cyrilzakka/clinical-trials huggingface dataset:
High Vs. Low Segmental Hysterotomy: Impact on Uterine Wall Defects Post-Cesarean

The purpose of this clinical trial is to compare the incidence of defects in the uterine wall at the site of the scar (niche) and surgical complications when using high-segment versus low-segment hysterotomy, with both cross-suturing and non-cross-suturing techniques, in pregnant patients undergoing their first cesarean section.

Researchers will compare four arms:

* Low Segment Hysterotomy + Crossed hysterorrhaphy
* High Segment Hysterotomy + Crossed hysterorrhaphy
* Low Segment Hysterotomy + Non-Crossed hysterorrhaphy
* High Segment Hysterotomy + Non-Crossed hysterorrhaphy

Participants will:

* Cesarean delivery
* Attend a follow up appointment between 6 to 16 weeks post surgery where will be perform a transvaginal sonography.

This study will be conducted as a single-blind trial. Patients will be approached in the delivery room, where a comprehensive review of the inclusion and exclusion criteria checklist will be conducted to determine their eligibility for the study. Once eligible patients are identified, the study will be thoroughly explained to them, highlighting its purpose, potential benefits, and risks. This will be followed by a detailed discussion of the informed consent form to ensure that participants fully understand what their involvement entails.

Upon obtaining informed consent, a randomization process will be implemented to allocate participants to one of the four study arms. The assigned procedure will be performed by their attending gynecologist, who is familiar with their medical history and care needs. Throughout the study, various outcomes will be measured, including intraoperative findings, postoperative recovery, and post-discharge progress.

A transvaginal pelvic ultrasound will be ordered to be performed between 6 and 16 weeks postoperatively. During the single follow-up appointment, this imaging evaluation will be carried out to determine the presence or absence of an isthmocele, as well as to assess its characteristics, such as size and location, if present.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women aged ≥ 18 years.
* Confirmed pregnancy through clinical history or ultrasound between 36 and 42 weeks of gestation.
* Indication by the attending gynecologist for a first cesarean section, either emergent or elective.

Exclusion Criteria:

* History of myometrial intervention, such as myomectomy.
* History of genetic or acquired conditions that alter the anatomy of the uterus.
* History of coagulation disorders.
* History of connective tissue disorders, such as Lupus and Scleroderma, which may affect healing.
* Hemodynamically unstable patients due to a clinical condition prior to performing the cesarean section.
* Failure to sign the informed consent.
Effects of Inspiratory Muscle Training on Diaphragm Thickness, Respiratory Muscle Strength and Balance in Dancers.

Dance is a performing art form consisting of sports and art intertwined and complex dynamic choreographic figures were handled aesthetically and physically of narrative. Scientific studies are insufficient on dance and health and performance of dancers in the literature although dance is the most used type of art and sport in all societies and for all age groups. It is seen that the core stabilization (central forces) of the dancers is insufficient when the current studies were examined, this insufficient stabilization causes biomechanical changes in the trunk, and indirectly affects the lower extremities. Consequently, insufficient stabilization was shown to be caused impairment of force generation and injuries. In addition, lack of core stabilization of dancers may cause impairment in balance and postural control. Therefore, dancers need a good postural control with provided by an effective core stabilization training in order to exhibit a successful and healthy performance. It is shown that inspiratory muscle training (IMT) improves diaphragm strength and diaphragm thickness. Considering the relation between diaphragm muscle forming the upper (ceiling) part of the core area, and balance, IMT may also have an impact on postural control and balance alongside the standard clinical parameters such as respiratory muscle strength and diaphragm thickness in dancers. Thus, the aim of this study was to investigate the effects of inspiratory muscle training on diaphragm thickness, postural stability, balance, respiratory muscle strength in dancers.


Eligibility Criteria:
Inclusion Criteria:

* Dancer (for least two years)
* Stable clinical condition (no injury in last 2 months)

Exclusion Criteria:

* Documented diagnosis of vestibular, neurological or orthopedic disorders which may affect balance and mobility
* Having of chronic pulmonary disease
Core Exercises Effects on Muscle Imbalances

This study aims in investigating the effects of a core muscles' strengthening program on core muscles' atrophy and contraction ability. Twenty healthy adults recruited and randomly assigned to either a 5-week training group developed to activate and strengthen local trunk muscles or a control group. The training program includes isometric bridging exercises from various positions and dynamic exercises for lumbopelvic stability. Core muscles' thickness will be assessed at rest and contracting conditions, prior and after the intervention, using ultrasonography.

A total of 136 male and female adults, members of local gyms, were initially invited for participation in the study after giving their written consent. After a second contact with the participants, forms regarding the inclusion and exclusion criteria were sent for completion.

Of the 136 that initially answered positively for participation, 62 did not meet the inclusion criteria, based on their reports and the clinical examination by a health professional. Of the remaining 74 participants, 32 were excluded because of previous low back pain incidents and other recent musculoskeletal injuries that led to rehabilitation, while 22 decided to not participate for personal reasons.

The remaining 20 participants were randomly allocated to either training group or intervention group, by a neutral, blinded investigator who had no involvement and was unaware of the study purposes. The intervention group will be trained and supervised by a certified fitness instructor in a gym class, who will be responsible for the correct execution of the exercises. The duration of the intervention will be 5 weeks, 3 times a week.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 45 years old
* Trained recreationally at least 2 times a week, for the past 3 years
* Healthy
* No musculoskeletal injuries in the 6 months prior to the study

Exclusion Criteria:

* History of chronic low back pain
* History of hip, pelvic or low back surgery
* History of acute low back pain with duration at least 1 week, the preceding 6 months
* Involvement in similar core stability training programs the last 12 moths prior to this study
Study of AT-752 in Healthy Subjects in a Dengue Human Challenge Model

This study will assess the safety and antiviral activity of AT-752 in healthy subjects in a Dengue Human Challenge Model

A Phase 1, double-blind, randomized, placebo-controlled study to assess the antiviral activity and safety of AT-752 in a Dengue Human Challenge Model

Eligibility Criteria:
Inclusion Criteria:

* Must agree to use protocol-specified methods of contraception
* Negative pregnancy test
* Willing to comply with the study requirements and to provide written informed consent

Exclusion Criteria:

* Pregnant or breastfeeding
* Abuse of drugs
* Other clinically significant medical conditions
Study of Different Concentrations of Epidural Bupivacaine for the Effects on Vasodilatation and Sensory Block

This study aims to compare human subjects receiving epidural bupivacaine local anesthetic at different doses and concentrations and to assess the effect on vasodilatation (sympathectomy), sensory and motor block.

The hypothesis is that the drug concentration is more important than drug dose in the determination of the extent and intensity of differential sympathetic, sensory and motor block following epidural local anesthetic.

There is controversy regarding the factors that determine the extent and intensity of epidural drug action. Most studies have focused on the inter-related triad of dose, concentration and volume.

We compare three groups: group A: 10ml of 0.5% bupivacaine; group B: 10ml of 0.25% bupivacaine and group C: 40ml of 0.0625% bupivacaine. When comparing these groups, groups A \& B have the same volume of epidural drug, and groups B \& C have the same total dose.

In particular this study compares different methods of assessing the sympathetic block (causing vasodilatation). These methods include skin temperature changes, hemodynamic changes and photoplethysmography.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for extracorporeal shock wave lithotripsy (ESWL) under epidural anesthesia between March to September 1999

Exclusion Criteria:

* graded as ASA 3 or higher, below 18 or above 70 years of age, if they had peripheral vascular disease, baseline neurological deficit, or had any other contraindication for regional anesthesia.
The Princess Alexandra Hospital and the QIMR Berghofer Medical Research Institute Head and Neck Cancer Study

This study is designed to refine the aetiological causes of cancers of the head and neck and investigate the ways in which human papillomavirus and life-style factors cause head and neck cancers. This study will determine if these factors affect the treatment of cancer.

All patients attending the Head and Neck Clinic at the Princess Alexandra Hospital is invited to complete a risk factor questionnaire and give consent for their clinical data and tissue samples to be available for future research activities. The risk factor questionnaire is based on existing validated instruments developed by the QIMR Berghofer Medical Research Institute Cancer Control Group, and will collect standardised information relating to demographics and causal factors (tobacco and alcohol intake), risk modifiers (dentition, asprin and non-steroidal anti-inflammatory drugs (NSAIDS), height, weight, physical activity, diet quality etc) and behaviours (oral sex etc)

Data is collected using a simple four-page paper-based questionnaire. Information to be collected include age, sex, height and weight (at age 20, current age, and heaviest ever), history of cancer (own and partner). Questions about recreational physical activity, smoking history and alcohol consumption, acid reflux, heartburn, denture use and tonsillectomy, frequency of use of paracetamol, antihistamine and NSAIDS.

The questionnaires also ask participants some detailed questions about sexual behaviour and history if they are comfortable to give this information.

Eligibility Criteria:
Inclusion Criteria:

* All patients presenting to the Head and Neck Cancer Clinic at the Princess Alexandra Hospital Brisbane Australia.

Exclusion Criteria:

* nil
A Placebo-controlled Study With an Extension Examining the Safety and Efficacy of Alefacept in Psoriatic Arthritis

Randomized, double-blind, 24-week study of patients with psoriatic arthritis comparing alefacept + methotrexate (MTX) vs. placebo + MTX followed by a 24-week open-label extension with only alefacept + MTX treatment.

Patients who completed the initial 24-week treatment course and met the inclusion and exclusion criteria for the 24 week open-label extension continued on their stable MTX dose and also received alefacept throughout this extension.

Eligibility Criteria:
Inclusion Criteria:

* Psoriatic arthritis
* MTX treatment for 3 months prior to enrollment with continuing disease
* Normal T-cell count

Exclusion Criteria:

* Other types of psoriasis
* History of malignancy or lymphoproliferative disorder
* Serious infection or fever
* Antibody positive for Hepatitis C, HIV or TB
* Hepatic transaminases \> 2X normal
Mediterranean Diet and the Microbiota Gut Brain Axis in Major Depression

The purpose of this study is to assess the efficacy of a Mediterranean diet on the function of the vagal nerve in patients with depression.

After being informed about the study and potential risks, all patients giving written informed consent will be screened for eligibility. Subjects meeting the inclusion criteria will be randomized in a group recieiving a Mediterranean diet (3 mediterranean meals a day) and dietary coaching (1 session per week for 4 weeks) or a group with conventional hospital food and psychoeducation on depression (1 session per week for 4 weeks).

Eligibility Criteria:
Inclusion Criteria:

* legally competent persons aged 18-80 years
* diagnosis of depression according to ICD-10 or DSM.

Exclusion Criteria:

* other neurologic or psychiatric disorders (epilepsy, brain tumor, head injury, head surgery, trauma)
* drug or alcohol dependency
* acute suicidality
* heart disorders, disorders of the circulatory system
* pregnancy and period of breastfeeding
* severe mental disability, dementia (MMST\<20)
* autoimmune disorder, severe immunosuppression (Lupus, HIV, multiple sclerosis)
* therapy with antibiotics in the last month
* chronic laxative abuse
* acute infectious diarrhea
* GI surgeries (except appendectomy)
* regular intake of probiotics, antibiotics and food supplements (1 month before and during the study)
* food allergies or other food intolerances which are incompatible with a mediterranean diet
* vegetarians, vegans
Switch Study of Existing Atypical Antipsychotics to Bifeprunox

The study will evaluate the safety and tolerability of switching subjects with schizophrenia or schizoaffective disorder from their existing antipsychotic medication to Bifeprunox.


Eligibility Criteria:
Inclusion Criteria:

* Males or females, 18-65 years, meeting DSM-IV TR diagnosis of Schizophrenia or Schizoaffective Disorder for whom a switch is indicated

Exclusion Criteria:

* Acutely psychotic or with a current Axis I primary psychiatric diagnosis other than schizophrenia or schizoaffective disorder based on DSM-IV TR criteria
Optimal Initiation of Helicobacter Pylori Eradication After Endoscopic Resection for Gastric Neoplasm

After endoscopic resection (ER) of gastric tumors, eradication of Helicobacter pylori (H. pylori) infection is advised to reduce metachronous recurrence. However, few studies have addressed factors influencing H. pylori eradication rates in the aftermath of ER, and none have focused on the optimal timing of therapy to eradicate H. pylori post-ER.Therefore, the investigators will conduct to evaluate whether differences in timing of eradication therapy after ER of gastric tumors.

Uur previous retrospective study unveiled that administering eradication treatment within 2 weeks post-ESD during the active reparative phase of ESD-induced ulcers yielded a markedly higher success rate compared to treatment post-8 weeks during the scarring phase of ESD-induced ulcers.Therefore, we conducted a multicenter, randomized, prospective study to ascertain whether the optimal timing of eradication post-ESD could influence the eradication success rate.

Eligibility Criteria:
Inclusion Criteria:

1. patients underwent endoscopic resection of gastric neoplasm
2. patients who diagnosed as H. pylori infection by rapid urease test

Exclusion Criteria:

1. Histories of gastric surgery
2. Histories of prior H. pylori eradication therapy
3. Use of drugs affecting H. pylori positivity (proton pump inhibitor, histamine-2 receptor blocker, or antibiotics) within the preceding 2 weeks
eXciteOSA for Treatment of Moderate Obstructive Sleep Apnea

The objective of this study is to assess the efficacy of the eXciteOSA device amongst a sample of patients with moderate OSA. The study is a multi-center, prospective, open-label, randomized, parallel-arm trial of eXciteOSA (administered at two doses) versus no-therapy for six weeks. Up to 120 participants will be enrolled, in order to randomized n=62.


Eligibility Criteria:
Inclusion Criteria:

* Aged \>=18 years;
* Diagnosed with moderate OSA;
* Smartphone or tablet capable of running the eXciteOSA app;
* Fluent in written and spoken English.

Exclusion Criteria:

* BMI \>=35 kg/m2;
* Implanted medical device;
* Dental braces and/or intraoral metal jewelry;
* Any condition impacting the tissue of the oral cavity, including but not limited to ulceration or periodontitis;
* Symptomatic nasal pathology such as septal deviation, nasal polyposis, or chronic rhinosinusitis;
* Tonsillar hypertrophy (tonsil size grade 3 or greater);
* Clinically significant facial or oropharyngeal abnormalities such as class 2 malocclusion;
* Prior oropharyngeal surgery for sleep-disordered breathing;
* At-home use of a mandibular advancement device or PAP for sleep-disordered breathing within the previous four weeks;
* Use of any overnight therapy that cannot be withdrawn during study enrollment;
* Diagnosed with any sleep disorder other than OSA;
* Chronic use of central nervous system depressants;
* Driver in a sleepiness-related vehicular accident or near-miss within the two years prior to enrolment (self-report);
* Employed as a commercial driver, pilot, or other occupation that may be impacted by hypersomnolence;
* Considered by the PI to be at risk of an AE resulting from hypersomnolence;
* Any periods of non-connectivity (wifi or cellular data) exceeding 48 hours planned to take place, or likely to take place, during enrollment;
* Current or planned pregnancy;
* Member of a vulnerable population, including but not limited to prisoners and those lacking consent capacity;
* Clinically-significant burden of comorbidities (including history of myocardial infarction, cardiac arrhythmia, heart failure, history of stroke, or transient ischemic attack), and/or any other limitation or condition that may impact the patient's ability to complete the study protocol and use the device per the Instructions for Use (PI discretion);
* Employee and/or residing household member who is an employee of a company that produces or distributes products designed to diagnose, treat, and/or monitor sleep or sleep-disordered breathing (including the Sponsor).
Prospects for the Prevention of Pregnancy-induced Hypertension and Preeclampsia Trial

Hypertensive disorders of pregnancy (HDP) are with 50.000 deaths every year one of the major causes of maternal mortality worldwide, especially in low and middle income countries. This trial aims to determine whether a daily dose of combined low-dose aspirin, calcium, vitamin D3, folic acid and vitamin B12 in pregnancy reduces the incidence of pregnancy-induced hypertension in women at risk. Secondary and tertiary objectives include other maternal and neonatal outcomes.


Eligibility Criteria:
Inclusion Criteria:

* \<16 weeks of gestation and over 18 years of age,
* Intention to have subsequent antenatal visits and delivery at the same clinic.
* Can receive text messages by phone or through the phone of a proxy.
* A moderate to high risk (\>20%) of developing PIH

Exclusion Criteria:

* Pre-existing hypertension or hypertension before 20 weeks gestation.
* Likely non-compliance with the protocol in view of the treating physician
* Comorbidity interfering with the protocol
* Known contraindications to Investigational Product components
A Study of MNRP1685A in Patients With Locally Advanced or Metastatic Solid Tumors

This is a Phase I, first-in-human, open-label, dose-escalation study of MNRP1685A administered by IV infusion every 3 weeks in patients with locally advanced or metastatic solid tumors for whom standard therapy either does not exist or has proven to be ineffective or intolerable. This study will be conducted at up to three study centers in the United States.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Incurable, locally advanced, or metastatic solid malignancy that has progressed on, or failed to respond to, at least one prior regimen
* Evaluable or measurable disease per RECIST (in certain circumstances, prostate or ovarian cancer patients with non-measurable disease)

Exclusion Criteria:

* Inadequate hematologic or organ function
* Anti-cancer therapy within 4 weeks prior to initiation of study treatment
* Recent history of or current clinically significant gastrointestinal, cardiovascular or pulmonary disorders
* Any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytics, or a filter of the inferior vena cava
* Active infection or autoimmune disease
* Known human immunodeficiency virus (HIV) infection
* Pregnancy or breast feeding
Maintenance Metronomic Chemotherapy for Metastatic Colorectal Carcinoma

Colorectal cancer patients with metastases (mCRC) at response under expensive chemotherapy which may be toxic +/- exhausting are candidates for an effective and more convenient maintenance treatment.

Objectives:

1. To define the efficacy of maintenance chemotherapy by a low-dose metronomic (LDM) regimen, in metastatic CRC patients responding under FOLFIRI + bevacizumab.
2. To discover predictive factors for response to this LDM regimen.

Hypothesis:

1. The re-growth of residual metastases can be slowed by the anti-angiogenic effects of LDM chemotherapy.
2. Serial measurements of angiogenic/ inflammatory factors in the plasma and/or evaluation of certain enzymes in the tumor may discover predictive factors of response to LDM chemotherapy in metastatic CRC patients.

At entry to the research protocol the up-till then administered treatment with Intra Venous FOLFIRI+BEVACIZUMAB will be stopped.Instead, the research oral treatment will be initiated to be taken daily on an ambulatory basis and under once monthly re-evaluation. If and when disease progresses the original FOLFIRI+BEVACIZUMAB treatment will be considered for re-institution.

Eligibility Criteria:
Inclusion Criteria:

1. Histologic (or cytologic) proof of colorectal carcinoma (CRC).
2. Age: between 18 and 80.
3. Sex: both sexes.
4. Previous treatment for metastatic disease is limited to FOLFIRI+ bevacizumab.
5. Prior adjuvant chemotherapy, with a fluoropyrimidine and/or Oxaliplatin, is allowed.
6. Prior radiotherapy, either as adjuvant treatment or palliation of metastatic sites is allowed, provided that there are other non-irradiated foci of disease for evaluation.
7. Persistent remission, either complete, partial or minimal response (CR, PR or MR) or stable disease (SD), one year+/-one month from initiation of first line treatment for mCRC.
8. Asymptomatic patients at break from chemotherapy.
9. Intact organ function, including complete blood counts (CBC) showing normal values or any toxicity limited to grade 1 and blood chemistry (SMA) showing liver and renal functions \< 1.5 upper normal limit (UNL).
10. Capability to understand and to sign the informed consent.

Exclusion Criteria:

1. Concurrent any other cancer (except BCC or squamous cell carcinoma of skin).
2. Inability to adhere to monthly visits to the oncology unit for evaluation.
3. Presence of brain metastases.
4. Any current or recent (within the last month) continuous treatment by steroids or by NSAIDs, or with therapeutic doses of anticoagulants for any reason.
5. Previous radiotherapy to the only site of measurable disease.
6. Evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac including arrhythmias, hepatic or renal disease), and/or existence of active peptic ulcer (clinically and/or by gastroscopy).