cyrilzakka/clinical-trials huggingface dataset:
the Insulin Resistance in Recurrent Miscarriage IN RECURRENT ABORTION

THE INSULIN RESISTANCE IN RECURRENT ABORTION

THE ROLE OF INSULIN RESISTANCE IN RECURRENT ABORTION

Eligibility Criteria:
Inclusion Criteria:

1. Women in the child bearing period between 23-40 years.
2. All patients are pregnant.
3. The gestational age of both groups 6-13 weeks

Exclusion Criteria:

1. Patients with gestational diabetes and gestational impaired glucose tolerance.
2. The patients who took medication that could affect glucose metabolism at the time of the study
3. Patients with other causes of recurrent abortion as(thyroid dysfunction, uterine anomalies chromosomal abnormalities, antiphspholipid antibody syndrome, uterine anomalies and TORCH syndrome).
4. Patients with PCOS.
5. Obese patients(BMI\>30)
Cryo Rib Fracture Study

The purpose of this study is to determine if patients with rib fractures who undergo cryoablation of the intercostal nerves have improved pain control 7 days from procedure when compared to those who have a ESP catheter.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are over 18 who have more than one ribs fractured.

Exclusion Criteria:

* Patients who have an exclusion to regional anesthesia.
* Patients who are pregnant via self-report or pregnancy test if they take one.
* Non-English speakers
* Patients who have cold urticaria
* Patients with bilateral fractures
* Patients currently intubated
Hemiarthroplasty Compared to Total Hip Arthroplasty for Displaced Femoral Neck Fractures in the Elderly-elderly

Total Hip Arthroplasty is equal to or better than Hemiarthroplasty in the treatment of displaced femoral neck fractures in the elderly-elderly

Total Hip Arthroplasty is equal to or better alternative to Hemiarthroplasty in the treatment of displaced femoral neck fractures in the elderly-elderly (patients 80 years and over).

Eligibility Criteria:
Inclusion Criteria:

* Acute displaced femoral neck fracture of hip (Garden classification 3-4)
* Independent walker with or without walking aides
* Patient willing to participate in the study and give written consent.

Exclusion Criteria:

* Fracture older than 36 hours before admission
* Osteoarthritis in the fractured hip
* Rheumatoid arthritis in the fractured hip
* Pathological fractures
* Contraindication for hip arthroplasty surgery
* Not suitable for inclusion for other reasons e.g. substance abuse
Ultrasound Evaluation of Cystic Lesions in the Knee:In Comparison to Magnetic Resonance Imaging

Benign cysts and cystic-appearing lesions in and around the knee are common and differentiation between them through the history, symptoms and clinical examination is difficult due to the presence of common findings such as pain, edema, and palpable mass. The clinical presentation depends on the location, size of the lesion and its relation with the surrounding structures.

The Benign knee cysts can be subdivided into four major categories as following:1- synovial cysts, 2- popliteal (Baker's) cyst, 3- ganglion cysts, 4- meniscal cysts. Whereas, The "cyst-like" lesions can be sub-classified into the following:1- normal knee bursae, 2- normal knee recesses, 3- miscellaneous cyst-like lesions as aneurysms, hematomas, seromas and abscess.

Many of these lesions have fairly characteristic locations and imaging features. Knowledge of these variants and lesions is essential for accurate diagnosis and to avoid mistaking them for aggressive soft tissue lesions, including sarcomas. Ultrasonography and magnetic resonance imaging are the most useful imaging modalities in evaluating these Benign cystic lesions. Ultrasonography can distinguish cysts from solid lesions and assess the degree of vascularity within the lesion. Magnetic resonance imaging can help to delineate the location of the lesion in relation to anatomic structures and also determine if the lesion is cystic or solid when contrast is administered.

Eligibility Criteria:
Inclusion Criteria:

1. clinically diagnosed cystic lesions in and around the knee.

Exclusion Criteria:

1. arthroscopy or surgical intervention to the knee joint.
2. fracture repaired by metal plates or screws.
3. claustrophobia.
4. contraindications to MRI as patients with implanted pacemaker or defibrillator, ferromagnetic aneurysm clips and metallic foreign body at the knee joint.
A Phase 2 Study of EIK1001 in Combo With Pembrolizumab and Chemotherapy in Patients With Stage 4 NSCLC

This study is for patients with advanced/metastatic non-small cells lung cancer (NSCLC) who have not received any treatment through the vein for the advanced disease.

This is a multicenter open-label phase 2 trial that aim to assess the safety, tolerability, and efficacy of EIK1001 in combination with standard of care in participants with both confirmed stage 4 squamous and non-squamous NSCLC who have not received prior systemic therapy for the advanced disease. The study includes dose finding and evaluates adverse events and efficacy.

Eligibility Criteria:
Inclusion Criteria:

1. be ≥ 18 years of age on the day of signing of informed consent.
2. confirmed Stage 4 NSCLC (squamous or non-squamous) and be considered for standard of care.
3. have confirmation that mutation-directed therapy is not indicated (documentation of absence of tumor activating mutations/fusions that are approved for first line therapy).
4. have at least 1 lesion with measurable disease at Baseline according to RECIST 1.1 as determined by the local site Investigator/radiology assessment.
5. have not received prior systemic treatment for advanced/metastatic NSCLC.
6. have an ECOG Performance Status of 0 to 1.
7. have adequate organ function.

Exclusion Criteria:

1. does not have predominantly squamous cell or non-squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the participant is ineligible.
2. is currently participating in or has participated in a study of an investigational agent and received investigational therapy within 4 weeks or 5 half-lives (whichever is shorter) of administration of EIK1001.
3. prior to the first dose of EIK1001, has received prior systemic therapy for metastatic disease, or had major surgery (\< 3 weeks prior to the first dose).
4. has completed palliative radiotherapy within 7 days of the first dose of study drug administration.
5. has a known history of prior malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years.
6. has an active infection requiring therapy.
Cancer Patients' Knowledge About Fatigue

Background: Result from an earlier study I carried out in the late 1990 showed that cancer patients were overall well informed about diagnoses, prognoses, symptoms, treatment, side-effects of treatment e.g. pain, nausea and vomiting and hair loss. Their knowledge about fatigue as a side -effect to cancer and cancer treatment was however different. Patients had minimal knowledge about fatigue and they were not prepared for this side-effect and as a result of this they did not know how to handle fatigue and fatigue was seen as a very frightening experience.

As a result of the findings I wanted to carry out an intervention study, where the aims were to develop an educational programme about fatigue and to evaluate the effect of the programme.

Purpose: The purpose of the project is to develop and describe a structured educational programme. The structured educational programme will serve as the intervention. The purpose is also to evaluate whether or not the structured educational programme increase the cancer patients knowledge about cancer related fatigue and to find out if increased knowledge about cancer related fatigue ease the experience of cancer related fatigue.

Another purpose of the study is to investigate the connection between fatigue and other symptoms and to find out how other symptoms influence the patients experience of fatigue.

The study will consist of 3 stages.

* Development of structured educational programme
* Implementation of structured educational programme
* Evaluation of the effect of the structured educational programme

Materials and methods: The study is a randomised experimental design. An intervention group and a control group, each consisting of 100 Breast Cancer patients (Stadium I or II) receiving chemotherapy or/and radiation therapy after surgery are included in the study. On a NR-scale (0-10) the patients had a fatigue score of 2,5 or more to be included in the study.

The intervention is an educational package of 120 minutes x 3 over three weeks. The intervention is given in groups of 10 patients. Both groups are responding to questionnaires just before the intervention, just after the intervention and three months after finishing the intervention. The educational package consisted of basic knowledge about fatigue, and strategies or techniques for coping with fatigue.


Eligibility Criteria:
Inclusion Criteria:

* Women with breast cancer stage I or II.
* Fatigue score more than 2.5 on a NRS (O-10).
* Give written consent.

Exclusion Criteria:

* Under the age of 10 years,
* Not able to read, write or understand Norwegian.
Safety and Efficacy Study of the Investigational Drug Pagoclone, in the Treatment of Persistent Developmental Stuttering (PDS)

This is a research study of the investigational drug, Pagoclone, in the treatment of persistent developmental stuttering (PDS), which includes frequent repetitions or prolongations of sounds or syllables or words, or frequent hesitations or pauses that disrupt the flow of speech. Pagoclone is an investigational drug, so it is not approved by the United States Food and Drug Administration.


Eligibility Criteria:
Inclusion Criteria:

* PDS defined as DSM-IV-TR criteria
* Symptoms starting before age 8
* Total overall score of 18-36 on the SSI-3
* English speaking, with an 8th grade education
* Able to understand and cooperate with study requirements with assistance
* Not pregnant or breastfeeding
* Able to provide consent

Exclusion Criteria:

* No diagnoses of other CNS/Mental health disorders in the last 6 months
* No use of psychotropic medication or other medication for stuttering within 4 weeks prior to screening
* No use of non-medicinal stuttering treatments for 5 months prior to the study
* No use of illicit drugs or opiates of any kind
A Clinical Study on Acuris™ - Conometric Concept for Single Tooth Restoration

The purpose of this study is to evaluate the outcome of prosthetic survival of the Acuris conometric concept 1 year after permanent restoration, since this is a new mode of retention using friction for seating the crown of single tooth restorations without using cement or screws.


Eligibility Criteria:
Inclusion Criteria:

1. Subject aged between 18-75 years
2. Subject signed and dated the informed consent form
3. In need of an implant replacing a missing tooth in position 17 to 27 or 37 to 47, and each subject can only receive one study implant.
4. Neighbouring tooth to the planned implant must have

   * a natural root or an implant supported restoration mesially
   * a natural root or an implant supported restoration distally Exemption: If the planned implant is in the second molar position, an edentulous space is accepted distally.
5. Presence of natural tooth, partial prosthesis and/or implant supported restoration in the opposite jaw in contact with the planned crown
6. Deemed by the investigator as likely to present an initially stable implant situation

Exclusion Criteria:

1. Unlikely to be able to comply with study procedures, according to Investigators judgement
2. Subject is not willing to participate in the study or not able to understand the content of the study
3. Involvement in the planning and conduct of the study
4. Severe non-compliance to CIP as judged by the Investigator and/or Dentsply Sirona Implants.
5. Unable or unwilling to return for follow-up visits for a period of five years
6. Simultaneous participation in another clinical study, or former participation in a clinical study during the last 6 months that may interfere with the present study
7. Previous enrolment in the present study
8. Uncontrolled pathological process in the oral cavity
9. Known or suspected current malignancy
10. History of radiation therapy in the head and neck region within 12 months prior to surgery
11. Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration
12. Uncontrolled diabetes mellitus
13. Corticosteroids, iv bisphosphonates or any other medication that could influence post-operative healing and/or osseointegration
14. Current need for major bone grafting and/or augmentation in the planned implant area (minor grafting and soft tissue grafting are allowed)
15. Present alcohol and drug abuse
16. Smoking more than 10 cigarettes per day

    Exclusion criteria at Visit 5 (Permanent Restoration)
17. Permanent restoration delivered later than 6 months after implant placement
Impact of Pacing Mode and Diastolic Function on Cardiac Output

Background It is known from previous research that in patients with complete AV (atrioventricular) block and pacemaker stimulation stroke volume and cardiac output are higher with AV-synchronous than with AV-dyssynchronous pacing. However, the extent to which patients profited from AV-synchronous stimulation varied substantially.

Aim of the study Aim of this study is to systematically analyze the impact of diastolic function and other echo parameters on the difference of stroke volumes/cardiac output between AV-synchronous and AV-dyssynchronous pacing modes.

Methods Patients fulfilling the entry criteria will be enrolled (two-chamber pacemaker of any vendor eligible) in this monocentric, prospective, interventional study. Baseline data will be collected with a standardized questionnaire. During an echo examination, parameters of diastolic, systolic and atrial function will be assessed. Then, the stroke volume/cardiac output will be measured twice in each patient, once with AV-synchronous and once with AV-dyssynchronous pacing. Therefore, each patient will represent their own control. It will be randomized (coin tossing) which stimulation mode is first and which is second (sonographer and patient will be blinded). Descriptive statistics will be applied and regression models will be fitted to explore the data.


Eligibility Criteria:
Inclusion Criteria:

* Patient is able and willing to give informed consent and is above the age of 18.
* Patient is implanted with a dual chamber pacemaker system for at least 6 weeks.
* Patient is in sinus rhythm on the day of recruitment.
* Patient has a ventricular pacing rate exceeding 90%.
* Upon initial device interrogation, parameters are within normal ranges.
* Calculated battery life is more than 1 year.

Exclusion Criteria:

* Patient is not in sinus rhythm on the day of echo examination.
* Intrinsic ventricular activation on the day of echo examination.
* Relevant shunt on the atrial, ventricular or pulmonary level.
* Moderate or severe heart valve dysfunction (stenosis or regurgitation).
* Presence of other medical devices that may interact with the pacemaker system.
* Women who are pregnant or breast feeding.
Effects of a 5:2 Diet on Weight Loss and Cardiovascular Risk Factors in Obesity

A randomized clinical trial comparing the effect on weight reduction and cardiometabolic risk factors of intermittent energy restriction and a isocaloric continuous energy restriction in obese subjects.

Background: The optimal diet for treating obesity and cardiovascular disease (CVD) risk is still not clarified. Could a five plus two diet, a form of intermittent energy restriction lead to good adherence, similar weight loss and reduction in CVD risk factors as a isocaloric continuous energy restrictions in obese subjects.

Methods: The study is a randomized controlled clinical trial in 120 men and women between 21 to 70 years with BMI (BMI 30-45 kg/m2), stable weight within ±3 kg last 3 months and 1 additional metabolic syndrome risk component.

Dietary intervention: Randomization will be to one of two diet groups. Participants in the intervention group will follow av 5:2 diet and participants in the control group will follow an isocaloric continuous energy restriction.

Primary research question: Compare the effect on weight reduction of intermittent energy restriction and a isocaloric continuous energy restriction in obese subjects? Secondary research questions Compare the effect of intermittent energy restriction and an isocaloric continuous energy restriction on cardiometabolic risk factors and tolerability and safety in obese subjects. The project consist of to randomized controlled clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Men and women between 21 to 70 years.
* BMI (BMI 30-45 kg/m2).
* stable weight within ±3 kg last 3 months.
* 1 additional metabolic syndrome risk component.

Exclusion Criteria:

* Diabetes if treated with insulin or incretin analogues.
* History of bariatric surgery.
* Use of antiobesity drugs or supplements.
* Eating disorder.
* Psychiatric illness that contributes to difficulties with study procedures.
* Alcohol or drug abuse.
Normative Data of Intra-epidermal Nerve Fiber Density

Intra-epidermal nerve fiber density can be assessed using skin biopsy. A decrease of this density is used to diagnose small fiber neuropathy, despite the absence of normative data in a selected normal population. To establish a normative set of data matched for age and sex is absolutely needed to evaluate the sensibility and specificity of this test.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman between 20-80 years old
* Normal subjects without pain and neurological impairment
* No history of neurological disorder
* Normal neurological examination
* Normal ECG
* Normal clotting sample from less than 6 months
* Available by phone

Exclusion criteria :

* History of alcoholic intoxication or chemotherapy
* History of diabetes, kidney insufficiency, monoclonal gammapathy, B/C hepatitis, HIV, coeliac disease, sicca syndrome, raynaud syndrome, systemic erythematous lupus, Fabry disease, amylosis, vascularitis
* Contraindication to xylocaïn with adrenalin
* At the site of biopsy : surgery, skin pathology, infection, vascular insufficiency
* Innate or acquired immunosuppression
* Innate or acquired clotting abnormality
Renal Denervation by Allegro System in Patients With Resistant Hypertension

The purpose of ALLEGRO-HTN trial is to evaluate the safety and effectiveness of renal denervation in subjects with resistant hypertension by using Allegro renal denervation system


Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 65 years at time of randomization
* Stable medication regimen including 3 or more antihypertensive medications of different classes, including a diuretic (with no changes for a minimum of 4 weeks prior to screening) and no expected changes for at least 6 months
* 1) Office SBP and/or DBP ≥160/100 mm Hg ( ≥ 150/95 mmHg for type II diabetic patients) , 2) ABPM 24 hour average SBP and/or DBP ≥140 and/or 90 mmHg
* Main renal arteries with ≥4 mm diameter or with ≥20 mm treatable length (by visual estimation)
* eGFR≥45 mL/min/1.73 m2
* Written informed consent

Exclusion Criteria:

* Type 1 diabetes mellitus
* Secondary hypertension
* Has an implantable cardioverter defibrillator (ICD) or pacemaker
* Myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within 6 months of the screening period
* Intravascular thrombosis or unstable atherosclerotic plaques
* Has hemodynamically significant valvular heart disease
* Pregnant, nursing, or planning to be pregnant
* Any serious medical condition that may adversely affect the safety of the participant or the study
* Currently enrolled in another investigational drug or device trial

Angiographic Exclusion Criteria:

* Renal artery stenosis (≥50%) or renal artery aneurysm in either renal artery
* History of prior renal artery intervention including balloon angioplasty or stenting
* Multiple renal arteries where the main renal artery is estimated to supply \<75% of the kidney
* Main renal arteries with \<4 mm diameter or with \<20 mm treatable length (by visual estimation)
* Renal artery abnormalities
The Effect of Zinc on the Gingival Crevicular Fluid Level of Total Oxidant Capacity in Type 2 Diabetic Patients

To evaluate the effect of systemic administration of zinc on the gingival crevicular fluid level of total oxidant capacity in controlled Type-2 diabetic patients with stage-II and III periodontitis after non-surgical periodontal therapy.

Hypozincaemia and hyperzincuria is known to be present in patients with type-2 diabetes, and Zinc supplementation is known to be helpful in restoring plasma Zinc levels to normal,Zinc's deficiency can lead to an increase in circulating glucose due to beta cells malfunctioning and resistance to insulin, which makes it easier for type 2 diabetes mellitus (DM2) to happen ,Zinc was found to be a structural part of key anti-oxidant enzymes such as superoxide dismutase (SOD), and Zinc deficiency impaired their synthesis, leading to increased oxidative stress

Eligibility Criteria:
Inclusion Criteria:

* Controlled Type-2 diabetes mellitus
* Stage-II \&III periodontitis
* At least 2 sites with clinical attachment loss 3 or 4 mm to ≥5 mm and radiographic bone loss 15% Extending to mid-third of root and beyond.
* Probing depth from ≤5 mm to ≥6 mm

Exclusion Criteria:

* Any periodontal or Antibiotic treatment during the last six months.
* Receiving trace element supplements in the previous three months
* Pregnant or lactating females
* Gastric or diuretic treatment
* Acute renal failure
* smoking
Study on the Patient-Ventilator Asynchrony Analysis Function

In this study, the incidence of patient-ventilator asynchronism in two groups of patients was studied when the ventilator was prompted by the PVA asynchronism analysis function

Incidence of patient-computer dyssynchrony events: defined as the proportion of patient-computer dyssynchrony events in the total number of cycles during the patient trial. The observation period began 48 hours after the participants met the inclusion and exclusion criteria and signed the informed consent, and the data collection was stopped 48 hours later.

Eligibility Criteria:
Inclusion Criteria:

1. Adults (≥18 years) requiring invasive mechanical ventilation
2. Patiens had spontaneous breathing;
3. Agreed to participate in the trial and signed an informed consent

Exclusion Criteria:

1. Patients with contraindications to esophageal catheter insertion and inability to monitor esophageal pressure;
2. pregnant women;
3. patients with severe central nervous system damage or neuromuscular related diseases;
4. Participating in other clinical research projects;
5. Patients deemed unsuitable by the investigator