cyrilzakka/clinical-trials huggingface dataset:
RCT Metformin for Reduction of Gestational Diabetes Mellitus Effects

The overall objective of the EMERGE trial is to determine whether metformin + usual care, compared to placebo + usual care (introduced at the time of initial diagnosis of GDM), reduces a) the need for insulin use, or hyperglycemia (primary outcome measure); b) excessive maternal weight gain; c) maternal and neonatal morbidities and, d) cost of treatment for women with Gestational Diabetes Mellitus.


Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to provide written informed consent
2. Participants aged 18-50
3. Pregnancy gestation up to 28 weeks (+ 6 days) confirmed by positive pregnancy test
4. Singleton pregnancy as determined by scan
5. Positive diagnosis of Gestational Diabetes Mellitus on a Oral Glucose Tolerance Test (OGTT) according to the International Association of the Diabetes and Pregnancy Study Groups (IADPSG) criteria if any one of the following are achieved: i) Fasting glucose \>/= 5.1mmol/l and \<7mmol/l, or ii) 1 hour post glucose load of \>/=10mmol/l, or iii) 2 hour post glucose load of \>/=8.5 mmol/l and \<11.1mmo/l
6. Resident in the locality and intending to deliver within the trial site

Exclusion Criteria:

1. Participants who have an established diagnosis of diabetes (Type 1, Type 2, Monogenic or secondary)
2. Participants with a fasting glucose \> 7mmol/l or a 2h value \> 11.1 mmol/l
3. Multiple pregnancies (twins, triplets etc.) as determined by scan
4. Known intolerance to metformin
5. Known contraindication to the use of metformin which include: i) renal insufficiency (defined as serum creatinine of greater than 130 µmol/L or creatinine clearance \<60 ml/min), ii) moderate to severe liver dysfunction (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) greater than 3 times the upper limit of normal, iii) shock or sepsis, and iv) previous hypersensitivity to metformin
6. Major congenital malformations or an abnormally deemed unsuitable for metformin by the site PI or attending consultant
7. Known small for gestational age (Small for gestational age (SGA) refers to foetal growth less than the 10th percentile (RCOG, 2014), or if foetal growth is deemed unsatisfactory by the treating obstetrician)
8. Known gestational hypertension or pre-eclampsia or ruptured membranes
9. Participants who have a history of drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements
10. Participants with significant gastrointestinal problems such as severe vomiting, Crohn's disease or colitis which will inadvertently affect absorption of the study drug
11. Participants with congestive heart failure or history of congestive heart failure
12. Participants with serious mental illness which would affect adherence to study medication or compliance with study protocol in the opinion of the investigator
13. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
High Intensity Interval Training VS Moderate Intensity Continuous Training in Chronic Low Back Pain Subjects

The current guidelines for non-specific CLBP, recommend a conservative approach with exercise therapy, as first line treatment. Endurance and resistance training are two examples of recommended exercise therapies. However, it appears that none is recommended as superior over the other.

The lack of studies using HIIT in CLBP subjects, is the reason why it is needed to conduct an investigation about its effects.

However, firstly it is needed to assess the feasibility and safety of the HIIT protocol, to integrate it in the daily practise and future research.

In a single-center, single-blinded randomized feasiblity study, the investigators aim to prove the feasibility and safety of a 12 week HIIT programm.

Eligibility Criteria:
Inclusion Criteria:

* Oswestry disability index (ODI) Score ≥ 14%
* Low back pain for at least 3 months.
* Declared suitable by their physician or hospital consultant to start an exercise programme and to perform a graded exercise testing to determine the heart rate peak.
* Good understanding of German or English, written and spoken.
* Age between 29 - 69
* No or stopped physical therapy.

Exclusion Criteria:

* Pre-existing unstable heart disease or suspected angina pectoris, cardiac dysrhythmias, heart failure, aneurysm or aortic stenosis.
* Known pregnancy.
* Previous low back spinal surgery in the last 2 years.
* Tumour, spinal stenosis, spinal fractures or radiculopathy.
* Comorbid health conditions like diabetes mellitus, rheumatoid arthritis or other systemic inflammatory diseases.
Use of Lumella-glycosylated Fibronectin for Diagnosis of Preeclampsia

women with symptoms of preeclampsia from antenatal clinic or triage will be offered Lumella test along with traditional blood tests. If Lumella test is positive which will be compared with the traditional blood test results. Once 50 positive cases have been analysed the study results will be submitted to NICE.

Pre-eclampsia is a potentially serious condition that affects pregnant women. It is usually diagnosed during routine antenatal appointments. This is based on blood pressure measurements and results of urine protein tests that are recommended at each routine antenatal visit to screen for the condition. The Triage PlGF test and the Elecsys immunoassay sFlt-1/PlGF ratio is also recommended to help rule out the condition in women presenting with suspected pre-eclampsia between 20 weeks and 34 weeks of pregnancy plus 6 days. If diagnosed with pre-eclampsia, women are usually referred to a specialist in hospital for further tests and more frequent monitoring. Depending on the severity of the condition, some women may be monitored as outpatients while others may need admission to hospital for closer monitoring or to have the condition managed in a critical care setting.

The Lumella test is based on the novel biomarker GlyFn. The company states that compared with other currently used biomarkers (such as soluble fms-like tyrosine kinase-1 \[sfIT-1\] and placental growth factor \[PlGF\] or PlGF alone), GlyFn is etiological to pre-eclampsia and maintains a linear progression throughout pregnancy. The company also claims that the test offers improved sensitivity and specificity over standard care tests. This would lead to a reduction in false positives and false negatives. The Lumella test requires a finger prick blood sample (5 microlitres). Other pre-eclampsia tests currently used in the NHS need a phlebotomy blood sample, which can be difficult to collect in some people. The test can also be transported and stored at room temperature. Other tests for pre-eclampsia need to be refrigerated and brought to room temperature before the test can be done. The Lumella test may improve patient experience and allow a more rapid turnaround time for results. The company states that Lumella is currently the only test that can be done within 10 minutes at room temperature.

Eligibility Criteria:
Inclusion Criteria:

* If they can speak English
* Can give informed consent
* Has symptoms of Preeclampsia

Exclusion Criteria:

* Can't speak English
* Does not want to participate
Safety of Tobramycin Inhalation Powder (TIP) vs Tobramycin Solution for Inhalation in Patients With Cystic Fibrosis

This study compares the safety of the tobramycin solution for inhalation with the tobramycin dry powder formulation, used with a simple inhaler


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of cystic fibrosis
* Male and female patients at least 6 years of age at the time of screening.
* Forced expiratory volume in one second (FEV1) at screening must be at least 25% and less than or equal to 75% of normal predicted values for age, sex, and height based on Knudson criteria.
* Pseudomonas aeruginosa, a type of bacteria, must be present in a sputum/deep-throat cough swab culture (or bronchoalveolar lavage \[BAL\]) within 6 months prior to screening and in the sputum/ deep-throat cough swab culture at the screening visit.
* Able to comply with all protocol requirements.
* Clinically stable in the opinion of the investigator.
* Use of an effective means of contraception in females of childbearing potential.
* Provide written informed consent, Health Authority Portability and Accountability Act (HIPAA) authorization (where applicable), and assent (as appropriate) prior to the performance of any study-related procedure.

Exclusion Criteria:

* History of sputum culture or deep-throat cough swab (or BAL) culture yielding Burkholderia cepacia (B cepacia), a type of bacteria, within 2 years prior to screening and/or sputum culture yielding B cepacia at screening.
* Coughing up more than 60 cc of blood from the respiratory tract at any time within 30 days prior to study drug administration.
* Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
* Females who are pregnant (positive pregnancy test), lactating, or are planning to become pregnant during the study.
* History of hearing loss or chronic ringing in the ears deemed clinically significant by the investigator.
* Use of systemic or inhaled antipseudomonal antibiotics within 28 days prior to study drug administration.
* Use of loop diuretics within 7 days prior to study drug administration.
* Use of any investigational treatment within 28 days prior to study drug administration.
* Initiation of treatment with chronic macrolide therapy, dornase alpha treatment or inhaled corticosteroids within 28 days prior to study drug administration (patients may be taking these therapies at the time of enrollment, but they must have initiated treatment more than 28 days prior to study drug administration).

Other protocol-defined inclusion/exclusion criteria may apply
A Laboratory Evaluation of the Humoral Immune Response in Adults and Children to the H1 Hemagglutinin (HA) Stalk Domain and Other Influenza A Virus Protein Epitopes, After Administration of GlaxoSmithKline (GSK) Biologicals' Pandemic Influenza Vaccines

The purpose of this exploratory, retrospective laboratory study is to assess the humoral immune response to H1 hemagglutinin stalk domain and other influenza A virus protein epitopes following administration, in adults and children, of GSK Biologicals' adjuvanted and unadjuvanted pandemic influenza vaccines, using archived serum samples from previously completed clinical trials.


Eligibility Criteria:
Inclusion Criteria:

Not applicable since no subjects will be actively enrolled in this study; only the sera samples of the subjects who were a part of previously conducted primary trials will be used for testing. However, the archived serum samples of only those subjects who satisfy the following criteria will be included in this study:

* Subjects who received two doses of influenza vaccine 21 days apart and were included in the ATP cohort for immunogenicity and Persistence cohort (depending on the study) in the primary studies listed.
* Subjects who had agreed that their blood samples could be used for further research while giving informed consent for any of the primary studies listed.
* Subjects who have sufficient residual sample volume (i.e., ≥0.5 mL) of serum at all time points.
* Subjects with vaccine homologous neutralizing antibody result available at Day 0 and at 21 (25 samples available per group in Study H9N2-001)

Exclusion Criteria:

* Not applicable since no subjects will be actively enrolled in this study; only the serum samples of the subjects who were a part of previously conducted trials will be used for testing.
TMS for Complex Regional Pain Syndrome

The aim of the current study is to assess the efficacy of TMS in the treatment of Complex Regional Pain Syndrome (CRPS). It is hypothesized that participants who receive TMS (Group 1) relative to sham treatment (Group 2) once daily for two days will demonstrate a greater improvement in CRPS-related pain and other associated symptomology (i.e., cognitive, emotional and physical) compared to baseline. Participants will be followed until they reach their baseline for two consecutive weeks to assess safety and duration of symptom alleviation.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70
* Diagnosis of CRPS (complex regional pain syndrome) for at least 3 months
* Average pain level reported on Numerical Rating Scale meets entry criteria
* Ability to perform the experimental task and procedures.

Exclusion Criteria:

* MRI contraindication (metal implants or devices, claustrophobia)
* TMS Contraindication (eg metal implant or devices near the site of stimulation)
* History of epilepsy
* History of a psychological or psychiatric disorder that would interfere with study procedures, at the discretion of the researcher.
* Neurologic illness that would interfere with brain integrity
* Current medical condition or medication use that would interfere with study procedures or data integrity, at the discretion of the researcher.
* Currently pregnant or planning to become pregnant.
* On going legal action or disability claim.
Effects of Leptin Replacement in Children

To assess the endocrine and immune effects of leptin replacement in leptin-deficient children, from a consanguineous family. The hypothesis is that leptin replacement will have significant effects on endocrine function.

The proposed study of the treatment of a child with congenital leptin deficiency will permit to elucidate key aspects of human endocrine function, and will give new insights on the role of leptin in human endocrine regulation.

Eligibility Criteria:
Inclusion Criteria:

* Children with a functional leptin gene mutation from a consanguineous Turkish family. Only one leptin-naïve child from this family is alive and eligible.

Exclusion Criteria:

* N/A
Study to Evaluate Potential Decrease in Hospitalization Events, Time Between Events, and Increasing Longevity in Patients With Symptomatic Heart Failure (0954-948)

This is a multicenter study to evaluate potential decrease in hospitalization events and time between events and increasing longevity in patients with symptomatic congestive heart failure and intolerant of first-line medication for heart failure. This study will evaluate if higher doses of the investigational drug given daily will be superior to the lower dose of the same investigational drug given daily.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic heart failure with known or recently diagnosed intolerance of treatment with first-line medication for heart failure
* May or may not be receiving an alternative and/or additional drug treatment
The Clinical Influence of Developing a Sustainable Cardiac Surgery Service to Reduce the Burden of Rheumatic Heart Disease in Sub-Saharan Africa

In this bi-directional program of education, training and research activities based on sustainable development goals aim is to develop cardiac surgery service in Ethiopia.

The aim is to evaluate the short and long-term outcome of cardiac surgery for rheumatic heart disease in a low-income country compared to individuals not offered cardiac surgery due to limited availability of the service. Second aim is to evaluate the quality of anticoagulant therapy in patients after cardiac surgery for rheumatic heart disease in a low-income country .

Our objectives are:

1. To evaluate the 30- and 180-days outcome of cardiac surgery for rheumatic heart disease (RHD), and impact of gender, age, clinical findings and echocardiographic classification, during the time of development of cardiac surgery at Black Lion hospital, Ethiopia, in comparison with matched individuals (from the same waiting list) which had no offer of surgery due to limited availability.
2. To evaluate the quality of anticoagulation therapy after cardiac surgery at Black Lion hospital, Ethiopia by evaluating the patients proportion of time in therapeutic INR-level, complications as valve dysfunction, bleeding and thrombosis compared to control patients undergoing valvular replacement due to RHD at Norwegian hospitals.

Population: Approximately 50 RHD patients operated by Our team at Addis Abeba University Hospital, Ethiopia.

Follow up for 180-days for objective 1 and continous follow-up for objective 2. Comparison With matched Controls. Outcome measures: Mortality, complications (heart failure, arrhythmias, thrombosis, bleedings, stroke, infections)

Eligibility Criteria:
Inclusion Criteria:

* Cardiac surgery due to rheumatic heart disease at the governmental Black Lion University Hospital during the bi-directional programme of education, training and Research to establish Cardiac surgery service

Exclusion Criteria:

* Not willing or able to provide written informed consent
Study of Retinal Vascular Parameters in Patients With Wilson's Disease

The rare disease reference center " Wilson disease and other rare copper-related diseases" of the Rothschild Foundation follows a large number of patients with Wilson's with varying degrees of impairment and located at different times of their care.

Many people with Wilson's disease have a characteristic greenish-brown ring, known as Kayser-Fleischer, appearing at the periphery of the cornea due to a deposit of copper at the Descemet membrane. As a general rule, if the patient is compliant with his treatment, the ring usually disappears within a few years, although it may persist in some patients. However, apart from the stage of diagnosis, and the evolution of the ring, ophthalmological examinations are little used for the follow-up of these patients.

The objective of this study is to describe the retinal parameters, in particular vascular with two new retinal imaging technologies (OCT-A :Optical Coherence Tomography-Angiography , Adaptive optics) in patients with Wilson's disease and to correlate them with the parameters of the usual follow-up of these patients (hepatic assessment, exchangeable plasma copper, neurological scores, compliance, etc.).


Eligibility Criteria:
Inclusion Criteria:

* Wilson's disease with Ferenci score ≥4

Exclusion Criteria:

* Neurological or behavioral handicap that does not allow for ophthalmological examinations
* Hepatic decompensation that does not allow for ophthalmological examinations
* Pregnant or breastfeeding woman
Effects of Music or Hypnotherapy on Cancer Patients During Chemotherapy

Chemotherapies often induce side effects. This study examines whether hypnosis, music therapy versus standard therapy influence these side effects.

Primary study goals are differences in quality of life, nausea and vomiting episodes, fatigue, depression and change of taste.

Eligibility Criteria:
Inclusion Criteria:

* no previous chemotherapy
* compliance of the patient to fill out questionnaires
* informed consent and signed forms
* histologic secured breast cancer or ovary cancer (residual tumor after surgery equal or less than 0,5 cm)
* One of following chemotherapy regime:

  4x Epirubicin / Cyclophosphamid, 12x paclitaxel oder 6x Carboplatin / Docetaxel / Perjeta/ Herceptin oder 6x Doxorubicin, docetaxel, Cyclophosphamid oder 6 x Carboplatin / paclitaxel + / - Avastin oder 4x Epirubicin / Cyclophosphamid -\> 12x paclitaxel /herceptin/ perjeta oder 4x Epirubicin / Cyclophosphamid q21-\>12xcarboplatin, paclitaxel 4 Epirubicin / Cyclophosphamid q14-\> 12 carboplatin, paclitaxel

Exclusion Criteria:

* does not understand the German language
* psychosis
* not able to sign consent form
Dropless Pars Plana Vitrectomy Study

To demonstrate that intraoperative use of subtenon triamcinolone acetonide at the time of surgery without postoperative eye drops is non-inferior to the regimen of postoperative eye drops following primary pars plana vitrectomy for retinal detachment.

This is a non-inferiority, single-center, randomized, controlled, open-label clinical trial. Investigators will recruit patients that present to their clinic or emergency department with newly diagnosed mac-on or mac-off rhegmatogenous retinal detachment. Patients will be randomized to one of the following groups:

* Group 1: A total of 84 study subjects (84 eyes) will receive topical antibiotic qid for one week after surgery, topical prednisolone 1% qid tapered by one drop weekly for four weeks (4/3/2/1 taper), and topical atropine 1% daily for one week.
* Group 2: A total of 84 study subjects (84 eyes) will receive sub-tenon injection of triamcinolone acetonide (40 mg/mL) at the time of surgery, with no post-operative eye drops.

Both groups will receive subconjunctival injection of antibiotic (cefazolin 50 mg/0.5 ml, moxifloxacin 0.5 mg/0.1 ml, or vancomycin 1 mg/0.1 ml) and subconjunctival injection of dexamethasone (4 mg/ml) at the time of surgery, as well as atropine 1% and antibiotic-steroid ointment (neomycin-polymyxin B-dexamethasone) at the time of surgery.

Eligibility Criteria:
Inclusion Criteria:

* Primary rhegmatogenous retinal detachment (mac-on or mac-off) requiring pars plana vitrectomy (23, 25 and 27-gauge)

Exclusion Criteria:

* Need for concomitant lensectomy or cataract surgery
* Pars plana vitrectomy taking place more than seven days after the initial diagnosis
* History of any prior vitreoretinal surgery (excluding laser surgery) in surgical eye
* History of previous retinal detachment in surgical eye
* History of ocular incisional surgery within six months of surgery (excluding laser surgery) in surgical eye
* History of ocular laser surgery within 1 month in surgical eye
* History of intravitreal injection within 1 month in surgical eye
* Diagnosis of glaucoma or intraocular pressure more than 21 mmHg in either eye
* Active or chronic or recurrent uncontrolled ocular or systemic disease
* Active or history of chronic or recurrent inflammatory eye disease
* Previous history of steroid response
* Current treatment with oral, topical, or intravitreal corticosteroids
* Presence of proliferative vitreoretinopathy at the time of diagnosis
* Presence of giant retinal tear at the time of diagnosis
* Diagnosis of proliferative diabetic retinopathy
* Anterior chamber inflammation on presentation in either eye
* Signs of ocular infection at presentation in either eye
* Acute external ocular infections
* Known or suspected sensitivity or allergy to any of the medications used in the operation or postoperatively
* Inability to use or apply topical eye drops
* Requirement for silicone oil as a tamponade agent
* Individuals with impaired decision-making capacity
* Non-English-speaking subjects