cyrilzakka/clinical-trials huggingface dataset:
Neuroscience of Marijuana Impaired Driving

Marijuana is one of the most widely used substances. However, marijuana intoxication is not fully understood in relation to driving. This study will help the investigators learn more about the potential impairments related to marijuana intoxicated driving. A combination of MRI and neuropsychological tests (which are computer and paper/pencil tasks) will be used to measure intoxication and impairment. This study will also assess levels of marijuana in blood and saliva samples. This study takes place in Hartford, Connecticut.

Cannabis is a commonly abused drug whose use cuts across social class, is linked to cognitive impairment, and may be a major contributor to intoxication-related accidents - either alone or with alcohol. However, cannabis intoxication is little studied in relation to driving compared to alcohol. Not only does the current NHTSA Strategic Plan for Behavioral Research prioritize understanding how drugs other than alcohol contribute to traffic crashes, it has recently become more pressing to understand the effects of cannabis because of increasing rates of legalized medical and/or recreational use, that will likely result in more cannabis intoxicated drivers. Social and legal policy will be unable to effectively address the many concerns about driving safety raised by more frequent and widespread use of cannabis without new research to better determine the parameters within which cannabis use does, or does not, increase automobile accident risk. The purpose of this study is to better describe specific, driving-related cognitive impairments caused by acute cannabis intoxication, their persistence over time, underlying functional brain anatomy, and relationship to performance on a state-of the art validated simulated driving task in which the investigators have prior experience. In a randomized, counterbalanced, double-blinded fashion, the investigators will administer two cannabis doses and placebo of smoked cannabis (paced inhalation using a vaporizer) to 48 regular cannabis users and 48 occasional cannabis users on 3 separate occasions. Following cannabis dosing cognitive and driving impairment will be assessed longitudinally for several hours using a combination of fMRI and neuropsychological tests, to clarify relationships between subjective and objective measures of intoxication and of impairment, that include expert assessment of THC and its metabolite levels in blood and saliva. This study takes place in Hartford, Connecticut.

Eligibility Criteria:
Inclusion Criteria:

* Must have a current driver's license
* Have used marijuana before
* Right handed

Exclusion Criteria:

* Females who are pregnant or breast feeding
* Unable or unsafe to have an MRI
* Any serious medical, or neurological disorder
* Any psychiatric disorder
* No major head traumas
A Prospective, Multicentre, Open-label Randomised Controlled Study to Investigate the Effectiveness of Pamidronate in the Prevention of Bone Loss in de Novo Renal Transplant Patients.

The purpose of the study was to evaluate the effect of Pamidronate on bone mineral density loss and fracture rates up to 2 years, in post renal-transplant subjects on a Ciclosporin A and glucocorticoid based immunosuppressive regimen.


Eligibility Criteria:
Inclusion Criteria:

1. First or second kidney transplant recipients, aged 18-75 years, PTH \> 150 pg/ml
2. De novo patients scheduled to receive ciclosporin A and prednisolone based immunosuppression.

Exclusion Criteria:

1. Previous or current bone disease unrelated to end stage renal failure.
2. Patients with PTH \< 150pg/ml who may be at risk of adynamic bone disease.
3. Treatment at any time with a bisphosphonate.
4. d. Calcitonin treatment during the previous month.
5. Malignancy (current or history within last 5 years)
6. Pregnancy or lactation, or women of childbearing potential unwilling to use an effective form of contraception for the 12 month duration of the study.

Protocol-defined inclusion/exclusion criteria may apply.
Intravenous Iron Isomaltoside Versus Oral Iron Supplementation for Treatment of Iron Deficiency in Pregnancy.

Intravenous iron isomaltoside versus oral iron supplementation for treatment of iron deficiency in pregnancy

Iron deficiency (ID) in pregnant women can cause iron deficiency anaemia (IDA). ID is defined by low iron stores, measured by a low level of s-ferritin. Iron is essential for the synthesis of haemoglobin (Hb). Anaemia is defined by a low Hb level (\<11.0 g/dL in 1st trimester, \<10.5 g/dL in 2nd, and \<10.5 - 11.0 g/dL in 3rd trimesters).

In Danish pregnant women, who do not take iron supplementation approximately 50 % have ID and 21 % have IDA. According to WHO anaemia, defined as Hb \<11.0 g/dL, regardless the cause is estimated to occur in 24 % of Danish pregnant women.

This trial is designed to evaluate and compare the effect of IV iron isomaltoside to a fixed dose of oral iron administered as tablet ferrous fumarate with ascorbic acid as correction of IDA in pregnant women after 4 weeks of standard treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Women aged ≥18 years
2. Pregnancy at GA 14+0 - 19+0
3. Ferritin \<30 μg/L after 4 weeks of standard treatment in a clinical setting
4. Willingness to participate and attend all planned follow-up visits, and signing the in-formed consent form

Exclusion Criteria:

1. History of anaemia caused by e.g. thalassemia, hypersplenism or haemolytic anaemia (known haematologic disorder other than iron deficiency)
2. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
3. Drug hypersensitivity (i.e. previous hypersensitivity to IV iron)
4. Known hypersensitivity to any excipients in the investigational drug products
5. History of active asthma within the last 5 years
6. History of multiple allergies
7. Known decompensated liver cirrhosis or active hepatitis
8. Active acute or chronic infections (assessed by clinical judgement)
9. Rheumatoid arthritis with symptoms or signs of active inflammation
10. Treated with IV iron products or blood transfusion within 4 weeks prior to inclusion
11. Treated with erythropoietin (EPO) within 4 weeks prior to inclusion
12. Participation in any other interventional trial where the trial drug has not passed 5 half-lives prior to inclusion
13. Any other medical condition that, in the opinion of the Investigator, may cause the subject to be unsuitable for the completion of the trial or place the subject at potential risk from being in the trial
14. Meeting RBC-transfusion criteria (Hb ≤6.9 g/dL= 4.3 mmol/L with intolerable symptoms of anaemia like severe palpitations, severe dizziness, shortness of breath at rest or syncope or an Hb ≤6.4 g/dL (4.0 mmol/L) without intolerable symptoms of anaemia)
15. Multiple pregnancies
16. Inability to read and understand the Danish language
Moxifloxacin i.v. in the Treatment of Complicated Intra-Abdominal Infection (cIAI)

This study is a local, prospective, open-label, company-sponsored, non interventional, multi-center study. Patients documented must suffer from a cIAI and take at least one dose of Moxifloxacin infusion.The primary objective is to define the types of cIAI infections that require Moxifloxacin i.v. therapy in China.


Eligibility Criteria:
Inclusion Criteria:

* Patients at least 18 years of age with a diagnosis of cIAI treated with Moxifloxacin infusion with/without sequential tablet treatment can be included into the study. The local Moxifloxacin product information must be considered.

Exclusion Criteria:

* Contraindications stated in the local Moxifloxacin product information. Warnings and precautions, stated in the local Moxifloxacin product information must be considered as potential exclusion criteria.
Nocturnal PtcCO2 Monitoring in Patients With Amyotrophic Lateral Sclerosis (ALS)

Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease affecting motoneurons, with a prevalence around 5/100.000. Respiratory muscle involvement is a major feature in ALS and remains the main prognostic factor. Timing and rate of progression of this respiratory muscle involvement is also highly variable among individuals.

Respiratory manifestations justify a careful follow up including clinical evaluation, pulmonary function tests and blood gases. Prognostic value of respiratory muscle assessment has been clearly demonstrated in ALS, although several cut off values have been published. The clinical benefit of non invasive ventilation (NIV) is well established in ALS, but the optimal criteria for its initiation remain debated .

The 1999 consensus for NIV selected classical criteria to consider NIV in patients with respiratory symptoms suggesting hypoventilation: daytime hypercapnia (PaCO2 \> 45 mmHg), nocturnal SaO2 \< 89 % more than 5 consecutive minutes and for progressive neuromuscular disorders (NMD) (mainly ALS), a vital capacity (VC) \< 50 % pred or a PImax \< 60 cmH2O.

Besides daytime clinical and PFT assessment, nocturnal evaluation is essential in ALS. The prevalence of sleep apnea ranges from 16 % to 76 %.

Transcutaneous PCO2 (tcPCO2) is an attractive technique to evaluate non invasively nocturnal hypoventilation. The technique is well validated in different settings. Its use in neuromuscular disorders (NMD) is recent. In particular one study has demonstrated a high predictive value of tcPCO2 for the development of daytime hypoventilation within 1 year. To our knowledge, this technique has not been specifically assessed in ALS. There is a potential role for nocturnal PtcCO2 monitoring in the close follow up of ALS patients. Indeed, a close respiratory follow up of ALS patients is essential to determine the optimal timing of NIV, avoiding the occurence of unexpected acute respiratory failure.


Eligibility Criteria:
Inclusion Criteria:

* Amyotrophic lateral sclerosis :definite, probable or probable with EMG (Airlie House Criteria, 1998).
* Forced vital capacity \>70% pred.
* Daytime PaCO2 \<43 mmHg.
* Venous HCO3- \<28 mmol/L

Exclusion Criteria:

* Patients unable to perform pulmonary function tests or nocturnal recordings.
* Coexisting significant lung disease: moderate to severe asthma or COPD
* Current NIV, CPAP or oxygen therapy.
Virtual Reality for Pain and Anxiety Distraction Strategy on Office Hysteroscopy

Hysteroscopy is a minimally invasive endoscopic technique that allows direct visualization of the uterine cavity and constitutes the gold standard for the diagnosis and treatment of most intrauterine pathology, such as heavy menstrual bleeding, fibroids, endometrial polyps, uterine malformations, etc. The "see and treat" strategy allows diagnosis and treatment in the same surgical act, and gives the technique a high resolution capacity, reducing the number of procedures the patient must undergo. The technological development of instruments has made it possible to have small-caliber endoscopic systems that have made this technique possible in an outpatient setting. Outpatient management allows patients to avoid the possible risks and inconveniences associated with the surgical environment, such as the waiting list and the need for anesthesia, as well as an earlier return to their activities of daily life. Despite the high resolution rates, a not inconsiderable percentage of women experience anxiety or pain during outpatient hysteroscopy, and this is the leading cause of treatment failure. In order to improve the tolerance and comfort of the patient, the usefulness of various strategies, both pharmacological and non-pharmacological, has been evaluated for pain reduction, with different results.

Virtual Reality (VR) has been used successfully to reduce perceived pain in various procedures such as chronic pain, burns, dental processes, chronic pruritus or venipuncture. There is no published study to our knowledge that evaluates the usefulness of VR in reducing the levels of anxiety and pain perceived during a hysteroscopic procedure.

The working hypothesis to be evaluated with this study is that the use of a VR device with reproduction of relaxing and distraction environments reduces the perception of pain and anxiety of the patient during an outpatient hysteroscopy.


Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years
* Understand and accept the study procedures
* Sign the informed consent.
* Indication of outpatient hysteroscopy according to the care protocols of the center
* Not taking drugs for the treatment of anxiety.

Exclusion Criteria:

* Not being able to understand the nature of the study and / or the procedures to be followed
* Not signing the informed consent
* Be under the age of 18
* Pregnancy
* Being diagnosed with anxiety disorder or being treated with anxiolytics
* Patients suffering from vertigo
* Patients with epilepsy
* Active ear infection
* Patients with diagnosed hypertension
* Patients with cardiovascular disease
* Patients with psychosis or severe mental illness
A Study of Grazoprevir (MK-5172) in Hepatitis C-Infected Male Participants (MK-5172-004)

This multiple dose study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of grazoprevir (MK-5172) in Genotype (GT) 1 and GT3 Hepatitis C virus (HCV)- infected participants. The primary hypothesis is that administration of grazoprevir for 7 days is sufficiently safe and well tolerated in HCV-infected males.


Eligibility Criteria:
Inclusion Criteria:

* Baseline health is stable.
* Has a clinical diagnosis of chronic HCV infection.

Exclusion Criteria:

* Has a history of stroke or chronic seizures.
* Has a history of cancer.
* Has a history of human immunodeficiency virus (HIV) infection.
* Has had major surgery, donated blood or participated in another investigational study within the past 3 months.
Vaginal Fluid Collection for Detection of Endometrial Cancer

The primary objective of this study is to obtain de-identified vaginal fluid specimens from participants with an endometrial tissue biopsy-based histopathological diagnosis of endometrial cancer (EC), endometrial hyperplasia (AEH) with atypia or endometrial intraepithelial neoplasia (EIN).

The samples will be used for the purpose of research and development of a new molecular diagnostic test for the detection of EC, AEH and EIN.

For participants providing written informed consent to participate in the study, samples of vaginal fluid will be obtained by the Principal Investigator (PI) during a pelvic examination. All vaginal fluid samples will be collected ≥7 days after the endometrial biopsy and prior to initiating any therapeutic interventions including surgery, chemotherapy, radiation or hormonal therapy PIs will be provided with multiple, individually packaged Copan eNat® sterile sample collection kits including a swab and a transport tube containing a stabilizer and preservative medium as well as a pre-addressed shipping container and single-use tubes of sterile saline solution After vaginal fluid sample collection, the swab will be inserted into the tube for storage and subsequent shipping to the Sponsor's designated laboratory. The samples can be stored at ambient temperature and should be shipped to the designated laboratory within 24 hours of collection. Site(s) will provide the Sponsor with de-identified endometrial biopsy histopathology report and post-surgery histopathology report (if any) confirming the histopathological diagnosis of EC, AEH or EIN. The final diagnosis will be based on the most severe clinical histopathology (at diagnostic endometrial sampling or surgery.)

Eligibility Criteria:
Inclusion Criteria:

1. Women ≥18 years of age.
2. Women with endometrial tissue biopsy-based histopathological diagnosis of EC (any histology, including uterine carcinosarcoma), AEH or EIN.
3. Women whose planned surgical intervention (if any) includes hysterectomy, D\&C, or hysteroscopic resection.
4. Participant understands the study procedures and can provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

   -

Exclusion Criteria:

1. Patient with recurrent and/or previously treated EC.
2. Receipt of preoperative neoadjuvant chemotherapy or radiotherapy for current EC diagnosis prior to study enrollment.
3. Prior hysterectomy.
4. Current known pregnancy diagnosis.
5. Prior or current biopsy and histopathology-proven cervical cancer.
6. The presence of concomitant biopsy and histopathology-proven cervical dysplasia.
7. Any prior pelvic or vaginal radiotherapy.
8. Any current or prior cancer diagnosis (except basal cell or squamous cell skin cancer, non-gyn) within the past 5 years.
9. Chemotherapy within the past 5 years.
10. Prior intervention to treat, or surgery with intent to completely remove, the target pathology for the current diagnosis during the current episode.
Effects and Interactions of Liquorice and Grapefruit on Glucocorticoid Replacement Therapy in Addison's Disease

Addison's disease is a rare disease, wherein the adrenals can not produce sufficient steroid hormones (cortisol and aldosterone). Patients with Addison's disease report impaired subjective health status, and they have increased all-cause mortality. Conventional therapy is by oral replacement of glucocorticoid and mineralocorticoid hormones, but this strategy imperfectly mimic the diurnal cortisol variations, and render the patients both over- and under-treated. Anecdotally, some patients with adrenal insufficiency may benefit from the use of various nutritional compounds. We hypothesised that liquorice and grapefruit altered the metabolism and absorption of cortisone acetate.

In the present study, cortisone acetate absorption and metabolism are assessed in subjects with Addison's disease on three occasions. On the first occasion, the subjects are on their regular diet, but avoid ingestion of grapefruit and liquorice. At the end of the baseline assessment the order of the nutritional compounds (liquorice-grapefruit juice or grapefruit juice-liquorice) to be investigated in the next two assessments are randomised.

On the two next occasions, the absorption and metabolism of cortisone acetate is studied when study subjects consume liquorice and grapefruit juice. Between the use of grapefruit and liquorice there is a wash out period of at least 3 weeks.

For studies on liquorice effects, the subjects ingest 24-gram liquorice per day (equivalent of 150-mg glycyrrhizinic acid per day). For studies on grapefruit juice effects, subjects drink 200-ml grapefruit juice three times a day for three days. They maintain their regular medication and usual diet.

Time-series of cortisol and cortisone are obtained in serum and saliva samples on the third day of liquorice/grapefruit juice use. 24-hour urine is also collected.

Measurements of cortisol and metabolites in serum and saliva are used to calculate pharmacokinetical parameters. The measurements from samples obtained when using the investigated nutritional compounds are compared to the baseline assessment in each subject. Metabolites in 24-hour urine are compared similarly to investigate changes in urinary excretion, and to estimate the activity of enzymes involved in the metabolism of cortisol (5alfa-reductase, 5beta-reductase, cytochrome P450 3A4 system, 11-beta hydroxysteroid dehydrogenase).

Eligibility Criteria:
Inclusion Criteria:

* Verified diagnosis of adrenal insufficiency (Addison's disease)
* Stable cortisone acetate replacement therapy
* Written informed consent

Exclusion Criteria:

* Malignant disease
* Pharmacological treatment with other glucocorticoids
* Pregnancy
* Current minor disease (ie the flu)
* Major disease or accident requiring hospitalization the last three months
* Use of grapefruit juice or liquorice the last two weeks before study start
* Blood pressure above 150mmHg systolic or 90 mmHg diastolic.
Functional MR Lung Imaging Using Hyperpolarised 129Xe

The aim of this study is to investigate the potential value of a novel imaging technique (hyperpolarized 129Xe lung imaging) in the diagnosis and assessment of lung disease in patients with COPD and IPF.


Eligibility Criteria:
General Inclusion criteria

* Male or Female aged over 18 years.
* Capacity to give informed consent
* Normal blood pressure (systolic BP \> 100 mmHg and diastolic BP \> 70 mmHg)
* Resting heart rate \> 50 bpm
* For women, negative urinary β-hCG at the screening and subsequent visits
* Subject able to hold breath for 10 seconds
* Subject able to fit into 129Xe chest coil used for MRI
* Subject able to understand the requirements of the study and to cooperate with the study procedures

Inclusion criteria

HEALTHY VOLUNTEERS

• No significant respiratory disease within the last year

PATIENTS

COPD

* Evidence of airflow obstruction (FEV/FVC \<0.7) and FEV1 \<80% predicted post bronchodilator
* Minimum FVC 1.5L

Exclusion criteria

HEALTHY VOLUNTEERS

* Unsuitable for MRI scanning (e.g. have metal implants or pacemaker or contraindicated following questionnaire)
* Acute respiratory illness within 30 days of MRI
* Subject has received an IMP (not including hyperpolarized 129Xe) within 30 days of MRI and administration of 129Xe deemed inappropriate in context of other study
* Subject deemed unlikely to comply with instructions during imaging
* Do not meet the inclusion criteria above
* Subject not deemed fit enough to tolerate procedure
* Subject deemed unsuitable by clinical investigator for other reasons

PATIENTS

* Unsuitable for MRI scanning (e.g. have metal implants or pacemaker or contraindicated following questionnaire)
* Acute respiratory illness within 30 days of MRI
* Subject has received an IMP (not including hyperpolarized 129Xe) within 30 days of MRI and administration of 129Xe deemed inappropriate in context of other study
* Subject deemed unlikely to comply with instructions during imaging
* Do not meet the inclusion criteria above
* Subject not deemed fit enough to tolerate procedure
* Subject deemed unsuitable by clinical investigator for other reasons
Pilot: Digital Therapeutic vs Education for the Management of Problematic Substance Use

Prior to launching a randomized controlled trial, this pilot study will investigate the feasibility and acceptability of the administration of a diagnostic interview and collection of a biomarker test, as well as engagement and preliminary efficacy with W-SUDs and the education arm, among a sample of adults who screen positive for problematic substance use.


Eligibility Criteria:
Inclusion Criteria:

1. Have a smartphone
2. Endorse a substance use concern
3. Be between 18 and 65 years of age
4. Be available and committed to engage with the Woebot app
5. Be literate in English.(This is required for inclusion because all materials will be in English).

Exclusion Criteria:

1. Pregnancy (as W-SUDs will not be specifically developed to address the unique needs of this population)
2. Suicide attempt within the past year (12 months)
3. Symptoms of severe drug/alcohol history: History of delirium tremens; Experiencing hypertension, drenching sweats, seizures or confusion after stopping alcohol or drugs; Liver trouble (cirrhosis or hepatitis); Convulsions or GI bleeding due to drug/alcohol use
4. Opioid overdose within the past year (12 months)
5. Opioid misuse without medication-assisted treatment
6. Not residing in the U.S.
7. Ever used Woebot
Effect of Probiotics in Reducing Infections and Allergies in Young Children During the Complementary Feeding Period

The aim of the intervention is to examine the effect of the bacterial strain BB-12, provided for 6 mo, on the prevalence of infections and allergic manifestations in small children, and how BB-12 affects the immune system, the gastrointestinal tract and the microbiota. Children are enrolled during 2 winter seasons.


Eligibility Criteria:
Inclusion Criteria:

* 9 - 12 1/2 month at intervention start
* Start in daycare 4 +/- 2 weeks after intervention start
* Single born

Exclusion Criteria:

* Children born before 37th gestational week
* Children with a birth weight \< 2500 g
* Children suffering from severe chronic illness
* Children receiving regular medication
* Children who have received antibiotics within a month before intervention start
* Children whose parents do not speak Danish