cyrilzakka/clinical-trials huggingface dataset:
Signs and Symptoms Associated With Molecular Defects in Genetically Inherited Heart Disease

Genetically inherited heart diseases (familial cardiopathies) are conditions affecting the heart passed on to family members by abnormalities in genetic information. These conditions are responsible for many heart related deaths and illnesses.

Researchers are interested in learning more about the specific genetic abnormalities causing heart diseases. In addition, they would like to find out how these abnormal genes can contribute to the development of other medical problems.

In order to do this, researchers plan to study patients and family members of patients diagnosed with genetically inherited heart disease. Those people participating in the study will undergo a variety of tests including blood tests, echocardiograms, and magnetic resonance imaging studies (MRI). These tests will be used to help researchers find the genetic problem causing the familial cardiopathy.

Researchers hope that the information gathered from this study can be used to develop better medical care through early diagnosis, management, and treatment plans.

Familial cardiomyopathies (FC) are important cardiovascular causes of morbidity and mortality that demonstrate both allelic and non-allelic genetic heterogeneity. We propose to perform genetic studies to determine novel molecular causes of FC and to describe their clinical correlates. This will permit: (1) pre-symptomatic diagnosis; (2) definition of cardiac phenotype, disease penetrance; (3) natural history; (4) study of abnormal physiology that is a consequence of the molecular defect; (5) elucidation of specific mechanisms of arrythmias and sudden death; and (6) demonstration and characterization of skeletal muscle involvement.

Eligibility Criteria:
INCLUSION AND EXCLUSION CRITERIA

The subjects will consist of family members who may have inherited FC and spouses that may help in the linkage studies. Family members or spouses who do not wish to participate in the research protocol will be excluded from the study.
Interpretability of the Quantra® Viscoelastic Test in Patients with Haematological Malignancies with Profound Thrombocytopenia Below 50x10 G/L.

The goal of this single-center, non-controlled, non-randomized exploratory clinical trial is to evaluate the interpretability of viscoelastic tests (Quantra® and ROTEM® type) in relation to platelet levels measured in standard biology in patients with haematological malignancies, hospitalized in day hospitals or full hematology wards, presenting thrombocytopenia strictly below 50 G/L.

Participants will undergo an additional blood sample to standard care. The total volume of blood drawn will be 12.1 mL. The following analyses will be performed: Quantra®, Rotem®, blood count, platelets, immature platelet count, plasma prothrombin time, activated partial thromboplastin time, International Normalized Ratio, fibrinogen.


Eligibility Criteria:
Inclusion Criteria:

* Patient age \> 18 years old ;
* Patients who have been informed of the study and have freely given their informed consent to participate in the study;
* Patients with hematologic malignancies, treated or untreated, at any stage of treatment;
* Patient with thrombocytopenia strictly below 50 G/L on a blood sample taken less than 72 hours ago;
* Patient hospitalized in day hospitalization or in full hematology hospitalization;
* Patient covered by a French social security scheme.

Exclusion Criteria:

* Patients treated with antiplatelet agents or anticoagulants in preventive or curative doses;
* Patient with a history of thrombopathy;
* Patient with a history of haemostasis pathology at risk of haemorrhage or thrombosis;
* Pregnant or breast-feeding patients;
* Patients under guardianship;
* Patients who do not understand French;
* Patients under court protection.
Testosterone Therapy of Men With Type 2 Diabetes Mellitus (T2DM)

A randomized, placebo-controlled, double-blinded study on 40 men with type 2 DM.

Type 2 diabetes mellitus (T2DM) is a common endocrine disorder characterized by hyperinsulinaemia and insulin resistance.

Hypothesis Testosterone therapy increases lean body mass and insulin sensitivity in men with low normal levels of bioavailable testosterone and type 2 DM.

Background Inadequate levels of androgens have been associated with an increased risk of chronic illnesses including obesity and diabetes. Moreover, testosterone treatment has been shown to increase lean body mass and lipid oxidation as well as insulin sensitivity in hypogonadal men.

Eligibility Criteria:
Inclusion Criteria:

* Male gender age 50-70
* Bioavailable testosterone \< 7,3 nmol/L
* Metformin treatment of T2DM for 3 months or more

Exclusion Criteria:

* HbA1c \> 9,0 %, BMI \> 40 kg/m2, Haematocrit \> 50%,
* Known malignant disease, PSA \> 3 ug/L, Nycturia \> 3 times,
* Abnormal routine blood samples,
* Severe hypertension,
* Significant EKG-changes,
* Wish of parenthood,
* Active mental illness,
* former or present abuse,
* Severe illness of heart-, lung- or kidney,
* Primary or secondary hypogonadism.
Effect of LLLT and Ozone to Reduce Complications After Extraction of Impacted Lower Molar

Many factors cause third molars to stay impacted in the jaws, hence the extraction of impacted wisdom teeth occurs often in dental clinics. Pain, trismus, and edema are typical postoperative complications following third molar surgery. Various strategies have been developed to prevent or reduce these postoperative complications, Among these is the use of Low-Level Laser Therapy (LLLT), which demonstrates numerous benefits in lowering pain, trismus, and edema by managing inflammation. The precise biological mechanism of action remains unknown. There seems to be evidence that it may have neuro-pharmacological impacts on the production, metabolism, and release of a number of biological compounds, the other option is use of ozone which has antimicrobial effectiveness (viricidal, bactericidal, and fungicidal). Additional well-known advantages include immunological modulatory and stimulating actions, including anti-inflammatory, biosynthetic, anti-hypoxic, and bioenergetic characteristics. Ozone can interact with blood components in the right amounts to positively impact oxygen metabolism and cell energy while also triggering antioxidant defense mechanisms


Eligibility Criteria:
Inclusion Criteria:

* Patients who had mandibular third molar, totally or partially impacted in the bone (Class II-III and position B, Pell and Gregory's classification), in need of surgical extraction, which were evaluated clinically and by radiological examination.
* Patients who were in age range between 18-40 years old.
* Patients who were willing to compliance with study and were available for follow up.
* Patients should be with good oral hygiene and without any acute illness

Exclusion Criteria:

* Patients with medical condition that prevent any surgical intervention such as patient with recent myocardial infarction, bleeding disorders, psychiatric problem and patients with pacemaker, uncontrolled systemic disease, immunocompromised patient and patients taking corticosteroid and anti-inflammatory drugs.
* Patients with history of head and neck radiotherapy.
* Pregnant or lactation women
* Active advanced uncontrolled periodontal disease and bad oral hygiene, or patients with local acute infection in relation to third molar especially pericoronitis.
* Patients who suffer from photodermatoses and photosensitized patients (photoallergies).
* Hyperthyroidism
Maternal Thyroid Function in Early Pregnancy and Their Relationship With Gestational Diabetes Mellitus

This study was conducted to analyze the role of TSH level and TPOAb status in early pregnancy and use this information in assessment of the risk of gestational diabetes mellitus at different weeks of gestation when the FT4 level is normal.

A total of 7,729 women with singleton pregnancies who were receiving antenatal care at Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine between December 2012 and March 2014 were included in the study. All these women underwent screening for thyroid function (TSH,FT4 and TPOAb) at the first antenatal visit and a 75 g oral glucose tolerance test at 24-28 weeks of gestation. The correlation between a combination of TSH level and TPOAb status and the risk of gestational diabetes mellitus was analyzed.

Eligibility Criteria:
Criteria:

Inclusion Criteria:

1. ≤19+6 weeks of gestation at the first antenatal visit;
2. singleton pregnancy;
3. FT4 level is within the normal range;
4. TSH level is normal or beyond the normal range.

Exclusion Criteria:

1. age \<18 years or \>40 years;
2. thyroid disease history before pregnancy, e.g. hyperthyroidism, clinical hypothyroidism and malignant tumors of the thyroid, regardless of medication treatment is needed or not;
3. twin or multiple gestations;
4. diagnosed with diabetes mellitus before pregnancy, or fasting blood-glucose level ≥ 7.0 mmol/L or HbA1C≥6.5% at the first antenatal visit;
5. diseases causing abnormal glycometabolism or severe co-morbidities or diseases causing abnormal glycometabolism.
Minimizing Facial Nerve Stimulation in Cochlear Implants

This study aims to understand how to manipulate the electrical stimulation from the cochlear implant to maximize hearing stimulation and minimize facial stimulation. It is know from animal data that the hearing and facial nerves have different sensitivities to things like electrical pulse shape, its pattern, and its duration. It is very unclear however if this applies to human cochlear implant patients, and what the optimal parameters are to selectively stimulate the hearing nerve in humans. The outcomes of this study will be used to more selectively program some patients with severe facial nerve cross stimulation and to inform the development of new types of implant stimulation.

The patients eligible for the study are deaf, and have consented as part of their standard of care to receiving a cochlear implant. There will be no interference with this process in any way. Those patients that are unfortunate to be affected by facial nerve stimulation following receiving their cochlear implant however will be contacted and with the aim to help improve their symptoms as indicated in prior animal studies

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.

  * Male or Female, aged 18 years or above.
  * Unilateral user of a cochlear implant or at least 6 months (post-operative group), or prospective CI user, meeting NICE criteria for implantation (intra-operative group).
  * First language English or sufficiently fluent in English to understand the consenting process
  * Post-lingual onset of severe to profound hearing loss
  * No other handicaps that would interfere with participation in the study in the opinion of the Principal Investigator

Exclusion Criteria:

* Unstable cochlear implant or hearing aid fitting

  * Using medication in an intermittent manner that might influence hearing levels
  * Cognitive or psychological challenges that might lead to variations in attention
Routine Care Study Evaluating Ocular Torsion

The paralysis of the fourth cranial nerve (paralysis IV), commonly known as the superior oblique muscle (SO) paralysis, represents half of vertical strabismus. The diagnosis of SO paralysis and of its congenital or acquired etiology, are based on a range of clinical findings. The three main clinical diagnostic elements are the hypertropia in paralyzed side which increases in adducted position, the positivity of Bielschowsky head tilt test and the twisting of the eye fundus. These criteria are always considered together and are interdependent. The diagnostic value and the sensitivity of each of these signs is not defined. Brain and orbital Magnetic Resonance Imaging (MRI) allowed a better understanding of the physiopathology of a number of oculomotor disorders.

For this reason, MRI constitute a reference for the SO palsy. The atrophy of the SO muscle is qualitatively determined by the asymmetry of muscle volume on two contiguous coronal MRI.

The diagnostic value of various clinical signs observed in SO paralysis (sensitivity, specificity) remains unknown.


Eligibility Criteria:
Inclusion Criteria:

For the subjects without oculomotor disorder

* no diplopia in different positions of gaze;
* no oculomotor disorder during the orthoptic examination (horizontal phoria \<8 prism diopter, vertical phoria \<4 prism diopter);
* corrected visual acuity \> 8/10 on both eyes;
* binocular vision present in Lang I test (defined by 3 elements seen or appointed);
* orbital MRI: normal oculomotor muscles (including absence of atrophy of the superior oblique muscle) and lack of intra orbital expansive process;
* brain MRI: no abnormalities in the ways of oculomotor (especially no abnormalities in posterior fossa).

For the patients with SO muscle unilateral paralysis

* clinical features compatible with unilateral paralysis of the SO muscle
* muscular body atrophy of the SO on the orbital MRI without other orbital or cerebral abnormality
* binocular vision in Lang I test

Exclusion Criteria:

* high refractive error (\< -6 diopter or \>6 diopter);
* history or current oculomotor disorder or restrictive neurological disorder (dysthyroid orbitopathy, orbital trauma, retinal detachment surgery, paralysis oculomotor palsy other than IV);
* optic nerve head abnormalities in the fundus (edema for example)
* lack of binocular vision Lang I test;
* pregnant or breastfeeding patient
* patient under legal protection
* patient opposition to participate in the study
Cervical Morphological Changes on Pregnancy Outcome

This study aims to assess how the proportion of the cervical volume/length removed during treatment for cervical intraepithelial neoplasia (CIN) varies and whether this correlates to the pregnancy duration at delivery

The high peak age of the Cervical intraepithelial neoplasia (CIN)patients was from 25 to 35 years old, which is the best women of childbearing age, Standard treatment for CIN is called Loop electrosurgical excision procedure (LEEP),but the inappropriate conization may damage the cervical function leading to infertility, abortion, preterm delivery and dystocia. Therefore, reasonable and standard conization is very important for treating and preventing the complication. The International Federation of Cervical Pathology and Colposcopy(IFCPC) advocates the length of cervical conization should be decided by the type of cervical transformation zone, however, the cervical lengths in female are different leading to the same cervical conization lengths cause the diverse influences on the cervical function.Therefore, individualized cervical conization therapies are very needed，At present, there are still lack of objective data about cervical morphology of women at childbearing age,besides the effects of cervical morphological changes caused by LEEP on pregnancy and childbirth has not been reported.

Our hypothesis is that the proportion of the cervical tissue removed is likely to influence both cervical healing and the cervical volume following surgery and as a result the risk of prematurity in subsequent pregnancies. The present prospective study investigates the variation in the proportion of the cervix removed during excisional treatment and provides pilot data on pregnancy outcomes in a sample population for which the dimensions and proportions of the cervical tissue excised are assessed at the time of treatment.

Eligibility Criteria:
Inclusion Criteria:

Having fertility requirements,antecedent biopsy read as

1. cervical intraepithelial neoplasia (CIN) grade 2 or 3 or microinvasive cancer
2. adenocarcinoma in situ
3. persistent CIN 1
4. antecedent pap read as
5. high grade squamous intraepithelial lesion
6. atypical glandular cells
7. persistent low grade squamous intraepithelial lesion

Exclusion Criteria:

1. anatomy unsuitable for safe office loop excision based on operator judgement
2. inability to tolerate procedure under local anesthesia
3. pregnancy
4. age less than 21 years
5. refusal of consent
6. prisoner
7. mental incapacity
8. anticoagulant or antiplatelet therapy, or known bleeding diathesis
9. use of analgesics other than over the counter medications(OTC meds include NSAIDS or Tylenol) within 7 days of scheduled LEEP.
A Study to Evaluate the Drug Levels of BMS-986166 in Healthy Male Participants

The purpose of this study is to assess the drug levels of BMS-986166 in healthy male participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory determinations
* Body mass index between 18.0 to 33.0 kg/m2 (inclusive)

Exclusion Criteria:

* Any significant acute or chronic medical illness
* Current or recent history of constipation or irregular bowel movement (less than 1 bowel movement per day within the last 1 week)
* History of allergy (such as rash, hives, breathing difficulties) to any medications, either prescription or nonprescription

Other protocol-defined inclusion/exclusion criteria apply
Efficacy and Safety of Tegoprazan and Minocycline Dual Therapy for Helicobacter Pylori Initial Treatment

The purpose of this study was to evaluate the efficacy and safety of tegoprazan and minocycline dual therapy for Helicobacter pylori initial treatment. It is hypothesized that tegoprazan and minocycline dual therapy is non-inferior to bismuth-containing quadruple therapy.Patients diagnosed with H. pylori infection will be randomly divided into one of the above treatments. At week 6 follow-up visits, a urea breath test#rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18\~70,both gender.
2. Patients with documented H.pylori infection who did not receive Helicobacter pylori eradication treatment;
3. Patients are willing to receive eradication treatment.
4. Women of childbearing age were required to use medically acceptable contraceptive methods during and 30 days after th

Exclusion Criteria:

1. Patients with contraindications or allergies to the study drug.
2. Severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases.
3. Constant use of anti-ulcer drugs ( including taking proton- pump.inhibitors(PPI) within 2 weeks before the \[13C\] urea breath test),antibiotics or bismuth complexes (more than 3 times /1 month before screening).
4. Pregnant or lactating women.
5. Underwent upper gastrointestinal Surgery.
6. Patients with moderate to severe dysplasia or high degree of intraepithelial neopla
7. Patients have symptom of dysphagia.
8. Evidence of bleeding or iron efficiency anemia.
9. A history of malignancy.
10. Drug or alcohol abuse history in the past 1 year.
11. Systemic use of corticosteroids, non steroidal anti-inflammatory drugs,anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).
12. Patients who has psychological problem or poor compliance.
13. Enrolled in other clinical trials in the past 3 months.
14. Refuse to sign informed conse
Observational Study of Low Dose FCR in Elderly/Comorbid CLL/SLL: The Q-lite Project

FCR (fludarabine, cyclophosphamide, rituximab) combination is currently accepted as the gold standard in treatment of younger and physically fit CLL patients. These excellent results, however, cannot be generally applied to the whole CLL population. This is because the median age at diagnosis of CLL lies between 65 and 72 years and patients older than 65 years in fact account up to 50%-75 % of the CLL population. Nevertheless, such population is considerably underrepresented in most of the large clinical trials in CLL/SLL. Therefore, it is not clear whether elderly/comorbid patients could profit from newer treatment approaches such as purine analog combinations or chemoimmunotherapy. Several publications demonstrated unacceptable toxicity of full-dose FC/FCR in elderly CLL patients. However, regimens using attenuated doses of fludarabine and cyclophosphamide showed promising efficacy and low toxicity.

The objective of this observational study is to provide additional data to confirm the safety profile and efficacy of low dose FCR for CLL patients treated in clinical practice.

Specific data of interest are: comorbid concitions, concomitant medication, CLL characteristics, prior treatment regimens, adverse events, reasons for discontinuation low dose FCR, overal response rates, complete response rate, progression-free survival, overall survival.

This is an observational, non-interventional, medical record review study in CLL patients. A total of 200 patients with CLL who have been previously treated with low dose FCR will be eligible for the study.

Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of CLL or SLL
* previously treated by low dose FCR for active disease requiring treatment per IWCLL criteria
* dose reduction of fludarabine and cyclophosphamide due to age, comorbid conditions, or reduce creatinine clearance

Exclusion Criteria:

* patients treated with low dose FCR within prospective clinical trials
Evaluation of the Effect of Central Sensitivity on Pain and Functional Status After Total Knee Joint Replacement Surgery

The study is a prospective observational study designed to determine the effects of central sensitization on pain and functional status of patients before and after total knee joint replacement surgery.

The aim of this study is to evaluate whether there is a difference in preoperative and postoperative pain and functional status between patients with and without central sensitization with knee osteoarthritis.

When the literature was reviewed, it was seen that central sensitization was one of the important mechanisms that caused pain in knee osteoarthritis, and it was determined that this had negative consequences in terms of postoperative pain and improvement in functional status. In this study, the effect of central sensitization on the results will be investigated by evaluating pain and functional status before and after knee total joint prosthesis in two groups of knee osteoarthritis patients, with and without central sensitization, and by comparing the groups.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary knee osteoarthritis
* Planning for total joint replacement surgery for the knee
* Being between the ages of 60-75

Exclusion Criteria:

* Having secondary knee osteoarthritis
* Planning for knee total joint prosthesis revision
* Having uncontrolled systemic disease (such as diabetes mellitus, hypertension, thyroid disease)
* Having neuromuscular disease
* Having a body mass index over 40
Self-regulated Flipped Classroom Strategy

To examine the effect of a self-regulated flipped classroom strategy on nursing students' self-regulation abilities and self-efficacy.


Eligibility Criteria:
Inclusion Criteria:

* (1) second-year undergraduate nursing students (2) students taking the Adult Nursing course this semesterand (3) willingness to participate in the study.

Exclusion Criteria:

* (1) having to quit school.