cyrilzakka/clinical-trials huggingface dataset:
ProSat - Long Term Effect of Probiotics on Satiety

The aim of the ProSat study is to examine the effects of a probiotic capsule containing Lb. Casei on subjective appetite sensation, ad libitum energy intake, and appetite hormone response in a single meal test and to determine whether the acute effects persist after daily supplementation of the probiotic capsule.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* Normal to slight overweight (BMI: 22-28 kg/m2)
* 20-45 years of age

Exclusion Criteria:

* Smoking
* Daily medicine use (oral contraceptives excluded)
* Use of pre- and probiotic supplements and foods
* Blood donation 3 months prior to the study
* Hb \< 7,5mmol/l
* Chronic illnesses such as hyperlipidemia, diabetes inflammatory diseases
* Pregnancy or breastfeeding
* Elite athletes (\>10 hours hard exercise/week)
* Vegetarians
Clinical Study of Perioperative Sleep Disorders in Cardiac Surgery

The aim of this clinical trial is to understand the effects of dexmedetomidine and esketamine on postoperative sleep in patients undergoing cardiac surgery. The main questions it aims to answer are:

Does dexmedetomidine or esketamine prevent the development of postoperative sleep disturbances? Which one works better? The researchers compared dexmedetomidine and esketamine with saline (a drug-free solvent) to see if dexmedetomidine and esketamine prevented the development of postoperative sleep disturbances.

Participants will:

1. Intraoperative continuous infusion of dexmedetomidine, esketamine or saline until the end of surgery
2. Postoperative sleep was assessed on the first and third postoperative days using a sleep rating scale


Eligibility Criteria:
Inclusion Criteria:

1. ASA class II-III, NYHA class I-III, EF ≥ 50%
2. Intended to perform cardiac surgery under extracorporeal circulation

Exclusion Criteria:

1. Patients undergoing second heart surgery
2. Patients with mental retardation, deafness, or other conditions that interfere with normal communication
3. Previous neurological or psychiatric disorders
4. Patients with a history of sleep disorders
5. Alcoholics, drug addicts, or psychotropic substance abusers
6. Significant hepatic or renal dysfunction affecting drug metabolism
7. Contraindication to the use of dexmedetomidine or esketamine.
Oligonucleotide Ligation Assay (OLA) Resistance Study

The investigators propose to gauge improvements in the rate of durable suppression of viral replication by ART when OLA is used to guide clinical decisions at the PEPFAR Coptic Hope Center in Kenya, and to determine the cost-effectiveness of implementing this strategy at Coptic Hope Center.

Durable suppression of HIV replication is critical to (1) improving the health of infected individuals, (2) to reducing HIV transmission to sexual partners and from mothers to their infants, and (3) to maintaining the effectiveness of the current 1st-line non-nucleoside reverse transcriptase inhibitors (NNRTI)- based ART. Across multiple trials, individuals with NNRTI-resistance, even at low-concentrations, have substantially greater virologic failure when treated with NVP- vs PI-ART. A cost-effective strategy is needed to detect and manage ARV-resistant HIV infections. A simple low-cost innovative assay the investigators developed and successfully transferred to Asian and African countries (oligonucleotide ligation assay (OLA)) can detect NNRTI+lamivudine (3TC) resistant HIV using reagents that costs \<$7.00/person. Furthermore, detection of NNRTI-resistance by OLA is highly (P\<0.001) associated with virologic failure of nevirapine (NVP)-ART in two retrospective studies; one of Thai women who had been previously randomized to single-dose NVP and the second of ARV-naïve Kenyan adults.

The investigators hypothesize that implementation of OLA into routine care will allow Kenyan clinicians to appropriately target protease inhibitor (PI)-based ART and improve rates of durable suppression of viral replication, and thus improve CD4 cell gains and individuals' health, reduce the transmission of ARV-resistant HIV within the community, and maintain the utility of NNRTI-ART. In addition, the investigators hypothesize that programmatically OLA-guided ART will be more cost-efficient compared to the current strategy of empiric use of NNRTI-ART as initial treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed HIV infection
2. \>2 years of age
3. Qualifying for 1st-line ART based on Kenyan Guidelines
4. Plan to reside in area for \>1 year
5. Adult patient or parent of minor agrees to study and provides informed consent

Exclusion Criteria:

1. Received ART previously from Hope Center
2. Ongoing ART
3. Plan to start 2nd-line ART
Probiotic Administration and Perennial Allergic Rhinitis

The purpose of this study is to evaluate the efficacy of a probiotic strain in improving the quality of life in adult subjects suffering from perennial allergic rhinit.


Eligibility Criteria:
Inclusion Criteria:

* Adults between 20-65 years old
* Confirmed allergy (allergic rhinitis) to dust mite for more than 2 years, as determined by anamnesis and by a miniRQLQ of ≥ 1
* Positive Skin prick testing measure greater than 3mm wheal diameter to the dermatophagoides pteronyssinus species of house dust mite extract
* Body Mass Index 19-29
* Having obtained his/her informed consent

Exclusion Criteria:

* Anemia
* Allergy to any food or medication
* Asthma
* Family history of congenital immunodeficiency or chronic consumption (more than one week at Screening) of immunosuppressive or anti-inflammatory treatments
* Ongoing treatment with antibiotics or undergoing allergen immunotherapy at Screening
* Consumption of probiotic and other dietary nutritional interventions
* More than 2 drinks/day alcohol consumption or use of illicit drugs
* Pregnant women
* Subjects with expected low compliance
* Blood donation in the past month or planning to donate blood until a month after the end of the study
* Currently participating or having participated in another interventional clinical trial during the last four weeks prior to the beginning the study
Far Forward Battlefield Telemedicine: Evaluation of Handheld Ultrasound

The goal of this study is to improve survival of battlefield trauma through ultrasound telemedicine and remotely guided therapeutics.

Specific aims to meet to improve the survival of battlefield trauma are 1)validation of portable ultrasound for diagnosis of various medical and surgical emergencies, ie cardiac tamponade, intraabdominal hemorrhage, 2)Extension of our expertise in digital echocardiography and local telemedicine to support other centers in such procedures as TEE 3)development of wireless telemedicine systems for rapid relay of ultrasonic images from portable ultrasound system to a remote review station. 4)development of a precision guide for diagnostic and therapeutic percutaneous procedures using ultrasound guidance 5)combining wireless telemetry with the guided percutaneous access tool to permit remotely guided emergency procedures 6)augmenting this work(2D/echo) with 3D/echo.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 yrs old
* Scheduled for clinical echocardiogram

Exclusion Criteria:

* None
Comparison of Metformin, Repaglinide or the Combination of Both in Subjects With Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to compare the efficacy of metformin and repaglinide used alone or combined administered as initial treatment in subjects with type 2 diabetes in which diet and exercise have failed.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with type 2 diabetes
* Treated by diet for at least 3 months
* Never treated with hypoglycaemic drugs
* HbA1c (glycaemic haemoglobin A1c) on inclusion time superior to 6.5%

Exclusion Criteria:

* Very symptomatic diabetes
* Advanced vascular complications
* Manifest renal failure
* Manifest hepatic disease
* Pregnancy, breast feeding or intention to become pregnant or if it is considered that the patient is not using adequate contraceptive measures. Adequate contraceptive measures are considered to be an intrauterine device, oral contraceptives and barrier methods
Nicotinic Modulation of the Default Network

Many disorders where attentional problems are a hallmark, such as Alzheimer's disease and schizophrenia, display abnormal regulation of the so-called default network of resting brain function that maintains internally directed thought when the mind is free to wander. There is indication that nicotine may improve attention by aiding the deactivation of the default network, and this mechanism may be of therapeutic benefit for the above disease states. The current project aims at providing a proof of concept by demonstrating that nicotinic drugs modulate default network function. The nicotinic agonist nicotine is hypothesized to improve attention by facilitating the down-regulation of default network activity, and the nicotinic antagonist mecamylamine is hypothesized to impair attention by impeding the down-regulation of default network activity during attentional task performance.

This study only enrolls healthy non-smokers. Participants perform attention tasks while undergoing functional Magnetic Resonance Imaging on three separate days. Across the three days, three difference conditions are tested in a double-blind manner, in randomized order. In all test sessions, participants receive a skin patch and swallow a capsule. In one session, both are a placebo. In another, the patch is a low-dose nicotine patch, and the capsule is a placebo. In another session, the patch is a placebo and the capsule contains a low dose of mecamylamine.

Eligibility Criteria:
Inclusion Criteria:

* Age 21 through 50.
* Did not consume cigarettes, cigarillos, cigars, or other tobacco or nicotine-containing products more than 20 times in lifetime, and did not use any nicotine-containing product at all within the last two years.
* Normal or corrected to normal vision (at least 20/80).

Exclusion Criteria:

* Presence of metal objects in the body, implanted electronic devices, or any other counter indication for MRI.
* Claustrophobia.
* Major psychiatric disorders including mood, anxiety or psychotic disorders.
* Cardiovascular or cerebrovascular disease, such as history of myocardial infarction, heart failure, angina, stroke, severe arrhythmias, or EKG abnormalities.
* Kidney or liver disease.
* Hypertension (resting systolic BP above 140 or diastolic above 85 mm Hg).
* Hypotension (resting systolic BP below 95 or diastolic below 60).
* Use of any prescription or over-the-counter drug other than supplements and birth control.
* History of or current neurological illnesses, such as stroke, seizures, dementia or organic brain syndrome.
* Learning disability, attention deficit disorder, or any other condition that impedes memory and attention.
* Glaucoma, organic pyloric stenosis, uremia or renal insufficiency.
* Prostatic hypertrophy, bladder neck obstruction or urethral stricture.
* Left-handed or ambidextrous.
* Pregnant as determined by urine test, or breast-feeding.
* History or current diagnosis of drug or alcohol abuse or dependence.
* IQ \< 85 as estimated by the WASI vocabulary subtest.
Lymphatic Drainage Versus Ultrasound for Postpartum Breast Engorgement: A Pilot Study

In this article, women were randomly assigned to the manual lymphatic drainage group, therapeutic ultrasound group, and control group, and the breast pain, swelling hardness, and milk excretion before and after each treatment were measured.

Breast engorgement as the swelling and distention of breast, which is one of the most common problems of postpartum of 3-8 days. At the same time, the congested blood vessels and tissue fluid will enter the surrounding tissues, resulting in the retention of tissue fluid and blood, resulting in interstitial fluid. In cases such as interstitial edema, the flow of milk is restricted.

There are many conservative treatments for relieving breast swelling. At present, there have been published studies on the application of ultrasound therapy and manual lymphatic drainage to breast problems during lactation. Previous studies have shown that manual lymphatic drainage and ultrasound therapy can significantly improve the pain, temperature, and firmness of breast engorgement. Manual lymphatic drainage and ultrasound therapy have been widely used in physical therapy, but there is little empirical evidence for manual lymphatic drainage on breast swelling. It is hoped that this empirical medical research method can be used to reduce the effect of breast pain caused by breast problems and improve breast milk. The purpose of this study was to examine whether manual lymphatic drainage and ultrasound therapy can improve breast pain, breast swelling, and increase the flow and volume of milk removed.

Eligibility Criteria:
Inclusion Criteria:

* Over 20 years old
* Physiological breast swelling, breast heaviness, lumps, milk plugging, breast pain after childbirth
* Able to read and understand Chinese
* At least four points on the Breast Swelling Scale

Exclusion Criteria:

* Autoimmune system problems
* physical and mental health problems
* Breast abscesses, mastitis
* Breast implants
* Cardiac pacemakers
* Malignant tumors
Complement Inhibition: Attacking the Overshooting Inflammation @Fter Subarachnoid Hemorrhage (CIAO@SAH)

Aneurysmal subarachnoid hemorrhage (SAH) can lead to devastating outcomes for patients, like cognitive decline. This is caused by early brain injury (EBI) followed by delayed cerebral ischemia (DCI). Neuroinflammation, triggered by the complement system, has been investigated to be a key mediator in the pathophysiology of EBI and DCI. Inhibition of the complement system is therefore considered to be a potentially important new treatment for SAH.

This trial aims to study the safety and efficacy of C1-inhibitor Cinryze, an approved inhibitor of the complement system, compared to placebo in patients with SAH. By temporarily blocking the complement system we hypothesize limitation of delayed cerebral ischemia and a more favourable clinical outcome for SAH patients due to a decrease in the inflammatory response.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of aneurysmal subarachnoid hemorrhage on CT-scan;
* Age ≥ 18 years on admission;
* WFNS grade 1-5.

Exclusion Criteria:

* Subarachnoid hemorrhage deemed most likely of 'peri mesencephalic' origin after consideration of history, clinical examination and radiological findings (including angiographic imaging); (not originated from an aneurysm and patients have by definition a favourable clinical outcome)
* Subarachnoid hemorrhage deemed most likely of post-traumatic origin after consideration of history, clinical examination and radiological findings (including angiographic imaging); (does not occur spontaneous)
* Participation in another clinical therapeutic study;
* Patients with definite infaust prognosis on arrival and/or expected death within 24 hours of admission
* Patients with a known hereditary complement deficiency (including hereditary angioedema);
* Patients with a history of sensibility to blood products or C1-inhibitor;
* Patients with a history of thrombosis (when known at time of inclusion);
* Pregnant woman
A Multi-Center Study Subjects With Dry Eye Syndrome

This is a Phase 1b, multi-center, double-masked, randomized, placebo-controlled, parallel-group study designed to evaluate the safety and biological activity of two doses of EBI-005 ophthalmic solution versus placebo in subjects with moderate to severe Dry Eye Syndrome. Approximately 72 subjects will be enrolled and randomized in this study at up to 9 centers located in the United States (US). Subjects will be enrolled in two groups or cohorts. The first enrollment group will consist of 33 subjects.

* To investigate the safety and tolerability of EBI-005 ophthalmic solution compared to placebo in the treatment of patients with moderate to severe Dry Eye Syndrome (DES).
* To evaluate pharmacokinetic (PK) parameters and immunogenicity of two different doses of EBI-005 ophthalmic solution.
* To investigate the biological activity of multiple doses of EBI-005 ophthalmic solution compared to placebo as assessed by both objective and subjective assessments.
* To investigate the comparative dose response of two different doses of EBI-005 ophthalmic solution.
* To investigate the comparative tolerability of two different doses of EBI-005 ophthalmic solution.
* To identify key biomarkers in the diagnosis and management of subjects with DES.

Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent prior to any study related procedures
* Are 18 years of age or older
* Are women of child bearing potential (WOCBP) who are non-pregnant, non-lactating and sexually inactive (abstinent) for 14 days prior to Visit 1
* Are willing and able to follow instructions and can be present for the required study visits for the duration of the study
* Have a history of Dry Eye Syndrome in both eyes supported by a previous clinical diagnosis
* Have ongoing Dry Eye Syndrome, in the same eye or both eyes, as defined by the following criteria:

  1. A score of ≥23 on OSDI
  2. A corneal fluorescein staining score of ≥6 (NEI scale)
* Have normal lid anatomy
* Are willing to withhold artificial tears for the duration of the study, with the exception of the study provided artificial tears: Refresh Plus®.

Exclusion Criteria: Subjects may not:

* Have previously used an IL-1 blocker (e.g., Anakinra, Rilonacept or Ilaris).
* Have an OSDI score ≥90
* Have a corneal fluorescein staining score of 15 (NEI scale). NOTE: If one of two eyes has a corneal fluorescein staining score of 15, the subject may be eligible.
* Within 30 days prior to the screening visit (Visit 1) have taken: Topical cyclosporine (Restasis®) Ocular corticosteroids Autologous serum Topical ocular antibiotics Topical ocular antihistamines or mast cell stabilizers Topical or nasal vasoconstrictors
* Within 30 days prior to the screening visit (Visit 1) have altered the dose of tetracycline compounds (tetracycline, doxycycline or minocycline).
L. Casei DG® in Patients With Irritable Bowel Syndrome.

To assess the effect of L. casei DG® (Lactobacillus paracasei CNCMI1572; Enterolactis® plus) on abdominal symptoms and gut microbiota metabolism/composition in non constipated patients with IBS (Irritable Bowel Syndrome). Patients will be randomized to receive L. casei DG® capsules, b.i.d. for 12 weeks the a 4 weeks Follow Up period will follow.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years and ≤ 65 years
* A positive diagnosis of non constipated IBS (i.e., IBS-D and IBS-M, both males and females), according to Rome IV criteria.
* A negative outcome of colonoscopy performed within 5 years before screening if patient is at least 50 years old, or if patient meet any of the following alarm features:

  1. Has a documented weight loss within the past 6 months; or
  2. Has nocturnal symptoms; or
  3. Has a familiar history of colon cancer; or
  4. Has blood mixed with their stool (excluding blood from hemorroids).
* Negative relevant additional screening or consultation whenever appropriate
* Ability to conform to the study protocol.

Exclusion Criteria:

* Patients with IBS-C or IBS-U according to Rome IV criteria
* Presence of any relevant organic, systemic or metabolic disease (particularly significant history of cardiac, renal, neurological, psychiatric, oncology, endocrinology, metabolic or hepatic disease), or abnormal laboratory values that will be deemed clinically significant on the basis of predefined values, (i.e..liver or kidney functional levels 2-times greater than the upper reference values)
* Ascertained intestinal organic diseases, including celiac disease, food allergies or inflammatory bowel diseases (Crohn's disease, ulcerative colitis, diverticular disease, infectious colitis, ischemic colitis, microscopic colitis).
* Previous major abdominal surgery.
* Active malignancy of any type, or history of a malignancy (patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrolment are also acceptable).
* Untreated food intolerance such as ascertained or suspected lactose intolerance, as defined by anamnestic evaluation or, if appropriate, lactose breath test.
* Use of probiotics or topical and/or systemic antibiotic therapy during the last month.
* Systematic/frequent use of contact laxatives.
* Pregnant females or females of childbearing potential in the absence of effective contraceptive methods.
* Inability to conform to protocol.
* Treatment with any investigational drug within the previous 30 days.
* Recent history or suspicion of alcohol abuse or drug addiction.
* Presence of red or white flags at the Rome IV Psychosocial Alarm Questionnaire for Functional gastrointestinal Disorders.
Manuka Honey in Second- and Grafted Third-degree Burns

Treatment strategies of II. degree burn wounds and split-skin grafted III. degree burn wounds aim at reducing infection and improving reepithelialization. The aim of this study is to evaluate time to reepithelialization, pain, microbiology and handling of manuka honey dressings with second-degree burn wounds and split-skin grafted burn wounds.

In plastic and reconstructive surgery, treatment strategies of second-degree burn wounds and split-skin grafted third-degree burn wounds aim at reducing infection and improving reepithelialization. Although previous studies indicate that burn patients benefit from wound dressings containing manuka honey, only a few studies can be found. Therefore, the aim of this study is to evaluate time to reepithelialization, pain, microbiology and handling of manuka honey dressings with second-degree burn wounds and split-skin grafted burn wounds.

Eligibility Criteria:
Inclusion Criteria:

* Consent-capable male and female patients (or guardian)
* ≥18 years of age
* ability to asses pain

Exclusion Criteria:

* Immunosuppressive Therapy
* Clinical wound infection
* Allergy against honey
* Relationship to someone who is involved in the study design or assessment
* Participation in other clinical trials
Effect of Granisetron on Usage of Sympathomimetics During Caesarean Section

The aim of the present study is to quantify the dose and usage of sympathomimetics used in caesarean section.

Recent metaanalysis showed significantly reduced hypotension and bradycardia in patients undergoing caesarean section in spinal anesthesia when 5-hydroxytryptamine 3 receptor antagonists were used prophylactically.

Due to this fact in our clinic the standard procedure was changed. All patients for caesarean section receive Granisetron before spinal anesthesia.

The aim of the present study is to evaluate the usage and dose of sympathomimetics during spinal anesthesia.

Therefore the investigators will evaluate approximately 120 participants who received granisetron and 120 participants who did not receive 5-hydroxytryptamine 3 receptor antagonists.

Eligibility Criteria:
Inclusion Criteria:

* caesarean section in spinal anesthesia

Exclusion Criteria:

* withdrawal
* incomplete documentation