cyrilzakka/clinical-trials huggingface dataset:
Restoring Molecular Circadian Rhythm

The goal is to address the mechanisms that account for alteration of circadian rhythms with age. As the blood of aged individuals can produce this alteration, the investigators propose to use such blood samples to "age" circadian rhythms in cultured cells. The investigators will verify aged blood-dependent alteration of rhythms and then conduct molecular screens to reverse this decline. If the investigators identify specific genes that can restore molecular circadian rhythm in vitro, the investigators will explore these in animal models (Drosophila, mouse).


Eligibility Criteria:
Inclusion Criteria:

* General good health with the following conditions permissible

  * cardiovascular risk prevention, intake of low dose aspirin,
  * hypertension, intake of beta-blockers, ACE inhibitors, diuretics, calcium channel blockers
  * hypercholesterinemia, intake of statins
* Cases: 70-85 years of age
* Controls: 20-35 years of age
* Patients must be able to read and understand English
* Participants must sign the informed consent form
* Participants must have a wrist-actigraphy-based average TST (total sleep time) ≥ 6 hours per night (measured over 7 consecutive days) occurring between 22:00 - 08:00

Exclusion Criteria:

* Known history of severe psychiatric or cognitive conditions, for example mania, schizophrenia, or mental retardation
* Shift work, defined as recurring work between 22:00-05:00
* History of clinically significant obstructive sleep apnea
* Transmeridian travel across ≥2 time zones in the two weeks prior to the blood draws and one week after,
* \> 2 drinks of alcohol per day
* Use of illicit drugs
Safety, Preliminary Pharmacokinetics and Bronchodilator Properties of V0162

Pulmonary administered anticholinergic agents have shown their importance in the chronic obstructive pulmonary disease (COPD) management to reduce morbidity, disability and mortality. To date, the recommended treatment of moderate to severe COPD patients consist in the combination of ß2 agonist and long acting antimuscarinic compounds. There is still a medical need in new product that could exhibit both anti-inflammatory and strong bronchodilation potency. V0162 is a compound with a potent anticholinergic activity.

Secondary PD properties of V0162 could enhance the efficacy of this antimuscarinic compound and could bring new option in the treatment of this life-threatening disease.

This study has two parts. Part A will be conducted in 72 healthy volunteers. Part B will be conducted in 20 patients diagnosed with COPD.

Part A The primary objective of this part of the study is to assess the local tolerability of escalating doses of V0162 in male healthy volunteers.

Part B The primary objective of this part of the study is to assess the bronchodilator properties of V0162 at the maximal tolerated dose (determined in Part A) in COPD patients.

In addition, pharmacokinetics and vital sign including ECG will be determined.

Eligibility Criteria:
Inclusion Criteria Part A:

* Male gender
* Age between 18 to 50 years included,
* 18 ≤ Body Mass Index (BMI) \< 30 kg/m²,
* Who had given their written consent for their participation in the study,
* Who, in the judgement of the Investigator, are likely to be compliant during the study,
* Registered with a social security insurance system.

Inclusion Criteria Part B:

* Aged 40 to 65 years-old,
* 18 ≤ BMI \< 35 kg/m2,
* Smokers ≥ 10 packs / year,
* Moderate to severe COPD
* Registered with a social security insurance system.

Exclusion Criteria Part A:

* History of asthma or significant respiratory disorder,
* History of allergic rhinitis,
* Upper respiratory tract infection in the last month,
* Blood eosinophil count ≥ 600/μL,
* Epilepsy, narrow angle glaucoma, prostatic hypertrophy or bladder neck obstruction,
* Abnormal spirography,

Exclusion Criteria Part B:

* Respiratory tract infection in the last 6 weeks,
* Asthma or significant respiratory disorder other than COPD,
* Allergic rhinitis,
* Blood eosinophil count ≥ 600/μL,
* Epilepsy, narrow angle glaucoma, moderate to severe prostatic hypertrophy or bladder neckobstruction,
* Myocardial infarction within the previous 6 months, heart failure or serious cardiac arrhythmia,
* Moderate to severe renal impairment,
* Moderate to severe hepatic impairment
* Use of short-acting b-agonist,
* Use of anticholinergics
Family-based Genetic Long-term Study of Brain Function in Schizophrenia

The goal of this research is to find out possible susceptible gene(s) in schizophrenic patients with family history and 5-year period functional changes of brain among the members of family, in order to further analysis factors and their interactions.

Schizophrenia is a serious mental disease, highly family inheritable inclination. By means of traditional psychiatry diagnosis, genetics and long term brain change researches will help to unveil the secret of schizophrenia and other factors. The advantage of comparative gene hybridization is that chromosome copy number alterations can be detected; this technique has been widely applied in many researches, such as cancer, mental retardation screening and autism. As we known, we are the first one use this technique in chromosome abnormality research for family history schizophrenic patient, this study also is the first one to track the relationship of long term brain function alteration and chromosome abnormality in Taiwan.

Eligibility Criteria:
Inclusion Criteria:

1.Psychiatry doctor diagnosed who met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia or schizoaffective disorder, family history, age older than 15 will be recruited for participation in this study. Participants agree and sign informed consent forms will eligible to participate this experiment.

2.10-20c.c blood will be drawn from the participants. 3.Participants need to understand procedures and assays of this experiment. 4.At least one psychiatry doctor interview needed, participants and their family voluntarily join this interview, approximately 30-45min.

Exclusion Criteria:

1. Participant can not understand procedures and assays of this experiment.
2. Participant has another major mental disease other than the inclusion criteria.
3. Participant has material abuse history, it could seriously influence diagnosis.
4. Participant has combination diseases, it could seriously influence diagnosis.
5. Psychopathy or psychosis can not be categorized in defined group.

Other considerations:

1. Participants, age fewer than 20 needs to their deputy guardians (parents) and their own consent altogether.
2. Participants who are inability needs to their deputy guardians (parents) and their own consent altogether.
Smoking Cessation Via Text Messaging: Feasibility Testing of Stop My Smoking USA

The investigators developed a text messaging-based smoking cessation program called SMS (Stop My Smoking) USA. It was tailored for the unique needs and smoking habits of young adults. The investigators hypothesized that those in the SMS USA intervention would be significantly more likely to be quit at 6-months compared to the attention-matched control group.

About one in four young adults are current smokers. Although over half report the desire to quit or cut down, quit rates in this age group have remained stagnant in the last ten years. Text messaging may represent a compelling intervention delivery method for smoking cessation for young adults because it is a medium they have widely adopted. Cell phone interventions also are unique because of their 'always on' capability - interventions are never far from the young adult's reach and they are received automatically instead of requiring the participant to initiate contact in order to receive the information. Dr. Ybarra, along with Drs. Holtrop and Graham, have developed SMS Turkey, an innovative behavioral intervention that uses text messaging to deliver CBT-based smoking cessation information to participants daily. Successful use of text messaging to deliver smoking cessation programs has been reported by Rodgers and colleagues in New Zealand and a replication study they are leading in the United Kingdom. These data provide optimism for the feasibility of text messaging-based smoking cessation programs in the United States. Using qualitative methods to inform design and content, and quantitative methods to assess the feasibility of the program, we propose to design and test SMS (Stop My Smoking) USA, a cell-phone based smoking cessation program for young adults ages 18-25. This innovative smoking cessation program uses technology widely adopted by young adults, an under-targeted population, to deliver a proactive, cognitive behavioral therapy (CBT)-based intervention. Our multidisciplinary team of researchers brings together expertise in Internet health and the design of tailored smoking cessation interventions.

Eligibility Criteria:
Inclusion Criteria:

* 28 cigarettes or more per week (at least 4/day) and on at least 6 days/week.
* Owning a text-capable cell phone and cognizant of how to send and receive text messages
* Currently enrolled or intending to enroll in an unlimited text messaging plan
* Enrolled with a cell phone carrier that was compatible with the program software
* Agree to verification of smoking cessation status by a significant other
* Able to read and write in English
* Informed consent

Exclusion Criteria:

None
Capacitive-resistive Electric Transfer Therapy for Recovery From Running Fatigue

Reducing fatigue and improving the recovery capabilities of runners has gained more interest over the last years. Recently, capacitive-resistive electric transfer (Tecar) therapy is commonly used by physical therapists to help athletes recover from muscle fatigue. However, empiric evidence supporting the benefits of Tecar to recovery is lacking. This study investigated the effects of a Tecar treatment performed shortly after an exhausting training session on both physiological and biomechanical parameters of running.

In this randomized controlled crossover trial all subjects will perform two test protocols separated by 2 weeks. Each protocol will comprise one exhausting training session (20-min warm-up consisted of 15-min of continuous self-paced running followed by 5-min of fast-finish progression runs increasing speeds (from approximately 60% to 80% of maximal heart rate, participant controlled), 10 x 500 m sprints at 90% of maximal heart rate with a 2-min rest period between bouts and a recovery phase consisting of 10-min of slow jogging). Twenty-four hours after this exhausting training, subjects will perform an incremental running test on a treadmill (Pre-intervention test) where subjects will start at 10 km/h for 6 min after which speed will be increased by 2 km/h every 6 min until a 16 km/h trial is completed. One hour after this test, in one protocol subjects will receive Tecar therapy (Tecar treatment group); in the other group (Control group) participants will rest passively in a sitting position for 30-min period. To evaluate the relevance of the changes induced by Tecar therapy/passive recovery, subjects will repeat the treadmill test 48 hours after the first test in both groups (72 hours after the exhaustive training).

Eligibility Criteria:
Inclusion Criteria:

* Recreationally active (current participation in races and a 10-km race time \<34.5-min)

Exclusion Criteria:

* Suffered from any injury within the preceding 4 months.
A Phase II Study of Imiquimod 5 % Cream for the Treatment of Hemangioma in Infancy

Hemangiomas of infancy, the most common benign tumors of infancy, are congenital or early infancy lesions characterized by a rapid postnatal growth, with high expression of angiogenic stimulators for 9-18 months, followed by slow regression for 5-9 years. Current therapies for the hemangiomas are usually restricted to more severe forms due to the risks of adverse effects, inconvenience and cost. Nevertheless, a substantial amount of the psychological discomfort and morbidity can be caused by untreated hemangiomas, especially those in the face.

Recently, Imiquimod 5% cream has emerged as a safe an effective drug for several skin conditions that benefit from modulation of the activity of the immune system, such as common warts and various forms of the skin pre-cancerous and cancerous lesions. Small case reports series have suggest that it could also be useful in hemangiomas, possibly through the inhibition of the angiogenesis by local IFN production.This is a small, open label study of 16 patients to document the efficacy of the Imiquimod 5% cream in the treatment of hemangioma of infancy (primary outcome). IFN and plasma drug levels, as well as clinical examinations and blood studies, will be carried out to evaluate safety of the treatment (secondary outcome). bFGF and VEGF will be measured in blood and urine in order to study the diagnostic and predictive value of these pro-angiogenic factors in the response of hemangiomas to the treatment with Imiquimod (secondary outcome).

The study is a phase II clinical trial of a once a day application of Imiquimod 5% cream, 3 to 7 times per week for a maximum of four months. The study held at the Dermatology Clinic of Sainte-Justine Hospital, and was completed within a 20 months timeframe after IRB approval.


Eligibility Criteria:
Inclusion Criteria:

* Healthy infants aged 2-12 months.
* Superficial or mixed hemangiomas in proliferative phase (growing in size in the last 1-2 months).
* Hemangiomas must be less than 10X10 cm and must not be ulcerated.

Exclusion Criteria:

* Preterm infant (less than 36 weeks of gestation).
* Ulceration of hemangioma prior to treatment.
* Immunosuppression.
* Hemangioma located on the eyelid or perianal region.
* Prior treatment of the hemangioma.
* Concomitant diseases.
* Presence of multiple hemangiomas and/or hemangiomas that would require systemic drug treatment.
* Potential difficulties with follow-up (patient from another town,difficult access to the hospital , etc.).
* History of allergy to any of the components of the drug preparation.
* Hemangiomas more than 10X 10 cm or ulcerated before the start of the treatment.
Transdermal Nicotine in Female Patients at High Risk for Post Operative Nausea and/or Vomiting (PONV)

The purpose of this study is to see if the nicotine patch reduces post operative nausea and/or vomiting (PONV) among non-smoking patients who are at high risk of PONV.

There are certain known risk factors for post-operative nausea and/or vomiting: the use of opioids during surgery, female gender, laparoscopic surgery, gynecologic surgery, strabismus repair, the use of a general anesthetic, obesity, and non-smoker. Patients with four or more of these risk factors have an 80% occurrence rate of post-operative nausea and/or vomiting and are classified as "high risk". It has been shown that those who use tobacco have about a 50% reduction in post-operative nausea and/or vomiting.

Eligibility Criteria:
Inclusion Criteria:

* age 18-65
* female
* health patient or acute illness
* undergoing outpatient-type general surgery, especially those associated with increased incidence of post-operative nausea and/or vomiting such as gynecological procedures
* undergoing general anesthesia for the surgery
* receiving opioids during surgery
* non-smokers

Exclusion Criteria:

* history of any heart condition
* history of uncontrolled hypertension, or presence of any condition that could be made drastically worse by an increase in blood pressure
* history of an aneurysm
* active tobacco use within the past five years
* works or lives in the presence of cigarette smoke
* pregnant
* mentally ill
* prisoners
* history of allergic reaction to nicotine or to adhesive patches
* history of allergic reaction to propofol, versed, fentanyl, zofran, decadron, and reglan
Assessment of Molecular Remission by ASO-qPCR After Bortezomib-dexamethasone (Vel/Dex) Followed by ASCT

The primary objective of this study is to determine the rate of molecular remissions (MolR) assessed by ASO-RQ-PCR technique after induction treatment with bortezomib and dexamethasone (Vel/Dex) prior to high-dose therapy with melphalan and autologous stem cell transplantation (HDT-ASCT), and after HDT-ASCT in patients with multiple myeloma.

HDT-ASCT is so far considered the standard of care for younger patients with multiple myeloma (MM). Current evidence indicates that quality of response is an important prognostic factor for long-term survival in MM. There are only very few data on molecular remissions (MolR) determined by the most sensitive technique, allele-specific-oligonucleotide - real-time quantitative - polymerase chain reaction (ASO-RQ-PCR) in MM, and there are no data available on molecular responses after bortezomib-based induction therapy followed by HDT-ASCT. The main aim of this study is to determine molecular response rate after ASCT following bortezomib-based induction treatment compared to a historical control group with conventional VAD induction treatment. A sensitivity of ASO-RQ-PCR technique will be compared to immunofixation and with immunophenotyping by flow cytometry.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic multiple myeloma
* Age 18-65 years
* Written informed consent

Exclusion Criteria:

* WHO performance status ≥ 2, unless related to MM
* Severe cardiac dysfunction
* History of hypotension
* Serious medical or psychiatric illness
* Severe hepatic dysfunction
* Severe polyneuropathy ≥ grade 2
* Active, uncontrolled infection
* Previously treated with chemotherapy or extensive radiotherapy for MM
* Known HIV positivity
* Severe renal dysfunction with need of dialyses
* History of active cancer during past 5 years, except non-melanoma skin cancer or stage 0 cervical cancer
* Female patients who are pregnant or nursing
* Male or female patients of reproductive potential who are not practising effective means of contraception
Study on Therapeutic Effect of Treating Mental Stress Induced Myocardial Ischemia

This study aims to discuss whether the combined treatment of traditional Chinese medicine (TCM) and western medicine for Mental Stress Induced Myocardial Ischemia (MSIMI) does effect, namely the conventional therapy for Coronary Heart Disease( CHD) combining with TCM - Xinkeshu tablets.

A large number of evidence-based medical researches have proven that bad mood and mental stress are related to poor prognosis. Having recognized that acute emotional stress can induce cardiovascular events, many clinical tests of mental stress have been carried out to observe the correlation between emotional stress and cardiac damage, which ultimately lead to the formalization of the concept of Mental Stress Induced Myocardial Ischemia(MSIMI). In the past 3 decades, it has been evidenced that mental stress is internally related to myocardial ischemia. According to current studies, over 70% patients with stable coronary heart disease have MSIMI and are exposed to three or four times higher risk of cardiovascular events. However, few articles are about the therapeutic effect of MSIMI treatment. This study aims to discuss whether the combined treatment of traditional Chinese medicine (TCM) and western medicine for MSIMI does effect, namely the conventional therapy for CHD combining with TCM - Xinkeshu tablets.

Eligibility Criteria:
Inclusion Criteria:

1. above 18 years old,
2. having coronary stenosis (\> 70%) measured by coronary arteriography,
3. with medical history of myocardial infarction or revascularization procedures,
4. or with sufficient proof for having CHD.

Exclusion Criteria:

1. patient age younger than 18,
2. clearly impaired cognitive function,
3. damage of functions of vital organs,
4. suicidal ideation,
5. mental diseases treated with selective serotonin reuptake inhibitor (SSRI)
Non-invasive Monitoring of Endovascular Repair of Abdominal Aortic Aneurysm (VBA)

This study evaluates a novel noninvasive method to dynamically monitor the effect of abdominal aortic aneurysm (AAA) and endovascular treatment of AAA (EVAR) on arterial pulse wave

Abdominal aortic aneurysm (AAA) develops slowly and degeneratively (increasing diameter, wall tension, thinning and decreased wall strength, altered compliance) which affects the aortic pressure and wave reflection. In 50% of cases, AAA rupture may lead to death and 50% of the remaining patients referred to hospital die. This results in high costs and preventable loss of lives. AAA can also be detected by pulse wave (PW) analysis. which could enable development of easy to use, affordable and accurate methodology for the detection of AAAs. The measurement system used in the present study is capable of wireless recording of PWs from several different locations utilizing two different sensor modalities (blood-volume related photoplethysmographic (PPG) PWs and dynamic blood pressure PWs). The objective is to study PWs in the detection of AAA and the effects of endovascular repair (EVAR) and whether adverse effects (i.e. endograft failure) can be detected. It is hypothesized that AAA and failure of the operation can be detected by PW features, especially by printed flexible sensors which will improve the usability, patient comfort and safety (hygiene). The technology could make it possible to screen AAAs at lower costs even in the municipal health centers or by the patients themselves, at similar accuracy, without skilled personnel operating the diagnostic devices and therefore improve the cost effectiveness of AAA screening resulting in significant savings, resource reallocation in the healthcare and also improved patient safety and prevention of deaths. It could also enable patient-centered, comfort follow-up for patients treated by EVAR.

Eligibility Criteria:
Inclusion Criteria:

* The patient has been clinically examined at policlinic of vascular surgery
* The patient has been examined with computed tomography (CT) imaging
* The patient has been considered a candidate for the EVAR of the AAA

Exclusion Criteria:

* A patient has a pacemaker
* A medical doctor decides that the measurement disturbs or risks the subject's treatment process
* Subject's denial (or withdrawal)
* A patient has at least one amputated limb
* The age of the test subject candidate is less than 18 years
* A test subject candidate is not able to understand the study or is not legally competent
* A test subject candidate has Ehlers-Danlos syndrome or Marfan syndrome
Drug Effects on Interpersonal Interaction

The investigators propose to use a Paired Partner design, in which subjects engage in a 45-min semi-structured conversation with one (novel) partner under the influence of MDMA and with another partner under the influence of placebo. At the end of each session, they will rate their feelings about the partner, and on the test day, subjects will be asked which partner they preferred and felt closer to.

The study will use a within-subject design with three sessions: i) MDMA and conversation with Person A, ii) placebo and conversation with Person B, iii) test session (online) assessing preference for Persons A and B. The MDMA dose will be 100 mg, administered under double blind conditions. The conversation will consist of a 45 min dialog between the participant and the partner, a person trained to engage in conversation for this purpose. The dyad will be provided with topics to discuss, at their own pace. The order of administration of drug and placebo will be counterbalanced, and the partners will be same-sex and varied across sessions. The primary outcome measures will be feelings of closeness and connection at the end of the two drug sessions, at the online test session and follow-up. After study completion, participants will be fully informed about the study.

Eligibility Criteria:
Inclusion Criteria:

* English fluency
* High school level education
* BMI between 19 and 30

Exclusion Criteria:

* Diagnosed medical condition
* women who are nursing, pregnant, or plan to become pregnant within 3 months
* History of psychotic disorder or family history of psychotic disorder