cyrilzakka/clinical-trials huggingface dataset:
Effect of Ketanserin After LSD Administration

LSD (lysergic acid diethylamide) is a serotonergic (5-HT) hallucinogen widely used for recreational and/or ethnomedical purposes. LSD is thought to induce its prototypical psychedelic effects primarily via stimulation of the 5-HT2A receptor. This study investigates whether an LSD experience can be attenuated and shortened using 5-HT2A receptor antagonist ketanserin administration after LSD once the psychedelic effects have established.

LSD is a so-called "classic" or serotonergic hallucinogen or psychedelic.The effects of LSD have been frequently investigated in the past in both healthy participants and patients. In these studies, LSD produced acute transient alterations in waking consciousness including visual perceptual alterations, audio-visual synesthesia, derealization and depersonalization. Moreover, several of these studies described robust and sustained effects of LSD in patients suffering from addiction, anxiety and depression.

Its psychedelic effects are mainly attributed to its potent partial 5-HT2A receptor agonism. Consistently, administration the 5-HT2A receptor antagonist ketanserin (40 mg) prior to the administration of LSD (100 μg) almost completely prevented the acute effects of LSD in another study of our research group (NCT03321136). The present study hypothesis is that ketanserin (40 mg) administered 1h after LSD shortens and reduces the acute subjective effects of LSD (100 μg) compared to LSD alone (100 μg) followed by placebo in healthy humans. Such a finding would confirm a primarily competitive antagonism of ketanserin and LSD at the 5-HT2A receptor in vivo and indicate that LSD produces its psychedelic effects only when present at the receptor.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 25 and 65 years old
2. Sufficient understanding of the German language
3. Understanding of procedures and risks associated with the study
4. Willing to adhere to the protocol and signing of the consent form
5. Willing to refrain from the consumption of illicit psychoactive substances during the study
6. Abstaining from xanthine-based liquids and foods from the evenings prior to the study sessions to the end of the study days
7. Willing not to operate heavy machinery within 48 hours after substance administration
8. Willing to use double-barrier birth control throughout study participation
9. Body mass index between 18-29 kg/m2

Exclusion Criteria:

1. Chronic or acute medical condition
2. Current or previous major psychiatric disorder
3. Psychotic disorder or bipolar disorder in first-degree relatives
4. Hypertension (\>140/90 mmHg) or hypotension (SBP\<85 mmHg)
5. Hallucinogenic substance use (not including cannabis) more than 20 times or any time within the previous two months
6. Pregnancy or current breastfeeding
7. Participation in another clinical trial (currently or within the last 30 days)
8. Use of medication that may interfere with the effects of the study medication
9. Tobacco smoking (\>10 cigarettes/day)
10. Consumption of alcoholic beverages (\>20 drinks/week)
Effectiveness and Possible Complications of Core Needle Biopsy of Orbital Tumors

Core needle biopsy of orbital mass lesions with a semiautomated needles is a safe procedure that provides a sufficient amount of tissue material for standard histological and immunohistochemical analysis and can be an alternative or supplement to fine needle aspiration biopsy


Eligibility Criteria:
Inclusion Criteria:

* unresectable mass lesions with diffuse involvement of the orbit or the tumors with infiltrative growth and indistinct borders which needed to have morphologic verification

Exclusion Criteria:

* An anti-coagulant therapy at the time of biopsy,
* bleeding diathesis,
* suspected hypervascular lesions,
* orbital roof destruction with a tumor,
* apical location of the tumor
Effect & Safety of Inhaled Isoflurane vs IV Midazolam for Sedation in Mechanically Ventilated Children 3-17 Years Old

This is a study to compare safety and efficacy of inhaled isoflurane delivered by the AnaConDa-S versus intravenous midazolam for sedation in mechanically ventilated children admitted to an intensive care unit.

This is a phase III, multi-centre, prospective, randomized, active-controlled, assessor-blind study. Primary endpoint: percentage of time of adequately maintained sedation, in absence of rescue sedation, within the COMFORT-B interval (light, moderate, or deep sedation) prescribed at randomization, monitored every 2 hours for an expected minimum of 12 hours (up to 48 hours).

Eligibility Criteria:
Inclusion Criteria:

* Patients at least 3 years to 17 (less than 18) years at the time of randomization, admitted to an ICU/with planned ICU admission.
* Expected mechanical (invasive) ventilation and sedation for at least 12 hours.
* Informed consent obtained from the patient, patient's legal guardian(s)

Exclusion Criteria:

* Ongoing seizures requiring acute treatment.
* Continuous sedation for more than 72 hours at time of randomization.
* Less than 24 hours post cardiopulmonary resuscitation.
* Uncompensated circulatory shock.
* Known or suspected genetic susceptibility to malignant hyperthermia.
* Patients with acute asthma or obstructive lung disease symptoms requiring treatment at inclusion.
* Patient with tidal volume below 30 mL or above 800 mL.
* Inability to perform reliable COMFORT-B assessment in the opinion of the Investigator
* Patients with intracranial pressure (ICP) monitoring or with suspected increase in ICP
* Patients with treatment-induced whole-body hypothermia.
* Patients with pheochromocytoma.
* Patients with prolonged QT interval or with significant risk for prolonged QT interval.
* Patient not expected to survive next 48 hours or not committed to full medical care.
Effects of Muscle Trainins Inspiratory Linked to Cardiac Rehabilitation Post-operative of CABG Surgery

Heart surgery procedures are still widely used worldwide for the treatment of patients with heart problems, and rates of complications in the postoperative period related to them remain high. In these patients, physical conditioning programs result in improved functional capacity, and reducing the heart rate and systolic blood pressure. The inspiratory muscle training is also emerging as a valuable strategy in the treatment of cardiac patients. The study of the interaction between cardiac rehabilitation and high intensity IMT about these changes is not yet understood in this population. The aim of this study is to assess the effects of inspiratory muscle training high intensity associated with cardiac rehabilitation exercise performance of patients in the postoperative period of CABG surgery.

It is a controlled, randomized clinical trial in which patients were randomly assigned randomly after referral to cardiac rehabilitation: Group 1 IMT-HI, group 2 - IMT-HI control. The evaluator of outcomes is blinded as to groups. The study protocol lasts 36 sessions for both groups. The group 1 patients performs cardiac rehabilitation protocol for 40 minutes with cardio and stretching and also inspiratory muscle training protocol of high intensity with 50% load increase in maximal inspiratory pressure during the first two weeks, 60% of MIP in third and fourth week, 70% of MIP in the fifth and sixth week and 80% MIP in the seventh and eighth week. The group 2 patients only perform the cardiac rehabilitation protocol for 40 minutes with aerobic exercise and stretching.

Eligibility Criteria:
Inclusion Criteria:

* Patients in the postoperative period of elective CABG
* Between the fourteenth and the thirtieth day after surgery
* Between 30 and 70 years old

Exclusion Criteria:

* Decompensated heart failure
* Unstable angina
* Moderate respiratory disease severe
* Active infectious disease or fever
* Disabling peripheral vascular disease
* Unstable ventricular arrhythmias
* Use of cardiac pacemaker.
The Effects of Short Message Notifications on Middle-Aged Diabetic Patients

The objective of our study was to assess awareness-raising of medication adherence (MA), physical activity (PA), fasting blood glucose (FBG), and glycated hemoglobin A (HbA1c) values by providing information on diabetes via short message (SMS) technology.

The study investigates T2DM patients who have not had surgery or cardiac event in the last 3 months, between the ages of 40 and 64 years, with T2DM diagnosis between the last 1 and 10 years and oral antidiabetic therapy for at least 1 The study design is a single-blinded randomized, controlled study, and was conducted in the Diabetes Polyclinic of the Istanbul University Medical Faculty Hospital.

Patients randomly assigned to the intervention group, in addition to traditional treatment received three to four informative SMS messages per week during the 6-month period, while the control group was followed in accordance with the traditional treatment schedule.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Type 2 Diabetes Mellitus (T2DM) between the last 1 and 10 years
* Being aged between 40 and 64 years old,
* Is treated for a minimum of 1 year with at least one oral antidiabetic drug.

Exclusion Criteria:

* Clinical diagnosis of T2DM for less than 1 year or more than 10 years.
* Those who have had surgery or a cardiac event in the last 3 months or during the investigation.
* Those under 40 and over 64 years of age.
* Patients with T2DM that have not been treated with oral antidiabetic medication.
* Volunteers who once did not participate in the control examinations in both groups were excluded from the evaluation.
Isolation of Volatile Organic Compounds (VOCs) Related to the Olfactory Signature of Breast Cancer

To ascertain the possibilities to isolate the breast cancer olfactive signature.

Patient recruitment during the first surgery consultation in Curie Institute. Odor sampling (non-invasive) with an odor-sensing polymer (Sorbstar® polymer developed especially for the trace level analysis), on:

* The hands, before and after surgical excision of the tumor (friction of the hands)
* The diseased breast, before and after surgical excision of the tumor (via a compress positioned on the breast for 1 night)
* The tumor, during the surgical procedure (odor collection over a tumor sample).

Each patient will be her own witness, before and after surgical excision, in an attempt to isolate the chemical signature tracks of breast cancer. The samples after surgery will be made after healing and before implementation of a treatment (chemotherapy and / or radiotherapy).

Eligibility Criteria:
Inclusion Criteria:

1. Patient received in surgery consultation for an invasive non metastatic breast cancer treated by breast-conserving surgery with axillary or sentinel node dissection
2. Of-Age female patient (over 18 years old)
3. Life expectancy \> to 1 year at the inclusion
4. Performance status: 0 or 1 or 2
5. Patient benefiting from the social security
6. Signature informed consent of the study

Exclusion Criteria:

1. Neoplasia in progress or neoplasia history of cancer other than breast to be treated.
2. Wound presence on breasts
3. Male subjects
4. Specified metastatic breast cancer
5. Concomitant medication taken one month before the surgical act (antibiotics, corticoids, anti-diabetics)
6. Persons under guardianship or deprived of liberty
7. Impossibility to submit to the medical monitoring expected by the study for geographical, social or psychological reasons.
Functional Electrostimulation on the Upper Lip in Multiple Sclerosis

Multiple sclerosis (MS) is an autoimmune disease where immune cells attack the body, triggering an inflammatory response. A study comparing multifield FES and conventional FES on upper extremity motor skills and functional independence in MS patients will be conducted. Results suggest that both types of FES treatments normalize muscle tone, showing superior results compared to those without FES therapy. The study aims to compare the effects of both types on MS patients.

Multiple sclerosis (MS) is an autoimmune disease in which cells of the immune system attack the body itself. This condition generates an activation of the immune system that triggers an inflammatory response. General objective: To compare the effect of multifield FES and conventional FES on upper extremity motor skills and functional independence in people with MS. Methodology: A three-arm prospective longitudinal multicenter randomized controlled trial (RCT) will be conducted: conventional therapy (Control Group, CG), an experimental group 1 (EG1) which in addition to this same treatment will use the conventional FES tool, through the Globus Elite device, and an experimental group 2 (EG2) which will differ from GE1 in that it will use the FES multi-field device through FESIA Grasp. Results: It is expected that people who have used any type of FES will have a more normalized muscle tone compared to those who have not received this type of treatment. The research compares the effects of two types of FES in people with multiple sclerosis, focusing on improved motor skills and functional independence. Both FES treatments are expected to normalize muscle tone, showing superior results compared to those who do not receive this therapy.

Eligibility Criteria:
Inclusion Criteria:

* Be of legal age and sign the informed consent form.
* Not suffer from any pathology in the upper limb such as tendinitis, oedema, fractures, etc.
* Intact skin (no breaks, scratches, cuts, and other superficial or deep injuries) on the arm where the devices will be placed if applicable

Exclusion Criteria:

* Severe medical problems.
* Use of a pacemaker.
* Pregnancy.
* Cutaneous neuropathies.
* Presence of other neuromuscular pathologies.
Single Ascending Dose Study of Lu AF76432 in Healthy Young Men

The purpose of this study is to investigate safety, tolerability and pharmacokinetics of the drug Lu AF76432 given as single oral ascending doses to healthy young men


Eligibility Criteria:
Inclusion Criteria:

-Healthy young non-smoking men ≥18 years of age and ≤45 years of age at the Screening Visit and a body mass index (BMI) ≥18.5kg/m2 and ≤30kg/m2 at the Screening Visit.

Exclusion Criteria:

* The subject has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder or the subject is, in the opinion of the investigator, unlikely to comply with the protocol or is unsuitable for any reason
* The subject has taken any investigational medicinal product \<3 months prior to the first dose of IMP

Other inclusion and exclusion criteria may apply
Tranexamic Acid in Abdominoplasty.

The investigators prepared a novel tranexamic acid (TXA) study designed to estimate the quantity of blood loss in patients undergoing abdominoplasty surgery. This study aims to quantify blood loss during abdominoplasty with and without TXA. The central hypothesis is that TXA administration reduces blood loss and fibrinolysis in patients undergoing abdominoplasty surgery.

Tranexamic acid (TXA) treatment is increasingly emphasized in plastic surgery because TXA inhibits fibrinolysis. Increased clot stability offers the possibility of preventing blood loss (prevention) and mitigating ongoing hemorrhage. TXA therapy has been principally studied in populations; the results of studies in plastic surgery still need to be improved.

Tranexamic acid is an antifibrinolytic agent that acts as a competitive inhibitor at the lysine binding sites of plasminogen and inhibits the ability of protease plasmin to cleave the fibrin clot. In large randomized controlled trials, it has been reported to be effective in decreasing perioperative blood loss in various circumstances, primarily involving trauma patients.

The investigators designed a randomized placebo-controlled trial comparing TXA dosing before incision for abdominoplasty. The purpose is to quantify blood loss during plastic surgery with and without TXA.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled abdominoplasty
* ASA 1 or 2
* age \>18 and \<75 years

Exclusion Criteria:

* BMI \<20 or \>35 kg/m2
* ASA 3 or \> 3
* medical history of thromboembolism
* history of hematological disease
* treatment with aspirin 14 days before the procedure
* treatment with anticoagulants 5 days before the procedure
* epilepsy
* allergy to tranexamic acid
* coagulation disorders
Effects of Postural Balance Exercises in Patients With Heart Failure

In this study, the effects of core stabilization and computerized wobble board exercise training programs on postural balance and functional exercise capacity in patients over 60 years of age with heart failure will be investigated.

This study will consist of core stabilization group (CSG), wobble board group (WBG) and control group. In CSG, exercises that focus basically on the abdominal, pelvic floor, trunk extensor and diaphragm muscles and comply with core stabilization criteria will be applied. In WBG, balance exercises which focus primarily lower limb and trunk muscles, will be performed on computerized wobble board with visual feed-back provided by computerized wobble board. In control group, no exercise will be performed, only the evaluation procedure will be applied at the beginning and 8 weeks later. It was planned to include in total of 36 patients and will be randomized them into three groups with 12 patients. Following the initial assessment, each patient will participate in a one-session patient education program. After that, patients in CSG and WBG will participate in their exercise training program which supervised by physiotherapist, 3 days a week for 8 weeks.When the exercise training programs for 8 weeks were completed, initial evaluations will be re-applied. Collected data will be analyzed with SPSS 22.0 (IBM Corp., Armonk, NY, USA) program. The differences between pre- and post-treatment evaluations will be analyzed with "paired t test" and/ or " wilcoxon test".The differences between three groups will be analyzed with one-way analysis of variance and/ or Kruskal-Wallis test.

Eligibility Criteria:
Inclusion Criteria:

* 60 years and older
* Patients with heart failure who diagnosed by cardiologist
* Patients have stable drug therapy and to be clinically stable at least last three months
* Patients who signed the informed consent form

Exclusion Criteria:

* History of myocardial infarction in the last 6 months
* Acute coronary syndrome
* Un-controlled diabetes and/ or hypertension
* Severe valvular heart disease and/ or arrhythmia
* Having a pacemaker
* Severe cognitive disorder
* Severe orthopedic and/ or neurological problem
* Visual or auditory impairment
* Walking with device
FinESS Registry Study

A prospective, post-approval registry study assessing subject rhinosinusitis symptomatic status over time following treatment with FinESS Sinus Treatment using self-administered quality of life survey data.


Eligibility Criteria:
Inclusion Criteria:

* adults 18 years or older undergoing balloon dilation with FinESS Sinus Treatment and have provided voluntary consent to participate in Registry

Exclusion Criteria:

* none
Phase I Drug Trial for S/E of Marimastat in Disabling Malformations When no Other Options.

3 patients were enrolled in each of 3 study cohorts. There three cohorts were given differing, incrementally larger doses of this phase I drug. The same safety measures are being obtained on all patients. Efficacy measures were individualized as enrolllees do not have the same underlying vascular anomaly. The study is structured to include a 24 month drug-phase and a 24 month follow-up phase. The study is now closed to enrollment.


Eligibility Criteria:
Inclusion Criteria:

* Patient with vascular malformation causing risk of one or more of the following based on unanimous assessment of designated physicians in the multidisciplinary Vascular Anomalies Team.

  * airway/respiratory/visual/auditory/neurologic compromise;
  * high output cardiac failure;
  * life-threatening or disabling hemorrhage(cutaneous/GI/intracranial/ parenchymal/cavitary);
  * skeletal distortion/destruction/erosion;
  * life-threatening or disabling soft tissue distortion or destruction
* Patient must be felt to have failed, be unable to significantly benefit from, or be at risk for other available therapies, including surgeries, embolization, and sclerotherapy based on unanimous assessment of designated physicians in the multidisciplinary Vascular Anomalies Team.
* Patient must be felt to have one or more physical, imaging, photographic, physiologic or other measurable features that can be measured on a regular basis for preliminary evaluation of efficacy. The feature(s) must be agreed on by the designated physicians in the multidisciplinary Vascular Anomalies Team).
* Signed Patient informed consent.

Exclusion Criteria:

* Pregnancy
* Patient nursing child.
* Female patient of childbearing potential unwilling to receive contraceptive counseling and use reliable contraceptive method.
* Patient enrolled in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
* Parent or guardian or child unwilling to provide consent or assent.
Study of Esomeprazole 20 mg or 40 mg vs Placebo Effectiveness on the Occurrence of Peptic Ulcers in Subjects on Low Dose Acetylsalicylic Acid (LDA)

The purpose of this study is to compare the effect of esomeprazole 20 or 40 mg once daily versus placebo on the occurrence of peptic ulcers during 26 weeks in subjects on continuous low-dose acetylsalicylic acid.


Eligibility Criteria:
Inclusion Criteria:

* Daily intake of low-dose Aspirin (ASA) - The subject must fulfill at least one of the following (a-e):
* Aged ≥65 years.
* Aged ≥18 years and with a documented history of uncomplicated peptic ulcer(s).
* Aged ≥60 years and naïve to low-dose ASA (ie, treatment started within 1 month prior to randomization).
* Aged ≥60 years and with stable coronary artery disease.
* Aged ≥60 years and with complaints of upper gastrointestinal (GI) symptoms that, as judged by the investigator, requires an Esophagogastroduodenoscopy (EGD) and with the finding of ≥5 gastric and/or duodenal erosions at the baseline endoscopy.

Exclusion Criteria:

* Peptic ulcer(s) at baseline esophagogastroduodenoscopy (EGD).
* Reflux esophagitis Los Angeles (LA) classification grade C or D at baseline
* History of peptic ulcer complications such as clinically significant bleeding and/or perforation.
fMRI in Deep Brain Stimulation

With fMRI, we want to understand the mechanisms of brain neuromodulation in (dys)functional brain circuits, to obtain knowledge on involved brain networks in DBS.

Deep brain stimulation represents a neurosurgical treatment option for specific refractory neurological and psychiatric disorders. In these patients a specific brain target is stimulated through an electrode with the use of an implantable pulse generator (IPG). In a functional MRI (fMRI) experiment, the investigators intend to perform imaging during stimulation ON and compare brain activations with the stimulation OFF condition. In this way, they aim to elucidate the involved brain network in deep brain stimulation. Since the connectivity of deep brain structures is complex, different activation patterns are expected in-between subjects and conditions. If specific activation patterns during the stimulation ON condition can be related to treatment response, this is of important clinical value. These findings can lead to an optimization of the deep brain target or even to different useful targets for brain stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Deep brain stimulation system implanted

Exclusion Criteria:

* Children and pregnant women will be excluded. Failure to follow to protocol is also an exclusion criterion.