cyrilzakka/clinical-trials huggingface dataset:
Effect of a Kefir Beverage on Immunity and Lipid Profile

This is an exploratory cluster randomized controlled trial to evaluate the effect of a kefir beverage, enriched with prebiotics components, on immunity, lipid profile and adiposity in a population-based study, using the family as the intervention unit.

The gastrointestinal tract is populated by a collection of microorganisms, primarily bacteria, that interact with intestinal host cells. In the past two decades, several studies have demonstrated the effects of the intestinal microbiota on host physiological, metabolic and immunological processes and have revealed that the microbiota is fundamental to host body function. There is currently a growing interest in manipulating the intestinal microbiota to enhance the effects on health and welfare of the intestine. In this regard, since its introduction, the concept of prebiotics has stimulated both scientific and industrial interest. A dietary prebiotic is a selectively fermented ingredient that results in specific changes, in the composition and/or activity of the gastrointestinal microbiota, thus conferring benefits upon host health. To date, the prebiotics most widely evaluated in human clinical trials are inulin-type fructans (inulin, fructo-oligosaccharides, oligofructose) and galacto-oligosaccharides (GOS).

The investigators goal is to conduct a human clinical trial to evaluate the impacts of a functional-prebiotic beverage on immunity and metabolic profile.

This study will be performed on a family-oriented basis. 44 families/clusters (\~ 150 children and adults, older than 3 years) will be selected to participate in the study and will be randomized into intervention group (n=22 families) and control (n=22 families) groups.

Weight, body mass index (BMI), waist circumference (WC), nutrient intake from food frequency questionnaire, physical activity, blood pressure, allergic sensitization, metabolic function (fasting blood glucose, HbA1c, insulin resistance and lipid profile), general lymphocyte overview (B-cells, T-cells and NK-cells) and sub-populations of T-helper cells (Th1, Th2, Th17 and T-regulatory), inflammation markers (C-reactive protein, interleukin-6 and tumor necrosis factor-alpha) will be measured at baseline and after 4 months.

Mixed effect models analysis will be performed to assess changes in the cardiometabolic and immune parameters.

Eligibility Criteria:
Inclusion Criteria:

1. For the index subject:

   * Female or male.
   * 18 years and older.
   * Living in a family unit with two or more people.
2. For the other family members:

   * Female or male.
   * Age between 3 to 85 years.
3. At family level: at least two members will meet inclusion criteria but no exclusion criterion

Exclusion Criteria for the index subject and the other family members:

* Alcoholism
* Pregnant
* Major cardiovascular disease
* Dementia
* Major autoimmune diseases
* Diseases or treatments that seriously affect the immune status
* Neoplasia
* Terminal disease
Vitamin Replacement in Abetalipoproteinemia

This study will determine whether short term intravenous infusion of vitamins A and E in patients with abetalipoproteinemia can reverse disease symptoms in these patients. Abetalipoproteinemia is an inherited metabolic defect that prevents fat-soluble vitamins, such as A and E, from being absorbed from the intestines into the bloodstream and from being secreted by the liver. The deficiencies of vitamins A and E can result in severe vision impairment and a gait disorder. Treatment with megadoses of these vitamins, taken by mouth, may delay or arrest symptoms, but many continue to progress.

For this study, a single patient with moderately severe eye and neurological defects will be given essential fatty acids and fat soluble vitamins directly through a vein (intravenously) using FDA-approved replacements with a fat emulsion and multivitamins containing fat-soluble vitamins. This route of administration will bypass the digestive tract, where the absorption problem occurs. The infusions will be given twice a week for one month and then weekly for another month. Blood tests will be done weekly to measure blood lipids (fatty acids and other substances), cell counts, and vitamin levels. Eye and neurological examinations will be done once a month.

Fat-soluble vitamins are normally absorbed from the diet through the gastrointestinal tract and incorporated into fat-rich particles called chylomicrons made in the intestinal wall. Chylomicrons are secreted by the intestine into the bloodstream. In a rare lipid metabolic disorder called abetalipoproteinemia, a defect in the assembly of the fat and vitamin containing particles prevents the formation of chylomicrons resulting in the malabsorption of fat and fat-soluble vitamins. A similar assembly defect of fat and fat-soluble vitamins occurs in the liver and prevents the secretion of these particles. Severe fat-soluble vitamin deficiency results even despite mega doses of oral fat-soluble vitamins. Clinically, the subjects develop neurologic and ophthalmologic symptoms similar to those in Vitamin A and E deficiency. This study is designed to determine whether short-term intravenous fat-soluble vitamins and fat emulsion can reverse the neurologic and ophthalmologic complications of fat-soluble vitamin deficiency based on noninvasive procedures routinely employed in clinical practice.

Eligibility Criteria:
None provided - protocol is intended for one patient only.
Study Investigating MEN1 and SDHD in Familial Carcinoid Tumors

There is a high incidence among the first degree relatives of the carcinoid patients, indicating the involvement of genetic components in its initiation and pathogenesis.

This proposed pilot study will conduct detailed interviews into the medical, environmental, and family histories and to collect blood specimen to obtain DNA. The Blood specimen and DNA will be processed by the Rutgers University Cell and DNA Repository (RUCDR) to rule out Familial Multiple Endocrine Neoplasia (MEN 1), and succinate dehydrogenase complex, subunit D (SDHD), gene inactivation thought to be associated with different types of carcinoid cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Over the age of 18 years
2. More than one ,member of a family with a history of biopsy confirmed carcinoid tumor
3. English speaking
4. Mentally and emotionally capable of answering questions
5. Willing and available for study participation
6. At least one other family member with carcinoid tumor

Exclusion Criteria:

1. If you are under the age of 18 years,
2. If you are unable to understand or unable to provide informed consent,
3. If you have a psychological condition (i.e. depression, anxiety disorder, substance abuse, etc.) which might cause you significant problems in dealing with test results.
Precise Diagnosis, Treatment and Prognostic Evaluation of Complicated Adrenal Tumor Diseases

The adrenal gland is an important organ that produces life hormones. There are many types of adrenal tumors, which tend to occur in young adults and affect the whole body. It has the dual threat: hormone secretion and tumor metastasis. At present, there are four major dilemmas in the clinical diagnosis and treatment of adrenal tumors: 1) Pulse secretion of the hormones, which are affected by many factors; and the diagnostic value of single hormone is limited; 2) Traditional imaging cannot accurately reflect the characteristics of hormone secretion. The prognosis cannot be accurately predicted; 3) The molecular characteristics of tumor cells and the microenvironment are unclear, making it difficult to implement early diagnosis and precise treatment; 4) Traditional pathology cannot determine the nature and long-term prognosis of the tumor, which makes the treatment delay, and the disease prognosis is extremely poor. It threatens the lives of patients.

Starting from solving the above-mentioned key problems in the early stage, the research team has systematically established new clinical diagnostic technologies, hormone dynamic tests to accurately assess hormone secretion and segmented blood collection hormone determination technologies to accurately locate adrenal tumors; A series of important research results have been published in Science, Lancet Diabetes \& Endocrinology, Cell Research, etc To sum up, the goal of this research is improving the early diagnosis rate of complicated adrenal tumors especially in malignant tumors, developing the optimal treatment plan, avoiding unnecessary surgical treatment, improving the quality of life of patients, reducing mortality. This project will further integrate the adrenal cortex and medulla hormone mass spectrometry detection and the molecular markers of adrenal tumors through phenotypic, functional imaging, and molecular pathological evaluations, and built a sensitive drug screening platform that integrates visual drug response and molecular characteristics, thereby achieving precise diagnosis and treatment of complicated adrenal tumors.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old and ≤ 75 years
* Diagnosis of Patients with primary aldosteronism, pheochromocytoma, and cortical cancer
* Gender: males and females
* Provide written informed consent
* Satisfactory compliance

Exclusion Criteria:

1. Patients with renal insufficiency (Cr\>2 times the upper limit of normal).
2. Patients with a history of liver cirrhosis.
3. Patients who are currently using corticosteroids.
4. Patients with cardiac insufficiency (NYHA cardiac function classification grade 3 and above or EF\<50%).
5. Patients with stroke and acute myocardial infarction in the past 6 months.
6. Patients during pregnancy and lactation
The Role of Local Tranexamic Acid on Periorbital Oculoplastic Surgery

This study investigates the effect of tranexamic acid, a medication that helps reduce bleeding, in patients undergoing surgeries around their eyes.


Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 and above undergoing periorbital oculoplastic surgery including but not limited to upper and lower blepharoplasty, four lid procedures, or dacryocystorhinostomy (DCR).

Exclusion Criteria:

* - Adults unable to consent
* Individuals less than 18 years of age
* Prisoners
* Pregnant women.
* Known contradictions or sensitivities to study medication (tranexamic acid)
* Patients with known prior thromboembolic events
* Previous eyelid surgery or same-side DCR (RE-DCR)
* Has any type of coagulopathy
Efficiency of Inspiratory Muscle Training in Elderly People

Efficiency of inspiratory muscle training in elderly people. Outcomes are lung function, muscle strength and chest expansion.


Eligibility Criteria:
Inclusion Criteria:

* healthy

Exclusion Criteria:

* pulmonary diseases
* cognitive disorders
Adagrasib in Combination With TNO155 in Patients With Cancer (KRYSTAL 2)

This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 in combination with TNO155 in patients with advanced solid tumors that have a KRAS G12C mutation.

This study will evaluate the safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics, and clinical activity of MRTX849 in combination with TNO155 in patients with advanced solid tumors with a KRAS G12C mutation. MRTX849 is an orally available small molecule inhibitor of KRAS G12C and TNO155 is a selective, orally bioavailable allosteric inhibitor of wild-type SHP2.

This study was terminated prior to phase 2 initiating. Only phase 1 of the study was conducted.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation (phase 2 must be either Non-Small Cell Lung Cancer or Colorectal Cancer)
* Unresectable or metastatic disease
* No available treatment with curative intent
* Adequate organ function

Exclusion Criteria:

* History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of study treatment or result in inability to swallow
* Other active cancer
* Cardiac abnormalities
Safety Study of Sertindole Versus Risperidone Under Normal Conditions of Use

The purpose of the study is to determine whether there is an increased all-cause mortality in sertindole-treated patients in comparison to patients treated with a well-known antipsychotic (risperidone) when used under normal marketed conditions in the treatment of schizophrenia.

The Committee for Medicinal Products for Human Use (CHMP) requested a post-marketing study to ascertain that the favourable benefit-risk profile and low mortality rates seen in the clinical studies with sertindole would not be offset by higher mortality rates when sertindole was used under more normal conditions of use. It was recognised that, in a clinical trial setting, strict patient selection and monitoring could lead to higher compliance in patient management and thereby to a lower mortality rate. Study 99824 was therefore designed in collaboration with the CHMP as an open-label, randomised study with minimum study management that focused on mortality and general patient safety. The duration of the treatment period was not fixed. No efficacy measures were included.

Eligibility Criteria:
Inclusion Criteria:

* The patient has signed the Informed Consent Form or, if he/she is not able to sign it (according to the ICH GCP guidelines and the Declaration of Helsinki), the patient's legal representative has signed the Informed Consent Form
* The patient has been diagnosed with schizophrenia
* Based on the patient's clinical status, new or change of antipsychotic treatment is indicated
* The patient is at least 18 years of age
* The patient meets the criteria set out in the national SPCs for sertindole and risperidone. For those countries in which sertindole was not marketed, the EU SPC applied

Exclusion Criteria:

* The last treatment taken by the patient was sertindole or risperidone
* The patient has never previously received any antipsychotic drug therapy
* The patient has contraindications to treatment with either sertindole or risperidone
* In addition to sertindole/risperidone, treatment with another antipsychotic is indicated
* The patient is homeless
* The patient has previously been included in one of the two H. Lundbeck A/S post-marketing studies, 99823 or 99824
* The patient is, in the opinion of the investigator, unlikely to comply with the study protocol or unsuitable for any other reason
Combined Flow and Pressure Study of Craniospinal Dynamic

Normal pressure hydrocephalus (NPH) can cause a type of dementia. However, this type of dementia is the only one that is reversible. To treat this dementia it is necessary to evacuate the accumulation of CSF from the brain to another body cavity using a device called a shunt. But the implantation of this shunt is only effective when the cause of the pathology is an alteration of the normal circulation of the CSF. To diagnose these patients, morphological MRI and lumbar puncture are standard approaches used but remain perfectible in diagnostic terms.

The main objective is to build a new model of the interaction of intracranial pressures and fluids in order to obtain a new parameter allowing to obtain information on the cerebral biomechanics.


Eligibility Criteria:
Inclusion Criteria:

* age \> 55 years
* Patients with suspected active hydrocephalus (HA) known as "normal pressure":
* Ventricular dilatation: Evans index \> 0.3
* Patients with cognitive impairment, and/or gait disorders and/or urinary incontinence or a combination of these three symptoms.
* Absence of other neurological diseases that could cause ventriculomegaly.
* Information and collection of the patient's non opposition

Exclusion Criteria:

* All patients with neurological disease other than active hydrocephalus will be excluded.
* Individuals who cannot tolerate an MRI examination
* All individuals with implants, pacemakers, prostheses and ferromagnetic objects
* Patients under guardianship, curators or safeguard of justice
Mindfulness-based Stress Reduction (MBSR) for Reduction of Chronic Pain and Drug Therapie

Mindfulness-Based Cognitive Therapy (MBCT) combines ideas of traditional cognitive therapies with meditative practices aimed at cultivating mindfulness. Mindfulness-based stress reduction (MBSR) is considered one of the original mindfulness-based interventions. It has been modified to be offered virtually,which has been useful throughout the COVID pandemic, and more importantly, has served to inform other mindfulness approaches, such as trauma-focused therapy. The investigators want to assess the efficacy of MBSR in patients with Chronic Pain undergoing drug treatment.

Mindfulness helps develop the ability to observe and detach from our mental, sensory, and emotional states, and thus increases our awareness and ability to manage emotions.

In the experimental arm, some have been foreseen group sessions, in which a maximum of ten people participate on the Mindfulness-based stress reduction (MBSR).

The protocol provides for eight meetings (one and a half or two hours each) on a monthly basis, for a total duration, therefore, of twelve months.

Eligibility Criteria:
Inclusion Criteria:

* Patients being treated for Chronic Pain
* Patients with Chronic Pain in Pharmacological Therapy

Exclusion Criteria:

* Patients with Chronic Pain not in Pharmacological Therapy
* Patients without Chronic Pain
Effect of Cafedrine/Theodrenaline and Urapidil on Cerebral Oxygenation

During clamping of one internal carotid artery for endarterectomy, blood flow through this vessel has to be compensated by collateral arteries including the contralateral internal artery and vertebral arteries. In 7 % of all patients undergoing carotid endarterectomy this collateral flow is not sufficient to maintain adequate cerebral perfusion during clamping and ischemic brain damage is likely to emerge. To maximize cerebral blood flow during clamping, increase of blood pressure is a common procedure and routine at our institution. Increasing blood pressure can be enabled by tapering a mixture of Cafedrine und Theodrenalin (Akrinor®) until the designated blood pressure is reached. After declamping, the blood pressure has to be reduced to normal values to avoid postoperative hyperperfusion syndrome. This is enabled by tapering urapidil until normal blood pressure is achieved.

It has been shown that cerebral oxygenation measured by near infrared spectroscopy is reduced by intravenous application of norepinephrine. Otherwise, intravenous nitroglycerine increases cerebral oxygenation during cardiopulmonary bypass. Hence, cafedrine/theodrenalin and urapidil may also have an effect on cerebral perfusion. In this prospective randomized study the effect of cafedrine/theodrenalin and urapidil on cerebral oxygenation measured by near infrared spectroscopy is investigated.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for carotid endarterectomy

Exclusion Criteria:

* Cerebral disease
The BALANCED Anaesthesia Study

General anaesthesia is a reversible drug-induced coma. Too little can result in patients being partially conscious during surgery; too much can slow recovery after surgery. There is a range of drug doses that can be used and some anesthesiologists use more than others. There is no convincing evidence that any particular dose within the usual range is better. Consequently, there are no guidelines on the best depth of anaesthesia. This study will determine whether general anesthetic concentrations at the low end of the usual range are better than those at the high end.

Participants will randomly be assigned to lighter or deeper general anesthesia. The first day after surgery, two short questionnaires about recovery and memories of the surgery will be completed. During the rest of the participant's hospital stay, a survey about how one feels will be completed.

There will be two telephone contacts after discharge from the hospital. One month after surgery three questionnaires will be completed about performing daily tasks, how you feel and memories of the surgery. Then one year after surgery pain will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥60 years
* ASA physical status 3 or 4
* surgery expected to last ≥2 hours
* post-operative hospital stay expected to be ≥2 nights
* general anaesthesia with or without major regional block
* able to monitor BIS throughout anaesthesia

Exclusion Criteria:

* Unable to monitor BIS (e.g. cranial or intracranial surgery)
* unable to consent
* surgery with 'wake-up' test
* propofol infusion for part or all of maintenance of anaesthesia ('total intravenous anaesthesia')
* previous enrolment in Balanced study
Anterior Chamber Versus Scleral Fixated Intraocular Lens: Long-term Vision and Safety Outcomes

This is a prospective comparative non-randomized cohort study to understand the long-term vision outcomes, safety, and stability of anterior chamber intraocular lenses (AC IOLs) vs. scleral-fixated intraocular lenses (SF IOLs).

On the pre-operative visit, specular microscopy, biometry, applanation tonometry and ocular coherence tomography (OCT) will be performed. The patient will then undergo treatment as per surgeon's discussion/ decision with the patient for implantation of an AC-IOL or SF-IOL. Participation in the study will not impact the management plan in any way. Specular microscopy will be performed wit the CellChek XL (Konan Medical, Irvine, CA). Biometry will be performed with the IOLMASTER (Carl Ziess Meditec, Jena, Germany), and anterior segment and macular OCT will be performed with the Cirrus-HD OCT (Carl Zeiss Metidec, Jena, Germany). EC count, OCT (macula and anterior segment) and specular microscopy will be performed at baseline, week 1, month 1, month 6, 12 and 24.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are undergoing AC IOL or SF IOL implantation for any reason (including but not limited to aphakia, posterior capsular rupture, primary or secondary lens dislocation/ subluxation or IOL exchange).
2. Patients on whom imaging (specular microscopy, biometry and OCT) can be performed without delaying their treatment (i.e. based on availability of operator).
3. Decision makers able to provide informed consent.

Exclusion Criteria:

1. Inability to obtain adequate imaging, in the form of specular microscopy and OCT data at baseline.
2. Patients unable to attend follow-up visits.
3. Patients who have had a corneal transplant prior to secondary IOL implantation.