cyrilzakka/clinical-trials huggingface dataset:
Enhancing Patient Recall in Urogynecologic Surgery

Patient counseling is an essential part of any new treatment implementation. This process becomes even more important when it involves surgical counseling. This is when the patient and the surgeon discuss the possible surgical options and ideally establish a plan for the appropriate surgical intervention. Unfortunately, multiple studies have shown that patients tend to have poor recall of the key elements discussed during the consultation (1-3). In the investigators' experience, the concern lies specifically in the level of recall that patients have regarding their planned surgical procedure, as most patients cannot correctly state the planned intervention despite extensive counseling and explanation. Lack of knowledge about the type of surgery can have serious implications for the patient in the future. For example, knowing facts like the presence or absence of the cervix and whether future pap smears are needed or the presence of an implant, such as a mesh are necessary for the patient's well-being and proper medical care down the line, especially when the patient has multiple medical providers. In addition, previous research has demonstrated that low-quality counseling and the feeling of being "unprepared for surgery" directly correlate with patient dissatisfaction (4). This is especially relevant in the field of female pelvic reconstructive surgery, where the success of surgical interventions relies heavily upon subjective patient-reported outcomes (5).

There have been many studies to augment the counseling process using supplemental materials. These have included use of multiple visual charts, anatomical models, and passive and interactive audiovisual aids (6). Some improvement in the outcomes has been observed in various fields of medicine with the dissemination of supplemental patient resources (7-10). However, in urogynecology, the effectiveness of surgical counseling sessions has not been achieved despite the different additional methods for patient education (6, 11). Reasons that urogynecologic supplemental materials have not seen the same level of success as those in other fields of medicine include the complexity of the surgeries and the language used in many of these educational aids (12). The investigators aim to address the problem of poor patient recall of their procedure by providing them with an easy-to-read patient card detailing the anticipated surgery at the time of their consult.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking females, ages \>18 and \<90 years, present for surgical planning for reconstructive urogynecologic procedures

Exclusion Criteria:

* Dementia, blindness, non-English speakers
RCT to Compare Orlistat and Polyglucosamine for the Management of Overweight and Obesity

This trial compares two treatment methods:

1. Orlistat 60 mg to be taken three times daily one capsule; indicated for weight loss in overweight adults. Important is also that it is taken along with a reduced-calorie and low-fat diet.
2. Polyglucosamine tablets to be taken two times daily two tablets, taken with the two main meals with the highest fat content, indicated for weight maintenance and weight loss.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 28 kg/m² and \< 45 kg/m²
* Waist circumference \> 80 cm (women) \> 94 cm (men)

Exclusion Criteria:

* Energy intake lower than the standard value according to Miffin St-Jeor equation
* Pregnancy or breast-feeding
* Addiction to alcohol
* Inability to fulfil the requirement of the trial protocol
* Cancer ,malignant tumour
* Hypersensitivity reactions to crustaceans or ingredient of the study medication
* Chronic diseases not under control with adequate therapy
* Diabetes
Comparison of Different Oxygen Delivery Strategies During Resuscitation of Babies

Preterm infants are born with immature lungs and often require help with breathing shortly after birth. This currently involves administering 100% oxygen. Unfortunately, delivery of high oxygen concentrations leads to the production of free radicals that can injure many organ systems. Term and near-term newborns deprived of oxygen during or prior to birth respond as well or better to resuscitation with room air (21% oxygen) compared to 100% oxygen. However, a static concentration of 21% oxygen may be inappropriate for preterm infants with lung disease. Our study will investigate how adjusting the amount of oxygen given to sick preterm newborns will affect the ability to maintain a safe oxygen level in their blood. Each infant will be assigned to receive one of three treatments at birth. Resuscitation will either start with 21% oxygen and be increased if needed, 100% oxygen and be decreased if needed or 100% oxygen with no changes made (current standard of treatment). The first two groups will have adjustments in oxygen concentration as needed to reach a safe target range of blood oxygen saturation. We anticipate that preterm newborn infants resuscitated with higher oxygen concentrations will have higher than "normal" levels of oxygen in their blood while those resuscitated initially with lower concentrations of oxygen will be more likely to have "normal" oxygen levels in their blood. All premature infants will have a surface probe placed on the right hand to measure the saturation of blood with oxygen. Following the resuscitation, treatment will proceed as per standard of care until hospital discharge. All infants will be admitted to the neonatal intensive care unit given their prematurity. The purpose of this study is to investigate how safely restricting the amount of oxygen delivered to newborns during resuscitation will affect the amount of oxygen in their blood.

Hypothesis: In this randomized control trial, infants resuscitated with a "low oxygen delivery (LOD)" strategy (initiation of resuscitation with 21% O2) will remain normoxemic for the greatest proportion of time during resuscitation and infants resuscitated with a "high oxygen delivery (HOD)" strategy (100% O2 used for the entire resuscitation) will be normoxemic for the smallest proportion of time during resuscitation.


Eligibility Criteria:
Inclusion Criteria:

* inborn
* \<= 32 weeks gestation
* respiratory support needed during resuscitation. Respiratory support is defined as provision of continuous positive airway pressure or positive pressure ventilation delivered via either a face mask or an endotracheal tube.

Exclusion Criteria:

* lethal anomalies
* cyanotic congenital heart disease
* known hemoglobinopathy
* risk of persistent pulmonary hypertension
Mitochondria and Metabolic Syndrome in a Southern California Chinese Cohort

There has been increasing support for our hypothesis that mitochondrial dysfunction plays an important role in the etiology of Type 2 Diabetes Mellitus and the overlapping Metabolic Syndrome.

Once the mitochondrial defect(s) of these subjects has been defined, the data will be used to develop two non-invasive screening tools to detect mitochondrial defects in Diabetes Mellitus and Metabolic Syndrome patients.

The device call Diffuse Optical Spectroscopy develope at Beckman Laser Instituteis is non-invasive measurement technique, to measure the properties of the muscle tisuue and vascular activity (calf, bicep, or the brain)to evaluate the patient's metabolic status and and to assess muscle mitochondrial OXPHOS function.

Eligibility Criteria:
Inclusion Criteria:

* Chinese descent and have been clinically diagnosed with diabetes mellitus (DM) or have met the study criteria for metabolic syndrome (MS).

Exclusion Criteria:

* non chiness descent
Escitalopram for the Prevention of PEGASYS-associated Depression in Hepatitis C Virus-infected Patients

Primary end points

* incidence of depression defined as a Montgomery Asberg Depression Scale Score (MADRS) of 13 or higher during antiviral therapy (up to 48 weeks, depending on genotype)
* effect of an antidepressive pre-treatment over two weeks and a continuously concomitant treatment with Escitalopram (S-citalopram) on frequency and severity of depression in patients with chronic hepatitis C (HCV) treated with Peg-interferon alfa-2a (PEGASYS) and ribavirin, measured by the Montgomery Asberg Depression Scale

Secondary end points

* time to depression defined as a MADRS score of 13 or higher
* incidence of major depression defined by Diagnostic and Statistical Manual IV (DSM-IV) criteria
* severe depression according to MADRS scale (score 25 or higher)
* Health related quality of life (HRQOL) measured by the Short Form 36 (SF-36)
* sustained virologic response
* tolerability
* safety
* changes/group differences in other psychiatric depression scales (Hamilton Depression Rating Scale, Beck Depression Inventory)

Other investigations:

* cognitive function, anxiety (word fluency test, trail making test part A and B, othe scales)
* Predictive parameters for patients especially gaining from an antidepressive therapy (e.g. age, gender, weight, height, alanine aminotransferase (ALAT) quotient defined as median ALAT values before treatment divided by the upper standard value, HCV-RNA serum concentration level of fibrosis in liver histology, baseline values of the different psychometric scales)
* alanine aminotransferase (ALAT), aspartate transaminase (ASAT), thyrotrophin (TSH)
* biomarkers (genetic parameters, cytokines,...)


Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis C infection defined as positive anti-HCV antibodies and serum HCV-RNA \>1000 IU/ml, naive to antiviral treatment
* age \>18 years

Exclusion Criteria:

* Antidepressive treatment within the last 3 years
* Psychiatric diseases including major depressive disorders in past medical history
* Active substance abuse during the last 12 months
* Pregnancy, lactation, wish to become pregnant
* Hepatitis B (HBV)/HIV-coinfection
* Decompensated liver disease, hepatocellular carcinoma, history of bleeding esophageal varices
* Neutropenia (\<1500/ul), thrombocytopenia (\<70/nl), anemia (\<12g/dl in females, \<13g/dl in males)
* History of autoimmune disease
* History of organ transplantation, concomitant liver disease, severe cardiopulmonary disease, hemolytic anemia, malignant disease
A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis

This is a randomised, double-blind, multicentre study to evaluate the efficacy, safety, PK, PD, and immunogenicity of SB16 compared to Prolia® in postmenopausal women with osteoporosis.

Subjects will be randomised in a 1:1 ratio to receive either SB16 or Prolia®. At Month 12, subjects in Prolia® treatment group will be randomised again in a 1:1 ratio to either continue on Prolia® treatment or be transitioned to SB16 treatment. Investigational product (60 mg in 1 mL of SB16 or Prolia®) will be given subcutaneously every 6 months up to Month 12, and the last assessment will be done at Month 18.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women who are 55 to 80 years of age at Screening
* Ambulatory and visually unimpaired to participate in the study at Screening, in the opinion of the Investigator
* Absolute BMD consistent with T-score at the total hip or lumbar spine of -4 and -2.5 at Screening
* At least three evaluable vertebrae within L1 to L4, one evaluable femoral neck, and one evaluable hip joint for BMD measurement at Screening
* Biologic naïve at Screening
* Body weight of 50 kg and 90 kg at Screening

Exclusion Criteria:

* One severe or more than two moderate vertebral fractures on spinal X-ray according to Genant classification at Screening
* History of hip fracture or bilateral hip replacement at Screening
* Uncorrected vitamin D deficiency at Screening
* Hypercalcemia or hypocalcaemia at Screening
* Inadequate haematological function at Screening
* Inadequate renal or hepatic function at Screening
* Known allergic reactions, hypersensitivity, or intolerance to denosumab or to any ingredients of the IP, including latex allergy or hereditary problems of fructose intolerance at Screening
* May not tolerate long-term calcium or vitamin D supplementation or subject with malabsorption of calcium or vitamin D supplements, in the opinion of the Investigator, at Screening
* Use of any of the medications that can affect BMD
* Use of any non-biologic IP that is not indicated for osteoporosis from another study or use of an investigational device at Screening
* Non-osteoporosis medical conditions that can affect BMD at Screening
* Any clinically significant disease or disorder or laboratory abnormality which, in the opinion of the Investigator, would prevent the subject from completing the study or the interpretation of the study results at Screening and Randomisation
Nexium Capsules Non-steroidal Anti-inflammatory Drug (NSAID) Specific Clinical Experience Investigation

The purpose of this investigation is to collect following data in patients given Nexium capsule (Nexium) for long term in usual-post-marketing therapy to prevention of recurrence of gastric ulcer or duodenal ulcer with non-steroidal anti-inflammatory drug (NSAID).

Nexium capsules Specific Clinical Experience Investigation for long-term use concerning prevention of recurrence of gastric ulcer or duodenal ulcer with NSAIDs

Eligibility Criteria:
Inclusion Criteria:

-Patients who are given NSAIDs for long terms to control pain due to disease such as rheumatoid arthritis and osteoarthritis, and given Nexium to suppress recurrence of gastric ulcer or duodenal ulcer.

Exclusion Criteria:

* Patients having gastric ulcer/duodenal ulcer when Nexium is started (Active phase (A1, A2) or healing phase (H1, H2) of Sakita-Miwa classification on endoscopy)
* Patients who had been given Nexium for suppression of recurrence of gastric ulcer/duodenal ulcer.
Effect of Stimulant Drugs on Social Perception

The study will improve our understanding of the "prosocial" effects of ± 3,4-Methylenedioxymethamphetamine (MDMA), relative to a prototypical stimulant, methamphetamine (MA). The investigators seek to characterize the "uniquely social" effects of MDMA.


Eligibility Criteria:
Inclusion Criteria:

* High school degree
* English fluency
* Healthy
* Has used MDMA

Exclusion Criteria:

* Pregnant or trying to become pregnant
* Any medical or psychiatry condition
Effect of Intraocular Lens (IOL) Centration and Tilt on Visual Performance With Clareon® Vivity® IOL Implantation

The goal of this observational study is to assess the effect of intraocular lens (IOL) movement in patients who have undergone Clareon® Vivity® IOL implantation.

The main question it aims to answer is: Does an association exist between IOL movement and patient quality of vision?

Participants implanted with Clareon® Vivity® and Vivity® Toric IOLs will be asked to do the following:

* consent to participate in the study
* allow researchers to access their personal medical records
* undergo a series of tests to assess the position of their IOLs and quality of vision

Researchers will assess participant examination results to determine whether an association exists between IOL movement and patient quality of vision.

This is a non-interventional, single-center, multi-surgeon, observational study to evaluate the effect of intraocular lens (IOL) centration and tilt on visual performance in patients who have undergone Clareon® Vivity® IOL implantation. The study population will include individuals implanted with Clareon® Vivity® and Vivity® Toric IOLs. IOL implantations reviewed will range from the earliest performed (May 2022) onward, until 100 implanted patients (200 eyes) are enrolled. Potential subjects will be consented, then retrospective chart review of pre-operative and operative implantation data will occur and postoperative data will be collected (1 or more months post-operation) via examination.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* History of adult cataract and uneventful, refractive cataract surgery with Clareon® Vivity® or Vivity® Toric intraocular lens (IOL) implantation with manifest refraction spherical equivalent (MRSE) within ±1.00 D
* Willing to undergo an eye exam with pupil dilation

Exclusion Criteria:

* Moderate to severe posterior capsule opacification (2+ or more)
* Yttrium aluminum garnet (YAG) laser capsulotomy within 1 month prior to enrollment
* Laser-assisted in situ keratomileusis (LASIK) or photorefractive keratectomy (PRK) within the one year prior to IOL implantation or any time after IOL implantation
* Any previous ocular surgery (excluding YAG, LASIK, PRK)
* Clinically significant ocular pathology; severe diabetic retinopathy, age-related macular degeneration (AMD), glaucoma, severe dry eye, irregular astigmatism, zonular weakness, pseudoexfoliation, ocular trauma
* Any additional procedure(s) at the same time as the Vivity implantation including but not limited to microinvasive glaucoma surgery (MIGS)
* Women who are pregnant at the time of screening (based on self-reported history)
* Medical or other problems which in the opinion of the investigator will render study participation unsafe
Neuropsychological Effects of Strengthening Exercise for Older Adults

This study aims to examine the benefits to thinking processes of a low intensity, strengthening exercise program for older adults.

The neuropsychological benefits, especially executive function impacts, of four weeks of a low intensity, strengthening exercise program will be examined for community residing older adults.

Eligibility Criteria:
Inclusion Criteria:

* independent living
* older adult
* interested in strengthening exercise program

Exclusion Criteria:

* must meet Strong Bone's screening criteria or have physician's approval
Hormonal Status, Performance and Health in Elite Female Athlete

The repercussions of the hormonal status of high-level sportswomen on their performance and health as well as on the Athlete's Biological Passport (ABP) have been little studied and remain poorly known. The investigators therefore propose to contribute to the improvement of current knowledge by determining, thanks to the implementation of a multidisciplinary monitoring, with the use of various tests and matrices, in female elite athletes and recreational athletes (control group):

* 1) the impact of cycle phase, absence of cycle or contraceptive use on physical and psychological performance, health as well as on ABP;
* 2) the potential confounding effects of the athlete's environment
* 3) correlations between the different matrices analyzed

Volunteers to be studied: 80 healthy female subjects (16 to 30 years old), divided into 2 groups:

Group 1: 60 athletes, from different sports disciplines, in amenorrhea, with menstrual cycle or taking contraceptives

Group 2: 20 leisure sports subjects with menstrual cycle or taking contraceptives

Following the oral and written information of the project, the subjects have a minimum of 15 days of reflection before signing the written consent form. They will have the possibility, at any time, to voluntarily interrupt the study without having to justify themselves.

Investigations to be performed:

1. Annual complete clinical examination :
2. "Out-of-competition" follow-up, time frame 6 months

   * medical, nutritional and respiratory monitoring
   * biological monitoring
   * psychological monitoring
   * performance monitoring
3. Non-invasive "in-competition" monitoring, only for Group 1, once in a year on the day before/after a major competition:

   * biological monitoring
   * psychological monitoring
   * performance monitoring (interview)

Eligibility Criteria:
Inclusion Criteria:

* Group 1: high-level athletes (qualified for national/international championships and/or training at least 15 hours/week)
* Group 2: recreational athletes who practice a regular physical activity

Exclusion Criteria:

* Participation in another trial
* History of cardiac pathology
* High blood pressure
* History of ulcers and other gastrointestinal disorders
* Myasthenia
* Renal insufficiency
* Person not affiliated or not benefiting from a social security system
Radiographic Assessment of Bone Gain Following Sinus Lifting With Simultaneous Implant Placement Using Crestal Approach With Membrane Control Technique for Bone Augmentation of Atrophied Maxillary Posterior Ridge

This study aims to evaluate the quantity and quality of the native and the newly bone around dental implants that's simultaneously installed with sinus lifting


Eligibility Criteria:
Inclusion Criteria:

1. Patients required dental implant treatment in the posterior maxilla, in the premolar and molar regions ( both sexes).
2. Residual bone height 4-8mm in the estimated implant positions.
3. The bone width of the alveolar ridge is at least 5mm in estimated implant positions.
4. The edentulous ridges are covered with optimal thickness of mucoperiosteum.

Exclusion Criteria:

1. Patients with a systemically diseases or inflammation whether local or generalized.
2. Patients with bleeding disorders.
3. Subjected to irradiation in the head and neck area less than 1 year before implantation.
4. Poor oral hygiene and motivation.
5. Pregnant or nursing.
6. Severe bruxism or clenching.
7. Active infection or severe inflammation in the area intended for implant placement.
8. Unable to open mouth sufficiently to accommodate the surgical tooling.
Triple Antigen vs Monoantigen Immunotherapy for Warts

Warts can be resistant to treatment or return despite the use of many therapeutic modalities. Combining immunotherapy might contribute to better response rates, particularly in recalcitrant warts, which is a real therapeutic challenge. The purpose of this study was to assess the effectiveness and safety of a triple intralesional immunotherapy combination composed of PPD, Candida antigen and MMR versus either agent alone in the management of multiple recalcitrant warts.

This study included 160 patients with multiple (\>3 warts) recalcitrant (at least 6 months duration and who did not respond to at least 2 treatment modalities) warts of different sites, size and duration, with or without distant warts after approval of the Institutional Review Board of Faculty of medicine, Zagazig university. They were randomly assigned to one of four groups (each with 40 patients): PPD, Candida antigen, MMR, or combination of the 3 antigens. Injections into the biggest wart were repeated every two weeks until clearance or for a total of five sessions.

Eligibility Criteria:
Inclusion Criteria:

* Multiple (\> 3 warts) recalcitrant (at least 6 months duration and who did not respond to at least 2 treatment modalities) warts of different sites, size and duration

Exclusion Criteria:

1. Patients with acute febrile illness or past history of asthma.
2. Allergic skin disorders such as generalized eczema and urticaria.
3. Past history of meningitis or convulsions.
4. Pregnancy or lactation.