cyrilzakka/clinical-trials huggingface dataset:
High Potency Cannabis: Acute and Protracted Effects

The purpose of this research is to assess the effects of smoked cananbis when cannabis is smoked during periods of cannabis use as usual and after a brief period of abstinence.

This outpatient study will assess the acute pharmacodynamic effects of smoked cannabis with \~50 mg and \~100 mg THC compared to placebo (\~0 mg THC) and whether a brief period of abstinence alters these effects. Metabolism (pharmacokinetics) of THC will be examined to associate behavioral and physiological effects to plasma concentrations of THC and metabolites.

Eligibility Criteria:
Inclusion Criteria:

* • Male or non-pregnant and non-lactating females aged 21-55 years

  * Report cannabis smoking near daily
  * Not currently seeking treatment for their cannabis use
  * Have a Body Mass Index from 18.5 - 34kg/m2.
  * Able to perform all study procedures
  * Must be using a contraceptive (hormonal or barrier methods)

Exclusion Criteria:

* Meeting DSM-V criteria for any substance use disorder other than cannabis, nicotine, caffeine
* Do not have positive urine toxicology for cannabis use during screening
* Evidence of severe psychiatric illness (e.g. mood or anxiety disorder with functional impairment or suicide risk, schizophrenia) judged by the study physician (and PI) to put the participant at greater risk of experiencing adverse events due to completion of study procedures, interfere with their ability to participate in the study, or their capacity to provide informed consent.
* Report using other illicit drugs in the prior 4 weeks
* Current predominant licit use of medical cannabis, prescription analgesics, or any medications that may affect study outcomes
* Current pain
* Pregnancy
* Currently enrolled in another research protocol
* Not using a contraceptive method (hormonal or barrier methods)
* Insensitivity to the cold water stimulus of the Cold Pressor Test
* Any disorders that might make cannabis administration hazardous as determined by evaluation physician after review of all medical assessments along with medical history.
* Not able to speak and read English
Fertility Preservation for Transfeminine Adolescents Via Semen Cryopreservation or Testicular Sperm Extraction

The goal of this observational cohort study is to identify and predict parameters for successful testicular sperm extraction (TESE) procedures or semen cryopreservation more accurately and to evaluate the decision making process and the experience of postponing or temporarily discontinuing puberty suppression to undergo successful fertility preservation. in transfeminine (assigned male at birth) adolescents. The main question\[s\] it aims to answer are:

* What is the optimal timing for fertility preservation before the start or after temporarily discontinuing puberty suppression puberty suppression
* How do transfeminine adolescents and their parents experience the decision making process of fertility preservation
* how do transfeminine adolescents and their parents experienced postponing or temporarily discontinuing puberty suppression to undergo successful fertility preservation?

Participants will be asked to use their medical data, answer a questionnaire or participate in a (online) interview.


Eligibility Criteria:
Inclusion Criteria:

* Before start of puberty suppresion with a wish for fertility preservation
* After discontinuing puberty suppersion before the start of hormone therapy

Exclusion Criteria:

* Tanner stage \> 4/5
Fetal Renal Artery Doppler in Patients With Preeclampsia

Preeclampsia is a major devastating disorder affects 2:10% of pregnancies worldwide. preeclampsia may be associated with placental insufficiency which may cause fetal blood redistribution to essential organs like brain, heart, kidney.

Preeclampsia is a major devastating medical condition that affects pregnant women after 20 weeks of pregnancy. It affects 2:10% of pregnancies worldwide according to World Health Organisation with higher incidence in developing countries.

Vascular endothelial dysfunction due to abnormal placentation is believed to be the main cause of multi-organ failure and uteroplacental insufficiency that occur in preeclampsia leading to major adverse effects in both mother and fetus.

Placental insufficiency causes a redistribution of fetal blood to essential organs ; brain, heart and adrenal glands by decreasing their vascular resistance on expense of peripheral organs such as kidney which exhibit increased vascular resistance and impaired perfusion. This is in contrast to normal pregnancies near term in which renal vascular resistance falls and increased blood flow to the kidneys is observed. Doppler ultrasound examination of vasculature of selected organs such as kidneys may have a role in detection of hemodynamic rearrangements that occur in cases of placental insufficiency and preeclampsia.

Eligibility Criteria:
Inclusion Criteria:

* a) Preeclampsia:

  * Women with preeclampsia \>28 weeks of pregnancy.
  * Singleton pregnancy.
  * Women with intrauterine growth restriction and abnormal amniotic fluid volume to simulate real world data.

    b) Control:
  * Women with healthy pregnancy matched by closest gestational age.

Exclusion Criteria:

* ● Multiple pregnancy.

  * Known Congenital fetal malformations.
  * Women with other comorbidity such as ischemic heart disease, DM, Autoimmune disorders, kidney disease, neurological disorders, liver or haematological disorders.
  * Women unable to provide informed consent.
  * Women who refuse to participate
Effect of Levodopa on Postural Motor Learning in Parkinson Disease

The primary goal of this project is to gain a better understanding of whether and how levodopa (a common anti-Parkinson disease medication) alters postural motor learning in people with Parkinson disease. A secondary goal is to assess whether motor cortical excitability, measured via Transcranial magnetic stimulation, is related to postural motor learning.

Participants with Parkinson disease will complete between 50 and 100 postural perturbations (via support surface translations), ON and OFF their dopamine replacement therapy (i.e. levodopa). Adaptation of responses to these perturbations will be tracked. Participants will also undergo transcranial magnetic stimulation to capture cortical excitability of the brain (in particular the motor cortex). Cortical excitability will be correlated to adaptation of stepping (i.e. postural motor learning) ON and OFF levodopa. Investigators will also capture postural motor learning and cortical excitability in age-matched healthy adults.

Investigators hypothesize that dopamine will have a negative effect on postural motor learning, and the cortical excitability will be correlated to postural motor learning.


Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 90 years of age.
* Individuals with Parkinson Disease
* Healthy adults age-matched to PD participants
* Participants with PD will be currently taking dopamine replacement (i.e. Levodopa)

Exclusion Criteria:

All subjects exclusion criteria:

* Deep brain stimulation
* Recent (within 6 months) orthopedic injuries influencing standing or balance
* Inability to stand independently

Transcranial magnetic stimulation exclusion criteria (for the subset of individuals taking part in the Transcranial Magnetic Stimulation portion of the study):

* History of epilepsy or currently taking any epileptic medication,
* History of seizures
* Family history of epilepsy or seizures
A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough (CALM-2)

This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of BLU-5937 in participants with Refractory Chronic Cough (RCC).

The primary efficacy objective is to assess the effect of BLU-5937 on 24-hour cough frequency in adults with refractory chronic cough (including unexplained chronic cough) at 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Capable of giving signed informed consent
* Refractory chronic cough (including unexplained chronic cough) for at least one year
* Women of child-bearing potential must use a highly effective contraception method during the study and for at least 14 days after the last dose

Exclusion Criteria:

* Current smoker/vaper (all forms of smoking and inhaled substances, including , cannabis/tobacco smoke and nicotine vapors) or individuals who have given up smoking within the past 6 months, or those with \>20 pack-year smoking history
* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, idiopathic pulmonary fibrosis or uncontrolled asthma
* Respiratory tract infection within 4 weeks before screening
* Laboratory confirmed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection at screening
* History of malignancy in the last 5 years
* History of alcohol or drug abuse within the last 3 years
* Has a positive serologic test for human immunodeficiency virus (HIV), hepatitis B virus surface antigen, or hepatitis C virus.
* Previous participation in a BLU-5937 trial
Using Multimedia Approaches to Communicate Probabilities in Patient Decision Aids for Low-Literacy Populations: Randomized Trial

The goal of this research study is to compare how people who are 45-75 years old respond to 3 different versions of a program about screening tests for colorectal cancer. Researchers want to use this study as part of a long-term project to learn the best ways to communicate health information to patients.

If you agree to take part in this study, you will be randomly assigned (as in a roll of dice) to 1 of 3 study groups. Neither you nor the study staff will be able to choose which group you will be in:

* If you are in Group 1, you will read a booklet about colorectal cancer screening tests. While reading the booklet, you will also listen to an audio CD that will narrate the booklet.
* If you are in Group 2, you will watch a video with non-moving images about colorectal cancer screening tests on an iPad.
* If you are in Group 3, you will watch a video with animated images about colorectal cancer screening tests on an iPad.

You will complete questionnaires before and after viewing the program that will contain questions about:

* Your age and what language you speak
* Your math and reading comprehension
* Your knowledge of colorectal cancer and colorectal cancer screening
* Your thoughts about colorectal cancer screening
* Your opinions about this study, and
* How well you understand the booklet/video you view as part of this study

It will take about 1 hour to complete all the questionnaires. In total, the study will take about 1 ½ to 2 hours to complete. After you have completed the questionnaires, your participation in the study will be over.

This is an investigational study.

Up to 201 people will take part in this multicenter study. Up to 67 will be enrolled at MD Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women 45 to 75 years of age.
2. Participant must speak English.

Exclusion Criteria:

1) Self-reported diagnosis of colon cancer.
Re³ (Re-Cube: Retain Remicade® Response)(Study P04249AM3)

This Phase IIIb, randomized, multi-national, multi-center, blinded study of Infliximab (IFX) in subjects aged 18 and older with active RA is being conducted to assess whether increasing either the infusion dose or infusion frequency in patients presenting with a disease flare after an initial response to infliximab results in a significant improvement in disease activity.

Subjects responding to an initial infliximab treatment regimen, who flare during continuation of treatment at 3 mg/kg administered every 8 weeks, will be randomly assigned to one of 3 different dosing regimens of infliximab and will be treated for 4 or 5 consecutive infusions for a total duration of 24 weeks. The infliximab control group and the infliximab increased dose group are evaluator and subject-blinded. The increased frequency group is not blinded. Clinical assessments of disease activity will be based the European League Against Rheumatism (EULAR) criteria for response. Safety parameters will be assessed at every infusion.

A disease flare is defined by an increase in DAS28 with 0.6 or more at screening, when compared to the DAS28 score measured immediately prior to the last Remicade® infusion and depends upon the actual score as well. Since prior to enrollment, the subject received Remicade® as per routine clinical practice, the days on which infusions were administered and assessments are done during the induction period do not have to be exactly at Week 2, 6 and 14.

* Drug: Infliximab Control (double-blinded)
* Drug: Infliximab Increased Dose (double-blinded)
* Drug: Infliximab Increased Frequency (open-label)


Eligibility Criteria:
Inclusion Criteria:

* aged 18 years or more
* with RA according to ACR criteria
* presented with a disease flare after initial response to infliximab, with both response and flare being defined using the DAS28 score (EULAR criteria)
* received the standard Remicade® dosing schedule per the EU label (3 mg/kg at Weeks 0, 2, 6, \[and 14\])
* an initial response documented by moderate or good DAS28 improvement (EULAR criteria) from Week 0 to Week 6 or 14.

Exclusion Criteria:

* a female who is, or intends to become, pregnant during or within 6 months of the end of the study, is nursing or not using adequate contraceptive measures
* has not observed the designated periods for concomitant medications
* used any investigational medical product within 30 days prior to Baseline
* any clinically significant deviation from normal in the physical examination or chest X-ray that in the investigator's judgment, may interfere with the study evaluation or affect subject safety
* rheumatic disease other than RA or has any systemic inflammatory condition with signs and symptoms that might confound the evaluations of safety and toxicity
* allergic reaction/sensitivity to the study drug or its excipients that requires corticosteroid pre-infusion medication.
Study Evaluating the Safety and Efficacy of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV

The primary objective of this study is to evaluate the efficacy of oral weekly islatravir (ISL) in combination with lenacapavir (LEN) in virologically suppressed people with HIV (PWH) at Week 24.


Eligibility Criteria:
Key Inclusion Criteria:

* Received bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) for ≥ 24 weeks at screening.
* Documented plasma human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) \< 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL) for ≥ 24 weeks before and at screening.
* Plasma HIV-1 RNA \< 50 copies/mL at screening.

Key Exclusion Criteria:

* History of prior virologic failure while receiving treatment for HIV-1.
* Prior use of, or exposure to, islatravir (ISL) or lenacapavir (LEN).
* Active, serious infections requiring parenteral therapy \< 30 days before randomization.
* Active or occult hepatitis B virus (HBV) coinfection, defined as hepatitis B core antibody (HBcAb) positive, hepatitis B surface antigen (HBsAg) positive, or HBV deoxyribonucleic acid (DNA) positive as determined by the central laboratory.
* Active hepatitis C virus (HCV) coinfection, defined as detectable HCV RNA.
* Any of the following laboratory values at screening:

  * Creatinine clearance (CLcr) ≤ 30 mL/min according to the Cockcroft-Gault formula
* CD4+ T-cells \< 200 cells/mm\^3 (Cohort 1); CD4+ T-cells \< 350 cells/mm\^3 (cohort 2).
* Absolute lymphocyte count \< 900 cells/mm\^3 (cohort 2).
* Individuals of childbearing potential (as defined in protocol) who have a positive serum pregnancy test at screening or positive urine and serum pregnancy tests at Day 1 prior to study drug administration.
* Individuals who plan to continue breastfeeding during the study.
* Documented historical or screening resistance reports showing nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) or non-nucleoside/nucleotide reverse transcriptase inhibitors (NNRTIs) resistance mutations in reverse transcriptase, including M184V/I (Cohort 2).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Effect of tDCS on Inflammatory Biomarkers in Chronic Schizophrenia

The study is a randomized, double-blind, parallel-arm, sham-controlled trial that aims to compare the effects of transcranial direct current stimulation (tDCS) versus sham stimulation on inflammatory markers (IL-6 and TNF-alpha) and clinical outcomes (PANSS, AHRS, CGI-SCH, GAF) in patients with chronic schizophrenia over 10 days of treatment. The primary objective is to assess changes in IL-6 levels, while secondary objectives include evaluating changes in TNF-alpha, symptom scales, and adverse events. The study will be conducted at the psychiatry department of AIIMS Bhubaneswar, with 60 patients aged 18-60 years with moderate-to-severe schizophrenia symptoms randomized to receive either active tDCS (cathode over left temporo-parietal junction, anode over left dorsolateral prefrontal cortex) or sham stimulation. The researchers hope to elucidate the potential immunomodulatory effects of tDCS and its impact on symptoms in chronic schizophrenia, which may lead to more targeted, multifaceted interventions to improve patient outcomes.


Eligibility Criteria:
Inclusion Criteria:

- 1. Patients clinically diagnosed with schizophrenia (F20 according to ICD-11) for a period more than 2 years receiving antipsychotics.

2. Moderate to severe symptoms (PANSS score \>75 and/or CGI-SGH score \>4) 3. Patients of both sex 18-60 years 4. Right-handed. 5. Legally authorized representative (LAR) giving voluntary written consent for participation in the study.

Exclusion Criteria:

* 1. Patients with chance of pregnancy. 2. Any psychiatric emergency (e.g. suicidal risk, catatonia, prolonged nutritional deprivation) or others (e.g.: aggression or excitement) 3. Co-morbid neurological disease: i) History of migraine. ii) History of seizure/epilepsy. iii) History of head trauma or organic disease.

  4. Any contraindication to tDCS procedure: i) Injury or local lesion in the scalp/head ii) Metallic implants in the head iii) Implanted brain medical devices 5. Left-handed.
Effects of Berries and Vegetables on Cardiometabolic Risk Markers and Cognitive Functions

The purpose of the study is to study the potential anti-inflammatory- and metabolic effects of polyphenols and dietary fibres in a product based on a mixture of several Swedish berries and vegetables that is known to have high amounts of polyphenols and other anit-oxidants. In addition the purpose is to investigate the effects on cognitive functions of the berry product.

The metabolic syndrome (MetS) includes a cluster of dysfunctions that identifies subjects at risk of developing type-2 diabetes and cardiovascular disease (CVD). A key feature appears to be chronic increased inflammation and activation of the innate system. Consequently, increased low-grade inflammation has been connected to adverse effects on insulin sensitivity, glucose- and lipid metabolism, and blood pressure, and circulating markers of inflammation such as IL-6. A growing body of evidence also link low-grade inflammation to poorer cognitive functioning. Type 2 diabetes, MetS, and glucose intolerance are increasingly being associated with impaired cognition.

Dietary patterns which promote sub-clinical inflammation are increasingly being considered predictive of future risk of CVD and type-2 diabetes. There is a growing insight regarding the role of the colonic micro flora in metabolic regulation and development of low-grade inflammation and obesity. The metabolic cross talk between the colon and peripheral tissues, especially adipose tissue, has been suggested to be regulated through colonic fermentation of indigestible carbohydrates e.g. dietary fibres (DF) and resistant starch. In addition, epidemiological data shows that a high consumption of vegetables and fruits is associated with a lowered risk of cancer and cardiovascular disease, which may be due to the high concentrations of polyphenols or other anti-oxidants that are found in such foods. In addition vegetables and berries are rich in dietary fibres with the potential to beneficially modulate the gut micro flora which may have implication on metabolic risk factors.

In the presently described project it is hypothesized that 5 w daily consumption of a food product containing berries and vegetables can improve metabolic risk variables and cognitive functions. The purpose is therefore to study the potential anti-inflammatory- and metabolic effects, and prebiotic properties, of a food product based on a mixture of several Swedish berries and vegetables that is known to be rich in dietary fibres, polyphenols and other anti-oxidants. In addition the purpose is to investigate the effects on cognitive functions of the food product.

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects

Exclusion Criteria:

* fasting plasma glucose \>6.1
* known cognitive decline
* other medications than for treatment of hypertension or hypothyroidism known gastro- intestinal problems
The CArdiac Imaging RegistrY Study

In this prospective longitudinal observational investigator-led single centre cohort study we will include patients undergoing cardio-CT for clinical reasons, to evaluate the role of cardio-CT terms of its diagnostic and prognostic value, as well as risk-benefit ratio.

Particular aims include:

1. To determine the prevalence of CAD for age, gender, ethnicity relative to established risk models
2. To determine associations between CAD severity and plaque type and:

   1. with traditional risk factors (arterial hypertension, diabetes, hypercholesterolemia, smoking)
   2. blood markers of increased cardiovascular risk
3. To determine predictive associations of between CAD with outcome (endpoint definitions in appendix)
4. To determine the risk-benefit ratio (number of subsequent interventions, complications, radiation exposure, late onset of cancer diseases, etc).

Particular aims include:

1. To determine the prevalence of CAD for age, gender, ethnicity relative to established risk models
2. To determine associations between CAD severity and plaque type and:

   1. with traditional risk factors (arterial hypertension, diabetes, hypercholesterolemia, smoking)
   2. blood markers of increased cardiovascular risk
3. To determine predictive associations of between CAD with outcome (endpoint definitions in appendix)
4. To determine the risk-benefit ratio (number of subsequent interventions, complications, radiation exposure, late onset of cancer diseases, etc).

Eligibility Criteria:
Inclusion Criteria:

1. Adults (=/\>18 years of age)
2. Able to provide informed consent
3. Clinical indication for cardio-CT in line with the latest clinical guidelines

Exclusion Criteria:

1. standard contraindications to CT (in line with local roles and guidelines - please see Appendix)
2. known allergy to iodinated contrast agent
3. suspected acute kidney injury
4. unstable hemodynamic status or arrhythmias
5. suspected acute coronary syndrome
6. manifest thyrotoxicosis