cyrilzakka/clinical-trials huggingface dataset:
Spinal or Epidural Fentanyl or Sufentanil for Labour Pain in Early Phase of the Labour

In this study the analgesic effect of two different opioids (fentanyl and sufentanil) will be compared when given either intrathecally or epidurally in primiparous parturients during early phase of the labour.


Eligibility Criteria:
Inclusion Criteria:

* Primiparous parturients
* In early phase of labour (cervical dilatation at or under 5 cm)
* No prior opioids by any route of administration within past 120 min
* Pain at or over 80 mm on 0-100 mm visual analog scale during contraction

Exclusion Criteria:

* Allergy for any of the medications used
* Contraindications for epidural/spinal analgesia
* BMI at the time of delivery under 20 or over 35 kg/m2
Prospective Study to Validate the Clinical Accuracy of the Norbert Device to Measure Pulse Rate

The study will evaluate the mean average error (MAE) of measuring pulse rate using the Norbert Device (ND) as compared to a reference heart rate measured using an electrocardiogram (ECG).

The study design is to validate the pulse and heart rate accuracy as required per ISO 80601-2-61, Clause 201.12.1.104. The study is a non-randomized, non-blinded single arm design to evaluate the clinical accuracy of the ND's pulse rate measurement compared to a reference heart rate manually measured by observing R-peaks in a standard concurrently recorded ECG from an FDA 510(k)-cleared reference clinical ECG (RCECG). The sponsor will ensure that the study staff enrolls a range of types of arrhythmias including tachycardia, bradycardia, atrial fibrillation, bigeminy, trigeminy, and others.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged 18 or over
* Ability to provide signed informed consent

Exclusion Criteria:

* Pregnant
* Otherwise deemed unsuitable to participate in the study based on judgment of the study investigator
Facilitating Physical Activity Behavior and Health Outcomes in Breast Cancer Patients Receiving Chemotherapy

Breast cancer and its treatments can take a toll on the physical and psychosocial well-being of cancer survivors. Few interventions can help breast cancer patients improve their physical strength, stamina, and overall well-being. Developing ways to facilitate PA behavior during chemotherapy for breast cancer are necessary. This trial explores ways that breast cancer patients receiving chemotherapy can learn about and engage in PA during chemotherapy. This trial will also give Southern Alberta breast cancer survivors an opportunity to participate in evidence-based programs designed to facilitate their health, breast cancer recovery, and disease-free survival.

The investigators primary hypothesis is that women receiving the PA intervention resource kit will report a more positive change in self-reported PA at the end of chemotherapy treatments when compared to the group receiving standard materials.

Primary Objective:

To compare the effects of an evidence-based intervention consisting of targeted breast-cancer specific PA print materials (i.e., Exercise for health), a step pedometer, a step-walking guidebook (i.e., Step into survivorship), and a physical activity and step journal (INT) to a comparison group receiving a generic, two-page public health PA resource (Standard Material: SM).

Eligibility Criteria:
Inclusion Criteria:

* are diagnosed with stage I -IIIA breast cancer
* are scheduled to receive neoadjuvant or adjuvant chemotherapy
* did not receive transabdominal rectus abdominus muscle (TRAM) reconstructive surgery
* are \>18 years of age
* receive approval from their treating oncologist to participate
* do not have uncontrolled hypertension, cardiac illness, or psychiatric conditions (i.e., indicated in patient medical charts).
Implant Stability Using Densah Bur Versus Expander

evaluating use of Densah bur in thin ridge enhance implant's primary stability when compared to screw expander.


Eligibility Criteria:
Inclusion Criteria:

* Patients with partial edentulous maxillary premolar area with crestal thickness ranging from 4 to 6 mm.
* Age 25 - 50 years.
* No intraoral soft tissue or hard tissue pathosis.
* No systemic condition contraindicating implant placement.

Exclusion Criteria:

* Ridges thickness less than 4 mm.
* Coexisting vertical defect.
* Heavy smokers (more than 20 cigarettes per day).
* Patients with systemic disease that may affect normal healing.
* Patient with psychiatric problems.
* History of radiation therapy to the head and neck region.
Express Implant Versus Trabeculectomy After Late Failure Trabeculectomy

To compare between outcome of Express implant and subscleral trabeculectomy (SST) in management of glaucoma after previous trabeculectomy with a fibrotic bleb.

Trabeculectomy is the main glaucoma surgery. Despite the good decline in intraocular pressure (IOP) that occur rapidly after the procedure, there is still failure occurring due to progressive subconjunctival fibrosis, with associated increased IOP.

If the bleb is revived by needling with adjunctive 5-fluorouracil (5FU) and mitomycin C (MMC) that used intraoperatively for the majority of these cases , the associated rise in IOP was controlled if the revision occured early within the first three months after surgery. But less success occurred if the bleb revision was delayed.

If these interventions fail, alternative approaches include new augmented trabeculectomy or aqueous shunt implantation.

Express shunt allows aqueous to pass from anterior chamber to subconjunctival space like trabeculectomy .Express shunt is a non valved shunt, It has an advantage of less traumatic, less complications, low diffuse bleb and high success rate.

Eligibility Criteria:
Inclusion Criteria:

* elevated intraocular pressure (IOP) with fibrotic bleb despite previous SST since more than 4 months
* follow up 12mo after the second surgery

Exclusion Criteria:

* SST failure other than fibrotic bleb were also excluded
* follow up less than 4mo after the first surgery, and those less than 12mo after the second surgery
The Neural Mechanisms of Split-belt Treadmill Adaptation in People With Multiple Sclerosis

Majority of people with multiple sclerosis experience difficulty with balance and mobility, leading to an increased risk of falls. The goal of this clinical trial is to learn about brain activity during walking adaptation in people with multiple sclerosis. Also, this clinical trial will test a form of nerve stimulation to see if it can improve walking performance.

The main questions it aims to answer are:

* What areas of the brain are the most active during walking adaptation?
* Can nerve stimulation make walking adaptation more effective?

Participants will walk on a treadmill where each leg will go a different speed which will create walking adaptation. At the same time, brain scans will occur. There will be two sessions of walking adaptation, one with nerve stimulation, and one without nerve stimulation. Researchers will compare people with multiple sclerosis to healthy young adults to see if there are differences in brain activity.

Most people with MS (PwMS) experience significant gait asymmetries between the two legs leading to an increased risk of falls and musculoskeletal injury. The objective of this study is to investigate the neural mechanisms of gait adaptation and the effects of transcutaneous electrical nerve stimulation (TENS) on adaptability during split-belt treadmill training in PwMS. Our hypothesis is that TENS will strengthen sensorimotor integration via amplified afferent signaling, thereby enhancing adaptation, and further improving gait symmetry chronically. Functional near-infrared spectroscopy (fNIRS) will be used during a split-belt treadmill training paradigm to assess cortical activation during gait adaptation. Additionally, the effect of split-belt treadmill training coupled with TENS on gait adaptability in PwMS will be tested with experimental and a sham TENS split-belt treadmill sessions. Cortical activation and the effect of TENS on gait adaptability will be compared between young neurotypical adults and PwMS to assess differences that can be attributed to multiple sclerosis.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of relapsing remitting multiple sclerosis OR a neurotypical adult (ages 18-86)
* Not experiencing an active relapse
* Able to stand and walk without an assistive device
* Able to walk for three tenths of a mile without stopping to rest

Exclusion Criteria:

* Unable to walk for three tenths of a mile without assistance
* Musculoskeletal injury in past 6 months
* Lower extremity surgery in past 6 months
* Unable to abstain from medications that impair balance
* Currently pregnant
* History of traumatic brain injury
* History of vestibular disease
* History of any other balance impairment unrelated to multiple sclerosis
OCT-guided LALAK in Children

The primary goal of the trial is to determine if laser-assisted lamellar anterior keratoplasty (LALAK) will reduce the risks of post-operative complications such as adhesions, glaucoma and cataract that are associated with pediatric penetrating keratoplasty (PK).

There is a great need for lamellar keratectomy in the treatment of congenital opacities because the rejection rate in pediatric PK is 4-5 times higher than in adults. In addition, the intraocular inflammatory reaction in infants often leads to synechiae, glaucoma, and cataract. Because LALAK does not penetrate the eye and preserves the host endothelium, it could reduce the risk of these complications. Keratoplasty must be performed at this early age to prevent amblyopia.

In this study, OCT-guided LALAK will be performed in patients whose vision is limited by opacity in the anterior 2/3 of the cornea. The objective is to determine if LALAK will provide an equal or better visual outcome than traditional PK without the associated post-operative complications.

Eligibility Criteria:
Inclusion Criteria:

* Vision limited by opacity in the anterior 2/3 of the corneal stroma
* Posterior opacity and endothelial defect must be less than 1 mm in diameter

Exclusion Criteria:

* Presence of cataract
* Presence of adhesions of the iris or lens to the cornea
* Inability/unwillingness of parents to give informed consent
* Inability of parents to commit to required visits to complete the study
Controlled Trial to Evaluate a Local Information Campaign on Antibiotic Prescribing in Italy

Use of information campaigns and educational interventions directed to citizens and supported by physicians, aimed at promoting the appropriate use of medicines, have been evaluated by several studies with conflicting results. These interventions are potentially relevant, favouring the reduction of unnecessary use of medicines and related risks. Several studies have specifically evaluated the promotion of the appropriate use of antibiotics in adults and children, with variable results. A controlled study has been proposed to evaluate the feasibility and effectiveness of a multifaceted intervention aimed at reducing antibiotic prescription by increasing awareness on risks of their unnecessary use.

Information has been provided to citizens through several media (posters, local TV, radio and newspapers, video terminals, websites of Local Health Authorities). Brochures with information on expected benefits and risks of antibiotics has also been available, either with direct access in waiting rooms and pharmacies or handed out and mediated by doctors. Physicians and pharmacists received specific data on local antibiotic resistance. A small group of representative doctors have also actively participated in defining the campaign key messages. A sample of general practitioners and paediatricians have been trained in patient counselling strategies.

The information campaign has been implemented in two Provinces of Emilia-Romagna during the fall-winter season (November 2011-February 2012). Change in the overall prescribing rate of antibiotics (expressed as DDD per 1000 inhabitants/day) in the intervention area will be compared versus other areas in the same Region. Knowledge and attitudes of the general population will be evaluated through a phone and internet survey on a representative sample.

This study could observe a reduction lower than 5% in the prescribing rate of antibiotics.


Eligibility Criteria:
Inclusion Criteria:

* the campaign has been targeted at the general population in the intervention areas
Follow-up Study of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants

The purpose of this two-month follow-up study is to continue to follow growth, safety, and other health outcomes of infants fed a new infant formula for term infants or comparator formula. A reference group of human milk-fed infants will also be followed. This study is designed in accordance with Good Clinical Practice guidelines.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who enrolled and completed the previous phase of the clinical trial: NCT04218929 "Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants"

Exclusion Criteria:

* Subjects who did not enroll in the previous phase of the clinical trial: NCT04218929 "Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants"
A Study to Investigate the Metabolism and Excretion of [14C]-TRV130 in Healthy Male Subjects

The purpose of this study is to determine the routes of excretion for TRV130 and it's metabolites, and to determine and characterize, structurally, the metabolites present in plasma, urine, and feces in healthy male subjects.

This study is an open-label, non-randomized, metabolism and excretion study of a single 2 mg IV dose of \[14C\] TRV130 (approximately 100 µCi) administered as a 10 mL manual IV push over 2 minutes in a fasted state.

Eligibility Criteria:
Key Inclusion Criteria:

* Males, between 18 and 64 years of age, inclusive
* With body weight ≥ 50 kg and body mass index (BMI) between 18 and 32 kg/m2, inclusive
* In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs
* Negative test for selected drugs of abuse at Screening and at Check-in
* Able to comprehend and willing to sign an Informed Consent Form (ICF) prior to any study procedure
* A typical minimum of 1 to 2 bowel movements per day

Key Exclusion Criteria:

* History of sensitivity to any of the study medications or components thereof or a history of medication or other allergy that, in the opinion of the Investigator, contraindicates their participation
* Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 28 days prior to Check-in
* Participation in any other radiolabeled investigational study drug trial within 12 months prior to Check-in
* Exposure to significant radiation (eg, serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring) within 12 months prior to Check-in
* Has current malignancy, current systemic chemotherapy, or cancer diagnosis within 5 years prior to Screening (excluding squamous or basal cell carcinoma of the skin that has been clinically stable and fully excised in a curative procedure);
* Use of any tobacco- or nicotine-containing products within 6 months prior to Screening
The Effect of Therapeutic Touch and Emotional Freedom Technique on Postpartum Mood and Fatigue in Postpartum Women

Therapeutic touch (TD) is a non-pharmacological/integrated treatment method used to balance the body by regulating the imbalanced energy field in the individual or resolving blockages in energy flow. Emotional freedom technique (EFT) is a psychophysiological intervention that combines elements of somatic stimulation using acupuncture points. This research will be conducted as a randomized controlled experimental study to determine the effect of TD and EFT intervention on postpartum mood and fatigue in postpartum women. The research will be conducted between November 2023 and November 2024 with women who gave birth normally and are registered at Karakulak Family Health Center in Konya. This research; It was planned to be carried out with three groups: TD intervention, EFT intervention and control group. The population of the research consists of women who gave birth vaginally and those who gave birth vaginally in the relevant hospital.


Eligibility Criteria:
Inclusion Criteria:

* Having a vaginal birth at term
* Being primiparous
* Postpartum 3rd-5th. to be in the days
* Being able to speak and understand Turkish
* Being 18 years or older
* Having a single and viable fetus
* Volunteering to participate in research
* Not having experienced TD or EFT treatment before

Exclusion Criteria:

* A psychiatric diagnosis has been made,
* Having a chronic systemic disease,
* The newborn's need for treatment
* Having postpartum complications in the mother or baby
* Those who have sensitivity or problems with touch,
* Wounds, infections, etc. in places that need to be touched. existence of situations,
* Women who have any disability that would prevent communication (deafness, hearing impairment, etc., use of languages other than Turkish) will be excluded from the research.
Study of Two Fasting Procedures Before Gastroscopy: 6 Hours Versus 2 Hours for Clear Fluids

Upper gastrointestinal endoscopy is the key examination for screening for precancerous and cancerous lesions of the esophagus and stomach. This study aims to describe the quality of the visualization of the esophageal and gastric mucosa, the safety of use of two fasting procedures before gastroscopy and the feeling of patients. The population evaluated here concerns cirrhotic patients, at high risk of developing a precancerous lesion of the upper gastrointestinal tract.

The investigator carries out a prospective, monocentric (Besançon CHRU), interventional and randomized study according to two fasting procedures before gastroscopy: 6 hours (F6 group) versus 2 hours (F2 group) for clear fluids. The primary endpoint was to describe and compare the quality of visualization of the esophageal and gastric mucosa, graded from A (good quality) to C (poor quality) according to a score. developed by Elvas et al. (Endoscopy 2017).


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years,
* Male or female
* Cirrhosis based on radiological, clinical, biological or histological criteria

Exclusion Criteria:

* Diabetes for more than 10 years;
* Under 18 years of age;
* History of inhalation
* Patients in whom the gastrointestinal anatomy has not been retained
* Subjects who were unlikely to cooperate with the study and / or in whom poor cooperation was anticipated by the investigator
* Pregnant women Patients taking drugs that may slow down gastric Emptying such as: anticholinergic drugs, phenothiazines, antidepressants History of esophageal radiotherapy Unsubstituted hypothyroidism
Study of HD Mesh Ablation System for Treatment of Paroxysmal Atrial Fibrillation

This is a randomized controlled study of the Bard High Density Mesh Ablation System for treatment of paroxysmal atrial fibrillation. This study will determine if the HD Mesh Ablation System is as safe as and more effective than anti-arrhythmic drugs.


Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic paroxysmal atrial fibrillation who have failed at least one class I or III anti-arrhythmic drug
* Other inclusion criteria

Exclusion Criteria:

* Previous surgical or catheter ablation to treat AF
* Permanent AF
* Uncontrolled or unstable medical conditions
* Other exclusion criteria
Development of Automated Analysis to Electroencephelogram (EEG) Data in Patients Treated at the Sagol Hyperbaric Medicine and Research Center at the Years 2017-2019.

DELPhI software developed for the analysis of EEG recordings in response to magnetic stimulation in relation to clinical data.

Collection of EEG data, recorded at Sagol center for hyperbaric medicine and research in the years of 2017-2019 of patients arriving to be treated at the hyperbaric chamber before,during and after treatments. EEG was recorded of patients during cognitive tests, resting state and during magnetic stimulation as a part of other array of tests performed at the Sagol center. Anonymous EEG data along with MRI scans, PET-CT, SPECT, cognitive tests, Medical history and medications will be transferred to QuantalX Neuroscience LTD.

QuantalX Neuroscience is intending to use the above mentioned data in order to improve DELPhI, an algorithm for the analysis of EEG recordings in response to magnetic stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Subjects over the age of 18.
* Subjects that performed at least one EEG test as a part of their hyperbaric treatment at Sagol center Asaf-Harophe.

Exclusion Criteria:

* Subjects with no EEG test or that their EEG recording is in pure quality, not allowing analysis of the data.
The SurgiMend PRS Retrospective Study

The SurgiMend® PRS Retrospective Study will evaluate the performance and safety of SurgiMend® PRS and SurgiMend® PRS Meshed when used for soft tissue reinforcement under the product's indications for use.


Eligibility Criteria:
Inclusion Criteria:

1. The patient has reviewed the ethics-approved consent form and has provided consent for data collection
2. Subject is a female over the age of 18 at the time of index surgery (mastectomy)
3. Subject had mastectomy performed for cancer or as a cancer prophylaxis
4. The surgical plan included one of the following approaches:

   1. Immediate unilateral or bilateral prepectoral DTI or TE/I breast reconstruction following nipple-sparing, skin-sparing, or skinreducing mastectomy with the use of SurgiMend® PRS or SurgiMend® PRS Meshed
   2. Immediate unilateral or bilateral submuscular DTI or TE/I breast reconstruction following nipple-sparing, skin-sparing, or skin-reducing mastectomy with the use of SurgiMend® PRS or SurgiMend® PRS Meshed
5. If subject received bilateral breast reconstruction, the subject must have received the same surgical technique for both breasts including the implantation of SurgiMend® PRS or SurgiMend® PRS Meshed
6. If subject received unilateral breast reconstruction, there was no surgical intervention on the contralateral breast within 12 months post-operatively
7. Subject underwent mastectomy (index surgery) at a minimum of 24 months prior to study initiation at site

Exclusion Criteria:

1. The surgical plan included muscle flaps to supplement the breast mound
2. The reconstruction plan included hybrid implant coverage with another type of mesh (e.g., use of another mesh or ADM in addition to SurgiMend®)
3. Subject had received prior breast augmentation, mastopexy, or breast reduction surgeries (does not include breast biopsy)
4. Subject was a user of any nicotine products (cigarettes, chewing tobacco, vapor, etc.) (within 6 weeks before index surgery)
5. Subject had uncontrolled Type I or Type II diabetes (HbA1C \>9)
6. Subject had previously undergone radiation therapy to the chest wall prior to index surgery
7. Subject had been diagnosed with advanced stage disease (stage 3 or 4, or inflammatory cancer)