cyrilzakka/clinical-trials huggingface dataset:
Modulation of Reproductive Microbiota by Ligilactobacillus Salivarius CECT5713

The objective of the project is to elucidate if the oral administration of Ligilactobacillus salivarius CECT5713 is capable of improving the rates of term pregnancies in couples with infertility problems of unknown cause. On the other hand, the project is aimed to detect microbiological, immunological and hormonal markers that allow the identification of couples in which the administration of the strain could be particularly effective. This is a randomized, double-blind, parallel-group controlled nutritional intervention study. The intervention (Ligilactobacillus salivarius CECT5713 or placebo) will be performed during the 6 months prior to the fertility treatment and during the first IVF cycle (estimated 1-2 months). In case of pregnancy, the woman will continue the treatment until 12 weeks of gestation.


Eligibility Criteria:
Inclusion Criteria:

* legal age
* Intention to achieve a pregnancy, but without achieving it;
* Be willing to undergo in vitro fertilization treatment;
* Be on the waiting list for the IVF cycle with an expected waiting time \> 5 months.

Exclusion Criteria:

* Sterility in one of the members of the couple (azoospermia; impermeability of the fallopian tubes...).
* Genitourinary malformations;
* Concurrence of other severe diseases (e.g.: cancer, AIDS, ALS, morbid obesity...) or uncontrolled diseases (inflammatory bowel diseases, diabetes...).
* Treatment/intervention other than the planned IVF after the start date of the intervention.
* Antibiotic treatment at the start date of the intervention.
* Intention to consume another probiotic supplement in the following 3 months.
* Participation in another clinical trial.
* Allergic/intolerant to the excipient.
* Inability to understand the informed consent form and/or to follow the basic instructions of the trial.
An Exploration of the Impact of Pain Education on GP Practice Staff

The aim of the research project is to quantify GP practice staffs' knowledge of chronic pain, their attitudes towards people with chronic pain and their management of a hypothetical patient with chronic pain, following a pain education session.

The study also seeks to explore GP practice staffs' experience of receiving the pain education, their understanding of pain following the education and if they perceive the education session has impacted upon their daily practice.

Inappropriate, biomedical based views of chronic pain are commonly held by health care professionals (HCPs) and these in turn can result in patients receiving sub-optimal care out of step with current guidelines. It has been found that healthcare professionals management techniques did not reflect recognised treatment guidelines and this was associated with their biomedical view of chronic pain.

Pain education/training sessions for health care staff may be an important step towards improving patient care for chronic pain. It has been found that there was improvement in nurses' knowledge after 2 different pain education sessions delivered to nurses however there was no long term follow up. Furthermore, no studies have targeted all members of staff at a GP surgery who will interact with the patient, and thus impact upon the care they receive.

Pain Neuroscience education (PNE) is an approach to pain education which uses pain science information to shift the belief system of the receiver away from a biomedical understanding of pain to a more biopsychosocial understanding of pain.

A number of studies have shown that this education can decrease biomedical attitudes in health care students. Thus, it may be that this education could produce similar positive effects in GP practice staff that could have positive implications for the care of patients with chronic pain.

Thus this study aims to assess the impact on attitudes and beliefs of pain education upon staff at a GP surgery in Middlesbrough. Attitudes and beliefs will be assessed before and after the delivery of education. In addition participants will be invited to attend one of two focus groups to further discuss their findings or thoughts about the lecture.

Eligibility Criteria:
Inclusion Criteria

* Clinical non-NHS staff at a Middlesbrough GP Surgery.

Exclusion Criteria

* Non-clinical staff at a Middlesbrough GP surgery and staff who are not directly employed by the Surgery.
A Clinical Trial Evaluating Efficacy and Safety of MC2-01 Cream

This trial is a randomized, investigator-blind, multicentre, vehicle- and comparator-controlled, parallel-group trial with the purpose of evaluating efficacy, safety and convenience of the MC2-01 cream.

The MC2-01 Cream is designed for optimal patient satisfaction - it quickly absorbs into the skin leaving it nicely moisturized allowing patients to move on in daily routines. In this trial, the MC2-01 cream will be compared to a marketed product CAL/BDP combination and vehicle. The purpose of the trial is to compare the clinical efficacy, safety, and convenience of this cream to the marketed product. The trial will include a 8-week treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Provided written informed consent
* Generally healthy males or non-pregnant females, of any race or ethnicity, who are at least 18 years of age at the time of screening
* Have a clinical diagnosis of plaque psoriasis (psoriasis vulgaris) of at least 6 months duration that involves the trunk and/or limbs that is amenable to topical treatment with a maximum of 100 g of trial medication per week
* Have a PGA of disease severity of mild or moderate on the body (trunk and/or limbs)
* An mPASI score of at least 2
* Have a treatment area involving 2- 30% of the body surface area (BSA)

Exclusion Criteria:

* Current diagnosis of unstable forms of psoriasis
* Other inflammatory skin disease in the treatment area that may confound the evaluation of the psoriasis vulgaris
* Presence of pigmentation, extensive scarring, pigmented lesions or sunburn in the treatment areas
* Planned exposure to either natural or artificial sunlight
* History of hypersensitivity to any component of the test product or reference product
* Current or past history of hypercalcemia, vitamin D toxicity, severe renal insufficiency, or severe hepatic disorders
* Systemic treatment with biological therapies
* Use of systemic treatments that suppress the immune system and other systemic chemotherapeutic antineoplastic therapy within 4 weeks prior to the baseline visit and during the trial
* Use of phototherapy within 4 weeks prior to Visit 1/Baseline and during the trial;
* Use of topical treatments, except for emollients and non-medicated shampoos, with a possible effect on psoriasis within 2 weeks prior to Visit 1/Baseline
* Clinical signs of skin infection with bacteria, viruses, or fungi
* Known Human Immunodeficiency Virus (HIV) infection
* Any chronic or acute medical condition that may pose a risk to the safety of the subject, or may interfere with the assessment of safety or efficacy in this trial
Study to Improve the Treatment of Patients With Heart Failure by General Practitioners

The purpose of this study is to determine whether it is possible to improve the care of general practitioners for patients with heart failure. The investigators try to reach that goal by training the GP's for 90 minutes in uptitrating the recommended medication according the guidelines. After 6 month the investigators ask the patients to fill out a questionary. The investigators ask them about their quality of live.


Eligibility Criteria:
Inclusion Criteria:

* Do have a general practitioners diagnosis heart failure mentioned twice in the electronical medical file.

Exclusion Criteria:

* Incapacitated patients with a life expectancy of less than 2 months
* Seniles
* Patients who do not speak the Dutch language
First in Human Study in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of BAY1214784

This study is a first in human study that will investigate the safety, tolerability and pharmacokinetics of ascending single doses of BAY1214784 using a placebo controlled, randomized, single center design. In addition the bioavailability of two different liquid formulations will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female subjects
* Age 45 to 65 years
* Body mass index (BMI) above/equal 20 and below/equal 30 kg/m2
* Postmenopausal state

Exclusion Criteria:

* Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
* Known or suspected malignant or benign tumors
* Known or suspected liver disorders, relevant kidney diseases, known cardiovascular diseases, known metabolic disorders
* Regular use of medicines
Pharmacology Study of Aerosolized Liposomal 9-Nitro-20 (S)-Camptothecin (L9NC)

The purpose of this study is to determine the amount of Aerosolized Liposomal-Nitro-20 (S)-Camptothecin (L9NC) in a patients blood and tumor.

Patients on this study are being asked to allow the researchers to take a piece of some normal endometrial tissue and tumor tissue. No additional endometrial tissue will be taken for this study other than what is surgically indicated to resect the patients tumor completely. Prior to this surgery, patients will receive one more dose of L9NC in the outpatient clinic in the same manner as the other L9NC treatments they have received. After the tumor has been removed, the tissue will be examined by a pathologist, who will take what is needed to diagnose the residual disease. What is not needed for patient care will be used for research. A piece of the tumor and some normal endometrial tissue surrounding the tumor will be sent to the Investigational Drug Program laboratory, which is located in the Cancer Center, to measure the amount of drug that is left in the patients tumor. The patients tissue will be kept until all tissues are collected from all patients, which could take up to 10 years. The tissue will not be used for any other purpose. The samples will be labeled with the patients initials.

Eligibility Criteria:
Inclusion Criteria:

* Patients participating in Phase II Study of Aerosolized Liposomal 9-Nitro-20 (S)- Camptothecin (L9NC) in Patients with Metastatic or Recurrent Cancer of the Endometrium are eligible.

Exclusion Criteria:

* Not specified.
Clinician Training Program to Integrate Digital CBTI Into Routine Psychotherapy

The goal of this study is to pilot test and refine a training program for licensed therapists to promote the integration of digital cognitive behavior therapy for insomnia (dCBTi) into their routine mental health care services.


Eligibility Criteria:
Therapist Criteria:

Inclusion Criteria:

* Licensed mental health clinicians
* Have a clinical care model that includes seeing patients weekly or biweekly
* Provide therapy in English
* Treat patients with depression and/or anxiety
* Can identify 1-2 patients who are willing to consent to be training cases.

Exclusion Criteria:

* Not meeting all of the inclusion criteria

Patient Criteria:

Inclusion Criteria:

* Aged 18+ years old
* Receive weekly or biweekly therapy from participating study therapist
* Identify improving sleep as a goal for treatment and experience insomnia (Insomnia Severity Index score greater than or equal to 10)
* Have daily access to a smartphone, tablet, or computer
* Can read, write, and speak in English

Exclusion Criteria:

* Conditions known to make study treatment less effective (e.g., current chronic medication use known to interfere with sleep, alcohol or substance use disorder, thought disorder)
* Conditions for which dCBTi is a safety risk (e.g., bipolar disorder, excessive daytime sleepiness)
* Current psychotherapy for insomnia
Influence of Food-intake on Desmopressin Oral Tablets and MELT-formulation

Alarm-treatment as well as Desmopressin, a synthetic analogue of human vasopressin, are considered the only evidence-based medicine (EBM) IA treatments in monosymptomatic nocturnal enuresis (MNE). Desmopressin exists in three different formulations for ambulant use: nasal spray, tablet and lyophilisate (MELT) each with differences in bioavailability (spray 2%, tablet 0.2%, MELT 0.5%). There 's insufficient evidence to confirm the actually used bioequivalent doses ( 10µg spray = 120µg MELT= 0.2mg tablet).

Although so frequently used, very few pharmacokinetic and -dynamic data on desmopressin are available for children.

Due to prolonged half life, associated with waterintoxication,the nasal spray has a black box warning from the FDA and is no longer recommended . For some authors oral formulations appear to be a safer alternative. However, based on clinical experience of less response rate with oral formulations, lower biodisponibility is suspected. Adult research confirms low bioavailability of tablets but also show major influences by food-intake and changes in gastro-intestinal motility.

To achieve maximum efficacy, recommendations are to take desmopressin tablet 1 hour before bedtime and 2 hours after meal: this is unrealistic in schoolaged children since there never is 3 hours between evening meal and bedtime.

In 2005 a dose response study demonstrated superior pharmaco-kinetic and dynamic properties for desmopressin Lyophilisate MELT formula.

Since these results implicate superior action of MELT, often a change to MELT is recommended if there is a suboptimal response with tablet: sublingual absorption would eliminate the influence of food-intake.

However, for this statement there's no evidence, since these tests were all conducted in children in fasting condition. Only one clinical study demonstrates bioequivalence for MELT and tablet.

Hypothesis is that desmopressin MELT formulation has a better bioavailability when administered together with meal due to its sublingual absorption.


Eligibility Criteria:
Inclusion Criteria:

* children aged 6-16 years old
* with MNE and nocturnal polyuria
* treated with desmopressin tablet, non or partial responders, for whom change to MELT formulation is indicated according to the international standard guidelines.

Exclusion Criteria:

* history of urologic disease, diurnal urinary incontinence, diabetes insipidus, urinary tract infection, clinically significant disease
* No systemic use of antibiotics, diuretics, other medication that influences urinary concentrating mechanism
* abnormalities of oral mucosa which could influence drugrelease or absorption
Analgesia Nociception Index-guided Anesthesia and Standard Anesthesia

The primary purpose of this study is to compare the analgesia nociception index-guided anesthesia and standard anesthesia on remifentanil requirement in desflurane anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of gastric cancer

Exclusion Criteria:

* Conversion to open laparotomy
* Prior opioid abuse
* Prior infection
* Cardiac arrythmia
Comparison of Rubber Band Ligation and Haemorrhoidectomy in Patients With Symptomatic Haemorrhoids Grade III

Rationale: Haemorrhoidal disease is one of the most common anorectal disorders which affects nearly half of the general population1. Given the current numerous modalities the obvious question which needs to be answered is which treatment is the best. An interesting conclusion from a recent systematic review regarding operative procedures for haemorrhoidal disease is that all procedures have their own advantages and disadvantages. There is a need for evaluating treatment from the patient's point of view and transparency in surgical and non-surgical treatment outcome. So far there is no sufficiently large trial that meets that demand.

Objective: To establish the best treatment of patients with symptomatic haemorrhoids grade III: haemorrhoidectomy versus rubber band ligation (RBL). Patient bound effectiveness, clinical effectiveness and cost-utility of both treatments is compared; primary outcome is quality of life at 24 months measured with the EQ-5D-5L with Dutch rating and recurrence at one year post procedure. The assumption is that treatment with rubber band ligation is equally effective in comparison with haemorrhoidectomy in terms of quality of life.

Study design:Multicentre randomized controlled non-inferiority trial with cost-utility analysis. Two treatment protocols are compared: haemorrhoidectomy and rubber band ligation.

Study population: Patients aged ≥ 18 years with symptomatic haemorrhoids gr III. Patients are recruited in multiple clinics during 18-24 months.

Intervention: Participants are allocated to either rubber band ligation or haemorrhoidectomy.

Main study parameters/endpoints: Primary outcome measure is quality of life at 24 months measured with the EQ-5D-5L with Dutch rating and recurrence at one year post procedure. Secondary outcomes are: complaint reduction with proctology specific patient-related outcome measure (HSS, PROM, PROMHISS), vaizey score, resumption of work, pain (VAS), complications and recurrence at two years.


Eligibility Criteria:
Inclusion Criteria:

* Haemorrhoids grade III (Goligher classification)
* Age 18 years and older
* Sufficient understanding of the Dutch written language (reading and writing)

Exclusion Criteria:

* Previous rectal or anal surgery with the exception of rubber band ligation
* Previous surgery for haemorrhoids (at any time)
* More than one injection treatment for haemorrhoids in the past 3 years
* More than one rubber band ligation procedure in the past 3 years
* Previous rectal radiation
* Pre-existing sphincter injury
* Inflammatory bowel disease
* Medically unfit for surgery or for completion of the trial (ASA\>III)
* Pregnancy
* Hyper-coagulability disorders
* Patients previously randomised to this trial
* Not able or willing to provide written informed consent
ACP-Family Programme for Palliative Care Patients and Their Family Member

The goal of this clinical trial is to test the effectiveness of a structured, family-supported, patient-centred advance care planning (ACP) in palliative care patients and their family members. The main question it aims to answer is: • the effectiveness of the ACP intervention on promoting end-of-life decision making and psychological outcomes in patients and family members. Participants will be assigned to either the ACP-Family group (ACP-Family) to receive a structured, family-supported, patient-centred ACP intervention or usual palliative care (ACP-UC) at the hospital. Researchers will compare the ACP-Family and ACP-UC groups to see if the ACP-Family group will produce better outcomes than the ACP-UC group.

This is a two-arm parallel randomized controlled trial with follow-ups at 6 and 12 months, aiming to examine the effectiveness of a structured, family-supported, patient-centred ACP programme for adult palliative care patients and their families.

This study will randomize 170 palliative care patients and their family members to the structured, family-supported, patient-centred ACP programme (ACP-Family) or ACP service under usual care (ACP-UC). Within one month, they will receive two 60-90 minute sessions of the family-supported, patient-centred ACP programme covering five elements in ACP discussions delivered by a trained ACP facilitator; or usual care provided by the respective hospital. All discussion sessions in the ACP group will be recorded for quality checking.

It is hypothesized that, as compare to ACP-UC, the ACP-Family group will significantly improve EOL decision making outcomes including (i) prediction accuracy of patient's treatment preferences between palliative care patients and their family members, (ii) new ACP documentation in palliative care patients, and (iii) family-reported patient's EOL care preferences was respected for deceased patients; and 2. psychological outcomes including family member's decision-making confidence, anxiety, depression, and quality of communication regarding EOL, and patient's decisional conflict, and perceived quality of communication regarding EOL.

In addition, 3. we also explore the potential moderating effect of type of hospital setting on the effectiveness of the ACP-Family on these patient and family outcomes.

Eligibility Criteria:
Inclusion Criteria:

Patient:

* aged ≥ 18,
* receiving palliative care at the study hospitals,
* able to communicate in Cantonese, and
* cognitively intact (Abbreviated Mental Test (AMT) score ≥ 7)13 at the time of recruitment

Family member:

* aged≥ 18
* able to communicate in Cantonese, and
* nominated by the patient who is likely to make substituted decisions for the patient in future health care issues.

Exclusion Criteria:

* are engaging in ACP discussion with healthcare professionals in the hospital at the time of recruitment.
Glutamine PET Imaging in LAM

In this study, subjects with spontaneous or tuberous sclerosis complex associated lymphangioleiomyomatosis (LAM) who have not been started on therapy with mTOR inhibitors such as sirolimus or everolimus to undergo a PET/CT scan using an novel PET tracer that may better evaluate disease activity in LAM subjects both before and after the initiation of mTOR inhibitor therapy will be enrolled. The procedure for each scan will be similar, involving one administration of the novel tracer C11-glutamine followed by a whole body PET/CT scan.

Objectives This is a hypothesis-driven prospective pilot study of the targeted PET reagent 11C-Glutamine in LAM.

The objective is to test the hypothesis that 11C-Glutamine PET/CT will demonstrate uptake within the lungs and/or associated neoplasm of patients with LAM and that this effect will be modified by treatment with mTOR inhibitors.

Rationale Our rationale is that 11C-Glutamine PET/CT may provide an improved ability to diagnose LAM, as well as predict and monitor treatment response to mTOR inhibitors.

Aims Test the hypothesis that 11C-Gln PET imaging of the lungs in humans will reflect the known "glutamine addiction" seen in mechanistic preclinical studies of LAM. As a result, PET imaging will show increased tracer uptake in affected areas of diseased lungs and will show reduced uptake after initiating treatment with mTOR inhibitors.

Approach: We will evaluate 11C-Glutamine PET/CT uptake in patients with known LAM, and if possible, we will test subjects again after 8 weeks of mTOR inhibitor therapy (either sirolimus or everolimus).

Eligibility Criteria:
Inclusion Criteria:

1. Female subjects
2. ≥ 18 years of age
3. Diagnosis of LAM via either a. Histopathologic diagnosis b. Compatible CT chest and one of the following i. Tuberous Sclerosis Complex\* ii. Angiomyolipoma or lymphangioma iii. Chylous Effusion iv. Serum VEGF-D level \>800 pg/mL

   * The diagnosis of TSC will be based on the presence of at least two major criteria or one major and one or more minor features per published guidelines.(30)

Exclusion Criteria:

1. Patients with any known intrathoracic cancer (primary lung cancer or metastatic disease) or undergoing active treatment for malignancy
2. Patients with use of investigational therapies for LAM either currently or in the prior 3 months
3. Patients with body weight ≥400 pounds or body habitus or disability that will not permit the imaging protocol to be performed
4. Patients known to be pregnant or breastfeeding
5. Patients with clinically active known or suspected pulmonary infection of any type
6. Patients known or suspected to have any inborn error of metabolism
7. Patients with known type I diabetes mellitus
8. Patients who cannot have a peripheral IV for any reason
9. Patients who cannot lie flat for the duration of the PET scan
10. Patients who are claustrophobic
11. Patients with a prior allergy to contrast agents or to PET tracers