cyrilzakka/clinical-trials huggingface dataset:
Effect of Influenza Vaccination on Donor Egg Recipient Outcomes

In this study the investigators propose a randomized controlled trial to evaluate the effect of influenza vaccination on clinical pregnancy rates among women undergoing in vitro fertilization as donor egg recipients.

Since 2004 flu vaccination has been recommended by American College of Obstetricians and Gynecologists (ACOG) Advisory Committee on Immunization Practices (ACIP) for all pregnant women during flu season, regardless of the trimester of pregnancy. Many studies have examined the safety of influenza vaccination and found benefits beyond the simple prevention of maternal infection including the reduction of still birth. Recently evidence has emerged that women who have received a flu vaccination were less likely to experience premature labor. The investigators hypothesize that some of the maternal benefits of influenza vaccination might be based on other than prevention of the flu, possibly secondary to the induction of immune system pathways that favor immunological tolerance. Induction of immune system pathways that favor immunological tolerance has long been considered a possible path to improved embryo implantation and reduce miscarriages, though the topic is still somewhat controversial.

Patients undergoing donor egg recipient cycles will be randomized in two strata:

1. History of recurrent miscarriage or implantation failure
2. No history of recurrent miscarriage of implantation failure

Consenting patients will be randomized to receive either influenza vaccine or a saline placebo. Vaccination will occur 10 days before initiating anticipated menses or fertility treatment cycle start.

All patients will be receiving an offered a second injection at the time of negative pregnancy test or at the time of sign-out with a clinical pregnancy. The second injection will either be placebo or influenza vaccination depending on the original randomization. Patients and clinical staff will remain blinded to the original treatment assignment, except for the study coordinator and the single staff member assigned to administer the injection.

Eligibility Criteria:
Inclusion Criteria:

* All women preparing to undergo an oocyte donor recipient cycle

  1. Women will only be allowed to participate in one treatment cycle
  2. Willingness to have an influenza vaccination
  3. Signed informed consent

Exclusion Criteria:

1. Any contraindication for flu vaccination
2. Unwillingness to have a flu vaccination
3. Unwillingness to sign informed consent
4. Previous diagnosis of unfavorable endometrial development
5. Unresolved uterine condition that significantly compromises the endometrial cavity
Electric Acupuncture for ICU-acquired Weakness in Mechanical Ventilation Patients

Intensive care unit acquired weakness (ICU-AW) is common and dramatically affect recovery. The purpose of this study is to determine whether electric acupuncture therapy is effective in the treatment of ICU-AW especially in the patients receiving mechanical ventilation with sepsis or multiorgan system failure.

The principle of acupuncture is to produce bioelectric current, as a consequence, to invigorate the circulation, promote tissue regeneration, relieve pain, enhance the immune function, etc. And electric acupuncture can stimulate bioelectricity activities at acupoints, out of reach for ordinary acupuncture effect, especially in the fields of nerve/muscle recovery and regeneration.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of sepsis or multiple organ dysfunction syndrome
* Within 48 hours from the initiation of mechanical ventilation

Exclusion Criteria:

* Pregnant patients
* Neuromuscular disease or cerebrovascular accident
* With temporary or permanent pacemaker
* Need to use neuromuscular blocking agents
* Inactivity for more than 5 days before ICU admission
COPD, Inflammation and Rehabilitation

Patients with chronic obstructive pulmonary disease, also known as COPD or emphysema, is like any other with a chronic illness not only affected by the physical discomfort the illness gives. For COPD patients that is: accelerated loss of lung function, conditioning and increased mortality: 25% of patients hospitalized with COPD exacerbation die 12 months later.

Patients are also characterized by various psychological factors such as reduced quality of life, depression, etc.

Therefore, everywhere in the country newly diagnosed COPD patients are offered rehabilitation in Region Zealand which consists of 10 weeks of classes 2 hours, 2 times a week with physical exercise, smoking cessation, medication, nutrition education and psychosocial support and patient education based on the National Health Service and international recommendations.

In the literature, the effect of rehabilitation on quality of life was measured using a questionnaire (St. George Respiratory Questionnaire (SGRQ)), and the increase in function has been measured using a walk test, but there are no studies which look at the effect on inflammation lungs.

It is important for COPD patients is to prevent exacerbations of the disease, which sometimes requires hospitalization and sometimes treated by their own doctor. It has been proven that inflammation in the lungs is associated with disease severity and exacerbation frequency, and therefore we would like to investigate whether both rehabilitation, close monitoring of patients with time in the pulmonary clinic every 3 months, and instruction in self-administration of medication (antibiotics and corticosteroids) have an effect on especially inflammation in the lungs, number of exacerbations, mortality, lung function and walking capacity.


Eligibility Criteria:
Inclusion Criteria:

* The study includes consecutive patients over 18 years admitted to the Medical dept, Næstved hospital with AECOPD (2 of 3 symptoms: increased breathlessness, sputum or purulens thereof) on the basis of known COPD (post-bronchodilator FEV1 \<80% and FEV1/FVC \<70% ; measured in stable phase, ie. earlier than 4 weeks after AECOPD). Patients included during hospitalization for AECOPD

Exclusion Criteria:

* Patients can not participate if they have asthma (post-bronchodilator FEV1 increased by\> 15%), are pregnant, nursing, has known serious comorbidities (eg cancer, chronic liver cirrhosis or hepatitis) or cannot give informed consent
Phase II Study to Evaluate Efficacy and Safety of RP101 in Combination With Gemcitabine

This will be a Phase II, multicenter, randomized, double blind, placebo controlled, study of six 28-day treatment cycles for patients with locally advanced, unresectable, or metastatic pancreatic cancer. The study will be conducted at approximately 55 sites in the North American, Europe, and South America. Approximately 153 subjects will be enrolled in a randomization (ratio 2:1).


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be 18 years of age or older
* Not previously treated with chemotherapy for Pancreatic Cancer
* ECOG performance status of 0 or 1
* Life expectancy \> 3 months
* Documentation of all sites of pancreatic disease within 28 days prior to randomization
* Adequate hematological, renal, and hepatic function
* Not pregnant or nursing
* Fertile subjects must practice a medically approved method of contraception

Exclusion Criteria:

* Prior history of other malignant tumors
* Participation in another investigational study within 4 weeks prior to treatment start
* Major surgery within 14 days prior to treatment start
* Radiation treatment within 28 days prior to treatment start
* Uncontrolled cardiac atrial or ventricular arrhythmias
* Gastrointestinal tract disease such resulting in an inability to take oral medication
* Known to be seropositive for HIV, HBV, or HCV
* Uncontrolled cancer pain
Comparison of Tear Evaporation Rate With Systane Complete in Dry Eye and Non-Dry Eye

The objective of the study is to compare the rate of tear evaporation, measured with a novel evaporimeter, before and for one hour after an eye drop containing nano-sized oil droplets has been instilled.


Eligibility Criteria:
Inclusion Criteria:

1. Is at least 18 years of age and has full legal capacity to volunteer;
2. Has read and signed an information consent letter;
3. Is willing and able to follow instructions and maintain the appointment schedule;
4. Is willing to be awake for at least 2 hours before visit 2;
5. Is willing not to wear eye makeup on the day of visit 2;
6. Is willing not to use eye drops or artificial tears on the days of visits 1 or 2;
7. Group specific criteria:

   1. Dry eye participant group: Symptoms: OSDI ≥ 13 and Signs: NIKBUT ≤ 5 s in the worst eye
   2. Non-dry eye participant group: Symptoms: OSDI \< 13 and Signs: NIKBUT ≥ 10 s in the worst eye

Exclusion Criteria:

1. Is participating in any concurrent clinical or research study;
2. Has any known active\* ocular disease and/or infection;
3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
5. Has known sensitivity to sodium fluorescein dye;
6. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
7. Is aphakic;
8. Has undergone refractive error surgery;
9. Has undergone ocular surgery in the last 6 months;
10. Has punctal plugs;
11. Has a known sensitivity to Systane eye drops (including Systane Balance, Systane Complete, Systane Gel Drops, Systane Ultra, etc.)
12. Has a known sensitivity to petroleum jelly (Vaseline);
13. Has epilepsy and/or sensitivity to flashing lights;
14. Has worn contact lenses within the past month or is planning to wear contact lenses during the study;
15. Has any physical impairment that would interfere with holding the evaporimeter;
16. Has taken part in another clinical research study involving ocular drops or treatments within the last 14 days; \* For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
Comparison of the Effects of Vapocoolant Spray and EMLA Cream on Pain During Needle Electromyography

The purpose of this study is to compare the effects of vapocoolant spray and topical lidocaine 2.5% + prilocaine 2.5% cream (EMLA) on reducing pain during needle electromyography.

The study was conducted on patients with patients that underwent needle EMGs in the lower extremity between July and August 2011 at the university hospital. The patients were divided into a total of three groups by random assignment: a control group that did not receive pretreatment, a group that received ethyl chloride vapocoolant spray and a group that received topical anesthetic cream (EMLA cream®).The patients with spray group, they were sprayed with ethyl chloride vapocoolant spray for 5 seconds from a distance of 30 cm just before the needle EMG, and patients with EMLA cream, they received an application of topical anesthetic cream on the needle electrode insertion site 60 minutes before the needle EMG. The 37-mm monopolar needle electrode was vertically inserted into the medial head of the gastrocnemius muscle in all patients.

To assess the degree of pain for each group, patients were asked to indicate their level of pain on a 100 mm VAS (0, no pain; 100, worst intolerable pain) after the needle EMG in the gastrocnemius muscle.

In both experimental groups, a 5-point Likert scale was used to evaluate patient satisfaction with the pain reduction method used and their willingness to use the same analgesic method in another EMG.

Eligibility Criteria:
Inclusion Criteria:

* Patients who had a normal schedule of needle EMGs in the lower extremity.

Exclusion Criteria:

1. those who refused to participate in the experiment
2. those who were unable to understand a VAS and Likert scale
3. those with a history of allergic reaction to vapocoolant spray or lidocaine
4. those with a history of cold intolerance (Raynaud's syndrome, etc.)
5. those who took oral pain medications or used topical anesthetics within 24 hours of the experiment
6. those who exhibited abnormal lower extremity sensation during the physical examination or who showed pain on gastrocnemius
Safety of Chlamydia Vaccine CTH522 in Healthy Women Aged 18 to 45 Years

The present trial is a phase I first in human, double blind, parallel and placebo controlled trial of SSI's adjuvanted chlamydia vaccine CTH522: CTH522-CAF01 (CAF01 is an adjuvant system) and CTH522-Al(OH)3. The trial will be conducted at Imperial College Research site in the United Kingdom.

Subjects are randomly assigned to one of the following three treatment groups in a ratio of 3:3:1.

This trial consisted of 10 visits and 5 telephonic interviews


Eligibility Criteria:
Inclusion Criteria:

1. Is a healthy female between 18 and 45 years of age on the day of first trial vaccination
2. Has provided signed informed consent
3. Is willing and likely to comply with the trial procedures
4. Is prepared to grant authorised persons access to their medical record
5. Willing to use acceptable contraceptive measures\* during the trial (2 weeks before and 2 weeks after the trial)

   * Heterosexually active female capable of becoming pregnant must (in addition to requiring male partner to use condoms) agree to use hormonal contraception, or to complete abstinence, from at least 2 weeks before the first vaccination until at least 2 weeks after the last. (Note: Periodic abstinence \[e.g. calendar, ovulation, symptothermal, post-ovulation methods\] and withdrawal and intrauterine device or intrauterine hormone releasing system and progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, are not acceptable methods of contraception)

Exclusion Criteria:

1. Has confirmed history of Pelvic Inflammatory Disease or significant gynaecological diseases
2. Is positive for C. trachomatis (PCR)
3. Is positive for gonorrhoea (urine), HIV, Hepatitis B/C, syphilis (blood)
4. Has a positive pregnancy test
5. Has a significant active disease - such as cardiac, liver, immunological, neurological, psychiatric; or clinically significant abnormality of haematological or biochemical parameters.
6. Has BMI of 35 kg/m2 or greater
7. Is currently participating in another clinical trial with an investigational or noninvestigational drug or device
8. Has received, or plans to receive, an active immunisation within 14 days of the start of the trial or any of the immunisation visits in this trial
9. Is currently receiving treatment with immunosuppressive agents e.g. oral, inhaled, nasal or injected corticosteroids. (Topical steroids are allowed, unless applied to the IM injection site.)
10. Is using an intrauterine device
11. Has a condition which in the opinion of the investigator is not suitable for participation in the trial
12. Known or confirmed allergy to any of the vaccine constituents -
Double Blind Study of Thymopentin Effects on HIV-1 Infectivity of Blood Mononuclear Cells and Semen in HIV Infected Patients

Examine the ability of Timunox (thymopentin) to reduce the amount and/or frequency of virus isolation. Examine the ability of thymopentin to stimulate the immune system and alter the clinical findings of patients infected with HIV who do not yet have AIDS.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Aerosolized pentamidine.

Patients must have the following:

- Seropositive for HIV-1 (ELISA assay) confirmed by Western blot. HIV-1 p24 antigen must be detected in supernatant fluids from co-cultures of patients' peripheral blood monocytes (PBMC) on two separate occasions. Voluntarily sign consent.

Patients with HIV "wasting syndrome" are included.

Prior Medication:

Allowed:

* Aerosolized pentamidine.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* AIDS as defined by the CDC (except for those with HIV "wasting syndrome").
* Significant hepatic disease.
* Thrombocytopenia.
* Hypersensitivity to thymopentin.
* Hemophilia A or B or other hematologic disorders requiring current or previous administration of blood products.
* Abnormal chest x-ray (indicative of active disease (opportunistic infection)) within 30 days prior to study entry.

Patients with the following are excluded:

* AIDS as defined by the CDC (except for those with HIV "wasting syndrome").
* Significant hepatic disease.
* Thrombocytopenia.
* Hypersensitivity to thymopentin.
* Hemophilia A or B or other hematologic disorders requiring current or previous administration of blood products.
* Abnormal chest x-ray (indicative of active disease (opportunistic infection)) within 30 days prior to study entry.

Prior Medication:

Excluded within 30 days of study entry:

* Immunomodulatory or experimental therapy.
* Excluded within 90 days of study entry:
* Zidovudine (AZT).

Intravenous drug abuse.
Effectiveness of IRK-19® on Body Weight Control

This randomized, double-blind, placebo-controlled, and parallel clinical study aims to investigate the effectivness of a pumpkin seed extract (IRK-19®) on weight management.


Eligibility Criteria:
Inclusion Criteria:

1. BMI: 25-30 kg/m2
2. Waistline circumference: ˃ 80 cm

Exclusion Criteria:

1. Pregnant women or preparing for pregnancy.
2. Lactating women.
3. Women gave birth 6 months before the study.
4. Subject uses diuretic, corticosteroids, anti-depressant medications, or antipsychotic medications.
5. Subject has undertaken obesity-related surgeries within one year prior to the study or other surgeries within six months prior to the study.
6. Change of body weight of subject is over 5% within 3 months before the study.
7. Subject has serious diseases (e.g., cardiovascular diseases).
8. Cancer patient.
9. Subject has engaged in another study within 3 months before the study.
10. Subject uses another dietary supplement related to weight management during the study.
A Clinical Study of Belzutifan (MK-6482) Alone or With Phenytoin in Healthy Participants (CA46602/MK-6482-035)

Researchers designed belzutifan, the study medicine, to treat certain kinds of cancer.

The goal of this study is to learn what happens to belzutifan in a healthy person's body over time when taken, by mouth, as a tablet. Researchers will learn what happens when belzutifan is taken alone and when it is taken after several days of treatment with phenytoin.


Eligibility Criteria:
Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

* Healthy, adult, male (vasectomized or surgically sterilized) or female (of non-childbearing potential)
* Has a body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* Has a history of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study
* History or presence of: Seizure (excluding simple febrile seizure), epilepsy, severe head injury, multiple sclerosis, or other known neurological conditions which the PI considers to be clinically significant; Hypersensitivity reaction to anticonvulsant therapy (including phenytoin, primidone, and phenobarbital); Depression, unusual changes in mood or behavior or suicidal thoughts and behavior; Hepatic porphyria (e.g., acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda)
Impact of Left Bundle Branch Area Pacing vs. Right Ventricular Pacing in Atrioventricular Block (LEAP-Block)

This is a multicenter, randomized controlled study. The aim of this study is to compare the impact of LBBAP on left ventricular function as compared with traditional right ventricular pacing in patients with atrioventricular block.

LEAP-BLOCK is a prospective, multi-center, randomized controlled trial that is designed to determine whether left bundle branch area pacing (LBBAP) may reduce the risk of RV ventricular pacing induced cardiac dysfunction as compared with traditional RV pacing (RVP) in patients with atrioventricular (AV) block and normal LV function (LVEF≥50%) who require high percent of ventricular pacing. The primary aim of this trial is to compare the time to first event (composite of all-cause mortality and newly heart failure hospitalization and device upgrade due to heart failure) between LBBAP and RVP group in patients with AV block. Patients with AV block and normal LV function who require high burden of ventricular pacing (expected \>40%) will be randomized to LBBAP or RVP group for therapy. Patients will be followed at least every 3 months for clinical status and every 6 months for echocardiographic evaluation until the study closure.

Eligibility Criteria:
Inclusion Criteria:

* a. Adult patients aged 18-90;
* b. AV block patients with ventricular pacing indications and the expected rate of ventricular pacing(VP)\> 40%, including (a)Third-degree AV block; (b) Second degree AV block (type II); (c) intermittent advanced AV block with expected VP\>40%; (d)Symptomatic first degree AV block and PR interval on ECG ≥ 250ms;
* c. The subject is able to receive a pectoral implant;
* d. The subject is willing and able to comply with the protocol;
* e. The subject is expected to remain available for follow-up visits at the study centers.
* f. Subject or authorized legal guardian or representative has signed and dated the study Subject Informed Consent

Exclusion Criteria:

* a. Baseline echocardiographic assessment of patients with impaired LV function (LVEF\<50%);
* b. Having difficulties in follow-up: Those who cannot accept 2-year follow-up on time due to physical condition or other reasons;
* c. Patients with persistent atrial fibrillation;
* d. Pacemaker replacement without new implanted ventricular electrodes;
* e. Patients with implantable cardioverter-defibrillator (ICD) indications;
* f. Surgery is required within 1 year due to severe structural heart disease;
* g. Patients with tricuspid mechanical valve replacement, or congenital heart disease (including transposition of the great arteries, or permanent left superior vena cava, etc), or AV block resulting from: (a) Hypertrophic cardiomyopathy(HCM)vpost (modified) Morrow surgery, (b) ventricular septal defect repair; and those who are unlikely to achieve successful LBBAP procedure.