cyrilzakka/clinical-trials huggingface dataset:
Water Method in Low-body Mass Index (BMI) Female Patients With Unsedated Colonoscopy

Water method with water exchange has been shown to reduce medication requirement and pain experienced during colonoscopy. It increases the success rate of cecal intubation in sedated and unsedated patients undergoing screening colonoscopy. Exchange of water during scope insertion minimizes distension of the colonic lumen and decreases loop formation. Exclusion of air from the colon during insertion by omission of air insufflations and suction removal of residual air prevent elongation of the colon. These maneuvers facilitate colonoscopy insertion in average patients and may enhance the success of difficult colonoscopy.

Female gender and low-body mass index (BMI) is independently associated with incomplete colonoscopy, respectively. The investigators postulate that low-BMI female patients may benefit from using the water method for colonoscopy. In this proposal the investigators test the hypothesis that compared with conventional air insufflations the water method with water exchange significantly enhances the success rate of cecal intubation in low-BMI female patients.

The aim of the study is to compare the outcome of colonoscopy using the water method versus the conventional air method in low-BMI female patients. The primary outcome is cecal intubation success rate. The secondary outcomes include cecal intubation time, maximum pain score during colonoscopy, overall pain score after colonoscopy and adenoma detection rate.


Eligibility Criteria:
Inclusion Criteria:

* Female patients with BMI \< 20

Exclusion Criteria:

* History of colorectal surgery
* Severe colonic stricture or obstructing tumor
* Patients who cannot give informed consent and those who are hemodynamically unstable
Evaluation of the Extension at Community Level of Safe Male Circumcision (ANRS 12126 ORANGE FARM 2)

This study is aimed at demonstrating whether or not Male Circumcision can be used as an effective public health prevention tool that will have an impact on HIV prevalence in the South African population.

A randomized, controlled trial (ANRS 1265) conducted in Orange Farm (South Africa) has demonstrated that male circumcision (MC) can reduce the risk of HIV acquisition by more than 50% among young men. This result has been confirmed by two similar studies conducted in Uganda and in Kenya.

Giving these findings, the next logical step is to demonstrate whether or not MC can be used as an effective public health prevention tool that will have an impact on HIV in populations as well as among individuals.

This research study aims to establish a MC intervention in the community where the first randomized controlled trial of the impact of MC on men's risk of acquiring HIV infection was carried out in order to evaluate its impact on:

1. knowledge, attitudes and practice regarding MC
2. existing means of prevention (sexual behavior change, condom use, STI treatment-seeking behavior and VCT (voluntary counseling and testing) attendance)
3. the spread of HIV and HSV-2

This research will be carried out over a period of 60 months and will have three major components: (1) the delivery of the intervention, (2) quantitative studies (cross-sectional surveys), and (3) qualitative studies.

Eligibility Criteria:
Inclusion Criteria:

* being uncircumcised
* living in Orange Farm (South Africa) for more than 3 months
* agreeing to follow the instructions given by doctors, nurses and/or staff, and in particular to abstain from sex for 6-weeks after being circumcised
* having understood and sign a consent form written in their own language
* for those younger than 18 years of age having a written authorization from one parent or guardian and having signed an assent form.

Exclusion Criteria:

* subjects with contraindications for male circumcision
* allergy to anesthesia
* hemophilia or bleeding disorders
* genital ulceration or other symptoms of sexually transmitted infections
* signs of infections or AIDS
* abnormal genital anatomy
* history of diabetes
Surgical Sympathetic Blockade in Heart Failure

The investigators sought to evaluate the feasibility and safety of surgical sympathetic blockade in systolic heart failure patients and secondary to assess its cardiovascular consequences.


Eligibility Criteria:
Inclusion Criteria:

* chronic heart failure (at least 1 month of symptoms onset)
* NYHA functional class II or III
* LV ejection fraction 40% or lower
* resting heart rate higher than 65 bpm
* either maximum beta-blocker therapy according to guidelines or no beta-blocker use for intolerance.

Exclusion Criteria:

* NYHA functional class I or IV
* cardiogenic shock
* resting heart rate ≤ 65 bpm
* systolic blood pressure \< 90 mmHg
* sustained ventricular tachycardia
* eligibility to other surgical procedures
* procedure-limiting comorbidity
* presence of ICD or pacemaker
* valvar, chagasic or congenital cardiomyopathy
* age \> 70 years
* patient refusal
* contra-indication to videothoracoscopy
* decompensated thyroid disease
* atrial fibrillation or flutter
* active infection
Adolescent Girls Initiative for Learning and Empowerment: Impact Evaluation of a Safe Space-Based Life Skills Training and Digital Literacy Training in Nigeria Space-Based Life Skills Training and Digital Literacy Training in Nigeria

The investigators will conduct a cluster randomized controlled trial in secondary schools in Nigeria to evaluate the impact of school-based life skills training delivered in safe spaces with and without digital literacy training. This study aims to estimate the causal impacts of the training on adolescents' school performances and retention, socio-emotional skills, digital skills, health, marriage, fertility, and labor market outcomes.

This study will evaluate the impact of a safe-space based life skills training program as well as a combination of life skills and digital literacy training programs on adolescent girls' empowerment, education, economic and sexual and reproductive health outcomes. The interventions form two sub-components of the Adolescent Girls' Initiative for Learning and Empowerment project. The interventions will be delivered to secondary school girls in Northern Nigeria.

The study will be conducted in the Kaduna, Katsina and Kano states of Nigeria. The study has a randomized controlled trial research design where schools are randomly allocated to three groups. Girls in schools assigned to the first treatment group will receive the safe-space based life skills training program. Schools allocated to the second treatment group will deliver a digital literacy training program along with a safe-space based life skills training program. The third group of schools will receive neither training program until the completion of the study. Girls between the age of 15 - 20 form the target group of the study.

The study will evaluate the impact of (i) a safe space-based life skills training program on adolescent girls' empowerment, education, economic and sexual and reproductive health outcomes; and (ii) a combination of a safe-space based life skills and digital literacy training programs on adolescent girls' empowerment, education, economic and sexual and reproductive health outcomes.

A total of 8,463 girls are drawn from 273 schools in the three states. The study will conduct baseline, midline and endline surveys by interviewing the girls and their respective caregivers. The baseline survey is conducted before the intervention roll-out. The midline survey will be conducted six months after intervention completion, while the endline survey will be conducted two years after the completion of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in study schools
* Enrolled in Senior Secondary 1 level
* Parental consent

Exclusion Criteria:

-
Scrutinizing and Promoting Mindfulness Via New Technologies

The overall goal of the outlined study is to scrutinize and to promote mindfulness via new technologies using a combination of smartphone-based assessment and micro-interventions, fMRI and real-time fMRI-neurofeedback.

The overall goal of the outlined study is to scrutinize and to promote mindfulness via new technologies using a combination of smartphone-based assessment and micro-interventions, fMRI and real-time fMRI-neurofeedback. More specifically, we aim to i) evaluate whether smartphone-based micro-interventions affect mindfulness, stress, and mood, ii) evaluate whether mindfulness, its neural substrate, and related mental and physiological functions can be modified by training volitional control over brain activity by means of real-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF), iii) differentiate neural activation patterns during mindfulness vs. mind wandering.

Eligibility Criteria:
Inclusion Criteria:

* Right-handedness
* Ability to participate in study procedures

Exclusion Criteria:

* Color-Blindness
* Present or past psychological or psychiatric therapy
* Presence of cardiovascular disease
* History of major cerebral injury
* Medical MRI contraindication
The Effect of Ischaemic-Reperfusion and Remote Ischaemic Preconditioning in Man - A Bradykinin Dependent Pathway

Heart attacks are usually caused by a blood clot blocking an artery supplying blood to the heart. Current treatments are designed at relieving this blockage as quickly as possible to minimize damage to the heart muscle. However in restoring the supply of blood local damage known as "ischaemia-reperfusion injury" may occur. The aim of this study is to assess how clot forming and clot dissolving pathways are affected during this process, and examine the role of a natural inflammatory hormone, bradykinin. This will help the investigators to understand the mechanism by which ischaemia-reperfusion injury may occur and to devise new treatments for heart attacks.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males between 18-65 years of ages.
* Non-smokers.

Exclusion Criteria:

* Any concurrent illness or chronic medical condition.
* Concurrent use of vasoactive medication.
* Smoking history.
Prospective Strength Measurement Involving Muscles Altered In Arthroscopic Latarjet

Open and arthroscopic Latarjet procedures are used to treat shoulder instability as primary and salvage procedures. During surgery the coracoid process is detached and repositioned to the anterior glenoid through a subscapularis split and fixed in place, resulting in an enlarged glenoid and therefor articular surface. However, before this is done, the pectorals minor, which inserts at the coracoid process, has to be detached and is left without further treatment. Moreover, the conjoint tendon, the origin of the short head of the biceps and coracobrachialis, is repositioned with the coracoid and therefor distalized and medialized.

No study currently followed up on the strength of the muscles altered. The aim of this study is therefor, to prospectively measure range of motion and strength of the operated shoulder at different time points pre- and postoperatively, comparing it with the healthy shoulder in each individual.

Strength, range of motion and stability will be assessed pre-operatively and at 6 weeks, 12 weeks, 6 months, 12 months and 24 months post-operatively. Next to standard radiological follow up, including X-ray, arthrographic computed tomography as well as arthrographic magnetic resonance imaging, specific shoulder scores will be utilised. Strength for general shoulder motion as well as specifically for the subscapularis, the pectorals minor, the coracobrachialis and the biceps will be measured with a shoulder dynamometer. Data will be analysed and published.

Eligibility Criteria:
Inclusion Criteria:

* Patients who experienced at least one shoulder dislocation.
* Patients who are willing to participate in the study
* Patients who receive arthroscopic Latarjet procedure for treatment of glen-humeral instability
* Patients who are at least 18 years old.
* Patients with an ISI-Score of at least 4 points.

Exclusion Criteria:

* Patients older than 50 or younger than 18 years of age.
* Patients with painful unstable (multidirectional) instability
* Patients with congenital defects of the bones involved (humerus, scapula).
* Patients with an ISIS of smaller 4 points.
Comparison of the Vividtrac™ and Other Videolaryngoscopes in Clinical Practice

Comparison of various videolaryngoscope devices (Vividtrac™ and KingVision™) and direct laryngoscopy with Macintosh blade regarding laryngoscopy time, intubation time, intubation success rate, percentage of visible glottic opening (POGO score) in elective and acute clinical anaesthesiology practice.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* over 18 years of age
* elective intervention
* no anticipated difficult airway or intubation
* preoperative anaesthesia risk assessment by American Society of Anaesthesiologists (ASA) physical status classification: ASA grade I-II

Exclusion Criteria:

-
Light vs. Moderate Intensity Exercise in Individuals With Myasthenia Gravis

The overall purpose of this pilot study is to examine the feasibility, acceptability, and tolerability of light and moderate intensity exercise in adults with MGeffect of light vs. moderate intensity exercise on health outcomes. Participants will be enrolled into the NeuroWell exercise program, which is geared toward individuals with neurological disorders or injuries and led by Certified Exercise Physiologists (CEPs) at the HealthPartners Neuroscience Center. A total of 20 people with MG will be enrolled in this study and participate in a small group exercise program 3 times a week for 12 weeks. Participants will be randomized into two exercise groups: 1) Light intensity or 2) Moderate intensity. We hypothesize that light and moderate intensity exercise will be feasible, acceptable, and tolerable in adults with MG and that individuals in the light intensity exercise group will be able to achieve the same improvement in health outcomes as the moderate intensity group.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide and provision of signed and dated informed consent form.
* Age 18-80
* Diagnosis of generalized MG.
* On a stable MG prescription medication regimen for the last 3 months.

Exclusion Criteria:

* Non-English speaking
* Regular exercise participation within the month prior to study enrollment or any outside exercise participation during the study intervention period.
* Significant cognitive impairment of any etiology that would impact study participation.
* History of heart failure, chronic lung disease, angina or any other condition that causes unreasonable shortness of breath on exertion.
* History of any serious neurological, psychiatric, or substance use disorders that would impact study participation.
* Women who are currently pregnant or planning to become pregnant during the study.
* Any other medical conditions that could affect their ability to participate in exercise for the study duration (as determined by study investigators).
* Active participation or past participation ≤3 months in any other interventional research study.
* Unwilling to participate in all study related activities.
Effect of Transversus Abdominis Plane Block With Compound Lidocaine and Esketamine on Pain After Surgery

Purpose:

To explore effects of ultrasound-guided transversus abdominis plane block with compound lidocaine and esketamine on postoperative pain after colorectal cancer surgery.

Poor post-surgical pain control is a leading factor that hinders the physical rehabilitation, and causes acute cognitive impairment and chronic pain syndrome. Recently, the multimodal analgesia strategies to minimise opioid related side effects are highly desirable in open surgical procedures. The transversus abdominis plane block is a novel technique involving injection of local anaesthetic between the internal oblique and the transversus abdominis muscles of the abdominal wall. Although ropivacaine is most commonly used for this technique, the analgesic duration remains not dissatisfied. Compared with ropivacaine, compound lidocaine injection has a better and longer analgesic activity since it contains menthol and ethanol with appropriate concentrations. However, whether compound lidocaine injection is efficiency in the transversus abdominis plane block for abdominal surgery lacks investigations. Herein, we will evaluate the efficacy of ultrasound-guided transversus abdominis plane (USG-TAP) block with compound lidocaine injection and esketamine for postoperative analgesia in patients undergoing colorectal cancer surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is scheduled to undergo colorectal cancer surgery under general anesthesia
2. Subject's American Society of Anesthesiologists physical status is I-II.
3. The subject's parent/legally authorized guardian has given written informed consent to participate.

Exclusion Criteria:

1. Subject has a diagnosis of bronchial asthma, coronary heart disease, severe hypertension, renal failure or liver failure.
2. Subject has a diagnosis of Insulin dependent diabetes.
3. Subject is allergy and contraindication to local anesthetics or any components of local anesthetics.
4. Subject has a history of chronic pain, a history of alcohol or opioid abuse, pre- existing therapy with opioids, intake of any analgesic drug within 48 hours before surgery.
5. Subject has any contraindication for the use of patient-controlled analgesia (PCA).
6. Subject is pregnant or breast-feeding.
7. Subject is obese (body mass index \>30kg/m\^2).
8. Subject is incapacity to comprehend pain assessment and cognitive assessment.
Optimizing Recovery After Reverse Shoulder Arthroplasty With a Personalized Mobile Health Application

Background: Mobile health (mHealth) - the use of medical applications in healthcare settings - include tools that can support self-management after surgery and thereby contribute to early postoperative recovery. Providing patients with timely and interactive information through mHealth is hypothesized to positively influence recovery after reverse shoulder arthroplasty (RSA).

Aim: The aim of this study is to determine the effectiveness of interactive and personalized information and rehabilitation protocol with a mobile application compared to generic information and generic rehabilitation protocol (standard care) on postoperative recovery in patients undergoing primary RSA.

Methods and analysis: A multicentre randomised controlled trial will be conducted in two Dutch hospitals. In total 170 patients undergoing elective, primary RSA will be included. Participants will be randomly allocated to one of the two groups on a 1:1 ratio. The intervention group will receive interactive postoperative information on a daily basis. The control group will receive standard care. The primary outcome is defined as functional recovery measured using the Oxford Shoulder Score (OSS) at 6 weeks. Secondary outcomes are: pain, physical functioning, quality of life, length of stay, complications, treatment satisfaction and app use. The between group difference will be analysed using linear mixed-effects regression.


Eligibility Criteria:
Inclusion Criteria:

* adults undergoing elective reverse shoulder arthroplasty

Exclusion Criteria:

1) do not own or are not able to operate a smart device; 2) are scheduled for revision surgery; 3) have a fracture as primary diagnosis; 4) an additional muscle transfer needs to be performed; or 5) are unable to read and understand the Dutch language.
Goat Milk Infant Formula Comfort Study

In this study, the investigators aim to assess that infants with mild symptoms have significantly less (severe) symptoms after 14 days goat milk-based formula use compared to infants using cow's milk-based formula supplemented with probiotic drops.

Anecdotal evidence shows that the use of goat milk-based infant formula decreases discomfort of infants with cow's milk related symptoms. In this randomized controlled pilot study, the effect on comfort during usage of goat-milk based infant formula is studied. Twenty formula fed infants (aged between 6 weeks and 3 months) who experience mild discomfort will receive goat milk-based infant formula (GMF) or cow's mik based infant formula supplemented with probiotics lactobacillus reuteri drops (CMFp). The infants will be assessed by a local paediatricians using the Cow's Milk-related Symptom Score (CoMiSS). This is a fast, non-invasive and easy-to-use and validated questionnaire to assess infant's reaction to proteins found in cow's milk. The higher the score, the more sensitive the child is to cow's milk proteins, the maximum score is 33 points. Infants with a CoMiSS Score between 6 and 12 will be enrolled in this study. It is expected that infants will have a better response to GMF, which will result in a decrease of the CoMiSS Score after a 2 weeks intervention.

Eligibility Criteria:
Inclusion Criteria:

* Healthy full-term infant with birth weight ≥2,500 to ≤4,500 g
* Infant aged between 4 weeks and 3 months at enrolment
* CoMiSS value at baseline between 6 and 12
* Infant is exclusively bottle fed with cow's milk based infant formula at baseline

Exclusion Criteria:

* Breastfed infants
* Congenital illness or malformation that may affect infant feeding or normal growth
* Gastrointestinal disorders
* Confirmed cow or goat milk protein allergy or lactose intolerance
* Supplemental feeding
* Readmission to hospital for longer than 3 days for another reason than hyperbilirubinemia prior to enrolment
* Infant participating in another clinical study
Impulsivity and Parkinson's Disease : a Neuropsychology With Magnetic Resonance Imaging Study

This study aims to characterize the nature of impulsivity in Parkinson's Disease (PD).


Eligibility Criteria:
Inclusion criteria :

Early onset PD patients and late onset PD patients with siblings available PD patients with or without impulse control disorders Current or past treatment with dopamine agonists or levodopa PD patients without dementia Age \< 80 ans

Exclusion criteria :

Early onset PD patients and late onset PD patients without siblings available PD patients with dementia Age \> 80 years
PREVALENCE OF WHITE SPOT LESIONS IN ENAMEL AFTER ORTHODONTIC TREATMENT IN YOUNG ADULTS

The aim of the study is to measure prevalence of enamel white spot lesions in enamel in young adults after orthodontic treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Patients whose age between 18-30 years old consulting in the outpatient clinic.
2. Provide informed consent.
3. Co-operative patients approving to participate in the trial.
4. Both sexes are included
5. Egyptian -

Exclusion Criteria:

1. Patients under or over this age group.
2. Patients with other developmental defect, such as; fluorosis, amelogenesis imperfecta and syndromes associated with enamel formation defects.
3. Patient with MIH .
4. Refuse to participate in the study.