cyrilzakka/clinical-trials huggingface dataset:
The Effect of Probiotics on Maintenance of Health in Pregnancy and Infants

This phase 2 study evaluates the effect of perinatal use of probiotics on the number of diagnosed viral, bacterial and fungal infections in pregnant women and on the maintenance of a health pregnancy. In addition, the effect of probiotics intake during pregnancy and breastfeeding on the infant's overall health status will be evaluated.

Throughout pregnancy women undergo many biological changes, including alterations in their microbiota. These infections can exacerbate pregnancy complications and increase the risk of preeclampsia and preterm birth. The present study aims to evaluate the potential effects of perinatal use of probiotics on the number of diagnosed viral, bacterial and fungal infections in pregnant women and on the maintenance of a healthy pregnancy. Potential infections include but are not limited to influenza/colds, bacterial vaginosis, mastitis, candidiasis, urinary tract infection and gingivitis. Additionally, the benefits of probiotic intake by the mother on the infant during pregnancy and breastfeeding will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Healthy pregnant women
* Less than 28 weeks of gestation (3rd trimester)
* ≥18 to \<40 years old
* Singleton gestation
* Availability and willingness to come in for morning visits
* Planning to breastfeed
* Willing to complete questionnaires, records, and diaries associated with the study and to complete all clinical visits
* Willing to discontinue consumption of fermented foods (e.g. foods that contain probiotics such as Kefir, pickles, etc.) or probiotics (e.g. yogurts with live active cultures or probiotic supplements)
* Able to provide informed consent

Exclusion Criteria:

* Known gestational diabetes or diabetes type 1 or 2
* Known blood/bleeding disorders
* Known liver and kidney disorders
* Known unstable cardiovascular diseases
* Women with a personal history of or currently diagnosed with preeclampsia
* Suffering from neurological diseases (e.g. Alzheimer's disease, Parkinson's disease, epilepsy, etc.)
* Suffering from gastrointestinal diseases (e.g. gastric ulcers, Crohn's disease, ulcerative colitis, etc.)
* Current symptoms of depression or experienced depressive symptoms in the past 2 years
* Maternal history of second trimester loss
* Women diagnosed HIV Positive or with Hepatitis B or C
* Known fetal abnormality
* Daily use of probiotic product within 2 weeks of the screening visit. The potential participant could be eligible to participate after a 2-week wash-out period
* Use of any antibiotic drug within 1 month of screening. The potential participant could be eligible to participate after a 2-week wash-out period
* Smoking, alcohol consumption or drug use during pregnancy
* History of alcohol or substance abuse six months prior to screening
* Allergies to milk, soy, or yeast
Efficacy and Tolerability of Blephademodex Wipes

Primary Objective

- To evaluate efficacy of Blephademodex eyelid hygiene wipe treatment with a subsequent maintenance period with Blephaclean lid cleansing wipes in Demodex blepharitis, as assessed by the change in ocular symptoms by a Global Discomfort Scale (GDS).

Secondary Objectives

* To evaluate the efficacy of Blephademodex eyelid hygiene wipe treatment in Demodex blepharitis as assessed by the change alone and in combination with a subsequent maintenance period of treatment with Blephaclean eyelid cleansing wipes ocular symptoms by: adapted TOSS; SANDE; specific blepharitis symptoms; Demodex count; ocular surface redness (Efron scale); lid margin redness/swelling (Efron / custom scale); Dandruff coverage at bases of eyelashes; ocular surface staining (Oxford scale; corneal only)
* To evaluate subject and physician satisfaction with Blephademodex eyelid hygiene wipes
* To evaluate ease of use for Blephademodex eyelid hygiene wipes
* Adverse events are documented and analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Patient \> 18 years old, all genders
* Able to read, to write and to fully understand German language
* Good general health as determined by the investigator by medical history and physical appearance
* Provision of written informed consent prior to inclusion
* Moderate to Severe Blepharitis - grade ≥ 2 (Efron Scale)
* Global discomfort score (GDS) ≥ 4
* Proof of demodex infestation by at least ONE of the following:Demodex visible after lash manipulation;Cylindrical dandruff along the lash line; Lid margin itching; Madarosis

Exclusion Criteria:

* History of ocular trauma, ocular infection or intra-ocular inflammation within the 3 months before screening visit
* History of ocular refractive surgery and any other ocular surgeries within 3 months before screening visit
* History of ocular allergy or ocular herpes within the 3 months before screening visit
* History of inflammatory corneal ulcer within the 6 months before screening visit
* Sjogren syndrome or any other rheumatologic disease related dry eye
* Concurrent treatment with other eye drops (anti-infectives, steroids, prostaglandins (but artificial tears are ok).
* Specific Exclusion Criteria for Women:Patient who verbally confirms pregnancy or lactation; Childbearing potential woman who is not using a reliable method of contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant, vaginal ring, patch or condom) and is not surgically sterilised
Informed Decision-Making Regarding Prostate Specific Antigen (PSA) Screening in 50-70 Year Old Latino Men

The purpose of this intervention trial is aiming to increase inform decision- making in Latino men regarding prostate cancer screening.

The investigators propose to find out how much Latino men know about the benefits and risks of prostate cancer screening and what factors influence how they decide whether or not to have screening. The investigators are also interested in learning how providing education information, both verbally and in print, about the risks and benefits of prostate cancer screening affects men's interest and knowledge.

The intervention is an interactive multi-media presentation made up of a small group of 8-10 Latino men gathered to discuss about prostate cancer, screening methods, treatment, and the controversy within the medical community regarding PSA screening. A facilitator guides the 1-hour discussion and encourages participant interaction. The effect of this intervention was tested on 1000 Latino men within Los Angeles county.

Participants were recruited from 38 community venues (churches, community center, etc.). All participants were interviewed before being randomized to receive written (control group) or oral (intervention) prostate cancer education material. All of the participants will be followed up at 6-months via a telephone interview.

The investigators hypothesize that the intervention group will have an increase knowledge of prostate cancer, will have increase communication with family, friends, and medical provider, and will have an increase rate of PSA screening compared to the control group.


Eligibility Criteria:
Inclusion Criteria:

* Latino men
* 50 to 70 years old
* Not ever having prostate biopsy
* Not ever having prostate cancer
* Not having had a PSA test within the past 12 months
* Not having BPH (prostate inflammation)
* Not currently experiencing prostate problems such as pain or burning sensation during urination, blood in urine, and/or desire to urinate frequently

Exclusion Criteria:

* Not Latino
* Younger than 50 or older than 70 years old
* Currently experiencing prostate problems such as pain or burning sensations while urinating, blood in urine, and/or desire to urinate frequently
* Living outside of Los Angeles county
* Having had a prostate biopsy
* Having had prostate cancer previously
* Having had a prostatectomy
Endoscopic Ultrasound-Guided Celiac Plexus Neurolysis (EUS-CPN) for Chronic Pancreatitis

Physicians need a tracking system for specific treatment modalities, and data to determine the impact of endoscopic ultrasound pain management for patients with chronic pancreatitis.

Chronic pancreatitis is extremely painful and pain management in patients with chronic pancreatitis is challenging. The etiology of abdominal pain in chronic pancreatitis is considered multifactorial. Current treatments for pain control primarily include narcotic \& opioid administration; however, these medications require titration of dosage for optimal pain control and are frequently followed by adverse effects such as constipation, nausea or drug addiction. Currently, the FDA has imposed strict regulations regarding the amount, frequency \& length of time patients may receive these medications. With tightly controlled regulations for prescribing narcotics and opioids for chronic pain management, the epidemic of street drug usage and overdose has dramatically increased. Alternatively, celiac plexus block and celiac plexus neurolysis performed under EUS guidance have been employed for pain control for at least 2 decades and deemed safe. Celiac plexus block refers to temporary inhibition of nerves of the celiac plexus, by using a combination of steroid and numbing medications injected into the celiac plexus ganglia. Celiac plexus neurolysis (CPN) refers to a temporary to semi-permanent inhibition of nerves of the celiac plexus ganglia. Injection of alcohol as a neurolytic agent is used in place of the steroid which causes neurolysis of the celiac plexus or ganglia.

This study will focus on collecting data related to endoscopic ultrasound procedures performed by Indiana University EUS physicians; specifically for the management of chronic pancreatitis pain. This data will be used for research purposes to determine the clinical impact of EUS-CPN management in chronic pancreatitis pain. The physicians will also be able to better understand the patient's condition and disease process that may lead to improved patient management.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Referral for the treatment of pain related to chronic pancreatitis

Exclusion Criteria:

* Less than 18 years of age
* Absence of chronic pancreatitis
Goal-directed Fluid Resuscitation in Acute Pancreatitis

Vigorous fluid resuscitation is currently believed to play a key role in reducing complications associated with acute pancreatitis. However, aggressive fluid replacement can be associated with complications such as pulmonary fluid sequestration. The purpose of this study is to evaluate alternative approaches to early fluid resuscitation for patients with acute pancreatitis.

Primary Aim: Evaluate the impact of a goal-directed fluid resuscitation protocol compared to standard fluid resuscitation on systemic inflammation in patients with acute pancreatitis.

Secondary Aim: Evaluate the impact of resuscitation with Lactated Ringer's compared to normal saline on systemic inflammation in acute pancreatitis.

Eligibility Criteria:
Inclusion Criteria:

* acute pancreatitis diagnosed by at least 2 criteria
* adult patients at least 18 years of age

Exclusion Criteria:

* history of severe cardiovascular, respiratory, renal, hepatic or hematologic/immunologic disease
* concurrent metabolic or physiologic derangement requiring specific fluid management
* pregnancy
* patients transferred from acute care hospital
Clinical Evaluation for Post Bleaching Hypersensitivity Using Desensitizing Agent During In-office Bleaching

Evaluating the effect of a desensitizing agent on post-bleaching hypersensitivity.

A randomized clinical trail will be done to evaluate the effect of a desensitizing agent ACP oral care gel in comparison to a control group on hypersensitivity after bleaching using a visual analogue scale.

Eligibility Criteria:
Inclusion Criteria:

* Patients must show no signs of spontaneous dental pain.
* Male or female patients between the ages of 18 to 40.
* Patients with good general and oral health.
* Patients having six caries-free maxillaryanterior teeth without restorations on the labial surfaces.
* Patients should have central incisors determined to be shade C2 or darker

Exclusion Criteria:

* Patient with spontaneous dental pain.
* Patient with anterior restorations or non carious cervical lesion.
* Patient having severe internal tooth discoloration (tetracycline stains, fluorosis, pulpless teeth), and bruxism habits.
* Tempro-mandibular joint problems involving symptomatic pain.
* Patients taking analgesics that could alter their normal pain perception level.
* Pregnant or breast feeding women.
Comparative Study of Anaconda System Use Versus Conventional Sedation in COVID-19 Patients.

At the beginning of 2020, a global alert emerged which saturated intensive care units due to COVID-19 worldwide. This caused a need for mechanical ventilation due to atypical pneumonias that had a rapid evolution and respiratory failure; therefore the consumption of sedative agents in the intensive care units escalated. Suboptimal sedation in the intensive care unit, increases the adverse effects, costs, and morbidity. For the time being, they focus on the use of intravenous agents such as propofol or dexmedetomidine, which are associated with tolerance, withdrawal, delirium, and hemodynamic effects. Consequently, the need arises to maximize availability and effectiveness, which is why the intervention of the ANACONDA conservation device is carried out, which works with a heat and humidity exchange filter capable of administering isoflurane or sevoflurane with an efficiency of 90%.

Analyze the difference in intravenous sedation requirements in patients with COVID-19. Patients who were assisted by a mechanical ventilator with sevoflurane versus conventional sedation.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with confirmed COVI-19 infection and assited with mechanical ventilation who entered critical care department.

Exclusion Criteria:

* Tranfers to a different hospital.
* Death within the first 24 hours of hospital stay.
A Study of Oral Ergocalciferol to Treat Pruritis in Hemodialysis Patients

Pruritis (itching) is common in many people with chronic renal failure on hemodialysis. There may be many different reasons for the pruritis. Efforts to treat the problem have not been very effective.

Vitamin D levels have been found to be low in many hemodialysis patients. Since vitamin D plays an important role in the skin and is effective in treatment of certain skin conditions that involve pruritis, it may have a role in treatment of pruritis in hemodialysis patients.

The objective of the investigators study is to determine the effect of supplementation with oral vitamin D2 (ergocalciferol) on pruritis in hemodialysis patients.

Vitamin D2 is a fat soluble steroid hormone precursor which must be hydroxylated in the liver and kidney respectively to make the active form 1-25-Vitamin D. This active metabolite and related analogs have been synthesized and are frequently used in the treatment of hyperparathyroidism in patients with chronic kidney disease. However the active metabolite may not be back metabolized to the precursor forms which may have functions in other organs including the skin. Supplementation of hemodialysis patients with oral vitamin D forms would provide a source of precursors for use throughout the body.

Eligibility Criteria:
Inclusion Criteria:

1. Hemodialysis treatment for \> 3 months
2. Subjective complaint of excessive itching

Exclusion Criteria:

1. Age \< 18 years
2. Failure to provide informed consent
3. Intact PTH \< 70 pg/ml or \> 1,000 pg/ml
4. Serum phosphorus \> 7.0
5. Serum calcium (adjusted for albumin)\> 11
6. Active malignancy
7. Likelihood of imminent renal transplantation
8. Current ergocalciferol treatment
Efficacy of Buprenorphine for Treatment of Acute Pain

The purpose of this study is to determine whether sublingual buprenorphine is effective in the treatment of acute pain in adult patients with extremity bone fractures


Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of extremity bone fracture Age\>16 years Acute pain of score 3 or greater on numerical rating scale

Exclusion Criteria:

Long term use of opium or opioids/dependence Previous administration of analgesic Known sensitivity to opioids Pregnant women History of medical problems (liver, kidney, heart, hematologic)
Non-routine Use of Antibiotics (Amoxi-light)

To evaluate, in routine operational settings of treatment of uncomplicated Severe Acute Malnutrition (SAM) in children aged 6-59 months, the risk of nutritional recovery and hospitalization with non-routine use of amoxicillin compared to the risk achieved with systematic use of antibiotics.

Upon admission, all children will receive nutritional treatment and standard medical care in accordance with the nutritional guidelines of the national protocol, with the exception of the routine distribution of antibiotics. Antibiotics will be provided at admission and during follow-up only if clinically justified. The results of the program (ie, nutritional recovery, hospitalization, death and abandonment) will be monitored in all children aged 6 to 59 months admitted for outpatient therapy in 2 outpatient treatment sites in the Madarounfa health district in Niger.

To ensure that the children included in the study receive appropriate care, the study will ask the children's leaders to return to the clinic for medical surveillance in the event of a clinical complication. Program staff will facilitate appropriate management, including prescription of antibiotics if clinically justified, and transfer to hospital of all children in need of close supervision and / or comprehensive medical management.

Eligibility Criteria:
Inclusion Criteria:

* Age 6-59 months
* Direct admission for the treatment of uncomplicated SAM (MUAC \<115 mm or PTZ \<-3 and / or presence of Grade + or ++ nutritional edema and moderate or good appetite with absence of medical complications)
* Signed Informed Consent

Exclusion Criteria:

* No Informed Consent given
* Not directly admitted for the treatment of uncomplicated SAM at the CRENAS (Center for Outpatient Nutritional Rehabilitation for Malnutrition) of the study
Effect of Ingestion of Human, Cow, and Modified-cow Milk, on Glucose and Hormone Responses in Humans.

Human milk, despite a much lower protein content, is as effective as cow milk on insulin stimulation under iso-lactose conditions. The causes for such a similar potency are unknown. This effect could be due to incretin and amino-acid responses, and/or to milk-protein interactions.In this study the investigators will address the above question(s) by testing, in young healthy volunteers, the effects of natural cow and human milk, as well as of the manipulation of the casein and whey protein content in cow milk, on insulin, C-peptide, GLP-1 and GIP secretion, as well as on circulating amino acids.

Objective: To determine plasma glucose, insulin, C-peptide, glucagon-like polypeptide-1 (GLP-1), glucose-inhibitory-polypeptide (GIP) and amino-acid responses, following administration of human and cow milk, either natural or with experimentally-modified casein and whey-protein content(s).

Design. Young healthy volunteers of both sexes will receive iso-lactose loads (0.36 g lactose / kg body weight) of: natural cow milk; natural human milk; and of cow milk with modified casein and whey protein contents. Blood samples will be frequently collected over 4 hours. Plasma glucose, amino acids, insulin and incretin concentrations will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-35 yrs
* Both sexes
* Healthy
* In post-absorptive state
* Hemoglobin Hb1c values within normal values.
* Previous regular, moderate physical activity
* Stable body weight and regular dietary habits.

Exclusion Criteria:

* Familial or personal history of diabetes.
* Altered fasting glucose and/ or impaired glucose tolerance.
* Any metabolic, hormonal, hepatic, renal, and cardiovascular disease.
* Current drug treatments
Platelet-rich Plasma (PRP) Injection for Treating Shoulder Subacromial Impingement Syndrome

The purpose of this study is to determine whether injection of platelet-rich plasma derived from patient's blood is effective in treatment of shoulder subacromial impingement syndrome as compared to the current protocol of methylprednisolone injection.

Patients presenting with shoulder pain to the study location will be screened by the principal investigator. Once diagnosed clinically with shoulder subacromial impingement syndrome, they will be invited to join the study. They will be invited to separate academic office to be explained about the study, its voluntary and confidential basis as per our Institutional Review Board (IRB) approved protocols.

After signing informed consent form and recruitment, they will be assigned randomly to one of the study arms through software-generated sequential allocation packaged in an opaque envelope. All involved except the principal investigator and patient are blinded.

There are two groups/arms in the study. The experimental arm will include subacromial injection of study subjects with autologous platelet-rich plasma; wheres subjects in the other study arm will be injected with methylprednisolone.

The outcome will be assessed through three scores. The study subjects will be asked to complete Oxford Shoulder Score questionnaire and health-related quality of life SF-36 questionnaire and Constant-Murley score will be measured through physician-based assessment done by the residents involved in the study. This will be done during the baseline visit before injection and repeated at 2, 6, 12 weeks and 6 months follow-up visits.

Also any adverse effects of both treatment arms will be monitored and reported as appropriate.

The investigators hypothesize that injecting platelet-rich plasma into the subacromial space of patients with subacromial impingement will result in decreased pain and increased function at 6 months follow-up (assessed by Constant-Murley Score, Oxford Shoulder Score, and Short Form-36 (SF-36) questionnaire) as compared to patients injected with methylprednisolone.

Eligibility Criteria:
Inclusion Criteria:

* Any adult male or female between 18 and 65 years of age, inclusive, with clinical diagnosis of shoulder subacromial impingement

Exclusion Criteria:

* Age below 18 or above 65 years
* History of prior shoulder injections or surgery
* History of fracture of the acromion, clavicle, scapula, or proximal humerus
* Known allergy to corticosteroids
* Known allergy to lidocaine