and / or Sociedad Andaluza de Enfermedades Infecciosas (SAEI), they are ideal for carrying out this study.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 with HIV infection and active chronic hepatitis or SVR after treatment.

Exclusion Criteria:

* None
Long-Duration Stimulant Treatment Study of ADHD in Young Children

This study will evaluate if Ritalin LA™ is safe and effective for ADHD treatment in 4-to-5-year olds.

This is a single site, open-label, four-week feasibility study of long-duration beaded methylphenidate (B-MPH), also known as Ritalin LA™. B-MPH is a FDA-approved medication for children 6 years and older with attention-deficit/hyperactivity disorder (ADHD), but there are no studies of its use in preschoolers. This study will evaluate the safety and effectiveness of B-MPH for ADHD treatment in 4-to-5-year old children.

Total study duration is approximately 5 weeks. It includes a screening evaluation and 4 weeks of B-MPH treatment with doses ranging from 10 to 30 mg (based on the individual tolerability and efficacy). The study doctor will conduct parent-training sessions during the treatment visits.

Eligibility Criteria:
Inclusion Criteria:

1. Parents/guardians and children must speak English and/or Spanish; parents/guardians must sign consent form; children must verbally assent.
2. Boys and girls from 4-5 years old (inclusive) at screening.
3. Children who meet the DSM-IV criteria for a primary diagnosis of ADHD (combined or hyperactive subtype), with symptoms present for at least 9 months.
4. Children who demonstrate adequate need for treatment due to ADHD symptom-severity and clinical impairment.
5. Children with IQ of at least 70 confirmed by valid IQ test.
6. Children who are in educational settings (pre-school, kindergarten, or elementary school program) with at least 8 same-age peers for at least two half days weekly.
7. Parents and children who can attend weekly study visits.
8. Children who are naïve to ADHD medications; received ADHD medications in the past but are not currently treated; or on ADHD medications but finding them inconvenient (due to short duration of action) or not very helpful

Exclusion Criteria:

1. Children and parents/guardians who do not understand or cannot follow necessary instructions; children and parents who are unwilling to comply with study procedures or cooperate with child psychiatrist.
2. Children taking excluded medications.
3. Children with history of intolerance to MPH/stimulant medications or no response to adequate stimulant trials.
4. Children with current adjustment disorder, autism, psychosis, bipolar disorder, significant suicidality, or other psychiatric disorders.
5. Children with history of physical, sexual, or emotional abuse, which lead to a significant impact on the clinical presentation and potentially some ADHD symptoms.
6. Children with screening abnormalities deemed clinically significant by child psychiatrist.
Characteristic Analysis and Surgical Exploration for Acetabular Roof Fractures: Multicenter Retrospective Cohort Study

Acetabular roof was a crucial structure for maintaining the stability of hip joint; however, its important role was not especially emphasized in the Letournel-Judet classification system. Acetabular roof was segmented into the roof column and roof wall in Three-column classification and fracture in this area alone was defined as A3 injury. Radiographic data and functional outcome of A3 injury patients were reviewed to explore the characteristics and surgical strategy.

Fracture data, surgical incision, operation time, blood loss, fracture healing， Reduction quality，functional outcome，and relevant complications

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years, acute (\<14 days) closed roof column/wall acetabular fractures (A3.1, A3.2 or A3.3) in Three-column classification, normal activity of the affected hip before the injury, received surgical reduction and internal fixation

Exclusion Criteria:

* open fractures, pathologic fractures, limited range of motion (ROM) of the hip joint before the injury, conservative treatment, risk factors affecting bone healing (such as smoking and metabolic diseases) and noncompletion of the two-year follow-up
Bilateral Ultrasound Guided Superficial Cervical Plexus Block After Thyroid Surgery

Evaluating ultrasound guided Bilateral Superficial Cervical Plexus Block as a part of enhanced recovery after thyroid surgery using Quality of Recovery-15 scale as a method for assessment of quality of recovery.

Surgery of the thyroid gland is increasingly popular performed as ambulatory procedures in many countries. Postoperative wound pain is a common complication, especially within 24 hr after thyroid surgery, which may delay discharge or even unplanned readmissions following day surgery.

Several strategies, including local and regional anesthesia, are now performed as core components of multimodal analgesia for postoperative pain. Adequate postoperative pain relief is imperative to improve functional outcome, accelerate early ambulation and discharge from the hospital.

Ultrasound-guided superficial cervical plexus block was introduced by Tran et al . The main advantages of Ultrasound-guided superficial cervical plexus block include: provide real-time visualization of anatomical structures, reduced volumes of local anesthetics, and avoid inadvertent damage or accidental puncture of vessels.

Owing to its feasibility and efficacy, ultrasound-guided Bilateral superficial cervical plexus block is a technique for providing adequate regional analgesia during thyroidectomy with improvement of patient recovery.

Quality of recovery after anesthesia is an important measure of the early postoperative health status of patients. Based on extensive clinical and research experience with the 40-item Quality of Recovery-40, the strongest psychometrically performing items from each of the five dimensions of the Quality of Recovery-40 were selected to create a short-form version. The Quality of Recovery-15 provides a valid, extensive, and yet efficient evaluation of postoperative Quality of Recovery.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 21 to 65 years
* American Society of Anesthesiologists physical status I or II.
* Scheduled for elective thyroid surgery.

Exclusion Criteria:

* Patient refusal to participate.
* Patients with history of allergy to local anesthetics.
* Patients with history of chronic use of pain killers .
* Patients presented with mental dysfunction.
* Patients with coagulation disorders.
* Patients presented with skin or soft tissue infection at the proposed site of needle Insertion.
* Patients with Chronic Obstructive Pulmonary Disease or Body Mass Index more than 40.