cyrilzakka/clinical-trials huggingface dataset:
Thalidomide Low Threshold in Epilepsy

The purpose of this study is to determine whether thalidomide is effective in the refractory epilepsy treatment.

Seven male patients with chronic, refractory epilepsy were included in the present study; in all cases antiepileptic treatment with multiple antiepileptic drugs had been unsuccessful in reducing the frequency or the intensity of seizures. Patients selected for this study were all males due to the high risk of thalidomide for teratogenicity in pregnant women; besides this drawback, thalidomide presents a fair tolerance profile in humans treated with low doses. Informed consent was obtained on each case by the patient and his legal guardian. The protocol was approved by the committees of research and ethics.

Treatment with thalidomide at 200 mg dosage twice daily was administered during a twelve month period. Electroencephalograms were obtained prior and at six months of thalidomide therapy; number and intensity of seizures were individually recorded in a diary by a caregiver (in most cases the patient's mother); signs of neuropathy, a frequent side-effect of chronic thalidomide therapy, were evaluated along the treatment; drowsiness and sedation, which are also common side-effects, were also recorded.

Patients were seen once a week during the treatment period at the Epilepsy Clinic of the National Institute of Neurology and Neurosurgery of Mexico. Once informed consent was obtained, all patients were given seizure diaries to be filled for three months before starting the treatment with thalidomide. Comparisons in the frequency of seizures were made on each patient by contrasting the three months previous to the beginning of thalidomide therapy with the twelve months of the drug trial. One patient (case 6) withdrew from the trial after seven months of thalidomide therapy due to sedation. Another patient (case 7) withdrew from the trial after 3 months of treatment due to exacerbation of seizures as narrated by his mother.

The same schedule of antiepileptic therapy was taken by each patient during three months prior to thalidomide administration and continued it without modification along the trial; therefore, bias due to changes in the associated antiepileptic medications were prevented and each patient served as his own control; so that the effect of thalidomide on the frequency and intensity of seizures could be reasonably evaluated. Thalidomide was purchased by the National Institute of Neurology and Neurosurgery of Mexico at regular price in the pharmaceutical market. No pharmaceutical company participated in any form in this trial.

Eligibility Criteria:
Inclusion Criteria:

* Refractory Epilepsy, males

Exclusion Criteria:

* Females, peripheric neuropathy
Internet-administered CBT for Young Adults With Low Self-esteem

The study will investigate a CBT based treatment approach for low self-esteem among young adults.

The study will test an adapted guided internet-delivered self-help program (Self-Esteem in Young Adults -SIYA) which lasts for seven weeks. Following recruitment via social media and a telephone interview, included participants will be randomized to active treatment or control. The control group will receive the intervention later.

Eligibility Criteria:
Inclusion Criteria:

Low self-esteem, as indicated by rating of \< 20 the Rosenberg Self-Esteem Scale.

Age between 18 and 25 years old. Access to a computer, smartphone, or tablet with internet access. Write and speak Swedish. In case of use of psychotropical medication, a stable dose for the past three months prior to registration and no planned changes during the treatment.

Exclusion Criteria:

Other ongoing psychological treatment that affects the treatment received in the study.

No comorbid severe depressive symptoms and no suicidal plans. Ongoing alcohol use disorder, as indicated by Alcohol Use Disorders Identification Test (AUDIT).

Severe psychiatric comorbidities (e.g. psychosis, anorexia nervosa) that requires specialist care within the regular psychiatric care.
Effects of Low Intensity Therapeutic Ultrasound on Endothelial Function

Endothelium is a cell layer that interposes blood and smooth muscle of vessels. This biological sensor reacts to physical and chemical stimuli by synthesis and/or liberation of regulatory substances like nitric oxide (NO), which acts on vascular tone, growth of muscle cells and platelet aggregation and leukocyte. Clinically, endothelial function measured by technique flow-mediated dilation (FMD) is a strong predictor of cardiovascular events and all-cause mortality. Previo study demonstrated that continuous and pulsed therapeutic 1-MHz ultrasound waveforms improved endothelial function in health volunteers and this vasodilation persisted for 20 min, which provided them with anti-inflammatory vascular effects. In subjects with type 2 diabetes (DM2) the chronical hyperglycemia and dyslipidemia reduce NO bioavailability causing endothelial dysfunction. Low intensity therapeutic ultrasound is an electrotherapeutic instrument employed in musculoskeletal injuries that promotes endothelium-dependent vasodilation, and its mechanism of action has not been studied on DM2. The aim of our study is evaluate endothelial function of patients with DM2 after different waveforms (placebo, continuous and pulsed) of therapeutic ultrasound. Therapeutic ultrasound is a electrotherapeutic instrument that can changes arterial endothelial function of subjects with DM2 because of NO bioavailability increasing, which implies anti-inflammatory and vasodilatory beneficial alterations for diabetic patients.

Evaluation of endothelial function will be made by flow-mediated dilation (FMD). The therapeutic ultrasound will applied over brachial artery using continuous (CUT: 0,4W/cm2), pulsed (PUT: 20% duty cycle, 0,08W/cm2SATA) and Placebo (equipment off) waveforms during 5min in 3 intercalated days.

Eligibility Criteria:
Inclusion Criteria:

* The subjects that joined the study will be alphabetized volunteers
* Age between 25 and 65 years old,
* Absence of morbid obesity,
* Non-smokers,
* With no symptoms of skeletal muscle disorders,
* No previous performing cardiovascular surgery,
* No previous diagnose of rheumatic, neurological, oncological, immune or hematologic diseases,
* Without evidence of psychiatric diseases and/or cognitive deficit.

Exclusion Criteria:

* Insulin dependent diabetes
* Leukocytosis, impaired fasting glycemia (\<70 and \>300 mg/dL) and
* Brachial artery diameter less than 2.5mm and larger than 5.0mm.
* On the day of the assessments have consumed of the alcoholic drink, caffeine and citrus juice
Quality Assessment in Endoscopic Retrograde Cholangiopancreatography(ERCP)

The investigators will prospectively collect patient and procedure-related data in an observational study in order to detect patient and procedure-related risk factors for poor outcome (i.e. technical failure of the procedure; procedure-related complications).

Data will be prospectively reported using standard report forms and patients will be followed up to 30 days to detect late-onset complications.

This is an investigator-driven, prospective multicenter trial which analyzes the impact of trainee participation on procedure-related outcome (technical success and procedure-related complications).

All ERCPs in the participating centers will be documented using a standard report form which will require the attending endoscopist to provide data relating to the patient (age, gender, diagnosis, bilirubin levels) and the procedure (including but not limited to the indication, technical aspects including cannulation technique, time to cannulation, degree of trainee involvement - where appropriate, procedure-related adverse events and their outcome).

Because teaching ERCP is not yet a standardized procedure, we aim to assemble a large database, stemming from the experience of several teaching centers in order to identify the main patient and operator-related factors which might influence the outcome of the procedure.

Eligibility Criteria:
Inclusion Criteria:

* all patients undergoing ERCP with attempted cannulation of either the major or minor papilla

Exclusion Criteria:

* refusal to sign the informed consent
Estimated Echocardiographic Pulmonary Capillary Wedge Pressure in Heart Failure

The aim of the study was to verify the effects of moderate versus low sodium intake on pulmonary capillary wedge pressure (PCWP), determined by Doppler echocardiography and tissue Doppler imaging in patients suffering from compensated heart failure.

the study outcome is hospital readmission and mortality after 12 months of two different sodium diet.

Eligibility Criteria:
Inclusion Criteria:

* compensated HF patients

Exclusion Criteria:

* decompensated HF patients
Effect of Aged Garlic Extract (AGE) on Improving Coronary Atherosclerosis in People With Type 2 Diabetes Mellitus

The purpose of this research study is to see the effect of taking Aged Garlic Extract (AGE) on the progression of coronary plaque, a condition called atherosclerosis, in people diagnosed with Diabetes.

This clinical trial is to determine on progression rates of low attenuation plaque under influence of Aged Garlic Extract as compared to placebo over the 1year period in individuals with Type 2 Diabetes Mellitus.The study also examines the effect of Aged Garlic Extract on endothelial function and arterial stiffness which was measured by cardio-ankle vascular index (CAVI) over the 3months period.

Eligibility Criteria:
Inclusion Criteria:

* Age 30-75 years
* Known Diabetes Mellitus (HgA1c \>6.5%, fasting blood sugar \>125 mg/dl, taking anti- diabetes medications)
* Subjects must provide written informed consent after the scope and nature of the investigation has been explained to them
* Calcium Score \>20 at baseline

Exclusion Criteria:

* A contraindication to AGE including: known hypersensitivity to drug.
* Any unstable medical, psychiatric or substance abuse disorder that in the opinion of the investigator or principal investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study
* Weight in excess of 350 pounds
* Bleeding disorder
* History of known coronary artery disease, myocardial infarction, stroke or life- threatening arrhythmia within the prior six months
* NYHA Class II- IV heart failure
* History of malignancy within the last 5 years (other than skin cancer) or evidence of active cancer which would require concomitant cancer chemotherapy
* Serum creatinine \> 1.4 mg/dl
* Triglycerides \> 400 at visit 1
* Drug or alcohol abuse, or current intake of more than 14 standard drinks per week
* Concurrent enrollment in another placebo-controlled trial
* Partial ileal bypass or known gastrointestinal disease limiting drug absorption
* Current tobacco use
* Current use of anticoagulants (except for anti-platelet agents)
* Renal failure
* History of hypertensive encephalopathy or cerebrovascular accident
* Hematological or biochemical values at screening outside the reference ranges considered as clinically significant in the opinion of the investigator or PI
* Pregnancy
Obesity-hypoventilation in Metabolic Syndrom Patients

The purpose of the study is to determined the prevalence of obesity-hypoventilation syndrome in patients with metabolic syndrom.

After being informed about the study and potential risks, patient agreed to participate and undergo :

a functional respiratory exploration, an arterial blood gas analyze, and a polygraphy coupled with a capnography during the same night.

Eligibility Criteria:
Inclusion Criteria:

* BMI\>30 kg/m2
* no treatment with CPAP nor NIV

Exclusion Criteria:

* obstructive respiratory disease
* non-treated cardiac dysfunction
Effect of Lanthanum Carbonate in Patients Previously Treated With Calcium-based Phosphate Binder Therapy

To assess the percentage of patients on lanthanum carbonate, that achieve Kidney Disease Outcome Quality Initiative (KDOQI) guideline suggested values for serum phosphorous in patients previously treated with calcium-based phosphate binder therapy.


Eligibility Criteria:
Inclusion Criteria:

Patients meeting all of the criteria listed below may be included in the study:

1. Patients aged over 18 years
2. Patients with ESRD on haemodialysis who are willing and able to provide written informed consent.
3. Patients on:

   * Lanthanum carbonate monotherapy for ≥1 month
   * Lanthanum carbonate monotherapy for ≤3 months
   * Calcium-based monotherapy for ≥3 months immediately prior to lanthanum carbonate therapy.
4. Values recorded in medical records detailing serum phosphorous, serum calcium-phosphorus product, iPTH, and medication ≤6 months prior to commencing lanthanum carbonate therapy and whilst on a calcium-based monotherapy.

Exclusion Criteria:

Patients are excluded from the study if any of the following criteria are met at screening:

1. Known or suspected intolerance or hypersensitivity to lanthanum, or any of the stated ingredients
2. Patients with known hypophosphatemia (phosphate level below lower level of normal)
3. Patients with severe hepatic impairment
4. Patients with requirement for calcium supplementation for reasons other than CKD
5. Pregnant or lactating women and women planning to become pregnant over the next 12 months
Neoadjuvant Nab-paclitaxel in Triple-negative or HER2-positive Breast Cancer

To evaluate the efficacy and safety of nab-paclitaxel combined with carboplatin for Chinese patients with triple-negative and HER2-positive breast cancer in the neoadjuvant setting.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent for all study according to local regulatory requirements prior to beginning specific protocol procedures.
2. Age at diagnosis ≥ 18 years, female.
3. Histologically confirmed diagnosis of HER2-opsitive or triple-negative breast cancer. ER/PR-negativity is defined as ≤1% stained cells； HER2-positivity is defined as IHC 3+ or in-situ hybridisation (ISH) ratio \>2.0.
4. cT2-4NanyM0 or cTanyN1-3M0
5. ECOG ≤ 1, LVEF ≥ 55%.
6. Laboratory requirements: for hematology, absolute neutrophil count (ANC) ≥ 1.5 × 109 / L and platelets ≥ 100 × 109 / L and hemoglobin ≥ 90 g/L; for hepatic function, total bilirubin ≤ 1.5 × UNL, AST and ALT ≤ 2.5 × UNL; for renal function, SCr ≤ 1.5 × UNL
7. Patients must be available and compliant for treatment and follow-up.

Exclusion Criteria:

1. Prior chemotherapy, endocrine therapy or radiation therapy for any malignancy.
2. Known or suspected congestive heart failure (\> NYHA I)
3. Currently active infection or severe symptomatic visceral disease.
4. Definite contraindications for the use of corticosteroids or known hypersensitivity reaction to one of the compounds or incorporated substances used in this protocol
5. rior malignancy with a disease-free survival of \< 5 years, except curatively treated basalioma of the skin, pTis of the cervix uteri.
6. Participation in another clinical trial with any investigational, not marketed drug within 30 days prior to study entry.
7. Pregnant or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices, sterilization) during study treatment.
Postoperative Analgesic Efficacy of Continuous Wound Infusion After Laparoscopy

Studies evaluating the effectiveness of continuous wound infusion (CWI) to manage postoperative pain following laparoscopy are markedly lacking. Especially, there was no study comparing CWI and placebo in treating gynecologic laparoscopy. Therefore, the investigators conducted this randomized, double-blind, placebo-controlled trial to investigate whether CWI of local anesthetics was an effective strategy for enhanced recovery after surgery (ERAS), compared with placebo in patients undergoing benign gynecologic laparoscopy.

Laparoscopic surgery has become an acceptable alternative for open surgery in treating benign gynecologic diseases. One of most important advantages of laparoscopy is a reduced postoperative pain compared with open surgery. Moreover, postoperative pain plays an important part in the enhanced recovery after surgery (ERAS) pathway. Although the length of hospitalization and recovery period after laparoscopy tends to be shorter, postoperative pain can still be an important issue.

Recently, continuous wound infusion (CWI) providing a constant flow of local anesthetic directly a surgical wound postoperatively has been widely used to reduce pain after cesarean section and open surgery. Studies evaluating the effectiveness of CWI to manage postoperative pain following laparoscopy are markedly lacking. Especially, there was no study comparing CWI and placebo in treating gynecologic laparoscopy. Therefore, the investigators conducted this randomized, double-blind, placebo-controlled trial to investigate whether CWI of local anesthetics was an effective strategy for ERAS, compared with placebo in patients undergoing benign gynecologic laparoscopy.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 80 years,
* American Society of Anesthesiologists physical status (ASAPS) classification I-II
* the absence of pregnancy at the time of surgery

Exclusion Criteria:

* allergy to amide local anesthetics including ropivacaine
* laparoscopic surgery needing ≥ 3 separate skin incisions
* history of ventral or incisional hernia
* pre-existing coagulopathy, neurologic or cognitive dysfunction
* systemic or regional (especially, umbilicus) infection
* previously taking opioids for acute or chronic pain
* inability to accurately express their pain.
Mechanisms of Exacerbation of Asthma

The purpose of this study is to identify the causes of asthma that were not previously suspected, to better understand the effects of inhaled steroids on asthma and to identify new way to treat asthma.

In this study, we will explore mechanisms of exacerbation in asthma by careful characterization studies in asthmatics presenting in acute severe exacerbation. Specifically, we will determine the frequency of secretor status in these subjects by blood and saliva testing, and we will also perform a detailed cellular and biochemical analysis of their airway secretions. We will collect airway secretions using two methods. One method will be to have subjects cough sputum into a clean plastic container. The other method only applies to asthmatics with near-fatal asthma requiring intubation and mechanical ventilation. In these asthmatics, we will collect airway secretions by tracheal aspirate using methods normally applied in their clinical care.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects with a history of asthma between the ages of 18 to 75 years.
2. Physician diagnosis of asthma.
3. Currently experiencing an acute exacerbation of asthma. This exacerbation may be severe necessitating treatment in the emergency room, ICU, or hospital ward.
4. Ability to provide informed consent.

Exclusion Criteria:

1. Lung disease other than asthma.
2. Females who are lactating or who are pregnant.
3. Use of recreational drugs in the 1 month preceding the study.
Postprandial Response After Intake of Meals With Different Fatty Acid Composition

The aim of the study is to understand more about how different fatty acids modulate postprandial lipid metabolism and inflammatory response.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 30 years of age
* Healthy or diagnosed with familial hypercholesterolemia (FH) (mutation in gene coding for LDL-receptor). FH subjects can be included if they are:

  1. Untreated
  2. Treated with low dose statin (\<20 mg atorvastatin, \<10-20 mg simvastatin or \<5-10 mg rosuvastatin)
  3. Treated with high dose statin and willing to use low dose statin during the last 4 weeks prior to both study visits (total 8 week period)
  4. Treated with high dose statins and willing to discontinue statin treatment during the last 4 weeks prior to both study visits (total 8 week period)
* BMI 18.5 - 30 kg/m2
* Stabile weight the last three months prior to the first study visit (weight change less than ± 5 % of body weight)

Exclusion Criteria:

* CRP \>10 mg/L
* TG \>4 mmol/L
* Comorbidities including diabetes type I and II, coronary heart disease, haemophilia, anaemia, gastro intestinal disease, renal failure and hyperthyroidism
* Pregnant or lactating
* Allergic or intolerant to gluten or egg
* Not willing to stop using n-3 fatty acid supplements during the last 4 weeks prior to both study visits
* Using medications affecting lipid metabolism or inflammation, except statins for FH subjects
* Hormone treatment (except contraception and thyroxin (stabile dose last 3 months))
* Donating blood 2 months within or during study period
* Tobacco smoking
* Large alcohol consumption (\>40g daily)
Safety and Immunogenicity of a Single Dose of Intranasal Seasonal Trivalent Live-Attenuated Influenza Vaccine

In this Phase II randomized controlled clinical trial, generally healthy male and female children from 24 through 59 months of age will be enrolled in Kamalapur (Dhaka), Bangladesh. The study is expected to continue for at least 6 months following vaccination. The experimental intervention is Serum Institute of India Ltd's Trivalent, Seasonal Live Attenuated Influenza Vaccine (SIIL LAIV). The study vaccine has been formulated according to WHO recommendations for the 2011-2012 Northern Hemisphere influenza season. The SIIL LAIV is administered in a 0.5 ml intranasal dose (one spray of 0.25 ml per nostril) via a reusable sprayer device and a single-use nozzle that produces a fine mist that is primarily deposited in the nose and nasopharynx. The comparator vaccine will be an inactive placebo identical in appearance to the active vaccine.

The primary study hypothesis is that LAIV is safe and well tolerated by children aged 24 through 59 months in Bangladesh. A secondary hypothesis is that LAIV is immunogenic among children receiving study vaccine as compared to children receiving placebo.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female child at least 24 months of age and no older than 59 months of age at the time of study vaccination
* A child whose parent or guardian's primary residence, at the time of study vaccinations, is within the Kamalapur surveillance site catchment area and who intends to be present in the area for the duration of the trial
* A child whose parent or legal guardian is willing to provide written informed consent prior to the participant's study vaccination

Exclusion Criteria:

* Has any serious chronic disease including progressive neurologic disease, tuberculosis, Down's syndrome or other cytogenetic disorder, or known or suspected disease of the immune system
* Is receiving immunosuppressive agents including systemic corticosteroids during the two weeks prior to study vaccination
* Has a history of documented hypersensitivity to eggs or other components of the vaccine (including gelatin, sorbitol, lactalbumin and chicken protein), or with life-threatening reactions to previous influenza vaccinations
* Is receiving aspirin therapy or aspirin-containing therapy currently or two weeks before
* Lives in household with somebody currently participating in a respiratory vaccination or antiviral study
* Has current or past participation (within 2 months of trial enrollment visit) in any clinical trial involving a drug or biologic with activity against respiratory disease
* Has any condition determined by investigator as likely to interfere with evaluation of the vaccine or be a significant potential health risk to the child