cyrilzakka/clinical-trials huggingface dataset:
Understanding Experimentally Induced Hot Flushes

The purpose of the study is to examine the impact of hot flushes on sleep, mood, and well-being. The investigators will cause hot flushes by giving study participants the hormone medication, leuprolide (Lupron), which is a manufactured (artificial) hormone that makes the body think that it has reached menopause temporarily. Most women begin to have hot flushes within 4 weeks after taking leuprolide and resume menses 3 months later. The investigators will administer questionnaires to evaluate changes in sleep and mood over the course of the study.


Eligibility Criteria:
Inclusion Criteria:

* Women 18-45 years old
* Premenopausal
* Willingness to use barrier methods of contraception during study and after completion of study until menses resume
* Good general health

Exclusion Criteria:

* Pregnancy
* Breastfeeding
* Hot flushes
* Hemoglobin at the screening visit less than 10 gm/dL
* Abnormal liver function tests
* Abnormal renal function tests
* BMI \> 35 kg/m2
* Previously diagnosed osteoporosis or osteopenia
* Psychiatric disorder involving mood, anxiety, psychotic disorder, current anorexia nervosa, or current alcohol or substance-use disorder
* Previous severe depression
* Evidence of suicidal or homicidal ideation
* Sleep apnea, narcolepsy, or other diagnosed sleep disorder
* Contraindication, hypersensitivity, or previous allergic reaction to GnRH agonists
* Regular use of centrally active medications
* Use of hormonal medications for at least 2 months
* Use of ketoconazole, clomiphene citrate, or anabolic/androgenic steroids in the preceding 3 months
* Renal insufficiency
* Abnormal vaginal bleeding
* History of thrombo-embolism or cardiovascular disease
* History of congestive heart failure or other conditions requiring sodium restriction
* History of spinal cord compression
* Metastatic vertebral lesions
* Memory disorders
* Urinary tract obstruction
* History of liver, kidney, pulmonary, or metabolic disease
Intestinal Perfusion After Feeding in Preterm and Term Infants

This is a pilot exploratory observational prospective cohort phase I study. In this study, we will gather preliminary data to evaluate (i) the magnitude of changes in blood flow in the bowel before and after feeding and (ii) the differences between preterm and term infants.

Necrotizing enterocolitis (NEC) is the most devastating intestinal disease which remains a major unsolved clinical challenge in neonatology. NEC is predominantly a disease of preterm or extremely preterm infants. NEC results in high mortality, neurodevelopmental impairment, intestinal failure, and reduced quality of life.

Prematurity and enteral feeding are two of the most important risk factors for NEC. More than 90% of infants with NEC have been enterally fed, suggesting that feeding is an important priming step in making the intestine vulnerable to NEC. Absorption of nutrients is energy-consuming and results in an increased oxygen demand after feeding, followed by an increase in intestinal blood flow above baseline (known as postprandial hyperemia). Our preclinical studies have shown an intriguing discovery, that prematurity is associated with a remarkably reduced intestinal response to feeding, which predisposes the intestine to NEC.

However, there is lack of reliable clinical evidence to compare the magnitude of difference in postprandial intestinal blood flow in human preterm versus term infants. If preterm infants do in fact demonstrate a diminished intestinal blood flow response to feeding, this will shed light on the need for interventions in the feeding protocol of this vulnerable population to prevent the development of NEC.

This study is a phase I exploratory prospective cohort study. We will gather preliminary data to evaluate (i) the magnitude of changes in blood flow in the bowel before and after feeding and (ii) the differences between preterm and term infants.

In a cohort of 20 patients (10 preterm, 10 term), we will evaluate feeding-related perfusion of the superior mesenteric artery and bowel wall immediately before and 60-minutes after feeding.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants (≤33 weeks gestational age) of any birth weight receiving full bolus enteral feeding.

Exclusion Criteria:

* Neonates receiving bolus enteral feeds lasting \>30 minutes or continuous enteral feeds will be excluded to avoid overlapping or close timing between pre- and post-prandial intestinal perfusion measurements.
* Large patent ductus arteriosus (PDA)
* Major congenital malformations
* Suspected genetic syndrome
* Ssuspected or confirmed infection
* Fraction of inspired oxygen of ≥0.60 at enrollment
* Confirmed diagnosis of necrotizing enterocolitis diagnosis. NEC will be diagnosed when at least two of the following clinical signs and one radiological sign will be present: (i) Clinical signs (1. abdominal distension; 2. abdominal tenderness; 3. abdominal discoloration; 4. blood in stool). (ii) Radiological signs (1. Pneumoperitoneum; 2. pneumatosis; 3. portal venous gas).
MICRO Study: Detecting Bacterial Infections Related to Orthopaedic Surgical Implants

A prospective trial conducted at Shock Trauma of patients between 18 years of age and older who have sustained a fracture with metal implanted. The investigators will be collecting between 1-3 routine blood draws for the purpose of laboratory analysis to assess biofilm growth. Patients may be infected or non-infected at the time of blood draw; they will be selected at random for purposes of this study. All patients will be followed as standard of care by their treating physician for all their follow up visits.

Surgical site infection in the orthopaedic surgery population is a significant public health issue. Wound infections result in both increased length of hospital stay and total cost of care.

Surgical site infection (SSI) is the most common preventable adverse outcome after a major operation. The economic costs to the US healthcare system are enormous estimated to be in excess of $1.8 billion per year. For patients who develop an SSI, the cost may be even higher with length of stay and risk of death doubled. Thus the benefits of any intervention decreasing the risk of SSI are very tangible.

A biofilm is a layer of bacteria that adheres to a surface; in Orthopaedics, this often means adherence to implanted metal after fracture surgery. The test that has been designed by one of the investigators on the study has been shown in an animal model to detect the formation of a biofilm up to 1 month prior to clinical detection. Having a blood assay such as this would allow earlier antibiotics and potentially prevent the need for further surgeries to remove metal implants and clean out the biofilm.

Eligibility Criteria:
Inclusion Criteria:

* Previous fracture fixation with an implant (intramedullary nail, plate, screws), or joint revisions, or periprosthetic fracture, or admitted from orthopaedic trauma clinic due to infection, or inpatient with a known infection.
* English speaking

Exclusion Criteria:

* Patients with planned follow-up at another medical center
* Patient lives outside of the hospital catchment area
Personality Profiles, Values and Empathy: Differences Between Ovo/Lacto-vegetarians and Vegans

Main goal is to collect and analyze possible differences between ovo / lacto-vegetarians and vegans with respect to their personality profiles, values and empathy through validated questionnaires. Main hypothesis: vegans and ovo / lacto-vegetarians differ in their personality, empathy and values


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years of age

Exclusion Criteria:

* Age under 18 and above 80 years of age
Effects of Fasting on Success Rates of Assisted Reproductive Techologies

This exploratory study investigates fasting as a potential supportive therapy for infertility treatment in women undergoing in-vitro-fertilization (IVF) / intracystoplamsatic sperm injection (ICSI)

This 2-arm, randomized, controlled exploratory clinical trial aims to explore fasting as a novel supportive treatment in female infertility during IVF / ICSI. The participants will be randomized in two groups: a fasting group and a waiting list. The intervention group follows a fasting intervention, whereas the patients on the waiting list continue their normal diet. All groups will be trained and accompanied by medical experts. In addition, qualitative interviews will be conducted including individual and focus group interviews with a subgroup of participants.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 25 to 38 years with planned IVF / ICSI
* 1 ng/ml ≤ Anti-Mullerian Hormone (AMH) ≤ 4 ng/ml
* Unfulfilled desire to have children \>1 year
* 25 kg/m² ≤ BMI ≤ 35 kg/m² declaration of consent

Exclusion Criteria:

* Language barriers
* Previously known serious mental illness or cognitive impairment
* Patients with anatomical/organic damage and proven uterine abnormalities
* Eating disorders in the medical history
* Serious previous internal diseases
* Lack of internet access
* No consent to randomisation
* Participation in other studies
Impact of Vitamin D3 Supplementation in Non-Sjogren Dry Eye Patients With Low Serum Vitamin D Level

Dry eye disease is multifactorial, ocular inflammatory condition causing irritation, stinging sensation, uneasiness and blurring. Non-Sjogren syndrome occurs due to absent or dysfunction of lacrimal gland. Fat soluble vitamin D act as an agent against inflammation and its deficiency may result in various inflammatory diseases including dry eye. Purpose of this study is evaluation of vitamin D3 supplementation role in treating non-Sjogren dry eye along with conventional treatment by using artificial tears in patients with hypovitaminosis D. A prospective study was conducted in Rural health center(RHC) Buchal Kalan on 108 patients presenting with non-Sjogren dry eyes and low serum vitamin D levels. Patients were subjected to the following examination; best corrected visual acuity (BCVA), slit-lamp examination, applanation tonometry, fundoscopy, tear breakup time (TBUT) after fluorescein staining, Schirmer tear test, numerical pain rating scale (NPRS) and ocular surface disease index (OSDI) score on day 0, 15, 30, 60 and 90. Vitamin D levels was assessed by electrochemiluminescence immunoassay (ECLIA) based analyzer. The sample was randomly divided into two groups by non-probability purposive sampling. Group 1 received only artificial tears 4times/day while group 2 were given oral vitamin D3 supplementation of 6000 international unit (IU) daily along with artificial tears. Impact of oral vitamin D3 supplementation on non-Sjogren dry eyes was assessed by comparing means of ocular parameters of both groups over different period of time by using Mann-Whitney Test and Friedman Test.


Eligibility Criteria:
Inclusion Criteria:

* Patients with non-Sjogren dry eyes with low serum vitamin D level.
* Both gender.
* Age group will be 20-50 years of age.
* Cooperative patients.

Exclusion Criteria:

* Autoimmune diseases (such as Sjogren syndrome and lupus syndrome).
* All ocular pathologies except dry eyes.
* All systemic pathologies that affects tear layers.
* All non- cooperative patients.
Comparing the Effects of Psilocin and Psilocybin in Healthy Adults

To compare the physiological and psychological effects of psilocin taken orally by pill or sublingually by dissolving a tablet under the tongue to those of psilocybin taken by pill in healthy adults.

The primary goal of this study is to compare the physiological and psychological effects of psilocin taken orally by pill or sublingually dissolved under the tongue to those of psilocybin taken by pill. Twenty participants, ages 25 to 50, with one previous experience with psychedelics, and who meet all other inclusion and exclusion criteria at screening will be enrolled. After baseline assessments, participants will engage in preparatory visits with trained facilitators, followed by drug administration, supervised by the facilitators and a clinician who will conduct safety monitoring throughout. Participants will then complete assessment and integration sessions with the facilitators in order to help process the experience. The same preparation, procedures, integration, and supervision will be repeated up to three more times with each participant.

Eligibility Criteria:
Inclusion Criteria:

* Age 25 to 50
* Comfortable speaking and writing in English
* Commit to attending all study visits and remote data collection tasks
* No planned surgeries during the study
* Had at least one prior experience with a psychedelic substance
* Generally mentally and physically healthy
* Agree to abstain from THC, CBD, or nicotine products during study

Exclusion Criteria:

* Participated in another clinical trial within 30 days of entry to this trial
* Regular use of medications that may have problematic interactions with psilocybin, including but not limited to dopamine agonists, MAO inhibitors, N-methyl-D-aspartate (NMDAR) antagonists, antipsychotics, and stimulants
* A health condition that makes study unsafe or unfeasible, determined by study physicians
Working Memory Training in Patients with Mild Cognitive Impairment

The purpose of this study is to test whether a special memory training program, called CogMed, can help people with early memory problems. The Investigators want to see if this training improves memory and also helps reduce stress.

The Investigators also want to see if CogMed results in changes to a blood biomarker called p-Tau 217, which possibly indicate Alzheimer's disease (AD).

The goal of this study is to conduct a pilot clinical trial aimed at comparing the effects of CogMed intervention plus Treatment As Usual (TAU) versus TAU alone in patients with Mild Cognitive Impairment (MCI). Based on our preliminary data from brain health program, the primary hypothesis is that the CogMed intervention may improve the CogMed measures and possibly working memory. This may improve sense of self-efficacy and lead to a decrease in perceived stress, thereby demonstrating possible transfer of cognitive benefits to biobehavioral construct of perceived stress. Additionally, the study aims to demonstrate the feasibility of collecting p-Tau 217, a blood based Alzheimer's Disease biomarker, from MCI patients. Though no significant changes in pTau 217 are expected due to the short duration of the study, the goal is to successfully recruit 10 MCI patients (5 in the intervention group and 5 in the control group) who are willing to undergo blood draws for p-Tau 217 level determination.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female outpatients ages ≥ 50 years;
2. Meet Mayo Clinic Criteria for MCI. (Patients with mild cognitive impairment)
3. Access to the internet through computer
4. A proficiency in speaking and reading English or having a family member who is proficient in reading and speaking English and is willing to serve as a translator.
5. Vision and hearing must be sufficient to comply with study procedures.

Exclusion Criteria:

1. Mini Mental State Exam (MMSE) score less than 19 or patients diagnosed with moderate or severe dementia by a clinician.
2. In the opinion of the investigator, participation would not be in the best interest of the subject.
Study on the Safety of the Approved Product Empedic L Cream During Its Routine Use (Active Ingredient is Clotrimazole 1%)

Researchers already did trials that showed Empecid L Cream worked for patients with Vaginal yeast infection who were in those trials. In this trial, they want to learn if consumers that use the cream under the guidance of a pharmacist have any medical problems during the trial


Eligibility Criteria:
Inclusion Criteria:

- Consumers who self-select and are then deemed appropriate users of the product by the pharmacist for treatment of Vulvar itching with rash due to recurrent vaginal candida (only in patients previously diagnosed and treated by a doctor).

Exclusion Criteria:

* Patient with first episode
* Patient with allergy to Empecid Cream (Clotrimazole)
* Patient under 15 years old/ beyond 60 years old
* Pregnant women or women who may possibly be pregnant
* Patient with diabetes
* Patient who repeats indicated symptom frequently, have recurrent episodes (once every month or two, or twice or more within 6 months).
* Patients who does not know whether it is a recurrence symptom
* Patients who have a fever, chills, lower abdominal pain, back or shoulder pain, colored or bloody vaginal discharge, fishy-smelling vaginal discharge, cessation of menses, irregular or abnormal bleeding from the vagina, or ulcer, edema or erosion in the vagina or vulva suggesting they may have a different disease.
Efficacy of Intermittent ThetaBurst Stimulation Compared to 10 Hz Stimulation on Dorsolateral Prefrontal Cortex in Treatment Resistant Major Depressive Disorder: a Double-blind Randomized Study

This trial will compare innovating stimulation parameters, intermittent Theta Burst Stimulation, to the standard high frequency stimulation protocol. The Left dorsolateral prefrontal cortex, targeted by MRI navigation will be the site of stimulation in both treatment conditions. The study seeks to determine if there is a superiority in therapeutic efficacy with iTBS protocol compared to conventional one.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years to 75 years
* Both gender eligible
* Volontary and able to give consent
* Major depressive episode (MADRS \> 20) single or recurrent
* Resistance to at least 2 antidepressants ,
* Treated by antidepressant at efficient stable posology since more than 6 weeks

Exclusion Criteria:

* Initiation or modification of antidepressant drug
* Neurodegenerative diseas
* Bipolar I, II disorder
* Schizophrenia, schizoaffective disorder, schizophreniform, delusional disorder, or current psychotic symptoms
* Substance abuse in past 15 days
* Substance dependence not weaned
* Benzodiazepine and any anticonvulsant during rTMS treatment course
* ECT failure in medical history
* Contra-indication to rTMS and MRI
* Pregnancy
* Difficulty to obtain informed consent
Safety and Efficacy of Wide Awake Local Anesthesia no Tourniquet Technique (WALANT) in Ankle Removal of Implant Surgery

Safety and efficacy of wide awake local anesthesia no torniquet technique (WALANT) in ankle surgery. Studying risks and benefits from WALANT compared to general anesthesia . WALANT expected to decrease in intraoperative/post operative pain at the surgical site and decrease hospital time .


Eligibility Criteria:
Inclusion Criteria:

* Age: \>18
* Previous ORIF for:
* Unimalleolar fractures
* Bimalleolar fractures
* Trimalleolar fractures

Exclusion Criteria:

* Allergy to local anesthesia
* Psychiatric diagnosis including: affect disorders, uncooperative
* Severe cardiovascular disease
Practice and Patient Compliance on the PPI (Proton Pump Inhibitors) Treatment of Gastroesophageal Reflux in South Korea

The purpose of this study is to examine the treatment profile of approximately 1,000 adult patients with gastroesophageal reflux who begin raberpazole sodium treatment for 4 months, and assess patients' adherence to the study drug.

This study is a multicenter, open-labeled, prospective, phase IV, observational study for patients visiting the gastroenterology department. The purpose of this study is to examine the treatment profile of approximately 1,000 adult patients with gastroesophageal reflux (GERD) who begin raberpazole sodium treatment for 4 months and assess patients' adherence to the study drug. The primary objective is to examine the treatment profile of gastroesophageal reflux in the secondary or tertiary clinical center. The secondary objective is to examine GERD patients' adherence to the study drug (rabeprazole sodium) during the treatment period. Of the patients who visit the study centers and complain about gastroesophageal reflux symptoms during the study period, those who are deemed to need rabeprazole sodium administration at the investigator's discretion will be considered for this study. The main outcome measures are the patterns of gastroesophageal reflux management (eg. treatment duration of initial therapy etc) and the compliance of proton pump inhibitor treatment.The compliance data (number of tablets taken) will be calculated at the clinical visit by counting the number of dispensed tablets that are remaining. Also, investigators will observe the gastroesophageal reflux symptom free rate at the end of initial therapy, gastrointestinal (GI) symptom relief and safety information at each visit. Study period is up to 4 months. During the study, no standardized treatment is stipulated, and patients may receive any treatment considered by their physicians. Rabeprazole sodium 10 mg - 20 mg tablet once daily for 4months.

Eligibility Criteria:
Inclusion Criteria:

* Patients complaining about heartburn or acid regurgitation, the typical GERD symptoms, more than once a week
* After a full explanation about the observational study, patients who fully understand it and sign a written consent form

Exclusion Criteria:

* Patients who took rabeprazole sodium within the last four weeks
* Patients who are hypersensitive to the active ingredient of rabeprazole sodium or benzimidazole
* Patient with other digestive tract diseases other than GERD (gastrointestinal cancer, liver disease, pancreatic disease, peptic ulcer, inflammatory digestive tract diseases \[in case of ulcer, however, scars from healed ulcer may be included\])
* Patients with other severe accompanying diseases including renal impairment, cerebrovascular disease, cardiovascular disease and severe respiratory disease
* Patients who must constantly take Proton Pump Inhibitors other than rabeprazole sodium during study period
* Pregnant or lactating women
Doppler Assesment of Blood Flow in the Spiral Arteries

In this study we will try to show that performing Doppler of the Spiral arteries is doable. No outcome will be followed at this stage

This will only be a pilot study to show that we can acurately perform Doppler studies of the spiral arteries

Eligibility Criteria:
Inclusion Criteria:

* Pregnancy 1st trimester

Exclusion Criteria:

* Not willing to participate