cyrilzakka/clinical-trials huggingface dataset:
Rheumatology Clinical Registry

The ACR Rheumatology Clinical Registry (RCR) is a tool developed to assist members in practice improvement, local population management, and efficient, successful participation in national quality programs. RCR integrates evidence-based quality measures aimed at improving care and drug safety for patients with rheumatoid arthritis, osteoarthritis, osteoporosis, gout and juvenile idiopathic arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Rheumatoid Arthritis

Exclusion Criteria:

* None
Effect of Fasting on Ghrelin and Growth Hormone in Healthy Young and Older Adults

The overall objective of this study is to determine the extent to which circulating ghrelin levels (total and bioactive ghrelin) are regulated by nutritional state and age.

Normal volunteers: young and older men and women studied under fed and fasting (total 62.5h) conditions, frequent blood sampling for ghrelin and other related hormones

Eligibility Criteria:
Inclusion Criteria:

Healthy young (ages 18-30) and older (ages \> 60) men and women with a body mass index (BMI) of \<35 kg/m2. Young and older subjects will be matched for BMI.

Exclusion Criteria:

1. A history of coronary artery disease, congestive heart failure, peripheral vascular disease, diabetes mellitus, significant hypertension (BP \>180 systolic or \>100 diastolic at rest); renal, hepatic, pulmonary disease; untreated hypothyroidism, untreated hyperthyroidism; history of seizure disorder; history of malignancy (other than some skin cancers), history of active chronic infections (e.g., HIV, tuberculosis): abnormal screening laboratory tests. This information will be obtained through the use of screening labs, history and physical exam and the medical record. See the GCRC protocol for details of the labs.
2. Hematocrit \< 41% men, \< 38% women
3. History of daily tobacco use within past 3 months
4. Chronic alcohol abuse
5. Recent weight change of \> 10 pounds in last 3 months
6. Strenuous exercise for average of more than 60 min/day
7. Investigational drug within past 6 weeks
8. Any history of major psychosis, severe depression, anorexia nervosa
9. Transmeridian travel within 2 weeks prior to or during study -
Postencephalitic Symptoms After Tick Borne Encephalitis

The purpose of this study is to assess clinical outcome in patients with tick borne encephalitis.


Eligibility Criteria:
Inclusion Criteria:

* serologically proved tick borne encephalitis in patients \> 15 years

Exclusion Criteria:

* pregnancy
Pilot Study of Internet-based Cognitive Behavior Therapy for Fibromyalgia

This pilot trial will include 30-40 participants with a diagnosis of fibromyalgia. The purpose of the study is to evaluate an internet-based treatment protocol based on cognitive behavioral therapeutic principles. Participants are required to have a previous diagnosis of fibromyalgia before entering into the trial. The treatment will be 10 weeks long and all included participants will be given treatment, i.e. there is no randomization to a comparison group.


Eligibility Criteria:
Inclusion Criteria:

* Current diagnosis of fibromyalgia

Exclusion Criteria:

* Current diagnosis of severe psychiatric disorder
Pressure Relief Education and Training for Wheelchair Users

There can be barriers for clients with progressive disorders who are power wheelchair users and their caregivers that prohibit them from performing pressure relief. Clients may struggle with consistent performance of pressure relief and may not recall the importance, have methods to perform, or be able to perform due to weakness or other disease changes.

Study the population of power wheelchair users with progressive disorders at the Neurology Specialty Care - Edgehill, Carolina Neuromuscular Amyotrophic Lateral Sclerosis (ALS)/ Muscular Dystrophy Association (MDA) Center to identify barriers, provide potential solutions, and provide education and training to both increase knowledge and understanding of pressure relief options and processes as well as to overcome these perceived barriers amongst the clinic population. Current adults of the Neurology Specialty Care practice who are complex power wheelchair users will be eligible for this project as an extension of usual care.

Eligibility Criteria:
Inclusion Criteria:

* Adult 18 years or older
* Diagnosis of a progressive disorder (amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), muscular dystrophy (MD), spinal muscular atrophy (SMA), Parkinson disease (PD)
* Current clinic client at the Neurology Specialty Care Edgehill clinic
* Currently using a complex (group 3) power wheelchair with power positioning of at least tilt/recline
* Currently sitting in the chair at least 2 consecutive hours/day

Exclusion Criteria:

* Dementia as noted by Medical Doctor / speech-language pathologists (SLP) in medical records
* Inability/unwillingness to control wheelchair power features (client)
* Unwillingness to be monitored, educated, trained by study staff
* Uses other mobility devices indoors (scooter, basic power wheelchair) more than complex power wheelchair
* Further exclusions may be added in future protocol versions
Palliation Dysphagia Cancer Oesophagus Stent+Brachytherapy Versus Brachytherapy Only

We wish to improve the swallowing function of patients with advanced cancer of the oesophagus, by carrying out a randomised clinical study in which we compare primary stenting followed by brachytherapy in the stent, 8 G x 3 with standard brachytherapy 8 Gy x 3.

The aim of the study is to investigate whether patients who receive a stent followed by brachytherapy have a better swallowing function without more pain at week +2,compared to patients who receive brachytherapy alone.


Eligibility Criteria:
Inclusion Criteria:

Patients must fulfill all the following criteria:

1. Histologically or cytologically verified carcinoma of the oesophagus
2. Reduced ability to swallow solid food, minimum grade 1 (see page 16)
3. Age ≥ 18 years
4. Ability to understand and answer (with or without help) the study questionnaires
5. Written informed consent received
6. A Completed questionnaire received from the patient
7. One of the following criteria must be fulfilled:

   1. Advanced disease and WHO performance status ≥2
   2. Advanced disease and WHO performance status 0-1 and other therapy excluded due to medical condition
   3. Advanced disease and WHO performance status 0-1 and patient's preference
   4. Local disease and WHO performance status ≥2 and other therapy excluded due to medical condition
   5. Local disease and WHO performance status ≥2 and patient's preference

Exclusion Criteria:

1. Oesophageal stent already inserted
2. Endoscopic procedures not tolerated
3. Cannot have (additional) radiation therapy
4. Tumour location not suited for stent or brachytherapy (the upper 3 cm of oesophagus or major component in the cardia)
College Student Stress: Transitions Over Time

This research study is being conducted to better understand how college students develop and cope with stress and to identify opportunities to help students notice and respond to stress early before symptoms contribute to significant negative consequences.

This project will be completed in two parts. In the first part (not a trial) participants will be asked to complete a screening survey to determine eligibility. Eligible participants (i.e., those with mild-to-moderate depressive symptoms and not receiving mental health care) will continue into the clinical trial portion (part two). There were 120 students in the clinical trial phase of the study, where 30 were randomly assigned to "assessment only" and 90 to the "intervention" condition.


Eligibility Criteria:
Inclusion Criteria:

* First-year college students that are full-time or part-time students enrolled at the University of Michigan, Ann Arbor or Flint campuses
* Mild-to-moderate depressive symptoms, and are not receiving professional mental health services will be eligible

Exclusion Criteria:

* Under the age of 17
* Currently be receiving mental health therapy/counseling from a healthcare professional
* Experiencing minimal depressive symptoms (defined in protocol)
* Experiencing moderately severe to severe depressive symptoms (defined in protocol)
A Four-week Clinical Trial Investigating Efficacy and Safety of Cannabidiol As a Treatment for Acutely Ill Schizophrenic Patients

Schizophrenia is a heterogeneous mental disorder that affects one percent of the world's population. Current antipsychotics are only partially effective, and their use is often associated with serious side effects. Cannabidiol is a natural counterpart of the psychoactive component of marijuana, delta-9-tetrahydrocannabinol. While cannabidiol has no psychotomimetic or addictive properties, it indirectly affects endogenous cannabinoid signalling by impairing the degradation of the endocannabinoid anandamide. In a controlled clinical trial of cannabidiol versus amisulpride (an established antipsychotic) in acute paranoid schizophrenics the investigators showed a significant clinical improvement in all symptoms of schizophrenia compared to baseline with either treatment. But cannabidiol displayed a significantly superior side-effect profile. This study is to evaluate the efficacy and safety of this novel treatment option in comparison to placebo and olanzapine, an established second generation antipsychotic in the treatment of acute schizophrenia and schizophrenia maintenance therapy, in a four-week clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent given by the subject
* DSM-IV-TR diagnosis of schizophrenic psychosis (295.10, 295.20, 295.30, 295.90 (American Psychiatric Association)
* Patients must be within the first three years of illness, i.e. first diagnosis of schizophrenia is no older than three years.
* Age 18 to 65 years, male or female
* Minimal initial PANSS score of 75 at baseline
* Female patients of childbearing potential need to utilize a proper method of contraception.
* Body Mass Index between 18 and 40

Exclusion Criteria:

* Lack of accountability (assessed by an independent psychiatrist)
* History of treatment-resistant schizophrenia, defined as no response to at least two antipsychotics given for a minimum of 6 weeks each in an adequate dosage
* Positive urine drug-screening for illicit drugs at screening (except cannabinoids and benzodiazepines)
* Serious suicidal risk at screening visit (Subject to investigator's and independent psychiatrist's judgement: Poses a serious suicidal or homicidal risk at screening visit or has made a serious suicide attempt within the last 12 months prior to screening visit, or has exhibited homicidal behaviour at anytime during her/his lifetime)
* Known intolerance or allergy to olanzapine or cannabidiol
* Other relevant interferences of axis 1 (e.g. serious depression) according to diagnostic evaluation (MINI) including residual forms of schizophrenia
* Pregnancy, as determined through a β-HCG pregnancy test, or lactation
Use of 3,4-Diaminopyridine in the Treatment of Lambert-Eaton Syndrome

To learn more about the effect of 3, 4-Diaminopyridine (3,4-DAP) on patient diagnosed with Lambert-Eaton myasthenic syndrome (LEMS).


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older,
* Diagnosed with LEMS,
* If female, have a negative pregnancy test, and
* If premenopausal, be willing to practice an effective form of birth control during the study,
* Tested and found by ECG not to have a prolonged QT syndrome,
* Agree to have a second ECG at the time of peak drug effect,
* Has understood and signed the Informed Consent.

Exclusion Criteria:

* Is known to have a sensitivity to 3, 4-DAP,
* Has a history of:

  1. past or current seizures,
  2. cardiac arrhythmia,
  3. hepatic, renal or hematologic disease, or
  4. severe asthma,
* Is believed by the investigator to be unable to comply with the protocol.
NICE - Nutritional Impact on Immunological Maturation During Childhood in Relation to the Environment

Role of the exposome on allergy, caries, and neurophysiological development in childhood.

Role of the exposome and epigenetics on allergy, caries, and neurophysiological development in childhood as studied in a birth cohort of 650 trioses. The exposome includes repeated measures of nutrition, micronutritients, microbiota, toxic agents and the clinical outcomes, diagnoses of allergy, caries and neurophysiological functions/dysfunctions.

Eligibility Criteria:
Inclusion Criteria:

* Born at Sunderby hospital, Region Norrbotten, during time period 2015-2018

Exclusion Criteria:

* Parents not able to speak or write Swedish
Diafert for Embryo Selection and Fertility Improvement (DESTINy)

Prospective, single-center, single-blind, randomized, controlled, two-arm, interventional study.


Eligibility Criteria:
Inclusion Criteria:

1. Women at least 18 years old at the time of Informed Consent.
2. Able to understand and voluntarily sign an Informed Consent form approved by the relevant Independent Ethics Committee (IEC) governing the site.
3. First or second fresh Assisted Reproductive Technology (ART) cycle attempt (since last successful implantation, if any).
4. Eligible for elective SET of fresh embryo on Day 2/3. Elective SET is defined as a transfer for which there is more than one embryo in the same morphological ("best") category as that of the selected embryo.

Exclusion Criteria:

1. Presence or history of ovarian endometriotic cyst.
2. Presence or history of diagnosed severe endometriosis (i.e. stage IV of the revised American Fertility Society classification for endometriosis).
3. Hormonal, functional, anatomical and/or other abnormalities potentially increasing the risk of miscarriage and/or ectopic pregnancy as judged by the Investigator and determined by medical history and clinical laboratory. This includes, but is not limited to, uncontrolled diabetes mellitus, uncontrolled thyroid disease, alcoholism, drug abuse, abnormal uterine cavity etc.
4. History of two or more consecutive miscarriages.
5. Known history of human immunodeficiency virus, Hepatitis C virus and/or Hepatitis B virus infection.
6. The subject has other serious or acute conditions that, in the Investigator's opinion, would preclude her participation in the study.
7. Need for preimplantation genetic diagnosis/screening.
8. Use of time-lapse embryo imaging
9. Participating in oocyte donation procedure.
10. Participation in any interventional drug clinical investigation within 2 months prior to screening.
11. Dependency on sponsor or investigator (e.g. co-worker or family member).
An Open-label Extension Study to Evaluate the Safety of the 13 mg Bimatoprost Ocular Insert

This study evaluated the long-term (9-months) safety of the Bimatoprost Ocular Insert in participants with Glaucoma or Ocular Hypertension who completed study FSV5-004. All the participants received Bimatoprost Ocular Insert and wore it for approximately 3 months (12 weeks), then had that Insert removed and a new Insert placed for another 26 weeks (approximately 6 months).


Eligibility Criteria:
Inclusion Criteria:

1. Completed FSV5-004 study.
2. Written informed consent prior to any study procedure.
3. Willingness to comply with the visit schedule.

Key Exclusion Criteria:

1. Participation in an investigational drug or device study other than FSV5-004 within the past 6 months or anticipated participation during the study period.
2. Subjects who will require contact lens use during the study period.
3. Any condition or situation (such as uncontrolled systemic disease) that, in the Investigator's opinion, might confound the results of the study, may put the subject at significant risk or might interfere with the subject's ability to participate in the study.
Glossopharyngeal Nerve Block for Post -Tonsillectomy Pain Relief

The aim of the present study is to evaluate the efficacy and safety of Ultra-sound guided submandibular parapharyngeal glossopharyngeal nerve block as regards time for first need of analgesic as a primary outcome as well as pain score, total postoperative analgesic requirement, and incidence of complications as secondary outcomes

Tonsillectomy is one of the most frequent surgical procedures performed all over the world that has been identified as being severely painful especially in the adult population. Management of post tonsillectomy pain is of paramount importance in order to improve swallowing and enhance oral intake as well as to decrease the risk of dehydration, infection and secondary hemorrhage with a subsequent hastening of recovery.

A variety of analgesic regimens have been implemented to alleviate post-tonsillectomy pain, however; no consensus on the ideal analgesic regimen has been yet identified.

The Ultrasound (US)-guided glossopharyngeal nerve (GPN) block has been acknowledged as a feasible option for providing perioperative analgesia in tonsillectomy patients. It blocks sensory impulses from the posterior third of the tongue, palatine tonsil, and mucous membranes of the mouth and pharynx. Conventional techniques for blocking the GPN carry the risk of vascular puncture, inadvertent block of closely adjacent other cranial nerves, with increased probability of local anesthetic toxicity and even upper airway obstruction. Recently, a novel, safe, and reproducible US-guided GPN block technique has been introduced by Azman et al, which would block the GPN distally, in the tissue plane just next to the pharyngeal wall and relatively far from high risk nearby structures.

Eligibility Criteria:
Inclusion Criteria:

* Patients classified by the American society of Anesthesiologists ASA I and II patients
* Scheduled for tonsillectomy procedure

Exclusion Criteria:

* Patients' refusal
* History of diabetes mellitus,
* Cardiac, liver or renal impairment
* Obstructive sleep apnea syndrome
* Swallowing difficulty
* Intake of chronic pain medications or substance abuse
* Bleeding disorders
* Hypersensitivity to the used medication
An Exploratory Study of the Effects of a Single Dose of QAX576 (an Interleukin-13 Monoclonal Antibody) on Simulated Hayfever

This study will investigate whether a single dose QAX576 (an interleukin-13 monoclonal antibody) gives protection against a model of hayfever


Eligibility Criteria:
Inclusion Criteria:

* History of allergic rhinitis.

Exclusion Criteria:

* Respiratory disease other than mild intermittent asthma.
* Received immunotherapy in past 3 years.
* History of clinically significant drug allergy.
* History of clinical schistosomiasis or travel within 6 months prior to or following study to an area with endemic schistosomiasis.
* History of exposure to human therapeutic antibodies, immunoglobulins or other plasma products.

Other protocol-defined inclusion/exclusion criteria may apply
Ocular Surface Disorders in Patients in Intensive Care Units, a Comparative Study of Three Preventive Approaches

60% of the patients hospitalized in intensive care and sedated suffer from insufficient inferior eyelid occlusion. Thus, they are at risk for corneal damage (estimated risk 20% to 57%). The prevention of such corneal damage can be done using several techniques (artificial tears, eyelid occlusion dressing, aqueous gel). The efficacy of these techniques has never been compared in a rigorous study. Therefore it is not yet possible to determine an evidence-based strategy to prevent corneal damage in intensive care patients.

This study aims at assessing the efficacy of primary prevention of corneal lesions in intensive care patients, in order to elaborate an evidence-based nursing protocol.


Eligibility Criteria:
Inclusion Criteria:

* adult patient
* hospitalized in an intensive care unit
* tracheal intubation and mechanical ventilation since less than 24 hours, with an expected duration of artificial ventilation superior to 72h

Exclusion Criteria:

* Patient currently treated by eyedrops for glaucoma
* antecedent of corneal transplant
* ocular prosthesis
Comparison Between 25 µg Vaginal Misoprostol vs Slow Release Pessary PGE2

For about 10% of pregnancies, it is necessary to induce delivery for medical reasons. Prostaglandins alone can be used to perform cervical ripening in cases of immature cervix. In France, dinoprostone is the own approved medication. It is in the form of gel or sustained release device whose effectiveness and side effects are comparable. The vaginal misoprostol has no marketing authorization in France, but is sometimes used. Some data in the scientific literature have showed that its use with low-dose (25 mcg) vaginally did not lead to more complications, was at least as effective and seems to be cost-effective compared with dinoprostone. Misoprostol with this dose and route of administration is now recommended by the American College of Obstetricians and Gynecologist (ACOG), Grade A (ACOG Practice Bulletin August 2009). This is not the case in France (French HAS 2008 Guidelines on induction of labor). According to HAS, the investigators still lack data on large samples to confirm the benefits of misoprostol 25 mcg vaginally, in terms of efficiency, rate of cesarean section, and lower cost compared to dinoprostone.

The primary objective is to demonstrate non-inferiority of vaginal misoprostol 25 mcg vs. dinoprostone in terms of cesarian section occurence with a non-inferiority margin of +5% difference.

To show if the experimental treatment (25μg of intravaginal misoprostol) used for induction of labor in singleton women ≥ 36 weeks gestation with an unfavorable cervix is not clinically and statistically inferior than the reference treatment , ie intravaginal dinoprostone sustained release (10mg), in terms of cesarian sectionto compare the cost-effectiveness and to assess the differential tolerance of the two strategies.

Non-inferiority will be demonstrated if the upper limit of the 90%-bilateral confidence interval of the difference between cesarian section rates (misoprostol - dinosprostone) is below 5% in the intention-to-treat analysis and the per-protocol analysis.

If non-inferiority is demonstrated, as a secondary analysis, superiority of misosprostol will be tested.

Orther secondary objectives are to assess the cost-effectiveness, the tolerance, maternal satisfaction and other efficacy endpoints of the two strategies.

Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancy
* Cephalic presentation
* Bishop ≤ 5
* ≤ 3 uterine contractions / 10 mn
* ≥ 36 weeks gestation
* Personally signed and dated informed consent document

Exclusion Criteria:

* History of cesarian-section
* uterine scar
* deceleration on Cardiotocogram (CTG)
* placenta praevia
* bleeding
* chorioamnionitis
* Fetal weight US ≥4500 g
* Contra-indication to vaginal delivery
* Hystory of myomectomy
* Herpes primoinfection or recurrence
* Allergy to prostaglandins