cyrilzakka/clinical-trials huggingface dataset:
Metformin in Breast Cancer, Visualized With Positron Emission Tomography

The general purpose of the trial is to investigate whether metformin is taken up into the breast tumor. Studies in the last few years have shown an effect of metformin on cell proliferation on breast cancer. It is though unclear whether the effect on tumor is direct, indirect or a combination of the two. The investigators plan to:

* investigate if metformin is taken up in breast cancer using our novel 11C-metformin tracer and positron emission tomography (PET)
* investigate whether the uptake is correlated to the amounts of organic cation transporters (OCT1-3, MATE 1 \&2 and PMAT) using quantitive polymerase chain reaction (qPCR).


Eligibility Criteria:
Inclusion Criteria:

* over 50 years
* C. mammae
* Tumor size: \> 10 mm in diameter
* Unilateral cancer
* WHO performance status 0-1

Exclusion Criteria:

* Severe heart- or kidney failure
* Pregnant or breast feeding
* If the patient is found not eligible for participation in the study på principal investigator
Impact of B. Bifidum 900791 Intake on Breast Milk Characteristics of Obese Mothers

Human breast milk harbours a specific microbiota including bacteria from the Lactobacillus and Bifidobacterium genera, that contribute to the bacterial colonization of the infant gut in the post-natal period. An entero-mammary pathway has been suggested by which selected bacteria from the maternal gut would be transmitted to the mammary gland through dendritic cell trafficking by the lymphatic pathway. Accordingly, some studies have detected the presence of probiotic strains in breast milk from mothers who were consuming them. The administration of probiotic supplements to lactating mothers has also been shown to modulate milk concentrations of inflammatory markers and metabolic hormones, impacting positively the infant health. Noteworthily, many of these inflammatory and hormonal biomarkers are altered in the breastmilk from pre-pregnancy obese mothers, compared with these who were normal-weight, possibly affecting the infant health. It is unclear whether the breast milk microbiota of obese mothers is altered and the impact of probiotic administration on the breastmilk microbiota and on the normalization of breastmilk alterations in obese mothers is unknown.

Based on these antecedents, the aim of this study is to determine if the administration of a B. bifidum 900791-containing foodstuff to mothers during the perinatal period normalizes the breast milk concentrations of interleukin (IL)-6, C-Reactive Protein (CRP), insulin, adiponectin and resistin, and the microbiota of obese mothers, compared with normal-weight mothers.


Eligibility Criteria:
Inclusion Criteria:

* Women in their last month of pregnancy, who were normal-weight (18.5\<BMI\<25kg/m2) or who were obese (BMI\>30kg/m2) before pregnancy, and their children

Women recruited should have expressed their wish to have their child through normal delivery, and to breastfeed at least during the first month post-partum.

Exclusion Criteria:

* Women with chronic diseases (type 2 diabetes, renal diseases, autoimmune diseases, tumor, chronic inflammatory diseases, etc.).
* Women with a history of digestive surgery.
* Women whose children are hospitalized more than 24hours in the neonatal unit
* Women who require antibiotic treatment during the perinatal period.
Clinical Effects of Bacillus Containing Oral Hygiene Products on Gingivitis: a Randomized Controlled Trial

Aim: Evaluating the clinical effects of a Bacillus subtilis, Bacillus megaterium and Bacillus pumulus containing toothpaste, mouthwash and toothbrush cleaner versus a placebo in patients with generalized gingivitis.

Materials and methods: In this double-blind placebo-controlled randomized clinical trial generalized gingivitis patients who were systemically healthy and who did not smoke were included. They used a placebo or probiotic Bacillus containing toothbrush cleaner for 8 weeks. Primary outcome measures of interest were plaque and gingivitis index, secondary outcome measures were pocket probing depth and bleeding on probing.

The administration of micro-organisms to improve the human health was already promoted by the Nobel prizewinning scientist Eli Metchnikoff in the beginning of the 20th century. However, it took several decades for this subject to become a topic of interest in medicine. At this moment these micro-organisms are called "probiotics" and defined as "living microorganisms which, when administered in adequate amounts, confer a health benefit for the host" (http://www.who.int/foodsafety/publications/fs_management/en/probiotics.pdf). Over the past decade probiotics have been extensively investigated from the perspective of oral health. It was shown that probiotics have the capacity to reduce mutans streptococci counts in saliva and/or plaque during their usage, that they have a positive influence on bad breath and that they can improve the results of scaling and root planing in periodontitis patients. A positive effect of probiotic usage on plaque accumulation and gingivitis measurements in gingivitis patients was also shown.To the investigators knowledge, at this moment no trials are available describing the effect of other probiotic genera on gingivitis. Since it is clear that probiotic effects are strain, dosage and mode of application dependent, the aim of this study was to evaluate the use of a probiotic toothpaste, mouthwash and toothbrush cleaner with Bacillus subtilis, Bacillus megaterium, and Bacillus pumulus versus a placebo in patients with generalized gingivitis.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with plaque-induced gingivitis
* a pocket probing depth not more than 5 mm
* at least 20 natural teeth
* no history of periodontal therapy or previous use of antibiotics or anti-inflammatory medication within the preceding 6 months

Exclusion Criteria:

* patients with hematologic disorders, or other systemic illness
* pregnant and lactating females
* patients undergoing orthodontic treatment
* those with smoking habits were excluded.
Evaluation of Salivary Level of miR-155 and IL-10 in Oral Lichen Planus Patients Before and After Treatment With Topical Corticosteroid

Thirty patients will be recruited from the outpatient clinic of the faculty of dentistry.fifteen systemically healthy individuals with normal mucosa and fifteen atrophic/erosive oral lichen planus patients. Oral lichen planus patients will be treated with a topical steroid and miR-155 and IL-10 will be assessed in saliva before and after 4 weeks of topical steroids use


Eligibility Criteria:
Inclusion Criteria:

* Patients clinically and histopathologically diagnosed as having atrophic/erosive OLP.
* Patients free from any other oral lesions
* cooperative patients who agrees to take the supplied medications.
* Patients who are systemically healthy

Exclusion Criteria:

* Patients suffering from any systemic disease.
* Treatment with any systemic treatment such as systemic steroids, other immunosuppressive drugs or non-steroidal anti-inflammatory drugs at least eight weeks.
* Treatment with any oral topical medications for at least four weeks prior to the study.
* Pregnant and lactating women.
Misoprostol for Second Trimester Termination of Pregnancy

To compare the efficacy of two different dose regimens of misoprostol administered vaginally in combination with mifepristone in second trimester termination of (non)viable pregnancy.

The study was designed as a prospective double blinded randomised controlled trial, comparing 200µg to 400 µg misoprostol given vaginally at four hour intervals, starting 36-48 hours after the oral administration of mifepristone 200 mg at a gestational age between 14 to 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Women with a gestational age between 14 to 24 weeks, confirmed by ultrasound, requesting termination of pregnancy

Exclusion Criteria:

* No informed consent
* Mifepristone allergy
* Chronic adrenal gland failure
* Kidney failure
* Liver failure
* Chronic use of corticosteroids
* COPD not responsive to treatment
* Cardiovascular disease
* Glaucoma
Effect of FES of Back Muscles on Spinal Posture and Gait in Hemiplegia

Hemiplegic patient have unbalanced posture because paralysis leads to muscle atrophy, which then causes an unbalanced alignment in the structure of spinal joints. Evaluation and therapy of postural alignment are important as early predictable factors in the overall daily function of stroke patients

To evaluate whether the application of FES of the back muscles in hemiplegic affect spinal posture and/or gait

Eligibility Criteria:
Inclusion Criteria:

* 20 children with c.p. hemiplegia
* moving and performing daily activities independently
* no problems in terms of verbal communication
* no physical and cognitive restrictions.

Exclusion Criteria:

* Having cognitive impairment as tested by the Mini-Mental State Examination (with scores \< 24)
* Uncontrolled hypertension (systolic blood pressure \> 160 mmHg)
* Joint replacement
* Incontinence
Efficacy of Shotblocker in Spinal Needle Related Pain

This was a single-blind, randomized controlled trial. Seventy-six patients who underwent spinal anesthesia for surgery were randomized into the Shotblocker group or Control group. Before the insertion of a 25-gauge spinal needle, Shotblocker was applied just before the spinal needle insertion in the Shotblocker group. 10-cm visual analog scale to evaluate the pain intensity of spinal needle insertion and a five-point scale for patient satisfaction were compared between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surgery

Exclusion Criteria:

* contraindications to regional anesthesia
* refusal of the patient's regional anesthesia
* intellectual disabilities that prevented completion of a visual analog scale (VAS)
Effect of General Anesthesia on Early Postoperative Cognitive Function in Cesarean Section

Cognitive dysfunction is the impairment of the mental process of perception, memory and information processing. The preoperative cognitive state is important, as mild cognitive impairment may be worsened following a cesarean section. Our study will aim to assess the incidence of early cognitive dysfunction after elective and emergent cesarean section under general anesthesia.

Mechanisms that lead to cognitive decline after anesthesia and surgery remain still unclear and mixed. Some studies suggested that an important role is played by the immune response to surgery. The inflammatory response could contribute to the development of postoperative cognitive decline (POCD0 through secretion of cortisol, cytokines, and other inflammatory mediators. Comparing the effects of general and spinal anesthesia on pregnant patients undergoing an elective cesarean section, found no cognitive change after both anesthesias. Our observational comparative study will be carried out at Beni Suef University Hospital. We will compare early cognitive functions undergoing general anesthesia in patients undergoing elective and emergency cesarean section.

Eligibility Criteria:
Inclusion Criteria:

* Women in reproductive age period between 25 and 35 years
* Women booked for an elective or emergency cesarean section.

Exclusion Criteria:

* Mental disorder preoperative
* Medical conditions ( as Hypertension or diabetes or cardiac diseases)
Extension Study to VEG105192 to Assess Pazopanib in Patients With Advanced/Metastatic Renal Cell Cancer

This is an open-label, international, multi-center study designed to provide access to pazopanib for subjects who have been enrolled in the Phase III renal cell carcinoma study (VEG105192) and have progressed on placebo. Subjects will receive 800 mg pazopanib once daily. The study treatment will continue until subjects experience disease progression, unacceptable toxicity, withdrawal of consent, or death. The primary objective of the study is to evaluate the safety and tolerability of pazopanib for the treatment of renal cell carcinoma. The secondary objectives of the study are to assess response rate (defined as complete response or partial response), progression-free survival, and overall survival. Response rates will be collected per investigator assessment (no central review). Subjects will have a CT/MRI scan every 6 weeks until week 24 and every 12 weeks thereafter.


Eligibility Criteria:
Inclusion criteria:

* Progressed from VEG105192 study treatment
* Patient's VEG105192 was placebo
* Baseline has good organ function

Exclusion criteria:

* No brain metastasis
VAC and Conventional Dressing in the Healing Process of Necrotizing Fasciitis

Find out the best management of Necrotizing Fasciitis after surgical debridement

Necrotizing fasciitis is a life-threatening condition that can occur as a result of trauma or foreign bodies in surgical wounds as well as idiopathically. Necrotizing fasciitis is characterized by a progressive infection in fascial planes with necrosis of the subcutaneous tissue. Necrotizing fasciitis affects the extremities more frequently than central areas. Risk factors for necrotizing fasciitis include diabetes mellitus, trauma wound infections, decubitus ulcers, alcoholism, carcinoma, peripheral vascular disease, smoking, and intravenous drug abuse. A varieties of micro-organisms, including gram-positive group A streptococcus, haemolytic streptococci, and staphylococcus aureus; gram-negative Enterobacteriaceae, Escherichia coli, Klebsiella spp., and Proteus spp.; anaerobes including Peptostreptococcus, Clostridium, and Pacteroides; and fungi such as Candida and acid-fast bacteria have all been implicated in the pathogenesis of Necrotizing fasciitis.

Necrotizing fasciitis is a surgical emergency for detoxification by debridement with good antibiotic coverage. It has mortality rate reaching 20-30% , this mortality rate is high and requires prompt diagnosis, antibiotic treatment and extensive necrosectomy up to intensive care units admission in some cases, the aim of our prospective analysis is to assess with a hypothesis-generating and exploratory purpose the possible role of VAC versus ordinary dressings in the wound therapy of Necrotizing Fasciitis in terms of expected time for wound closure and survival rate.

Eligibility Criteria:
Inclusion Criteria:

* Immunocompromised patients such as; diabetic, HIV and leukaemia.

And other chronic debilitating diseases.

Exclusion Criteria:

* Necrotizing Fasciitis of Head and neck and upper limbs.
The Effect of Gemcabene on Insulin Sensitivity in Nondiabetic Subjects

The purpose of this study is to determine the effect of gemcabene on insulin sensitivity as defined by average glucose disposal rate.


Eligibility Criteria:
Inclusion Criteria:

* Good health, as determined by medical history, physical examination, EKG and clinical laboratory assessments
* Males; and females of non-reproductive potential
* Obesity
* Non-diabetic

Exclusion Criteria:

* Use of any medication considered unacceptable by the clinical investigators during the 14-day period before the start of Day 1. Hormone Replacement Therapy is acceptable.
* Use of a lipid-lowering agent (niacin, fibrates, statin) during the 8 weeks before screening
* Use of any anti-diabetic medications
* Use of any steroid medications
* Donation of any blood or plasma product or participation in another study in the 30 days prior to Day 1
* If female, pregnant, lactating or of childbearing potential; and
* History of significant reaction to any fibrate lipid-lowering agent
Introducing Mifepristone-Misoprostol for Menstrual Regulation in Public Sector Facilities in Bangladesh

This open-label study is being conducted to determine whether a mifepristone-misoprostol regimen for uterine evacuation which consists of 200 mg mifepristone followed 24 hours later by 800 mcg buccal misoprostol is acceptable to women and providers and feasible for introduction in public sector facilities in Bangladesh. It will also determine the feasibility of women availing the option of taking their dose of misoprostol outside the facility.

This open-label study is being conducted to determine whether a mifepristone-misoprostol regimen for uterine evacuation which consists of 200 mg mifepristone followed 24 hours later by 800 mcg buccal misoprostol is acceptable to women and providers and feasible for introduction in public sector facilities in Bangladesh. It will also determine the feasibility of women availing the option of taking their dose of misoprostol outside the facility.

The specific aims of this project are as follows:

* Assess whether a uterine evacuation regimen that allows women the option of taking their misoprostol outside the facility and which consists of 200 mg mifepristone followed 24 hours later by 800 mcg buccal misoprostol is feasible for introduction in a range of clinical settings in government facilities in Bangladesh;
* Determine whether a mifepristone-misoprostol regimen for uterine evacuation is acceptable to women and providers; and
* Determine what proportion of women, if offered the choice, would prefer to take misoprostol in the facility and what proportion would prefer to take it outside the facility.

Eligibility Criteria:
Inclusion Criteria:

* Be willing and able to sign consent forms;
* Be eligible for menstrual regulation (MR) services according to clinician's assessment;
* Be willing to undergo a surgical evacuation if necessary;
* Be willing to provide a urine sample prior to administration of the mifepristone
* Have ready and easy access to a telephone and
* Agree to comply with the study procedures and visit schedule

Exclusion Criteria:

* • Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass;

  * Chronic renal failure;
  * Concurrent long-term corticosteroid therapy;
  * History of allergy to mifepristone, misoprostol or other prostaglandin;
  * Hemorrhagic disorders or concurrent anticoagulant therapy;
  * Inherited porphyrias; or
  * Other serious physical or mental health conditions.
International Multi Centre Randomized Clinical Trial Of Anticoagulation In Children Following Fontan Procedures

Compare heparin/warfarin to ASA for thromboembolic prophylaxis in the first two years following Fontan procedures.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is scheduled to have a Fontan or modified Fontan procedure

Exclusion Criteria:

1. Requirement for long-term anticoagulation (e.g., prosthetic heart valve, active DVT)
2. Risk of significant bleeding or any other known medical contraindication to Heparin, Warfarin, or ASA.
3. Inability to supervise therapy due to social or geographical reasons.
4. Pregnancy or potential pregnancy during study period
Randomized Controlled Trial to Test an Alzheimer's Family Caregiver Intervention in Vietnam

This is a cluster randomized controlled trial to determine the feasibility and preliminary effectiveness of culturally adapted psychosocial intervention for Alzheimer's family caregivers in Vietnam. The psychosocial intervention is being compared with an enhance control condition.


Eligibility Criteria:
Inclusion Criteria:

* Family member providing care to someone in household with Alzheimer's disease or a related dementia

Exclusion Criteria:

* Cognitively impaired
MicroTrans - A Multicenter Registry of Fecal Microbiota Transplantation

The registry collects cases of patients received fecal microbiota transplantation (FMT) due to Clostridium difficile associated diarrhea (CDAD). The main objective of this study is to analyze the safety and effectiveness of FMT. Furthermore, data analysis will be used to implement a standardization of FMT in German hospitals and improve patient outcome. Therefore, a detailed description of completions of FMT are documented on our web-based survey platform www.ClinicalSurveys.net.

Concerning the documentation of patients received fecal microbiota transplantation (FMT) due to Clostridium difficile associated diarrhea (CDAD), physicians from all German hospitals performing a FMT are invited to provide prospective and retrospective information on these cases. Documentation of patient is performed by using the web-based survey platform www.ClinicalSurveys.net which was set up by researchers of the University Hospital of Cologne. This survey platform enables an optimal performance in epidemiological, observational, and interventional trials and is characterized by layered access security and frequent data backup. It has been used for numerous registry and cohort studies with approval of competent authorities and ethics boards.

The following data items are retrospectively or prospectively documented into our database, depending on if a informed consent exists or not:

* Patient characteristics (age, gender, weight, height, underlying disease)
* Indication for FMT
* Administration of antibiotics, chemotherapy, and immunosuppression prior to FMT
* Bowel movement prior to FMT
* Screening prior to FMT
* Description concerning completion of FMT
* Basic informations of the donor
* Outcome
* Prospective long term follow up (10 days, four weeks, three months, six months, and 24 months)

The following two differences of data documentation are observed:

1. Retrospective data documentation:

   Data of patients without an informed consent are documented strictly retrospectively after completion of the FMT. No pseudonymization of patient data is carried out so that no re-identification is possible.
2. Prospective data documentation:

Data of patients with an informed consent prior to FMT are documented prospectively. A pseudonymization of patient data allows a post-FMT contact (by writing or phone) to patients with respect to the 10 days, four weeks, three months, six months,and 24 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Clostridium difficile associated diarrhea

Exclusion Criteria:

* Patients \< 18 years old
Promoting Maintenance of Change Following Brief Intervention for Alcohol Use

All students who enroll in the study will receive an efficacious counselor-delivered brief motivational intervention. The intervention is based in principles of motivational interviewing. Students complete a baseline assessment on their alcohol use and alcohol-related consequences. During the hour-long session, the counselor uses information from the baseline assessment to compare the student's level of alcohol consumption to that of peers at the same university, discuss choices that may lead to experiencing negative consequences, and provide opportunities for the student to set goals for risk reduction.

This study will develop and pilot a maintenance enhancement intervention. The intervention is expected to consist of four components, for example: (1) Student participants may learn to use techniques based in mindfulness to cope with negative emotions. (2) Student participants may identify barriers to reducing their alcohol use and identify protective strategies for navigating those barriers. (3) Student participants may be presented with narratives from other students who successfully resumed moderate drinking after a heavy drinking episode. Students may also be prompted to identify alcohol free activities that they enjoy and can engage in after experiencing a heavy drinking episode. (4) Parents may also receive a handbook encouraging communication with their student about alcohol use.


Eligibility Criteria:
Inclusion Criteria:

Student participants must meet the following eligibility criteria:

* Currently enrolled student at the University of Massachusetts Amherst
* First time violator of the university alcohol policy
* Mandated to complete the Brief Alcohol Screening and Intervention of College Students (BASICS) intervention
* Minimum age 18

Parent participants must meet the following eligibility criteria:

• The parent or guardian of students who meet all of the student participant criteria

Exclusion Criteria:

• None.