cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Effectiveness of Two Marketed Multi-Purpose Solutions for Silicone Hydrogel Contact Lenses - Study 2

The purpose of this study was to evaluate the performance of Opti-Free® PureMoist® Multi-purpose Disinfecting Solution (MPDS) compared to AMO RevitaLens OcuTec® MPDS (US brand name)/COMPLETE RevitaLens (Europe brand name) in silicone hydrogel contact lens wearers.

In this 2-period crossover study, eligible participants were randomized to either Opti-Free® PureMoist MPDS or RevitaLens MPDS in Period 1 for use with their habitual contact lenses, after which they switched to the alternate solution in Period 2. Each period was 30 days in length. A 2-day washout period during which participants refrained from using a multi-purpose contact lens solution preceded Period 1 and Period 2.

Eligibility Criteria:
Inclusion Criteria:

* Wear single vision sphere silicone hydrogel contact lenses (CooperVision™ Biofinity®, Alcon® Air Optix® Aqua, Bausch+Lomb® PureVision™ or ACUVUE® Oasys™) on a daily wear basis (a minimum of 8 hours per day, 5 days a week) for at least 1 month prior to Visit 1;
* Willing to wear lenses on a daily wear basis (a minimum of 8 hours per day, 5 days a week) for the duration of the study, and wear lenses for 16 hours on 2 days during the study;
* Must have habitually used a biguanide preserved multi-purpose solution (other than RevitaLens) for at least 30 days prior to Visit 1;
* Vision correctable to 20/30 Snellen (feet) or better in each eye at distance with pre-study contact lenses at Visit 1;
* Have access, capability and willingness to review and answer text messages;
* Read, sign, and date IRB/IEC approved informed consent and privacy document before enrollment;
* Willing to follow the study procedures and visit schedule;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Need to wear lenses on an extended wear (i.e overnight) basis during the study;
* Known sensitivity or intolerance to biguanide, polyquaternium-1 (POLYQUAD), or ALDOX preserved lens care products;
* Monocular (only one eye with functional vision) or fit with only one lens;
* Wearing toric or multifocal contact lenses or fit with monovision;
* Use of additional lens care products other than a biguanide preserved multi-purpose solution such as daily or enzyme cleaners within the 1 week prior to Visit 1;
* Use of topical ocular over-the-counter (OTC) or prescribed topical ocular medications, with the exception of rewetting drops, within 7 days prior to Visit 1;
* Abnormal ocular condition observed during the Visit 1 slit-lamp examination;
* Current or history of ocular infections or severe inflammation within 6 months prior to Visit 1;
* Ocular surgery within the 12 months prior to Visit 1;
* Participation in any other clinical trial within 30 days of enrollment;
* Other protocol-defined exclusion criteria may apply.
Safety and Efficacy of an Intrastromal Transform Corneal Allograft (TCA) for Presbyopia Correction - Long Term Follow-up

The objective of this clinical study is to evaluate the long term safety and effectiveness of intrastromal implantation of the Allotex TransForm corneal allograft (TCA) for providing near vision in presbyopic subjects.

A maximum of 101 eyes of qualified and consented subjects will undergo long term follow-up after instrastromal implantation of the TCA for presbyopia.


Eligibility Criteria:
Inclusion Criteria:

* Provide informed consent, have signed the written informed consent form, and been given a copy.
* Subjects must be willing and able to return for one scheduled follow-up examinations.
* Subjects must have undergone implantation with the TCA under study protocol PRO-010 between April 24, 2019 and October 31, 2019.

Exclusion Criteria:

• There are no known exclusion criteria.
The Value of Addition of Human Menopausal Gonadotropin Drug Following Oocytes Retrieval in IVF Cycles

The aim of this study is to test the hypothesis that addition of daily small dose of human menopausal gonadotropin (HMG) drug following oocytes retrieval could improve the fertility outcome in women undergoing in-vitro fertilization

The study will be conducted in the IVF unit of Cairo University. Females undergoing ICSI cycles in the age between 20 and 40 years will be allocated to one of 2 groups. Long agonist protocol will be used. Allocation to either one of 2 groups will be done on the day of oocytes retrieval. The first group will take (in addition to the routine care) daily human menopausal gonadotropin drug injection for 2 weeks. The second group will receive the routine care.

Eligibility Criteria:
Inclusion Criteria:

* Females undergoing Intra-Cytoplasmic Sperm Injection (ICSI) cycles
* Age between 20 and 40 years

Exclusion Criteria:

* Females who have high response (estradiol at time of ovulation trigger is \> 5000 pg/ml or more than 15 oocytes are retrieved)
Transition of Adolescents and Young Adults With Diabetes From Pediatric to Adult Care

The purpose of the study is to compare two interventions for preparing diabetic teens and young adults for transition from pediatric to adult diabetes care.

One will represent a short-term intensive social-behavioral intervention supported by peer-to-peer social networking in which subjects receive "usual care" from their current diabetes provider outside the parameters of the study. The second intervention will be a traditional transition clinic model, where subjects will receive the standard of diabetes care from a team of combined pediatric and adult practitioners and educators, with added educational modules and behavioral evaluation and support designed to facilitate the transition to adult care (i.e., that foster "developmentally tailored care"). The first is a much less intensive intervention from the standpoint of the providers and gives special prominence to peer support; the second is provider-intensive. The goal of both interventions is to improve self-efficacy (confidence in taking ownership of and managing one's diabetes); i.e., to prepare the patient to move from primary support by family and providers to a reliance on self-ownership and self-management as a responsible, independent adult.

Optional sub-study available for parents, spouses, and significant others.

Eligibility Criteria:
Inclusion Criteria:

* Age 16-29
* Diagnosis of type 1 diabetes, or type 2 diabetes managed with insulin, at least one year prior to study initiation
* English-speaking
* Some form of private or public (e.g., Medicaid) health insurance

Exclusion Criteria:

* Cystic fibrosis-related or pancreatitis-related diabetes
* Diabetes related to a known specific genetic defect such as Down's Syndrome, Lipoatrophic Diabetes, Leprechaunism or Rabson-Mendenhall Syndrome, etc.
* Chronic liver disease
* History of chronic renal failure
* Serious psychiatric illness that in the judgment of the investigators would preclude the individual's ability to complete the study
* Pregnant or planning to become pregnant within 6 months
Holbæk Obesity Treatment (HOT) Versus Conventional Obesity Treatment (COT) in Children With Overweight or Obesity.

The HOT versus COT trial aims to compare the effectiveness of two different lifestyle interventions for treatment of childhood overweight and obesity with the purpose of informing future clinical practice guidelines within this field. The aim is to conduct this investigation in an optimal trial design with the lowest possible risk of bias.

Obesity is a chronic, progressive, and severe disease that compromises growth, development, and the general health and well-being of children, adolescents, and adults all around the globe. Current treatment within this field varies considerably, but the prevailing concept is that treatment should be lifelong with a focus on implementing and maintaining changes regarding diet, physical activity, sedentary behavior, sleep, etc. The Holbæk Obesity Treatment (HOT) is built on the understanding that obesity is a complex chronic disease regulated by a neuroendocrine system, where weight-reducing actions initiate counteractive mechanisms to defend fat mass. Conventional obesity treatment (COT) is based on a view that obesity results from energy imbalances and focuses on motivation, few changes at a time, and a narrative approach towards healthy energy intake and physical activity. These two approaches represent fundamentally different treatments of overweight and obesity.

Eligibility Criteria:
Inclusion Criteria:

* Overweight or obesity defined as BMI corresponding to or above the 90th percentile for age and sex (International Obesity Task Force cut-offs).
* Age six to \< 12 years at enrolment.
* Signed informed consent from both parents or legal guardians.

Exclusion Criteria:

* Participation in multidisciplinary obesity treatment (i.e. treatment involving more than one type of healthcare profession) within the past 12 months.
* Having a sibling already enrolled in the HOT versus COT trial.
* Both parents or legal guardians unable to communicate in Danish (written or oral).
* Child unable to communicate in Danish (oral).
* Current or previous clinical diagnosis of either anorexia or bulimia according to ICD-10.
A Study to Investigate Different Formulations of S-337395 in Healthy Adult Participants

The aim of this study is to investigate different formulations of S-337395.

This single-center study comprises an open-label, randomized, crossover study, and a double-blinded, placebo-controlled, randomized, multiple-dose study to examine the relative bioavailability, food effect, pharmacokinetics, safety, and tolerability of different formulations of S-337395.

Eligibility Criteria:
Inclusion Criteria:

* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
* Body mass index within the range of 18.5 to approximately 30.0 kilograms/meter squared (inclusive) at screening.
* Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for those participating in clinical studies.

Exclusion Criteria:

* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the investigational intervention; or interfering with the interpretation of data.
* Lymphoma, leukemia, or any malignancy in the past 5 years, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
* Breast cancer within the past 10 years.
* Known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
* Sensitivity to S-337395, or any components of the formulation, or drug or other allergy, that in the opinion of the investigator, contraindicates participation in the study.

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
A Study of LY3108743 in Healthy Participants and Participants With Type 2 Diabetes

The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3108743 in healthy participants and in participants with type 2 diabetes.

The study will also investigate how LY3108743 affects the levels of blood sugar and other naturally occurring substances (e.g. hormones that control the way sugar is used) in the body, how much of the study drug gets into the blood stream, and how long it takes the body to get rid of it.

Information about any side effects that may occur will be collected. The study is expected to last approximately 7 to 8 weeks for each participant.

The study will have up to 3 parts. Participants may enroll in only one part.


Eligibility Criteria:
Inclusion Criteria:

* Must be a male, or a female who cannot become pregnant, and who is either a healthy participant, or who has type 2 diabetes
* Have a body mass index (BMI) of 18.5 to 40.0 kilogram per square meter (kg/m\^2), inclusive, at screening
* Have normal blood pressure
* Participants with diabetes must not be taking any anti-hyperglycemic medications with the exception of metformin. If on metformin, participants must be on a stable treatment regimen for at least for 4 weeks prior to screening
* Participants with diabetes must have a hemoglobin A1c (HbA1c) level between 6 to 11%, inclusive, at screening

Exclusion Criteria:

* Have previously completed or withdrawn from this study
* Have or used to have health problems or laboratory test results or electrocardiogram (ECG) readings that, in the opinion of the doctor, could make it unsafe to participate or could interfere with understanding the results of the study
Single Follicular Dexarelix for LH Suppression During Ovarian Stimulation in Oocyte Donors.

A randomized prospective study in the evaluation of the long acting GnRH antagonist Degarelix against the classical multidose regime with Ganirelix for LH suppression during the follicular phase of an ovarian stimulation cycle in oocyte donors.

A randomized prospective study of the use of single dose of the long acting GnRH antagonist Degarelix for ovarian stimulation cycle in oocyte donors: Ovarian stimulation started on cycle Day2 with gonadotropins 175-300 IU and either GnRH antagonist single dose Degarelix or multidose GnRH antagonist Ganirelix initiated on Day6 of the stimulation cycle. Agonist triggering was used in both groups for oocyte maturation. Blastocyst formation rate and Live Birth Rates were estimated for both groups.

Eligibility Criteria:
Inclusion Criteria:

* age 20-34 years;
* body mass index (BMI) 18-29kg/m2;
* regular menstrual cycle of 26-35 days,
* AMH levels age appropriate (≥2.3 ng/ml)
* early follicular- phase serum concentration of FSH within normal limits (1-12 IU/l).

Exclusion Criteria:

* women with diabetes and other metabolic disease
* women with hereditary genetic diseases;
* women with heart disease, QT prolongation,heart failure
* elevated liver enzymes, liver failure, hepatitis
* women with inflammatory or autoimmune disease
* abnormal karyotype;
* endometriosis stage III/IV;
* history of recurrent miscarriage;
* severe OHSS in a previous stimulation cycle or any contraindication for the use of gonadotrophins.
The Effect of a Multimodal Lifestyle Program on Male Fertility

A non-pharmacological study, which examines the effect of lifestyle intervention on sperm quality among men in fertility treatment.

The primary endpoint is to increase the total amount of motile sperm in male patients undergoing fertility treatment


Eligibility Criteria:
Inclusion Criteria:

* Men of couples who are about to start 2nd or 3rd fertility treatment
* \> 18 years old
* Sperm concentration between 2-40 mill./ml

Exclusion Criteria:

* Use of testicular sperm
Risk Factors and Results of Emergency Ventral Hernia Repair

The aim of present study was to evaluate the clinical course after emergency ventral hernia repair in terms of 30-day-readmission, -reoperation and -mortality and to identify risk factors for emergency repair.

All incisional, umbilical and epigastric hernias registered in the Danish Ventral Hernia Database

Eligibility Criteria:
Inclusion Criteria:

* All incisional, umblilical and epigastric hernia repiars
Acute Diverticulitis and Advanced Colonic Neoplasia. When to Perform Colonoscopy (ADACOLON Study)

This study evaluate the prevalence of advanced colonic neoplasia (ACN) in acute diverticulitis. A sub-analysis of complicated and uncomplicated acute diverticulitis will be made in order to determinate whether there are differences of advanced colonic neoplasia (ANC) prevalence in both groups and to assess if a colonoscopy is necessary.

This is a prospective study that eliminates biases in the selection, design and variability of retrospective studies to reliably assess the global prevalence of advanced colon neoplasia (ACN) and the difference in prevalence among populations with complicated and uncomplicated acute diverticulitis diagnosed by computed tomography. Another objective is to assess the diagnostic prediction of computed tomography to detect ACN in acute diverticulitis. It also aims to assess the safety and quality of colonoscopy in a patient recently diagnosed with acute diverticulitis. Finally, it aims to study whether other diagnostic tools such as the presence of clinical risk symptoms or the performance of fecal biological tests could help in narrowing the indication of colonoscopy in this clinical scenario.

Eligibility Criteria:
Inclusion Criteria:

All patients consecutively diagnosed with acute diverticulitis in the participating hospitals during the study inclusion period will be included. For this purpose, a multidetector computerized tomography confirming the diagnosis of acute diverticulitis must be performed on all patients with initial clinical suspicion.

Exclusion Criteria:

1. Patient refusal to participate in the study.
2. Impossibility of obtaining informed consent by the patient or guardian.
3. Age \<18 years and\> 85 years
4. Impossibility of performing a diagnostic CT of AD.
5. Intercurrent medical or surgical process with prolonged recovery in time that prevents a colonoscopy before 6 months after the resolution of the episode of acute diverticulitis.
A Study to Test if Trevogrumab or Trevogrumab With Garetosmab When Taken With Semaglutide is Safe and How Well They Work in Adult Patients With Obesity for Weight Loss and Fat Loss

This study is researching experimental drugs called trevogrumab and garetosmab (called "study drugs") in combination with another drug, semaglutide (Wegovy®). This study will be done in 3 parts, Part A, Part B, and Part C where different study drugs will be tested.

Part A of the study is focused on healthy participants. Part B and C of the study is focused on participants with obesity.

The aim of Part A of the study is to see how safe and tolerable the study drug is in healthy participants. The aim of Part B and Part C of the study is to see how safe and effective the study drug is when combined with Wegovy.

Parts A, B, and C of the study are looking at several other research questions, including:

* What side effects may happen from taking the study drug
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Part A Healthy Volunteers

Part B and Part C (starts after treatment for Part A has completed) Participants with Obesity

Eligibility Criteria:
Key Inclusion Criteria

Part A

1. Male or female participants age ≥18 to ≤55 years of age at the time of screening
2. BMI ≥18 and ≤32 kg/m2, at the screening visit

   Part B and Part C
3. Male or female participants ≥18 to ≤80 years of age at the time of screening
4. BMI ≥30 kg/m2, at the screening visit
5. History of 1 or more self-reported unsuccessful dietary attempts to lose weight

Key Exclusion Criteria

1. History of diabetes (Type 2 or Type 1). History of gestational diabetes is permitted
2. Previous bariatric surgery or planned bariatric surgery
3. History of hypertrophic cardiomyopathy
4. Abnormal electrocardiogram (ECG) findings at screening that meet Cornell voltage criteria for left ventricular hypertrophy
5. Any malignancy in the past 5 years prior to screening (except for nonmelanoma skin cancer that has been resected with no evidence of metastatic disease for 3 years prior to screening)
6. History of poorly controlled hypertension, as defined in the protocol
7. Have a history of any other condition (such as known drug abuse, alcohol abuse, diagnosed eating disorder, or a severe mental illness) that, in the opinion of the investigator, may preclude the participant from following and completing the protocol
8. Have history of use of marijuana/tetrahydrocannabinol (THC) within 90 days prior to Visit 1 of enrollment and are unwilling to abstain from marijuana/THC use during the trial
9. Has a history of any neuromuscular disorder (eg, multiple sclerosis, myasthenia gravis, myopathy, peripheral neuropathy, etc)

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
ALXN1830 in Patients With Warm Autoimmune Hemolytic Anemia

The main objective of the study is to evaluate the safety and efficacy of ALXN1830 compared to placebo in adult participants with warm autoimmune hemolytic anemia (WAIHA).

This study will consist of a 4-week Screening period, 13-week Primary Treatment period, and optional Extended Treatment period (up to 2 years).

Eligibility Criteria:
Key Inclusion Criteria:

* Primary or secondary WAIHA, diagnosed at least 6 weeks prior to Screening
* Failed or not tolerated at least 1 prior WAIHA treatment regimen, for example, corticosteroids, rituximab, azathioprine, cyclophosphamide, cyclosporine, mycophenolate mofetil, danazol, or vincristine
* Hemoglobin \< 10 g/dL and ≥ 6 g/dL
* Positive direct antiglobulin test (Coombs) (IgG positive, complement C3 \[C3\] positive or negative)
* Evidence of active hemolysis including any of the following: a) Lactate dehydrogenase (LDH) \> upper limit of normal (ULN), b) Haptoglobin \< lower limit of normal (LLN), c) Indirect bilirubin \> ULN
* Total IgG \> 500 mg/dL

Key Exclusion Criteria:

* Human immunodeficiency virus (HIV) infection (positive HIV-1 or HIV-2 antibody test)
* Positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody test
The Effect of Proton Pump Inhibitors on Calcium and Bone Metabolism

This prospective, single-blind, matched controlled study aims to evaluate the effect of proton pump inhibitors on biochemical markers of calcium and bone metabolism in an effort to establish additional biological plausibility for the apparent association between proton pump inhibitors (PPIs) and osteoporosis-related fractures.

Young males (age 18-45 years), who are either healthy volunteers, or who complain of daily or frequent heartburn but are otherwise healthy, will be recruited and enrolled in the study. Patients with heartburn will be assigned to the intervention group and will be assigned to take a PPI for three months. Healthy volunteers will be matched by age to patients in the intervention group and will act as the control group. 70 patients will be enrolled in total. Blood studies for all subjects will be taken at 0, 1 and 3 months to test for various biochemical markers of calcium and bone metabolism, which act as surrogate markers of calcium absorption and bone remodeling.

Levels of biochemical markers in the two groups will be compared using two-way analysis of variance (ANOVA). Changes in biochemical parameters within a group will be assessed using repeated measures ANOVA.


Eligibility Criteria:
Inclusion Criteria:

* Males aged 18-50 years
* Healthy (or healthy with heartburn only)

Exclusion Criteria:

* Female gender
* Previous allergy to PPI
* Regular beach seekers (more than once a week)
* Intestinal disease
* Recent fracture (within the past six months)
* Kidney stones
* Intake of the following medications:

  * Vitamin D or calcium supplements
  * PPIs or H2 receptor antagonists within the past year
  * One-Alpha
  * Anticonvulsants
  * Glucocorticoids
Comparative Study Between Thrombosis Prophylaxis Protocols

Background: Compare the American and Brazilian protocols for prophylaxis of deep vein thrombosis (DVT), seeking to draft a new protocol, more comprehensive and applicable. Methods: A prospective study was conducted over a year, covering 212 patients, comparing the protocols on the stratification of risk of DVT, and the type of prophylaxis indicated. A new protocol was proposed, applied and compared to previous.

Not desired

Eligibility Criteria:
Inclusion Criteria:

Patients who underwent plastic surgery in the Hospital of the Medical School of Botucatu, in the period of one year

Exclusion Criteria:

refusal to participate in the research protocol