cyrilzakka/clinical-trials huggingface dataset:
Effect of Metformin on Healthy Live Birth in Women With Prediabetes

To evaluate the efficacy and safety of metformin pretreatment on reproductive outcomes in infertile women with prediabetes.

To evaluate the efficacy and safety of metformin pretreatment on reproductive outcomes in infertile women with prediabetes and to determine whether either starting metformin pretreatment before ovarian stimulation (aiming at improving the quality of oocyte/embryo) or starting before frozen embryo transfer (FET) (aiming at improving the receptivity of endometrium) could increase the chance of a healthy live birth compared with placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Women who are diagnosed with prediabetes by ADA criteria, including either IFG, IGT, or HbA1C 5.7-6.4%.
2. Women aged 20-40 years.
3. Women who plan to undergo a new cycle of IVF, ICSI, or PGT-A.

Exclusion Criteria:

1. Women who are diagnosed with diabetes according to the ADA criteria11,12, which is meeting one of the following criteria: fasting plasma glucose ≥7.0mmol/L, 2-h plasma glucose during 75-g OGTT ≥11.1mmol/L, HbA1c≥6.5%, or a random plasma glucose≥11.1mmol/L.
2. Women who are taking medicine that interfere with glucose metabolism, such as metformin, oral anti-diabetic agents (sulfonylureas, glinides, thiazolidinediones, α-glycosidase inhibitors, GLP-1 receptor agonist, etc.), weight loss drugs (i.e.orlistat, etc.), glucocorticoids, and growth hormones within 2 months before enrollment.
3. Women with un-corrected hyperthyroidism or hypothyroidism.
4. Women with congenital or acquired abnormal uterine cavity including septate uterus, unicornous uterus, uterus duplex, and intrauterine adhesions.
5. Women with a diagnosis of adenomyosis.
6. Women with untreated hydrosalpinx.
7. Women who plan to undergo PGT-SR or PGT-M.
8. Women with major medical comorbidities, such as known liver disease, known renal disease, or known significant anemia.
Study of Vitamin C, Vitamin E and Their Combination to Treat Restless Legs Syndrome in Hemodialysis Patients

The purpose of this study is to determine whether vitamin C, vitamin E and their combination are effective in the treatment of RLS in hemodialysis patients.

RLS is a common problem in hemodialysis patients; 20 to 40% of hemodialysis patients suffer from RLS. Hemodialysis patients have a high oxidative stress status. Oxidative stress has been proposed to play an important role in the pathogenesis of RLS. Vitamin C and vitamin E are potent antioxidant agents that have already been shown to be effective in the treatment of periodic limb movement disorder (PLMD) in hemodialysis patients. PLMD is closely associated with RLS in hemodialysis patients. The aim of this study was to evaluate the efficacy of vitamin C, vitamin E and their combination in the treatment of RLS in hemodialysis patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients who fulfill Restless leg syndrome international criteria(IRLSSG)
* Patients who are stable on HD without any internment illness or admission

Exclusion Criteria:

* Patients who have renal stone
* Patients who receive medications with RLS aggravating or alleviating properties
Effectiveness of a Multi-component Physical Training in Hyper-fragile Elders: A Randomized Clinical Trial

Objective: To compare short-term and medium-term effectiveness of a multimodal program that integrates a program of therapeutic exercise, medication review, adequacy of diet and health education, compared with standard medical practice in improving neuromuscular and physiological status on frail elderly. Another aim is to analyze the maintenance of these effects by monitoring long-term (12 months) from the start of the intervention.

Design: Randomized controlled trial Scope / Study subjects: recruited frail elderly in Basic Health Zone of Malaga. Methods: The subjects to be included in the study (after meeting inclusion / exclusion) will be randomized into two groups: a control group whose intervention will be to review medication + adequacy of diet + health education (physical activity recommendation (within a comprehensive advice on healthy lifestyles) and an experimental group whose intervention will be a Multimodal Intervention: therapeutic exercise + review medication + adequacy of diet + health education program.

Sociodemographic, Clinical and monitoring Variables will be collected at baseline. Moreover, tracking variables will be collected at 2 and 6 months after starting the intervention and at 3 and 6 months after the end of the intervention (monitoring).

The monitoring variables that will be measured are: BMI , general health, fatigue, brittleness, Motor Control, Attention - Concentration - Memory, Motor Memory , spatial orientation, grip strength, balance (static - semi-static and dynamic ), gait speed and metabolomic variables.

One descriptive analysis of the sociodemographic variables of the participants will be performed. Further the change on the variables intra-subjects (pre-post intervention) and inter-subjects (experimental group vs control group) will be calculated. For the intra-subject analysis will be performed a ANOVA-one factor analysis. The intersubject outcome variables will be compared between the two groups in each moments of data collection, using the student t-test or Wilconxon (depending of the sample distribution). The level of significance was set at P ≤ 0.05.


Eligibility Criteria:
Inclusion Criteria:

* People 65 years older than after screening of fragility as the test battery Short Physical Performance Battery (SPPB), can perform the therapeutic exercise program

Exclusion Criteria:

* Presence in the medical history of neuromuscular , metabolic, hormonal and / or cardiovascular disorders.
Narrow-band Imaging, Autofluorescence Imaging and Gastroesophageal Reflux Disease

Aim of this study is to compare the efficacy of narrow band imaging (NBI) and autofluorescence imaging (AFI) to distinguish subtle mucosal change related to acid reflux that is not visible in standard white light imaging (WLI) endoscopy, and help indicating the diagnosis of gastroesophageal reflux disease (GERD).

GERD is a common condition that develops when the reflux of gastric and/or duodenal contents causes troublesome symptoms with or without mucosal damage or complications. Despite the high prevalence of GERD in the general population, up to 60% of patients with reflux symptoms is insufficiently characterized as having normal endoscopic finding based on standard WLI endoscopy: non-erosive reflux diseases (NERD).

NBI is an optical-digital imaging technology that uses two specific narrow-banded shot wavelength lights (400-430 nm and 525-555 nm) instead of broad band white light. The NBI contrasts surface structure and vascular architecture of the superficial mucosa and facilitates evaluation of indistinct mucosal morphology. AFI produces real-time computed images of endoscopically detected autofluorescence emitted from endogenous fluorophores in the digestive tract (collagen, nicotinamide, adenine dinucleotide, flavin, and porphyrins) caused by light excitation. The AFI can identify lesions due to differences in tissue fluorescence properties that are not detectable by standard WLI. Hence, our hypothesis is that new endoscopic imaging i.e. NBI and AFI would help to identify subtle mucosal change which indicates the diagnosis of GERD

Eligibility Criteria:
1. Inclusion criteria

   * GERD symptom: heartburn or regurgitation (either one) at least 2 days a week
   * Presence of symptom for longer than 1 month before screening
   * Provision of written informed consent
2. Exclusion criteria:

   * Any known esophageal disease or disorder, other than reflux esophagitis
   * Active or healing gastroduodenal ulcer (except scars)
   * History of esophageal or gastric surgery.
   * Clinically significant heart, lung, liver or kidney disease
   * Allergy to proton-pump inhibitor
   * Pregnancy
Visual Function and Patient Satisfaction After Bilateral Implantation of AcrySof Natural ReSTOR (Model SN60D3) or AcrySof Natural Monofocal (Model SN60AT)

The purpose of the study is:

* to compare visual parameters (Subjective refraction and Visual Acuity (VA)) and safety (tilt, decentration and posterior chamber opacification (PCO)) in a prospective series of 40 patients after bilateral implantation of AcrySof Natural ReSTOR (Model SN60D3) or AcrySof Natural Monofocal (Model SN60AT)
* to assess patient satisfaction before and after implant


Eligibility Criteria:
Inclusion:

* Written informed consent
* Age: ≥ 50 years ≤ 75 years
* Bilateral age related cataract, to be extracted and followed by the implantation of Posterior Chamber Intraocular Lenses (IOLs)
* Pre-operative and post-operative astigmatism ≤ 1 Diopter (D), as from Keratometry readings
* Potential post operative Visual Acuity (VA) ≥ 20/40
* Second eye surgery to take place no longer than 45 days after the first implant

Exclusion:

* Irregular optical aberrations;
* Pupil diameter in scotopic conditions more than 6 mm
* Degenerative visual pathologies (ex: Age-related Macular Degeneration (AMD))
* Other exclusions as from ReSTOR Directions for Use (DFU)
Sperm Oxidative Stress and Pregnancy Success During IUI and IVF

Oxidative stress (OS) is characterized by an imbalance between the production of reactive oxygen species (ROS) and the ability of the body to eliminate them. Such an imbalance can lead to lipid peroxidation, DNA damage and cell apoptosis. Studies have suggested that infertile men are more likely to have high concentrations of ROS in their seminal plasma. The investigators hypothesize that a high level of oxidative stress (OS) in patients with abnormal sperm parameters could influence fertilization and / or pregnancy success. Our first goal is to compare OS levels to semen parameters, as defined by the World Health Organization in 2010, as well as DNA fragmentation and chromatin decondensation in sperm. Our second objective is to compare OS levels in sperm to fertilization and blastulation rates at first, and then measure the impact of OS levels on pregnancy success, both in intrauterine insemination (IUI) and in vitro fertilization (IVF). Sperm samples from men in 3 groups will be analyzed: a group of fertile men with confirmed paternity (n = 50), a group of men in IVF (n = 100) and a group of men in their first three cycles of IUI (n = 100). The static oxidation reduction index (sORP) will be measured by the MiOXSYS © system, a rapid sperm analysis system using electrochemical technology. A small portion of the fresh sperm sample will be deposited on a MiOXSYS sensor and the ORP will be measured. Sperm ROS will also be measured using the CellROX Deep Red probe. The sperm parameters will be measured by the techniques used routinely in the Fertilys Reproductive Health Center andrology lab. Regarding couples in IVF, fertilization and blastulation rates, embryo quality and pregnancy success will be noted. Pregnancy success will be noted for IUI couples. If the usefulness of sORP levels in predicting pregnancy and its outcome is demonstrated, it could be a new marker in the diagnosis of male infertility and act as a guide for clinicians to apply appropriate treatment.


Eligibility Criteria:
Inclusion Criteria:

* All men with confirmed paternity aged 18 to 40 years, agreeing to participate in the study and having signed the consent form.
* All patients aged 18 to 40 using IVF or their first cycle of IUI at the Fertilys Reproductive Health Center, agreeing to participate in the study and having signed the consent form.

Exclusion Criteria:

* Patients under 18 and over 40 years old.
* Men who can not produce a sperm sample by anterograde ejaculation.
* Men going to the Fertilys Reproductive Health Center for a post-vasectomy spermogram.
* Couples who have already completed IUI cycles.
* Couples using gamete donation (eggs or sperm).
* Men with a mobile sperm concentration of less than 5 millions/mL after preparation of the sperm sample during the IUI process.
Improvement of Trans-operatory X-ray Visualization During Anterior Cervical Surgery

The purpose of this study is to establish which of five different maneuvers could bring the best trans-operatory x-ray exposure during anterior cervical surgeries with the higher security

Anterior cervical spine surgery (ACSS) is one of the most common spine surgery performed by neurosurgeons. One of the challenging aspects during ACSS is to achieve a correct visualization and identification of the lower levels specifically below the fifth and sixth cervical vertebras due to the difficulty of penetrating X-ray beams through the shoulders. Several methods such as taping the shoulders throughout the entire case or tying straps around the wrists and pulling them caudally temporally while shooting X-rays have been used trying to improve visualization during surgery. Both of these methods may cause problems such as brachial plexus injury, shoulder dislocations and peripheral nerve injuries.

The feet compression maneuver will be tested in terms of it's efficacy and security, as well as compared with four previous described maneuvers, using intra-operative neurophysiology monitoring (IONM).

50 consecutive patients programmed for elective ACSS that could meet inclusion criteria will be monitored with IONM using transcranial electric motor evoked potentials (tceMEPs), somatosensory evoked potentials (SSEPs) and spontaneous electromyography (EMG) after total endovenous anesthesia. On the operating table, a basal lateral x-ray picture and a first determination of IONM will be performed and used for comparison. Five maneuvers will be sequentially performed: 1) Feet compression, 2) Arm traction, 3) Arm traction plus feet compression combined, 4) Shoulder taping and 5) Shoulder taping plus feet compression.

All five maneuvers will be maintained for 1 min, time during IONM will test for changes in voltage amplitude and duration that potentially could be risky (risky is defined as a change in determinations more than 50% compared to basal determinations). Lateral x-rays will be performed during each maneuver to measure changes in segments visualization and levels exposed.

After all maneuvers are completed, we will proceed as the surgery was scheduled.

Eligibility Criteria:
Inclusion Criteria:

* Patients with any stable biomechanically cervical pathology (like disk herniations, vertebral tumors, etc.), scheduled for ACSS

Exclusion Criteria:

* Any cervical pathology associated with segmental instability
* History of shoulder, arm, elbow or wrist pathology, including surgery or implants.
* Radiological signs of myelopathy by MRI or clinically detected
* Preoperative identified neurological deficit
A Phase 2, Open-Label Study of Amuvatinib in Combination With Platinum-Etoposide Chemotherapy in Small Cell Lung Cancer

The purpose of the study is to evaluate the safety and potential benefit of combination amuvatinib with standard of care chemotherapy treatment (platinum and etoposide) in small cell lung cancer (SCLC) subjects.

Amuvatinib is an oral multi-targeted tyrosine kinase inhibitor which inhibits the mutant forms of c-Kit and PDGFR alpha. It also disrupts DNA repair likely through suppression of Homologous Recombination protein Rad51. In a Phase 1b clinical study in combination with VP-16 and carboplatin, responses in SCLC were observed. In vitro and in vivo data demonstrated amuvatinib synergy with VP-16 thereby further supporting this combination for continued evaluation in clinical trials. Pharmacokinetic data from Phase 1 clinical trials suggest that co-administration of amuvatinib did not alter exposures of standard of care agents VP-16 or carboplatin as measured by overall exposure.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥ 18 of age at the time of consent and have histologically or cytologically confirmed SCLC
2. Measurable SCLC per RECIST guideline that meets one of the following:

   * Disease progression by RECIST at anytime during platinum-etoposide (PE) chemotherapy;
   * Relapse by RECIST within 90 days after completing PE chemotherapy;
   * Stable disease by RECIST as best response after at least two (2) ≥ 21-day cycles of PE chemotherapy. The assessment of stable disease should be made at least 2 weeks after the start of the second cycle

   Subjects who received another second-line therapy are eligible if they still fulfill any one of the above three conditions, and all other eligibility criteria
3. Start treatment with the same last regimen (dose and schedule) of first-line PE chemotherapy that they progressed or relapsed on, including any dose reductions because of toxicity, prior to study entry
4. ECOG performance status 0 to 2
5. Adequate organ function
6. Subjects with screening 12-lead ECG with measurable QTc interval of \< 450 msec. If QTc ≥ 450 msec, then confirm the reading by evaluating the mean QTc interval of triplicate ECGs.
7. Sign approved informed consent form

Exclusion Criteria:

1. Prior exposure to amuvatinib
2. No longer eligible for first-line PE chemotherapy due to toxicity and the Investigator believes that the risk of retreating with the same PE chemotherapy regimen would outweigh the benefit
3. Ongoing toxicity from prior treatment unless the toxicity has resolved, or in the opinion of the Investigator, is stable and does not compromise the safety of the subject
4. Mixed SCLC and non-small cell lung cancer, or large cell lung cancer
5. Untreated, unstable, or symptomatic brain metastasis
6. Hypersensitivity to amuvatinib, excipients of amuvatinib, or any agent given in association with this trial
7. A life-threatening illness, medical condition or organ system dysfunction which, in the Investigator's opinion, could compromise the subject's safety or interfere with study outcomes
Pulmonary Disposition of TR-700 Following Once-Daily Oral 200 mg

The primary purpose of this study is to determine the steady-state plasma pharmacokinetics (PK) and properties of TR-700 into the pulmonary epithelial lining fluid (ELF) and alveolar macrophages (AM) of healthy volunteers.

No applicable.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females, between 18 and 55 years of age, inclusive
* Females must be nonpregnant, nonlactating, and either postmenopausal or surgically sterile or practicing an effective method of birth control
* Males must be surgically sterile, abstinent, or practicing an effective method of birth control
* BMI between 20 and 34.9 kg/m2, inclusive

Exclusion Criteria:

* Allergy to lidocaine, midazolam, or other anesthetics/sedatives of similar classes
* Physician-diagnosed migraine headaches within 3 years
* Previous enrollment in a TR-701 or TR-701 FA trial
A Study to Assess the Safety, Tolerability and Glucose-Lowering Efficacy of MK-0893 in Participants With Type 2 Diabetes Mellitus (MK-0893-005)

This study will assess the safety, tolerability and glucose-lowering efficacy of MK-0893 in participants with type 2 diabetes mellitus. The primary hypothesis is that MK-0893 will reduce 24-hour weighted mean glucose (WMG) significantly more than placebo.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Not currently on antihyperglycemic agent (AHA) or AHA monotherapy (not to include treatment with insulin or thiazolidinediones \[i.e., peroxisome proliferator activated receptor-gamma, PPARγ agents\])
* male or a female of non-childbearing potential. Women must be postmenopausal or premenopausal and documented surgically sterilized
* A body mass index (BMI) that is \> 20 and ≤ 40 kg/m2

Exclusion Criteria:

* History of type 1 diabetes or assessed by the investigator as possibly having type 1 diabetes
* History of ketoacidosis; clinically unstable or rapidly progressive diabetic retinopathy, nephropathy, neuropathy
* Treatment for diabetes within 3 months of study participation with combination anti-hyperglycemic therapy, insulin or thiazolidinediones (e.g., rosiglitazone or pioglitazone)
* oral corticosteroid medications within 2 weeks prior to study participation, or requires digoxin, warfarin, warfarin-like anticoagulants, theophylline, anti-dysrhythmic or anti-seizure medications, immunosuppressants, or anti-neoplastic agents, or herbal remedies
* History of acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV)
* History of gastrointestinal problems or disorders or extensive bowel or gastric surgery
* History of significant or unstable cardiovascular disease
* History of neoplastic disease
* History of hepatic disease
* History of seizures, epilepsy or other neurologic disease
* History of myelodysplastic or pre-leukemic disorders or other severe hematological disorder
Comparison of Woodcast vs Traditional Cast in Distal Radius Fracture

The investigators project is a randomised controlled trial that will compare the efficacy of the traditional casting method against the woodcast splint in distal radial fracture. After the investigators have taken consent and the patients have agreed to be a part of the project, the investigators will randomly divide the participants into two groups. One with the traditional cast and one with the wood cast. The difference will be measured by using the EQ-5D-Y tool alongside the use of the DASH score and our own questionnaire.

The study will take place over the following year with the Sheffield Children's Hospital being the only site involved. Woodcast products have the CE declaration of conformity which is covered for the use in children, and apart from the type of cast the child is given, the course of treatment is the same for both group

Distal radial fractures are a very common fracture. Without good plaster immobilisation these fractures are prone to slipping. As a result, patients may end up with surgical treatment which would otherwise not be needed if the plaster were to hold the fracture position adequately. If one was shown to be better compared to the other, then all hospitals could start to use a more effective treatment.

With traditional casting, some of the details of the fracture are missed due to the shadowing on the x-ray. The woodcast aims to reduce this shadowing, allowing a more detailed image of the fracture and hopefully a better outcome. Problems may arise with the plaster cast, at one or two week scans, in which the cast may need to be removed for imaging, this could lead to displacement of the fracture effecting the outcome. Woodcast would potentially not need to be removed or is easily removed due to the fact that it is not a complete cast and so would hopefully improve the outcomes for the patient.

Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of 3 and 16 that present with a distal radial fracture.

Exclusion Criteria:

* Patients with underlying physical and learning disabilities.
* Patients with significant co-morbidities that would put the patient at risk of extra distress.
* Pathological fractures for instance Osteogenesis Imperfecta, metabolic bone diseases etc...
* Patients who aren't fluent in English as we only have questionnaires available in English.