cyrilzakka/clinical-trials huggingface dataset:
Human Solute Carrier Family 5 Member 2 (SLC5A2) Deficiency and the Glucagon-Incretin Axis

Sodium-glucose-cotransporter 2 (SGLT2) are a new type of oral antidiabetic drugs. SGLT2 inhibitors increase the urinary glucose excretion and thereby decrease blood glucose levels. Beside their glucose lowering effects SGLT2 inhibitors showed beneficial effects on the cardiovascular health. But several studies in cell culture and mice showed that the physiological inhibition of glucagon after meal consumption is impaired when using SGLT2 inhibitors.

The patients carry a rare genetical disease called Familial renal glucosuria (FRG), a human model of life long SGLT2 inhibition. To elucidate the effects of partial and complete SGLT2 inhibition in humans the investigators perform a mixed-meal tolerance test (MMTT), the gold standard for elucidation of insulin and glucagon dynamics.

The index patient was referred to the Department of Internal Medicine I at the Medical University of Innsbruck for evaluation of unclear glucosuria in combination with normal blood glucose levels. The patient suffered from recurrent urinary tract infections and increased urinary frequency, showed a physiological hemoglobin A1c and no further signs of renal dysfunction. Sequencing of the SLC5A2 coding region confirmed that the patient was compound heterozygous for two SLC5A2 mutations. The patient is a mother of five healthy children which are willing to take part in the test. The children show a 50/50 distribution of the mother's mutations. The MMTT will take place after 48 hours of alcohol, sport abstinence and an overnight fasting period. The patients will be given 6 ml/kg body weight of a standardized liquid meal. Blood samples will be collected 10 minutes before consumption of the meal, at the time point of consumption and 15, 30, 60, 120, 150, 180, 210 and 240 minutes after consumption. At each time point six blood tubes will be taken, except at time point -10 and 240 minutes, there is one sample more collected. The investigators aim to assess glucagon, insulin, c-peptide, gastric inhibitory polypeptide (GIP), Glucagon-like peptide-1 (GLP-1), Glucagon-like peptide-2 (GLP-2) levels.

Glucose tolerance will be assessed by using the 4 hours area under the curve (AUC) for glucose. To evaluate the beta-cell function the 4h-AUC's for insulin, c-peptide and the 4h-AUC insulin:glucose ratio will be calculated and compared. The calculation of the alpha-cell function will be performed with the AUC of glucagon and the AUC glucagon/glucose ratio. GIP, GLP-1 and GLP-2 will be determined using the AUC. The AUC's will be calculated by the trapezoidal method.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years
* Capable of giving consent
* One or more SLC5A2 mutations leading to FRG
* Written consent

Exclusion Criteria:

* Impaired glucose tolerance
* Diabetes mellitus
Transcranial Electrical Stimulation for Mal de Debarquement Syndrome

The goal of this study is to determine whether external neuromodulation using transcranial electrical stimulation (TES) can reduce the perception of self-motion that is experienced by patients with MdDS. Mal de debarquement is translated as the "sickness of disembarkment," and refers to the chronic feeling of rocking dizziness that occurs after exposure to passive motion. A similar form of rocking dizziness can be experienced without a motion trigger in individuals with certain risk factors.

Treatment for MdDS is limited and morbidity is high.The goal of the study is to determine whether TES can suppress the rocking dizziness of MdDS either as a standalone therapy or as an adjunctive therapy to other forms of neuromodulation such as transcranial magnetic stimulation. The investigators will determine the optimal treatment duration and stimulation parameters.

Eligible participants who meet study criteria and pass the safety screen will be invited to participate in the study. If TES is used as add-on treatment to repetitive transcranial magnetic stimulation (rTMS), the training for TES application will be done on-site. However, in a portion of the study that does not involve rTMS, remote training will be performed via a webcam provided that a suitable "Study Buddy" is available to assist the participant.

Participants will maintain web-based diaries of their symptoms for up to four weeks prior to treatment with TES. Before the actual treatment sessions are started, the subjects will complete baseline questionnaires online which will be repeated once a week for up to 12 weeks. Over the course of the study, the subjects will also keep a daily log of their sessions such as how many sessions they performed, for how long, and whether they had any side effects with each session.

The studies will include a sham arm, allocated at a ratio of 1:1. On-site studies will involve the application of EEG, MRI, balance, cognitive, and visual/auditory stimulation tests.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old
2. Willing and capable of interacting with the informed consent process
3. Primary disorder being a persistent perception of motion with no other cause determined after a careful interview.
4. Able to identity a study buddy and provide contact information

Exclusion Criteria:

1. Subjects who cannot comply with study conditions.
2. Active psychiatric condition such as mania or psychosis
3. Unstable medical condition
4. Implanted metal in the head or neck (metal or shrapnel, deep brain stimulators, aneurysm clips, cochlear stimulators, retinal implants, etc). Dental fillings are acceptable.
5. Any active skin disorder that affects skin integrity of the scalp.
6. Pregnant
Comparison of Corneal Incision Versus Toric Intraocular Lens Techniques Used in Cataract Surgery

Eyesight and quality of life improves in patients after refractive cataract surgery because this surgery treats myopia, hyperopia and presbyopia except astigmatism. In order to make a patient spectacle free Ophthalmologists use different methods during cataract surgery to minimize astigmatism.

These methods includes limbal relaxing incisions (LRIs) or the insertion of toric IOLs, which are specifically intended to cancel out pre-existing astigmatism and astigmatic keratometry. This research will be conducted to see which method benefits more for treating preoperative astigmatism in eye.

Eligibility Criteria:
Inclusion Criteria:

* Both genders were included.
* Patients having astigmatism was included. Patients having cataract was included.
* Eyes having no other ocular pathology was included.
* Patients having no history of corneal scar was included

Exclusion Criteria:

* Eyes having any ocular pathology will be excluded.
* Patients with corneal suture will be excluded.
* Those using contact lenses instead of spectacles for vision correction will be excluded.
* Participants with a history of eye surgery within the past year will be excluded.
Screening for Gaucher Disease and Acid Sphingomyelinase Deficiency

High-risk screening for Gaucher disease and Acid Sphingomyelinase Deficiency in patients with splenomegaly and/or thrombocytopenia in Taiwan

Late-onset Gaucher disease (GD) present a unique set of challenges compared to their early-onset counterparts. Symptoms may not appear until adulthood, leading to delayed diagnosis and treatment. This delay can result in irreversible damage to affected tissues and organs, such as the liver, spleen, and central nervous system. Additionally, many late-onset GD are underdiagnosed or misdiagnosed due to their rarity and the variability of symptoms. This study is divided into two phases. In the first phase, patients with hepatosplenomegaly of unknown etiology will be initially screened using an electronic medical record database, and in the second phase, laboratory analysis of biomarkers, including Dry blood spot (DBS) for GBA1 enzyme activity, plasma Lyso-GB1 levels and GBA1 gene sequencing, will be performed. Acid sphingomyelinase deficiency (ASMD) is another lysosomal storage disorder that shares symptoms with GD. Consistent with the above screening strategy for GD patients in two phases (DBS for ASM enzyme activity, plasma Lyso-SM levels and ASM gene sequencing). This study will involve 2,000 candidates from electronic healthcare databases, 240 patients from outpatient clinics, and a cohort of 6 GD1/GD3 patients as controls. In conclusion, initial screening for late-onset GD and ASMD can provide patients with treatment opportunities that can improve outcomes for those affected by these rare diseases.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of splenomegaly
2. Clinical diagnosis of thrombocytopenia

Exclusion Criteria:

1. Clinical diagnosis of gaucher disease
2. Clinical diagnosis of acid sphingomyelinase
3. Clinical diagnosis of malignant tumors
Neonatal Outcomes in Instrumental Delivery

The aim of this study is to compare the impact of instrumental delivery on newborn head mark and newborn comfort over the impact of non-instrumental delivery. It is also to evaluate how mothers age, Body Mass Index, instrumental extraction indication, extractor type, variety and height of the fetal presentation, operator, time of birth (day or night) and birth weight impact on head mark existence and newborn comfort.


Eligibility Criteria:
Inclusion Criteria:

* term infant
* non-opposition of the newborn parent

Exclusion Criteria:

* outborn child
* premature newborn
* newborn transferred
Efficacy and Safety of Repaglinide Combined With Insulin in Type 2 Diabetes

This trial is conducted in Asia. The aim of this trial is to compare oral anti-diabetic drug (OAD) combined with insulin vs. insulin alone in subjects with type 2 diabetes not adequately controlled on the current OAD therapy.


Eligibility Criteria:
Inclusion Criteria:

* HbA1c between 7.5 % and 13.0% (both inclusive)
* Fasting C-peptide above or equal to 0.33 nmol/l
* BMI (Body Mass Index) between 25 and 32 kg/m2 (both inclusive)

Exclusion Criteria:

* Medical history of treatment with insulin within the last 6 months
* Impaired renal function, defined as serum creatinine above to 1.7 mg/dl (150 µmol/l)
OD-PHOENIX in Talus Osteochondral Lesion

Treatment of osteochondral lesion of Talus with a devitalized viro-inativated sterile osteochondral graft. To avoid having to harvest autograft material from the knee, a processed allogeneic osteochondral can be used instead autograft. The surgical technique is to implant in the osteochondral defect one to three products in the defect.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients between the ages of 18 and 50
* Isolated osteochondral lesion of the talus due to trauma (fracture) or osteochondritis dissecans
* Osteochondral lesion \> Anderson Grade I (MRI)
* 1 to 3 cm2 lesion
* Presence of disabling and clinically meaningful symptoms (subjective OMAS \< 50)
* Patient who has been treated previously for this lesion, except if this treatment consisted of autologous osteochondral grafting
* No significant obesity (BMI \< 30)
* Patient able to understand, sign and date the informed consent form
* Patient affiliated with a national health insurance system or who is the beneficiary of such as system
* Women of childbearing age may not be included in the clinical trial unless their pregnancy test is negative. If this test is negative, they will be asked to use an effective birth control method during the entire the study.

Exclusion Criteria:

* Pregnant or breast feeding women: Women of childbearing age will be asked to undergo a pregnancy test before being enrolled into the study and to use an effective birth control method.
* Previous mosaicplasty treatment of this lesion
* Fracture or bone defect or subchondral lesion without cartilage involvement, untreated osteonecrosis, collapse of talar dome
* Presence of osteoarthritis, rheumatoid arthritis, excessive hindfoot deformity or any other condition of the talocural joint that, in the surgeon's opinion, is likely to compromise the allograft's outcome
* Excessive laxity or recurrent instability that could affect the score evaluation
* Presence of an ulcerative disease, heavy smoking, tuberculosis, chronic psychiatric disorder or disease requiring long-term treatment with a medication that would affect bone or joint metabolism
* Persons with cancer or a history of cancer
* Persons deprived of their freedom by a judicial or administrative decision
* Adults subject to legal protection measures or who are unable to provide their consent
A Study of Symptom Improvement of Ulcerative Colitis After an Induction Dose of Ustekinumab in Japanese Clinical Practice

The purpose of this study is to describe the initial response to ustekinumab induction treatment for ulcerative colitis (UC) in Japan.


Eligibility Criteria:
Inclusion Criteria:

* Must have a confirmed diagnosis of ulcerative colitis (UC) in accordance with local practice
* Has a current UC severity that is judged by the treating physician to be moderate to severe (being a partial Mayo score of 5 to 9, inclusive)
* A decision has been made by the treating physician and the participant within routine clinical practice to commence treatment with ustekinumab, having been deemed to have an inadequate response to, or intolerant to, previous UC therapy
* Must sign an informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements. If the participant is 16 to 19, informed consent might be obtained from each study participant according to the regulation of institution/hospital and their legally acceptable representative must sign an ICF
* Must be able to read, understand, and complete participant-reported outcome instruments, and intend to cooperate with completion of participant-reported outcome instruments using smartphone/tablet

Exclusion Criteria:

* Has ever previously received ustekinumab (including clinical trial use)
* Are currently receiving, or have received within the past 3 months, systemic treatment with a biologic therapy for any other indication (example Crohn's disease, psoriasis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis)
* Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 3 months before the start of the study or the first data collection time point
* Currently enrolled in an interventional study or another Janssen-sponsored observational study (including post-marketing surveillance)
* Based on physician judgement has i) severe extensive colitis and is at imminent risk of colectomy OR ii) a stoma or history of a fistula OR iii) previously had extensive colonic resection (example, less than 30 centimeter (cm) of colon remaining) OR iv) current fulminant colitis OR v) currently hospitalized for worsening of UC-related symptoms (not excluded if the reason for hospitalization is first dose of ustekinumab)
Improving Uptake and Adherence to HIV Prevention Services With Pre-exposure Prophylaxis (PrEP), HIV Self- Testing and Adherence Support for Very High Risk HIV-negative Young Women Aged 15-24 in Kampala, Uganda

The main aim is to develop and assess an intervention to enhance initiation and adherence to PrEP among HIV negative young women of high risk (YWHR). The specific aims are (1) To conduct formative research to enhance our understanding of the dynamics of the social and sexual networks, and context of young HIV-uninfected women (aged 15-24) engaged in high risk sexual behavior in Kampala, Uganda (2) Document barriers and opportunities for PrEP uptake and adherence as well as repeat HIV testing by self test; (3) To develop and test a socially and culturally acceptable and feasible prevention intervention on uptake and adherence to PrEP and HIV self-testing for young women at high risk for HIV.


Eligibility Criteria:
Inclusion Criteria:

* Female age 15- to 24-years old
* Engaging in high-risk sexual behavior having had sex at least once in last three months, --HlV-negative
* Agree to participate in a minimum of four interviews over a 12-month period; including baseline
* Willing to receive services at Good Health for Women Project (GHWP)
* For those initiating PrEP (Truvada):
* Participants should have immunity to Hepatitis B infection and serum creatinine before
* Contra-indications for starting Truvada to be considered include Creatinine \> 1.2 ( (mgldl) or 0.106 (mmolil) and a weight below 35kg.

Exclusion Criteria:

* Inability to consent to participation in the study
* Condition impeding participation in the study, including severe mental reason to the discretion of the principal investigator, cognitive impairment or illness; serious medical illness or developmental disability and any other reason to the discretion of the principal investigator.
Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine

Primary Objective:

To demonstrate non-inferiority of SAR342434 versus Humalog in glycated haemoglobin A1c (HbA1c) change from baseline to Week 26 in participants with type 1 diabetes mellitus (T1DM) also using insulin glargine.

Secondary Objectives:

To assess the immunogenicity of SAR342434 and Humalog in terms of positive/negative status and antibody titers at baseline and during the course of the study.

To assess the relationship of anti-insulin antibodies with efficacy and safety including during the safety extension.

To assess the efficacy of SAR342434 and Humalog in terms of proportion of participants reaching target HbA1c (\<7%), Fasting plasma glucose (FPG), self-measured plasma glucose (SMPG) profiles, and insulin dose.

To assess safety of SAR342434 and Humalog.

The study consisted of a:

* Up to 2 weeks screening period
* 26-week treatment period
* 26-week comparative safety extension period
* 1-day follow-up period
* The maximum study duration would be 54 weeks per participant and a 1-day safety follow-up

Eligibility Criteria:
Inclusion criteria:

* Participants with T1DM diagnosed for at least 12 months and had been treated with insulin glargine and Humalog or Novolog®/Novo Rapid® (at least 3 times daily before each meal) in the 6 months prior to the screening visit.
* Written informed consent.

Exclusion criteria:

* At screening visit, age under legal age of adulthood.
* HbA1c \<7.0% or \>10% at screening.
* Diabetes other than T1DM.
* Status post pancreatectomy.
* Status post pancreas and/or islet cell transplantation.
* Pregnancy and lactation.
* Women of childbearing potential not protected by highly effective contraceptive method of birth control.
* Less than 1 year on continuous insulin treatment.
* Use of insulin pump in the last 6 months before screening visit.
* Use of glucose lowering treatments other than insulin including non-insulin injectable peptides in the last 6 months prior to screening visit.
* Use of insulin other than insulin glargine and Humalog or Novolog/Novo Rapid as part of a multiple injection regimen (3 to 4 injections per day) in the last 6 months before screening visit. Liprolog® is a European Union approved insulin lispro and is allowed in those countries where it is marketed.
* Hospitalization for diabetic ketoacidosis in the last 6 months before screening visit.
* Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment, or injectable drugs) during the study period.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Polydeoxyribonucleotide (PDRN) for Cuff Regeneration

This study is to evaluate the effect of polydeoxyribonucleotide (PDRN) for healing and fatty degeneration of rotator cuff. The investigators will enroll 130 patients with rotator cuff tear who will undergo arthroscopic rotator cuff repair. 130 patients will be classified into two group. One group (PDRN) will be injected at the repaired cuff with 3cc polydeoxyribonucleotide just after surgery and be injected with another 3ml polydeoxyribonucleotide under ultrasound guidance 2 weeks after the surgery. The other group (CONTROL) will be injected with 3ml normal saline in the same manner.

Polydeoxyribonucleotide is a tissue regeneration activator. It binds an adenosine receptor and stimulate VEGF(vascular endothelial growth factor) synthesis and stimulate collagen synthesis. Nowadays, a lot of arthroscopic rotator cuff repairs are being performed. but the failure rate of rotator cuff repair is considerably high. Therefore, this study is to evaluate the effect of polydeoxyribonucleotide for healing and fatty degeneration of rotator cuff.

Visual analog scale (VAS) of pain and other functional scores of the two group will be checked preoperatively and postoperative 3, 6, 12, 24 months. Growth factors (VEGF, fibroblast growth factor(FGF), insulin like growth factor(IGF)) will be checked preoperatively and postoperative 1h, 2 days, 2 weeks, 6 weeks, 3, 6 months. Follow up MRI will be checked at postoperative 6 months. The parameters will be compared using statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* definite rotator cuff tear on preoperative MRI, which needs repair
* acceptance of arthroscopic surgery including rotator cuff repair

Exclusion Criteria:

* history of ipsilateral shoulder operation or fracture
* concomitant neurological disorder around the
To Investigate the Effect of Esketamine Hydrochloride on Pulmonary Complications

The objective of this study was to evaluate the effect of esketamine on intraoperative hemodynamics in patients with heart valve replacement and to mitigate postoperative pulmonary complications

After being informed of the study and potential risks, all patients who gave written informed consent will undergo pre-operative screening to determine eligibility for study enrollment. Before operation, eligible patients were randomly divided into esketamine group (0.2mg/kg, intraoperative pump), esketamine group (0.4mg/kg, intraoperative pump) and blank control group (physiological salt pump) in a double-blind way at a ratio of 1:1:1.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years old, gender unlimited.
* Elective heart surgery.
* Patients who plan to undergo mitral and (or) aortic valve replacement (or repair) surgery, requiring extracorporeal circulation and aortic occlusion.
* The New York Heart Association class is less than 4.
* Voluntarily sign informed consent.

Exclusion Criteria:

* Non-cardiac surgery.
* Second heart surgery.
* Interventional surgery in heart valve surgery (TAVI, mitral clamp).
* The patient refuses.
* Pregnant women.
* Patients with a history of lung surgery.
* Patients with acute kidney injury requiring dialysis.
* Patients with chronic renal insufficiency (stage III and above).
* The patient was intubated before arriving at the operating room.
* Patients with existing pulmonary complications (respiratory tract infection, pneumonia, pleural effusion, respiratory failure, atelectasis, pneumothorax, bronchospasm, ARDS).
* The patient had neuropsychiatric disease and cognitive impairment before surgery.
* Drug users and other long-term use of antipsychotic drugs.
* Patients with any of the following contraindications for the use of ESketamine injection: patients with serious risk of elevated blood pressure or intracranial pressure; Patients with high intraocular pressure (glaucoma) or penetrating ocular trauma; Patients with poorly controlled or untreated hypertension (arterial hypertension, resting systolic pressure exceeding 180 mmHg, or resting diastolic pressure exceeding 100mmHg); Patients with untreated or undertreated hyperthyroidism (hyperthyroidism).
* Liver function ALT, AST \> 2 times normal.