cyrilzakka/clinical-trials huggingface dataset:
Interaction Between Early Trauma and Odor-induced Dopamine Release

This prospective, double-blind, parallel-group controlled trial aims to investigate the consequence of early trauma on dopamine release evoked by positive valence odors.

The occurrence of early trauma has been linked to alterations in the development of emotion regulation circuits and functional brain connectivity (particularly in the dorsolateral prefrontal cortex - DLPFC), the dopaminergic response to stress and an alteration in hedonicity (including olfactory hedonicity), which can lead to the onset of psychiatric disorders such as anxiety or depression.

However, few studies have investigated the influence of early trauma on the release of dopamine (DA) evoked by odors with a positive emotional valence. Yet hedonicity is a key component of olfaction, as a positive odor leads to reinforced behavior in areas such as food intake and social interaction. This reinforcement process is thought to be underpinned by the very close link between the olfactory system (olfactory tubercle), the emotional regulation system (DLPFC) and the reward system (striatum), including the release of DA.

The aim of the study is to investigate the influence of early trauma on DAergic transmission evoked by odorants with a positive emotional valence.

To this end, 30 participants will be recruited and divided into two groups: those with early trauma and those without, according to their score on the Childhood Trauma Questionnaire. They will undergo an MRI-PET scan during which they will be exposed to pleasant odors. Subcortical dopaminergic transmission will be analyzed using the PET activity of \[11C\]Raclopride (a D2 receptor antagonist).

Investigators hypothesize that early trauma resulting in abnormal cortico-subcortical and cortico-cortical connectivity would lead to a deficit in the hedonic appreciation of a pleasant odor, associated with a reduction in DAergic reactivity evoked in the reward system.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Have been selected based on the Childhood Trauma Questionnaire score
* Non-smoker
* Be able to speak and read French
* Sign a consent form before intervention.

Exclusion Criteria:

* A pre-existing condition that affects olfaction including congenital anosmia, upper respiratory tract infection, nasal and/or sinus disease,
* Be on medication, with the exception of oral contraceptives
* Pregnant or breast-feeding woman (check with urine pregnancy tests);
* Contraindications to TMS or MRI (implanted medical devices or metallic foreign body in the head);
* Psychiatric disorders
* Use of psychotropic drugs
* Have participated in a study involving the injection of a radiotracer during the year
The Pulmonary Protection Trial

The purpose of this study is to investigate whether patients with a preoperative reduced pulmonary function have a better preserved oxygenation capacity after open heart surgery, using either pulmonary perfusion or pulmoplegia compared with TAVI and the control-group with standard ECC (Extra Corporal Circulation).


Eligibility Criteria:
Inclusion Criteria:

1. Planned and urgent surgery on legally competent patients over 18 years:

   * Coronary Artery Bypass Graft Surgery
   * Aortic Valve Replacement
   * Coronary Artery Bypass Graft Surgery + Aortic Valve Replacement
   * Transcatheter Aortic-Valve Implantation
2. Spirometry FEV1 measurement show less than or equal to 80% of the anticipated. We expect that these patients provide the largest signal with lung protective interventions in relation to lung healthy patients.

Exclusion Criteria:

* Previous surgery on the heart or lungs
* Previous thoracic irradiation
* Preoperative heart failure (ejection fraction below 20%).
* Surgical demanding mitral regurgitation
* Unstable patients (heart rate above 100 and systolic blood pressure below 100 mmHg)
* Intubated patients
* Patients with an ongoing preoperative treatment with antibiotics for suspected pneumonia.
* Patients with renal insufficiency requiring hemodialysis
* Pregnant and lactating
A Trial of the Fatty Acid Amide Hydrolase Inhibitor Palmitoylethanolamide in Bipolar Depression

The purpose of this study is to o evaluate the antidepressant efficacy of the PEA in Bipolar Depression and the association between antidepressant response with endogenous cannabinoids and cytokine levels


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Bipolar Disorder according to the Diagnostic and Statistical Manual of Mental Disorders (Structured Clinical Interview), Fifth Edition, (DSM5), with a score of ≥16 on the 17-item HAM-D
* currently in use of at least one FDA approved mood stabilizer with or without antidepressant
* medically and neurologically healthy on the basis of medical history, physical examination

Exclusion Criteria:

* Cannabis misuse according to clinical judgement
* unstable medical condition or uncontrolled medical problem with known central nervous system (CNS) effects
* active DSM-5 substance use disorder in past three months (other than alcohol or nicotine use disorder)
* acute high suicidal risk
* in a manic episode
* current psychotic features or cognitive impairment that would preclude understanding of the consenting process or tests/examination
* pregnant or nursing women
* unstable medical conditions
* clinically significant abnormal laboratory tests based on complete blood count, liver and kidney function when available
Efficacy and Tolerability of Buscopan Plus in Painful Gastric or Intestinal Spasms

Study to evaluate efficacy and tolerability of Buscopan® plus versus Buscopan®, paracetamol, and placebo in patients with painful gastric or intestinal spasms.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients
* Age: 18 - 70 years
* Diagnosis: recurring painful gastric or intestinal spasms such as occur e.g. in irritable bowel syndrome, which are not organic in origin, have been present for at least 2 months, and are serious enough to interfere with everyday activities
* Patient briefing as per §§ 40/41 of the Arzneimittelgesetz (AMG) and patient's declaration of Informed Consent in writing, in agreement with Good Clinical Practice (GCP) and current legal requirements
* A pain assessment of 3 cm or more on the visual analog scale on at least one of the 2 days immediately preceding the second visit

Exclusion Criteria:

* Painful gastric or intestinal spasms of organic origin such as Crohn's disease, ulcerative colitis, lactose intolerance
* Tumour pain/malignant growths
* Patients with other severe pain states of organic origin (e.g. biliary colic)
* Mechanical stenoses of the gastrointestinal tract, megacolon
* Urinary retention associated with mechanical stenoses of the urinary tract (e.g. in prostate adenoma)
* Narrow-angle glaucoma
* Tachyarrhythmia
* Myasthenia gravis
* Glucose 6-phosphate dehydrogenase deficiency (danger of haemolytic anaemia)
* Known hypersensitivity to N-butylscopolammonium bromide or paracetamol
* Severe liver impairment (e.g. through chronic alcohol abuse, hepatitis):

  * a) Serum-Glutamate-Oxalacetat-Transaminase/ Aspartate Aminotransferase (SGOT) higher than four times the norm
  * b) Bilirubin \> 3 mg/dl
  * c) Quick's value \< 70%
* Meulengracht-Gilbert syndrome (metabolic disturbance with episodes of jaundice)
* Severe kidney failure: creatinine \> 2 mg/dl
* Known depression or known mental illness, anxiety disturbance
* Concomitant intake of analgesics, nonsteroidal antiinflammatory drugs (NSAIDs) and/or spasmolytics, anticholinergics, nitrates
* Concomitant medication affecting gastrointestinal motility
* Regular (daily) use of laxatives
* Drugs that induce liver enzymes
* Concomitant administration of chloramphenicol
* Use of narcotics
* Antidepressant treatment or treatment with psychoactive drugs
* Pregnancy and lactation
* Alcohol abuse (more than 60 g alcohol/day)
* Frequent vomiting that might prevent adequate absorption of the active ingredient after the film-coated tablet is taken
* Patients who are unlikely to be able to keep the examination appointments or cannot reliably take the study medication regularly
* Simultaneous participation in another clinical study
* Patients who are not trained in the VAS (PI) at Visit 1
Relationships Between GLP-2 and Markers of Bone Turnover Following Feeding

This study has been designed to study differences bone turnover in relation to glucagon-like peptide-2 (GLP-2) following feeding in lean and obese premenopausal women. Given the preliminary evidence that GLP-2 may act directly on osteoclasts, the investigators plan to determine whether GLP2 receptors are expressed in osteoclasts and the effect of GLP-2 on bone resorption.

Hypotheses:

1. Acute responses of GLP-2 and bone resorption markers following feeding are affected by body fat mass.
2. Serum levels of GLP-2 are lower in obese pre-menopausal women and are associated with a reduction in trabecular and/or cortical bone mass
3. GLP-2 has direct actions on osteoclast resorption via a functional receptor

Study objectives:

1. To determine if differences in baseline serum levels of GLP-2 are related to differences in bone microarchitecture, structure and strength at the distal tibia and distal radius between obese and lean premenopausal females.
2. To determine whether obesity in premenopausal females influences levels of circulating GLP-2 following a standardised glucose meal with a resultant change in markers of bone formation and resorption
3. To test whether GLP-2 directly affects osteoclast function via an identifiable receptor

Eligibility Criteria:
Inclusion Criteria:

* Age 25-40
* Caucasian
* Premenopausal
* Able and willing to consent
* BMI either 18.5-24.9 kg/m2 or ≥30 kg/m2
* Completion 'The Effects of Obesity on Bone Structure and Strength' study REC ref 10/H1308/61
* Consented to be approached for future research studies

Exclusion Criteria:

* Fracture less than twelve months prior to recruitment
* History of any long term immobilization (duration greater than three months)
* Current pregnancy or trying to conceive Pregnancy or breast feeding less than one year prior to recruitment
* Diabetes mellitus
* History of or current conditions known to affect bone metabolism, which may include:

  * Diagnosed skeletal disease or osteoarthritis
  * Chronic renal disease
  * Acute or chronic hepatic disease
  * Hyperparathyroidism or Hyperthyroidism
  * Malabsorption syndromes
  * Diagnosed endocrine disorders
  * Diagnosed diabetes mellitus
  * Clinically significant hypocalcemia or hypercalcemia
  * Diagnosed restrictive eating disorder
* Current or clinically significant previous use of medications or treatment known to affect bone metabolism, for example:

  * Depot medroxyprogesterone or the combined oral contraceptive pill
  * Glucocorticoid therapy
  * Anti-convulsant therapy
  * Bone treatments (e.g. Bisphosphonates)
* Alcohol intake of greater than 21 units per week
* Athlete, defined as an individual participating in competitive sport at amateur or professional level
* Monogenic and obesity syndromes
* History of cancer within the past 5 years excluding skin cancer non melanomas
Evaluation of Treatment Duration of En-masse Versus Two Steps Retraction in Patients Having Maxillary Protrusion

Brief summary: there's a scarcity in literature concerning time needed to retract anterior segment following premolars extraction. the purpose of this study is to determine, in orthodontic patients with maxillary protrusion, which form of technique of retraction offers a faster treatment duration of retraction : en-masse or two step techniques

Anterior segment retraction can be done in one of two ways: through En masse or two step techniques. Both are viable options, but, ideally, the investigator wanted to retract and complete the orthodontic treatment as quickly as possible, in order to decrease the negative effects that may occur during treatment. Which of these techniques results in a decreased treatment time is still up for debate.

Eligibility Criteria:
Inclusion Criteria:

* Adults and adolescent patients ( both gender)
* Age range (14- 24)
* patient with maxillary protrusion requiring first premolars extraction ( bimaxillary protrusion or class II division 1 cases)
* patients with fully erupted permanent teeth ( not necessarily including the third molar).
* cases required maximum anchorage during retraction.
* good general and oral health

Exclusion Criteria:

* patients suffering from any systemic diseases interfering with tooth movement.
* patients with extracted or missing permanent teeth (except for third molars).
* patients with badly decayed teeth.
* patients with any parafunctional habits ( i.e. Bruxism, tongue thrusting, mouth breathing, etc.,.....)
* patients with previous orthodontic treatment
CD7 CAR-T for Patients With r/r CD7+ Hematologic Malignancies

This is a open-label, phase 2 study to evaluate the efficacy, safety and PK of CD7 chimeric antigen receptors treatment for patients with refractory/relapsed CD7 positive hematological malignancies.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed CD7 positive relapsed/refractory hematological malignancies.
2. Echocardiography shows left ventricular ejection fraction (LVEF) ≥ 50%;
3. There is no active pulmonary infection, and the oxygen saturation during air inhalation is more than 92%;
4. The estimated survival time is more than 3 months;
5. Eastern cooperative oncology group (ECOG) performance status of 0 to 2
6. The patients or their legal guardians voluntarily participated in the trial and signed the informed consent.

Exclusion Criteria:

1. Patients with history of epilepsy or other central nervous system diseases;
2. Patients with prolonged QT or severe heart disease;
3. Pregnant or lactating women
4. Patients with uncontrolled active infection.
5. Positive for any of the following etiological tests: HIV, HBV, HCV
6. Any other conditions that researcher think it is inappropriate for the subject to anticipate the trial
The Effect of Rectus Muscle Approximation at Cesarean Delivery on Pain Perceived After Operation

This is a prospective randomized controlled study to determine the clinical outcome of rectus muscle re-approximation at Cesarean delivery.

This is a prospective randomized controlled study to determine the clinical outcome of rectus muscle re-approximation at Cesarean delivery. Postoperative pain will be assessed in 2 groups. Rectus muscle approximation will be done to the first group. The second group will be the control group.

Eligibility Criteria:
Inclusion Criteria:

* Women who will undergo first elective cesarean section
* Singleton pregnancy

Exclusion Criteria:

* Previous abdominal or pelvic surgery
* Medical or psychiatric disease
* Previous pelvic inflammatory disease
* Obesity
* Allergy to analgesics
Incorporating MR Imaging Into Prostate Radiotherapy Treatment Planning

This research study is evaluating whether a standard prostate MRI examination can improve radiation therapy planning for prostate cancer.

In this research study, the investigators want to determine if prostate radiotherapy treatment planning can be improved by using an MRI scan to help doctors more accurately target the prostate with radiation and decrease radiation dose to the rectum, which is just behind the prostate.

To do this, the investigators will create a treatment plan based on the MRI scan and compare it to the standard treatment, which currently uses a CT scan rather than an MRI. The results of this study will help inform doctors whether it is beneficial to routinely use an MRI scan for prostate radiotherapy treatment planning.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have histologically confirmed prostate cancer.
* PSA level and prostate biopsy must be reviewed at Brigham and Women's Hospital or the Dana Farber Cancer Institute and should support a diagnosis of stage I-III prostate adenocarcinoma.
* Candidates with PSA greater than 20, digital rectal exam consistent with disease outside the prostate (clinical T3/T4 disease), or Gleason score 8 or greater, should have a bone scan and diagnostic pelvic CT or MRI to exclude metastatic disease.
* Prostate biopsy, serum PSA measurement, and any indicated diagnostic imaging studies must be performed within 60 days of the date of registration.
* Participants should not have had prior curative local treatment for prostate cancer, including no radiotherapy or prostatectomy. A maximum 90 days of systemic androgen deprivation therapy prior to registration is allowed.
* Participation is limited to adult patients, age 18 years or older.
* ECOG performance status ≥2 (Karnofsky ≥60%)
* Life expectancy of greater than 10 years.
* Able to tolerate an MRI examination.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Participants with known or suspected metastatic (stage IV) prostate cancer.
* Participants with an implanted device, prosthesis, or any other foreign body with ferromagnetic properties that would make them ineligible to undergo MRI examination.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Participants With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)

This study evaluates the effect of the addition of ublituximab, a novel monoclonal antibody, to ibrutinib compared to ibrutinib alone on antitumor activity, as measured by the overall response rate (ORR = CR \[complete response\] + PR \[partial response\]) in previously treated Chronic Lymphocytic Leukemia (CLL) participants with high-risk cytogenetic features. Half of the participants will receive ublituximab in combination with ibrutinib, while the other half will receive ibrutinib alone.


Eligibility Criteria:
Inclusion Criteria:

* Previously treated Chronic Lymphocytic Leukemia (CLL) requiring treatment
* At least one high-risk cytogenetic feature defined by the presence of 17p deletion, 11q deletion and/or p53 mutation
* Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion Criteria:

* Any major surgery, chemotherapy or immunotherapy within the last 21 days
* Evidence of hepatitis B virus, hepatitis C virus or known human immunodeficiency virus (HIV) infection
* Autologous hematologic stem cell transplant within 3 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded
* Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation)
* Previous therapy with ibrutinib, or any drug that specifically inhibits Bruton's tyrosine kinase (BTK)
First Time Right of Vancomycin

In 2020, only 16% of the Intensive Care Unit (ICU) patients achieved therapeutic drug concentrations after continuous administration of the first vancomycin dose. Many beneficial population pharmacokinetic (PPK) models are available however these are prevented from being widely implemented in daily practice due to the complexity. The aim of this study is to evaluate the effectiveness of individualized dosing with PPK models using a newly developed user-friendly pharmacokinetic (PK) tool.

In a preceding retrospective study, the percentage of patients within the target range after initiation of continuous vancomycin increased from 28% to 39% (excluding CRRT and ECMO patients) with calculated concentrations based on theoretical dose adjustments. In this study we want to prospectively evaluate the concentration of vancomycin at 24, 28 and 72 hours after the start of treatment with individualized dosages based on (a combination) of available PPK models in 134 adult ICU and orthopedic patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients who receive continuous vancomycin treatment at the ICU or orthopaedic department
* Patient or their legal representative is able and willing to sign the Informed Consent Form

Exclusion Criteria:

* Pregnant woman
* Children
* Patients with a transplantation history
* Patients on continuous renal replacement therapy (CRRT)
* Patients receiving extracorporeal membrane oxygenation (ECMO)
Early Markers of Radiation-Induced Cardiac Injury in Hodgkin Lymphoma Treated With Radiation Therapy

The purpose of this study is to evaluate if radiation and chemotherapy treatment cause cardiac abnormalities among survivors of Hodgkin's lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Completed radiation and chemotherapy treatment for Hodgkin lymphoma involving the mediastinum.
* Patient must be ≥ 18 years at time of consent.

Exclusion Criteria:

* Pregnant women at time of Cardiac MRI
* Contraindications to Cardiac MRI (contrast allergy, metal implants, medical devices)
* Glomerular filtration rate (GFR) \< 30, unless approved by Radiologist (UF Health Jacksonville Radiology Policy: Administration of Gadolinium-Based Contrast Agents).
Analysis of Knee Joint of Patients with Anterior Cruciate Ligament Injury Undergoing Physiotherapy After Two Different Surgical Techniques: a Randomized Clinical Trial.

The objetive is compare knee joint stability, functional capacity, postural control, activation, and muscle strength of patients undergoing conventional Anterior Cruciate Ligament Reconstruction or the conventional Anterior Cruciate Ligament Reconstruction + Anterolateral Ligament Reconstruction technique of the knee, and rehabilitation for up to nine months. This project aims to include patients with ACL injuries already treated at the Knee Outpatient Clinic of the Hospital das Clínicas da UEL (HC-UEL), coordinated by the orthopedic physician Dr. Lucas da Fonseca Borghi, who has his master's degree related to this research project. Twenty patients between 18 and 50 years old, of both sexes, sedentary and/or active and/or athletes, diagnosed with unilateral injury of the Anterior Cruciate Ligament will be included. These patients will be evaluated, submitted to ACL surgery (conservative) or associated with ALL reconstruction and undergo rehabilitation with physiotherapy in conjunction with the extension project Sports Physiotherapy from Theory to Practice - Phase III (PROEX-UEL No 02675), coordinated by Prof. Dr. Christiane S. Guerino Macedo - advisor of this research. Expected results: It is expected that the group undergoing ACL + ALL reconstruction will present better knee joint stability, functional capacity, postural control, activation and muscle strength.


Eligibility Criteria:
Inclusion Criteria: - participants with 18 to 50 years old; - both sexes; - sedentary; -active; - athletes; - diagnosed unilateral ACL injury; - patients residing in the city of Londrina - PR.

Exclusion Criteria: - BMI (Body Mass Index) above 35 kg/m2; - multidirectional ligament laxity; - associated multiligament injury (PCL and posterolateral corner); - previous or current lower limb fractures; - previous ACL reconstruction (revision); - signs of osteoarthritis; - indication for meniscus suture; - neurological disease; - pregnant women; - heart disease; - previous lower limb surgeries.