cyrilzakka/clinical-trials huggingface dataset:
COaching Lifestyle Intervention for FErtility

In Finland, every third woman is overweight (BMI\>25) and 11,5% obese (BMI\>30). Cohort and national studies reveal that 46% of fertile-aged men have BMI≥25 and 20% BMI≥30. Overweight has negative impact on both female and male fertility and weakens markedly the results of infertility treatments. In this study, 780 infertile couples will be randomized to control group (conventional infertility treatment) and lifestyle intervention arm undergoing 4 sessions of video-mediated motivational interview, anthropometric measurements, laboratory tests and epigenetic samples. Economic evaluation of the intervention will also be performed.


Eligibility Criteria:
Inclusion Criteria:

* infertility
* BMI 27-34.9 kg/m2

Exclusion Criteria:

* no mobile device available
* evident sperm defect or ovarian tube block
* hinder for fluent treatment schedule due to the subjec´s obstacle (inadequate language skills, major time table problems)
Effect of TEAS on the Incidence Rate of SIRS in Patients Undergoing Abdominal Surgery

The purpose of this study is to access the effect of Transcutaneous Electrical Acupoint Stimulation(TEAS) on the Incidence rate of Systemic Inflammatory Response Syndrome (SIRS) in patients undergoing radical surgery for gastric cancer

Patients undergoing elective radical surgery for gastric cancer under general anesthesia were randomly assigned to three groups, control group , TEAS group and sham TEAS group.

TEAS group receiving TEAS before general anesthesia induction , 1th day and 2nd day after surgery. TEAS was given through electrodes attached to specific acupoints. The time for TEAS was 30min.

Sham TEAS group receiving sham TEAS before general anesthesia induction , 1th day and 2nd day after surgery. Sham TEAS was given through electrodes attached to non-acupoints. The time for sham TEAS was also 30min.

Control group were given no TEAS. Incidence rates of SIRS in each group were compared .Venous blood samples from all groups(control group , TEAS group and sham TEAS group) were collected before general anesthesia induction,1th day and 3rd day after surgery. Inflammatory cytokines index including interleukin-6,interleukin-10,Tumor Necrosis Factor- alpha(TNF-α),Interferon-γ(IFN-γ),Monocyte Chemotactic Protein 1(MCP-1),IgG,IgM were measured.

Eligibility Criteria:
Inclusion Criteria:

* Age\>30yrs,\<75yrs
* ASA 1-2
* Scheduled for radical surgery for gastric cancer under general anesthesia；
* Informed consented

Exclusion Criteria:

* Patients with implanted pacemakers
* Patients with severe hypertension or cardiac dysfunction；
* Patients with severe pulmonary disease
* Patients with hemoglobin\<90g/L
Use of Stealth Liposomal Doxorubicin HCl ( DOX-SL ) in the Treatment of Moderate to Severe AIDS-Related Kaposi's Sarcoma.

To provide Stealth liposomal doxorubicin hydrochloride ( DOX-SL ) as a therapy for Kaposi's sarcoma patients who have no remaining treatment options other than DOX-SL or patients who have been participating in another DOX-SL protocol and for whom continuation in DOX-SL is medically indicated. Also, to evaluate the safety and efficacy of DOX-SL in patients with Kaposi's sarcoma who have previously received systemic chemotherapy with or without an anthracycline.

Patients receive DOX-SL every 3 weeks for up to 20 cycles.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* AIDS-related Kaposi's sarcoma that requires systemic chemotherapy.
* EITHER a medical indication for continuation of DOX-SL following treatment on another DOX-SL protocol, OR no remaining treatment options other than DOX-SL.

Prior Medication:

Allowed:

* Prior anthracyclines.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Cardiac ejection fraction \< 50 percent or clinically significant cardiac disease.
* Eligibility for a Liposomal Technology comparative protocol.

Concurrent Medication:

Excluded:

* Other cytotoxic chemotherapy.

Patients with the following prior condition are excluded:

History of idiosyncratic or allergic reaction to anthracyclines.

Prior Medication:

Excluded:

* Chemotherapy within the past 3 weeks.
Assessment of Stability Using Satellite Implant for Immediate Loading in Posterior Mandible

The research aims to evaluate the long-term effectiveness of satellite implants in the posterior mandible by assessing the levels of crestal bone after six months of first loading and secondary stability issues at fourth-month , primary stability at time of implant loading . In particular, the primary outcome of this study is to assessment stability of satellite implants, which will be evaluated by anycheck device.

satellite dental implants show potential for improving stability, and reducing crestal bone loss in the posterior mandible site, it offers effective solution for cases where primary stability is compromised due to poor bone quality or quantity. By providing additional support and anchorage, they enhance the overall stability of the implant, reducing the risk of failure and allowing for successful immediate loading. clinical evidence for their efficacy is still lacking. This prospective case series intends to fill this gap by evaluating crestal bone levels and stability factors in patients who are getting satellite implants for immediate loading in the posterior mandible. The results will improve clinical recommendations and practice for implant placements in the posterior mandible.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring implants for the posterior mandible.
* Patients aged between 18-45 years old.
* Implants must be at least 8mm in length.
* A sufficient quantity and distribution of implants to enable cross-arch stability.
* Implants must have good initial stability, with insertion torques ranging from 35 to 50 N/cm.
* Sufficient bone for implant placement and plate fixation.
* Patient able to give informed consent.
* Sufficient inter-arch space.

Exclusion Criteria:

* Contraindications to implant surgery in general.
* Bruxism.
* Immunosuppression.
* History of radiation to the head and neck region.
* Uncontrolled diabetes.
* Heavy smokers (more than ten cigarettes per day).
* Poor oral hygiene.
* Current or previous bisphosphonate therapy.
* Substance abuse.
* Mental illness.
* Failure to complete 6-month follow-up.
* Pregnancy or breastfeeding.
* Insertion torque of less than 35 N/cm.
* Removal of interim repair during the osseointegration stage.
* Patients suffering from parafunctional behaviors.
Clinical Trial to Evaluate the Efficacy and Safety of the Use of Ozone Versus Sunflower Oil in Treating Diabetic Foot

This is a open, phase III, multicenter, prospective, comparative, controlled, randomized clinical trial to evaluate the efficacy and safety of the use of ozone released by Philozon Medplus device versus conventional therapy in treating patients with diabetic foot.

* Clinical trial, open, phase III, multicenter, prospective, comparative, controlled, randomized to evaluate the efficacy and safety of the use of ozone released by Philozon Medplus device versus conventional therapy in treating patients with diabetic foot.
* Primary Objective: evaluate the efficacy and safety of ozone released by the device Philozon Medplus in the treatment of patients with diabetic foot.
* Secondary objective: evaluate ozone analyzer by environmental ozone Philozon Medplus released by the device in the clinical setting after using the device for rectal insufflation in a patient with diabetic foot.
* Study population: Patients of both sexes, consisting of 100 patients over 18 years, patients with diabetic foot.
* Treatment: 50 patients receive ozone therapy (topical and rectal insufflation of ozone). 50 patients will receive conventional treatment (Sunflower Oil).

Eligibility Criteria:
Inclusion Criteria:

* Consent form signed;
* Patients with Diabetes Mellitus Type I or Type II trophic lesions presenting in the lower limbs;
* Injury whose largest diameter is less than 5 cm;
* Patients of both sexes, aged above 18 years;
* Heart rate 60 to 100 bpm.

Exclusion Criteria:

* Presence of severe septic conditions;
* IMC \> 30;
* Presence of Lymphedema;
* Presence of trophic lesions in the lower limbs: exudative, traumatic and parasitic;
* Trophic lesions caused by venous disease requiring treatment;
* Hepatic or renal dysfunction;
* History of alcohol abuse and drugs in the last 6 months;
* Laboratory parameters:
* hemoglobin \< 10 g/dl;
* Glycated hemoglobin \> 9%;
* Diagnosis of hyperthyroidism (TSH \< 0.50 μUI/mL, free T4 \> 1.80 ng/dL);
* Deficit of Glucose 6 Phosphate Dehydrogenase (G6PD) \> 20%;
* Use of immunosuppressive drugs or anticonvulsants;
* Pregnant woman or lactating;
* Any significant medical condition which in the opinion of the Investigator may bring risks to the patient;
* Known hypersensitivity to drugs and/or treatments to be used in the study;
* Inability to compliance with the protocol;
* Participation in another clinical trial for less than 30 days.
The Northern Ireland Sensory Ageing Study

A visual function focused add-on study to the Northern Ireland Cohort for the Longitudinal Study of Ageing (NICOLA). There are three key aims:

1. Quantify age-related decline in a variety of visual functions within a populations based cohort.
2. Explore the mechanisms underlying age-related visual impairments.
3. Investigate how visual function impacts vision related quality of life.

The investigators propose to put together a battery of test to assess different aspects of visual function and apply them to two groups of participants in order to explore differences in chronological and physiological aging.

Group 1: 25 participants from each decade from 20-90. Those from 50+ will be recruited from the NICOLA study and retinal/lens images assessed to confirm normality (drusen \<63µm or clear retina, LOCS III \<1). Those younger will be recruited via advertisements in the University and targeting friends and relatives or NICOLA participants. This will enable the rate of decline with age to be calculated. Linear, bilinear, and simple nonlinear candidate functions of parameter vs. age will be applied to determine which best characterises the change.

Group 2: 250 participants NICOLA participants aged 60 will be invited to participate; only those whose ocular images confirm normality will be included. This will enable mechanisms underlying individual differences in aging to be investigated. Normal aging will be determined from group 1 analysis and participants will be able to be categorised as aging well or aging poorly. Multivariate regression analysis will be used to investigate the relationship between visual function and lifestyle and environmental factors. Principal components analysis will be used to look at the relationships between visual parameters. These participants will also be asked to complete the NEIVFQ-25, to characterise visual function related quality of life and this will be compared with their measured visual function.

Visual function parameters measured after protocol refraction will include: Photopic and mesopic visual acuity and contrast sensitivity using City Occupational acuity-plus software17, near visual acuity, reading speed and SKILL card18, MAIA microperimetry and cone dark adaptation.19 Intra-ocular scatter will be assessed using the Oculus C-quant to assess the extent to which ocular factors are degrading vision.20 Three-point vernier acuity will also be measured as this is thought to stay stable throughout life.15 Time will be taken to ensure participants receive sufficient training to produce reliable thresholds.

All study visits will occur at the Welcome-Wolfson Clinic Research Facility.

Eligibility Criteria:
Inclusion Criteria:

* No diagnosed ocular disease.
* Non-diabetic.

Exclusion Criteria:

* Any diagnosed ocular disease.
* Diabetic.
* Cognitive impairment.
Enhancing Motor Learning in Children With Cerebral Palsy Using Transcranial Direct-current Stimulation

The goal of this study is to test the effects of transcranial direct current stimulation (tDCS) on motor learning and brain plasticity in children with unilateral spastic cerebral palsy (USCP).


Eligibility Criteria:
Inclusion Criteria:

Children between 6-17 years old who have been diagnosed with cerebral palsy, with the following joint mobility: wrist extension 20º, metacarpophalangeal and proximal interphalangeal joints 10º. Ability to cooperate and follow simple directions.

Exclusion Criteria:

* Seizure beyond age 2, use of anti-seizure medication, history or family history of epilepsy, cranial metal implants, structural brain lesion, devices that may be affected by tDCS or TMS (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
* True positive response on the Transcranial Magnetic Stimulation and MRI Safety Screen
* Current use of medications known to lower the seizure threshold
* Previous episode of unprovoked neurocardiogenic syncope
* Indwelling metal or incompatible medical devices
* Centrally-acting medications including anti-seizure medications
* Evidence of scalp disease or skin abnormalities
* Current medical illness unrelated to CP
* High motor ability in affected arm (i.e. no asymmetry in scores of hand function)
* Severe spasticity
* Lack of asymmetry in hand function
* Orthopedic surgery in affected arm
* Botulinum toxin therapy in either upper extremity during last 6 months, or planned during study period
* Currently receiving intrathecal baclofen
* History of broken arm (either arm) 1 year prior to study enrollment
Application of Geographical Information System Data in the Emergency Department, Effect on Trauma Team and Medical Emergency Team Wait

In the Emergency Department Regional Hospital Horsens a monitor will display Geographical Information System data (GIS data) for all ambulances with the hospital as final destination. The location, estimated time of arrival (ETA) and urgency code for the ambulances will be showed. Furthermore the patient's name, personal identification number and the primary message received by the emergency medical dispatch center resulting in ambulance dispatch will be displayed. This may enable the coordinating nurse to optimize timing of the ad hoc trauma team and medical emergency team activation. The teams are activated if the patient's condition is assessed to be of the highest urgency and/or severity - triage 1 or "red". The coordinating nurse makes this assessment on the basis of information from the ambulance personnel and makes the decision to activate the team and when to do it. In this study the investigators want to examine if the availability of GIS data in the emergency department results in reduced waiting time for the members of the trauma team and medical emergency team. The study will be conducted as a before and after study.


Eligibility Criteria:
Inclusion Criteria:

* Critically Ill or Severely injured patients transported by ambulance
* Patients must be in triage category 1/"red"
* Emergency Medical Team og Trauma Team must be activated.
Brodalumab Drug-Drug Interaction (DDI) and Intensive Pharmacodynamic (PK) Study in Psoriasis Subjects

This is a phase 1, multi-center, open-label, drug-drug interaction (DDI) and PK study in subjects with moderate to severe plaque psoriasis. It is designed to evaluate the effect of brodalumab on midazolam PK in addition to assessing single dose PK of brodalumab in subjects with moderate to severe plaque psoriasis.

Approximately 30 subjects will be enrolled into two groups. Group 1 consists of 20 subjects and will receive 2 oral doses of midazolam and a single subcutaneous (SC) dose of brodalumab. Group 2 consists of 10 subjects and will receive a single SC dose of brodalumab.

Eligibility Criteria:
Inclusion Criteria:

* Subject has had stable moderate to severe plaque psoriasis for at least 6 months
* body mass index (BMI) between ≥ 18.0 and ≤ 38.0 kg/m2
* body weight between ≥ 50 and ≤ 130 kg
* no known history of active tuberculosis

Exclusion Criteria:

* Female subjects who are lactating/breastfeeding
* History or evidence of clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
A Clinical Investigation of the Discovery™ Elbow System

The purpose of this study is to perform a five-year, multi-center prospective evaluation of the Discovery™ Elbow System for outcome and durability. Relief of pain and restoration of function will determine long-term clinical outcome while durability will be measured by the absence of revisions.

Patient follow-up outcomes measured by the ASES score, radiographs and adverse events/revisions.

Eligibility Criteria:
Inclusion Criteria:

* Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
* Inflammatory arthritis
* Revision where other devices or treatments have failed
* Correction of functional deformity
* Treatment of acute fractures or non-union about the elbow

Patient Selection factors to be considered include:

* Need to obtain pain relief and improve function.
* Ability and willingness to follow instructions including control of weight and activity levels.
* Patients who are able and willing to return for follow-up evaluations.
* Patients with a good nutritional state.
* Patients with full skeletal maturity.
* Patients of all races and gender.
* Patients who are able to follow care instructions.

Exclusion Criteria:

* Patients less than 18 years.
* Patients with marked bone loss which would preclude proper fixation of the prosthesis.
* Metabolic disorders, which may impair bone formation.
* Patients who are pregnant.
* Patients with an active or suspected infection in or around the elbow or distant foci of infections, which may spread to the implant site.
* Patients with a highly communicable disease or diseases that may limit follow-up (e.g. immuno-compromised conditions, hepatitis, active tuberculosis, neoplastic disease, etc.).
* Patients unwilling or unable to comply with a rehabilitation program for elbow replacement or who indicate difficulty or inability to return for follow-up visits prescribed by the study protocol.
* Patients who qualify for inclusion in the study, but refuse consent to participate in the study.
Vildagliptin 100 mg Once Daily vs. Placebo as add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin

This study will investigate efficacy and safety of vildagliptin in patients with low baseline levels starting at an HbA1C level of 6.5% to support convenient early intervention with combination therapies. In parallel, morning and evening dosing will be evaluated in this patient population for the first time.


Eligibility Criteria:
Inclusion Criteria:

* Male, non-fertile female or female of childbearing potential using a medically approved birth control method
* Patients who have received metformin for at least three months prior to visit 1 and have been on a stable dose for a minimum of 8 weeks prior to visit 1
* Agreement to maintain the same dose of metformin throughout the study
* Age in the range of 18-85 years inclusive.
* HbA1c in the range of 6.5 - 8.0% (inclusive) at visit 1
* Agreement to maintain prior diet and exercise habits during the full course of the study
* Ability to comply with all study requirements and signed informed consent to participate in the study.

Exclusion Criteria:

* Pregnant or lactating female

A history of:

* type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g. Cushing's syndrome and acromegaly.
* acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months.

Any of the following significant laboratory abnormalities:

* ALT, AST greater than 2 times the upper limit of the normal range at visit 1.
* Direct bilirubin greater than the upper limit of the normal range at visit 1.
* Serum creatinine levels equal to or greater than 1.5 mg/dL (132 umol/L) males, equal to or greater than 1.4 mg/dL (123 umol/L) females, or a history of abnormal creatinine clearance at visit 1.
* Clinically significant TSH values outside of normal range at visit 1.
* Clinically significant laboratory abnormalities, confirmed by repeat measurement, other than hyperglycemia, hyperinsulinemia, and glycosuria at visit 1 Treatment with any oral anti-diabetic other than metformin within 3 months prior to visit 1

Other protocol-defined inclusion/exclusion criteria may apply
Non-surgical Peridontal Treatment on Cardiovascular Risk Markers

The study evaluates the influence of non-surgical mechanical periodontal treatment in patients with severe chronic periodontitis on inflammatory markers related to risk for cardiovascular diseases

A total of 80 non-smokers with systemically healthy, including 40 patients with severe chronic periodontitis and 40 periodontally health subjects were included into the present study. The probing depth, clinical attachment level, plaque index, gingival index and blood samples were collected at baseline and at the 3rd months after treatment and the serum levels of asymmetric dimethylarginine (ADMA), endothelial nitric oxide synthase (eNOS), homocysteine (Hcy), monocyte chemoattractant protein-1 (MCP-1) were determined with enzyme-linked immunosorbent assay (ELISA).

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of severe chronic periodontitis

Clinical diagnosis of periodontal health

Exclusion Criteria:

Systemic diseases such as diabetes, cardiovascular disease

Periodontal treatment within the previous year

Drugs such as systemic steroids, non-steroidal anti-inflammatory drugs, immunosuppressants, hormone drugs, contraceptives, anticoagulants, cholesterol regulating drugs, systemic antibiotics, antioxidants within the previous 3 months

Pregnant or lactating

Consumed alcohol

Smoker
Short-term Effectiveness of Transcutaneous Nerve Stimulation in Reducing Migraine Related Pain

The purpose of this study is to evaluate the short-term effectiveness of combined occipital and supraorbital transcutaneous nerve stimulation in reducing migraine related pain.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with confirmed diagnosis of migraine headache without aura or with typical migraine with aura (ICHD-II code 1.2.1 or 1.1).
* Subjects with 1-6 migraine episodes per month in the last 2 months.
* The subject is capable of understanding the study and to sign an informed consent.

Exclusion Criteria:

* Subjects who have concomitant epilepsy.
* History of neurosurgical interventions.
* Subjects with metal implants or shrapnel in their head, except for dental implants.
* Subjects with implanted cardiac pacemaker, neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
* History of drug abuse or alcoholism.
* History of medications overuse headache.
* Participation in current clinical study or participated in a clinical study within 3 months prior to this study.
* Skin lesion or inflammation at the region of the stimulating electrodes.
* Personality or somatoform disorder.
* Pregnancy or Lactation.
* Women of reproductive age not using efficient contraceptive method.
* History of cerebrovascular event.