cyrilzakka/clinical-trials huggingface dataset:
An Evaluation of the Safety and Efficacy of Memantine in Patients With Acute Mania Associated With Bipolar I Disorder

Bipolar disorder affects 2.4 million adults in the USA between the ages of 18-65 and has considerable economic impact on our society. Bipolar mania accounts for 1 in 7 psychiatric emergencies and is associated with significant morbidity and mortality. The purpose of the study is to evaluate the safety and efficacy of open-label memantine in the acute management of adults with bipolar I disorder hospitalized for mania.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have a documented clinical diagnosis of bipolar I disorder and must be currently experiencing a manic or mixed episode.
* Patients must be voluntarily hospitalized with a primary diagnosis of mania.

Exclusion Criteria:

* Rapid cycling bipolar disorder.
* Suicidal risk.
* First manic episode.
* ECT, clozapine or a depot neuroleptic in the past 3 months.
* Substance dependence.
* Known HIV infection.
* Co-morbid serious, uncontrolled systemic illness.
Effect of Science Research Wellness Ndo1 on Glycaemia in Adults With Pre-diabetes

The objective of this study is to test the effect of 12 weeks of supplementation SRW Ndo1 on metabolic health and general health in adults with prediabetes. The primary question it aims to answer are:

* How does SRW Ndo1 affect the Haemoglobin A1C (HbA1C) test outcome for adult individuals?
* How does SRW Ndo1 affect the body measures and blood pressures of adult individuals?

Investigators will compare the supplement to a placebo (a look-alike substance that contains no supplement) to see if SRW Ndo1 works to support normal blood sugar metabolism.

Participants will:

* Take supplement SRW Ndo1, two capsules a day for 12 weeks.
* Be asked to refrain from changing their diet and lifestyle drastically during the study and to refrain from starting new health supplements during the study.
* Visit the clinic at the start and the end of intervention for a blood test (8 hour fasting required prior to test)
* Keep a diary of their symptoms or adverse events during intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years and over.
2. Prediabetes, defined as fasting plasma glucose of 6.1-6.9 mmol/L and/or HbA1c of 5.7-6.4% and/or 2 h plasma glucose of 7.8-11.0 mmol/L after ingestion of 75 g of oral glucose load. Blood tests conducted within 3 months before randomisation will be accepted.
3. Able to read and write English.
4. Has access to internet.
5. Provided informed consent to participate in the study.

Exclusion Criteria:

1. Has a medical condition known to affect the glycaemia.
2. Regular intake of a health supplement with effects on glycaemia.
3. Currently participating in another trial/study of a supplement or drug.
4. Has any known food or allergy or intolerances to the ingredients of the intervention.
5. Pregnant, trying to conceive or breastfeeding.
6. Has any current substance abuse (including tobacco, alcohol and recreational drugs) or currently in substance withdrawal.
7. Moderate to severe medical conditions (defined as a significant impact on social areas of functioning).
8. Any medical conditions that was not stable over the last 3 months.
9. Taking any prescription medication known to affect glycaemia or had a change in their medication within the last 3 months.
10. Currently taking celiprolol, metformin, or any angiotensin-converting enzyme inhibitor medications.
11. Major medical or surgical event requiring hospitalization within the last 3 months.
12. Any other medical reason that may make participation in this study pose a risk to the participant, including potential herb-drug interactions, at the discretion of the study medical supervisor.
A Study of LY3209590 in Participants With Type 1 Diabetes

The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have a diagnosis of type 1 diabetes mellitus for at least 1 year
* Participants must have been using multiple daily injections without interruption for at least 3 months
* Participants must have HbA1c values of 5.6% to 9.5%, inclusive
* Participants must have a body mass index (BMI) of ≤35 kilograms per meter squared (kg/m²)

Exclusion Criteria:

* Have had more than 1 emergency room visit or hospitalization due to poor glucose control within 6 months prior to study screening
* Have any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening
* Have any of the following cardiovascular (CV) conditions: acute myocardial infarction, New York Heart Association Class III or IV heart failure, or cerebrovascular accident (stroke)
* Have acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease
* Have an estimated glomerular filtration rate (eGFR) \<30 milliliters/minute/1.73 m²
* Have active or untreated cancer
* Are receiving chronic (\>14 days) systemic glucocorticoid therapy
Enhancing Interdisciplinary Understanding of Ophthalmology Notes Through a Local Large Language Model

This prospective, randomized controlled trial evaluated the efficacy of adding Large Language model (LLM)-generated Plain Language Summaries (PLSs) to Standard Ophthalmology Notes (SONs) in enhancing comprehension among non-ophthalmology providers. The study utilized surveys to assess non-ophthalmology providers\&#39; comprehension and satisfaction with the notes and ophthalmologists\&#39; evaluation of PLS accuracy, safety, and time burden. An objective semantic and linguistic analysis of the PLSs was also conducted.


Eligibility Criteria:
Inclusion Criteria:

* Evaluation by an Ophthalmologist in the Mayo Clinic Department of Ophthalmology in Rochester, MN in either the inpatient or outpatient setting between Feb 1, 2024 - May 31, 2024.

Exclusion Criteria:

* No in-network non-Ophthalmologist care providers in the medical record
* Procedure-only visits containing only a procedure note
Heart Failure and Peritoneal Ultrafiltration

The objective of the study is to determine if the addition of peritoneal ultrafiltration to standard therapy in treatment-resistant severe heart failure patients will improve fluid balance and functional capacity such that they will spend less time in the hospital and have an improved ambulatory quality of life in comparison to patients who remain on standard therapy alone.


Eligibility Criteria:
Inclusion Criteria:

* Adults with congestive heart failure (CHF) who remain fluid overloaded despite standard treatment.

Exclusion Criteria:

* Patients who have reversible CHF or have diseases or conditions that would contraindicate the use of peritoneal dialysis.
A Trial to Compare the Pharmacodynamic and Pharmacokinetic Properties of Biochaperone® Combo With Humalog® Mix25 and With Simultaneous Injections of Humalog® and Lantus® in Subjects With Type 2 Diabetes

This is a single centre, randomised, double-blind, double-dummy, 3-treatment, 3-period cross-over, euglycaemic clamp study in subjects with type 2 diabetes on stable insulin treatment. Each subject will be randomly allocated to a treatment sequence and will be administered single subcutaneous doses of 0.8 U/kg Biochaperone® Combo, 0.8 U/kg Humalog® Mix25 or simultaneous subcutaneous injections of 0.2 U/kg Humalog® and 0.6 U/kg Lantus® during three separate dosing visits.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus (as diagnosed clinically) for ≥ 12 months
* HbA1c levels ≤ 9.0%
* Total insulin dose of \< 1.2 U/kg/day
* Body mass index between 20.0 and 35.0 kg/m2 (both inclusive)
* Body weight ≤ 125.0 kg
* Fasting serum C-peptide ≤ 1 nmol/L
* Treated with a stable insulin regimen for ≥ 3 months prior to screening

Exclusion Criteria:

* Type 1 diabetes mellitus
* Known or suspected allergy to the trial products or related products
* Previous participation in this trial. Participation is defined as randomised
* Participation in any clinical trial within 3 months prior to this trial
* Clinically significant abnormal haematology, biochemistry, lipids, or urinalysis screening tests, as judged by the Investigator considering the underlying disease
* Supine blood pressure at screening outside the range of 90-160 mmHg for systolic or 50-95 mmHg for diastolic and/or resting supine heart rate outside the range 50 -90 beats per minute. This exclusion criterion also pertains to subjects being on antihypertensives
* Use of GLP-1 receptor agonists or oral antidiabetic drugs (OADs) other than stable intake of metformin within 4 weeks prior to screening
* Women of child bearing potential, not willing to use contraceptive methods
Single Non-fasting OGTT Versus Fasting OGTT for Screening of Hyperglycaemia in Pregnancy (HIP)

With the increasing prevalence of diabetes in pregnancy it is necessary to design a simple, sensitive, cost effective method for screening of hyperglycaemia in pregnancy specially in resource constrained settings.

There is no universally agreed screening and diagnostic criteria to detect hyperglycemia in pregnancy. In present study, DIPSI (non-fasting OGTT) is compared with fasting oral glucose tolerance test (OGTT) to evaluate sensitivity and specificity of both methods in our population.


Eligibility Criteria:
Inclusion Criteria:

All pregnant women

Exclusion Criteria:

Known diabetic
Universal Screening for Tuberculosis and Anemia With the CHICA System

The CHICA system is a clinical decision support system that uses adaptive turnaround documents to provide point-of-care information to clinicians. The investigators will be studying whether it can help in the diagnosis and treatment of tuberculosis and iron deficiency anemia.

The CHICA system is a clinical decision support system that uses adaptive turnaround documents to provide point-of-care information to clinicians. We will be studying whether it can help in the diagnosis and treatment of tuberculosis and iron deficiency anemia.

Eligibility Criteria:
Inclusion Criteria:

Age 3 to 11 years old and seen in a study clinic

Exclusion Criteria:

None
Telemedicine for First Trimester Abortion in South Africa

The study aim to determine if medical abortion facilitated by a physician online (s.c. telemedicine), combined with a simplified physical exam, is equally effective, safe and acceptable to women in South Africa as standard medical abortion care.

The proposed study is non-inferiority randomized controlled trial that will investigate the safety, effectiveness and acceptability for women of early medical abortion performed through telemedicine, compared to standard care in South Africa. Standard care, in the Western Cape, includes face to face eligibility screening, counselling and information with a nurse or physician, as well as an ultrasound to confirm the gestational age of the pelvic exam. The intervention will include a pelvic exam and gestatonal age based on LMP assessment and uterine size by bimanual palpation. Eligibility screening, counselling and information will occur through an existing online telemedicine application, content and language-adapted to suit women in South Africa, and managed by a HPCSA certified doctor. The study is a non-inferiority study. Our hypothesis is that the intervention is not inferior to standard care with respect to safety, effectiveness and acceptability. The study is performed to provide an alternate model of abortion care to be applied in settings where abortion is in any way restricted and increase access to safe abortion. Importantly the study is planned for a context where abortion services are legal but restricted by stigma. South Africa therefore provides a uniquely suited setting for this study.

Eligibility Criteria:
Inclusion Criteria:

* Able to read and write
* Able to speak English, IsiXhosa or Afrikaans
* Gestational age \<9 wks 2 days
* In possession of a smartphone

Exclusion Criteria:

* Contraindication to medical abortion
Methylphenidate Raclopride Positron Emission Tomography (PET) Test - 11

The purpose of this study is to evaluate PET methodology to study in vivo synaptic dopamine release.

The objective of this study is to evaluate PET methodology to study in vivo synaptic dopamine release.

Eligibility Criteria:
Inclusion Criteria:

Healthy normals

Exclusion Criteria:

History of head trauma or loss of consciousness. Significant medical history. History of seizures.
Sirolimus, Mycophenolate Mofetil and Bortezomib as Graft-Versus-Host Disease (GVHD) Prophylaxis After Reduced Intensity Conditioning (RIC) Hematopoietic Stem Cell Transplantation

This trial will test the hypothesis that the combination of sirolimus, mycophenolate mofetil, and bortezomib will be effective in preventing both acute and chronic GVHD after reduced intensity allogeneic stem cell transplantation.

The combination of tacrolimus and methotrexate is standard therapy for prevention of GVHD, however, our recent experience has demonstrated that the substitution of sirolimus for methotrexate provides superior GVHD control with reduced transplant-related toxicity. One limitation to the use of calcineurin inhibitors in GVHD prevention is the disruption in Treg function and proliferation. Based on our evolving understanding of the role of Treg in the development of chronic GVHD, we propose a GVHD prophylactic regimen that is effective in prevention of acute GVHD, but by virtue of the maintenance of Treg activity may be able to prevent chronic GVHD. We hypothesize that the substitution of mycophenolate mofetil for tacrolimus as well as the addition of bortezomib may provide similar protection against acute GVHD and prevent chronic GVHD while minimizing renal toxicity after transplantation.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with hematologic malignancies, who are at high risk of complications after conventional myeloablative transplantation
2. Patients must have a 6/6 matched, related donor. Matching at HLA Class II will be based on PCR of sequence specific primers (SSP). Among family member transplants, serologic matching at Class I is sufficient
3. Patient age greater than 18
4. Performance status 0-2
5. Life expectancy of \> 100 days without transplantation
6. Written informed consent must be obtained in all cases from the patient

Exclusion Criteria:

1. Pregnancy
2. Prior Allogeneic Stem Cell Transplantation from any donor
3. Evidence of HIV infection or active Hepatitis B or C infection
4. Heart failure uncontrolled by medications
5. Total bilirubin \> 2.0 mg/dl that is due to hepatocellular dysfunction
6. AST \> 90
7. Cholesterol \> 300 mg/dl or Triglycerides \> 400 mg/dl while adequately treated
8. Uncontrolled bacterial, viral or fungal infection
9. Requirement for voriconazole at the time of hospital admission
Use of Intravenous Ferric Carboxymaltose in Treatment of Anemia in Cancer Patients Undergoing Chemotherapy

This study is a nonrandomized, single arm, open-label study stratified by iron-deficiency status.

The study aims to investigate the effect of FCM (without ESAs) on anemic cancer patients undergoing chemotherapy (with or without radiotherapy); stratified by status of iron deficiency (i.e. non-iron deficient vs. iron deficient patients ). The study will also try to find out whether serum level of Hepcidin and C reactive protein can correlate with response

Patients will receive one or two doses of FCM, based on the body weight and Hb level. Patients will be followed-up for a total of twelve weeks. The study is divided into a screening, treatment and follow-up phases and is expected to be completed in 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Patient is an adult more than or equal 18 years old at the time of informed consent.
* Patient has pathologic diagnosis of solid tumor (breast cancer, colorectal, lung, sarcoma, head and neck, sarcoma, genitourinary or gynecological cancer).
* Patients who started chemotherapy (with or without radiotherapy) or planned to receive chemotherapy for at least 12 weeks.
* Patient has an Eastern Cooperative Oncology Group performance status between 0 and 2.
* Patient with Hb ≤11 g/dL.
* Patient has a Life expectancy at least 6 months.
* Adequate hepatic and renal function defined as a serum aspartate aminotransferase or alanine aminotransferase level that are no more than 3 times the upper limit of the normal range, a serum bilirubin level that is no more than 2 times the upper limit of the normal range and a serum Creatinine level of less than 2 mg per deciliter.
* Patient is able to understand and provide informed consent to participate in the study.

Exclusion Criteria:

* Patient has Hb \< 8.0 g/dL
* Patient presenting with hematologic malignancy including
* Prior gastric surgery.
* Patients on definitive radiotherapy alone.
* Patients with relevant history (within six weeks) or clinical evidence of hemolysis or active bleeding that could, in the investigator's judgment, be a potential cause for the anemia (no gross hematuria, hemoptysis, hematochezia or melena and negative stool for hemoccult)
* Presence of other nutritional anemia; deficiency of vitamin B12 less than 187 pg/ml and deficiency of Folate less than 3.1 ng/ml according to the local laboratory normal ranges
* Patient has Iron overload (Serum Ferritin more than 800 ng/ml or Transferrin saturation (TSAT) more than 40%)
* Patient is pregnant or lactating.
* Patient has a personal or family history of hemochromatosis.
* Patient has hypersensitivity to any form of IV iron.
* Patient has received red blood cells transfusion or used erythropoietin within 2 weeks of enrollment into the study.
* Patient has received any form of intravenous iron within the last 12 weeks
* Patient has received oral iron supplements within 1 month of enrollment to the study, except for multivitamin supplements containing less than 30 mg iron.
High-Concentration Nitrous Oxide for Dental Procedural Sedation in Children

The use of nitrous oxide as a sedative agent is very common in pediatric dentistry. In concentrations up to 50% it is considered as mild sedation and it is very safe. Despite its safety and widespread of its use nitrous oxide is not a potent drug and many times dentists fail to gain cooperation in moderate or high anxious children, and the alternatives are to use moderate sedation with drugs such as Midazolam, Atarax or general anesthesia. Higher concentration was not conducted in Pediatry densitery. The aim of this study is to compare the effectivity and safety of providing nitrous oxide at increasing concentrations 60%, 70% with 50% parameters, sedation depth, adverse events and cooperation of the child during the dental treatment.Our hypothesis is that nitrous oxide in concentrations higher than 50% up to 70% is a safe and effective sedation method in dental treatment of children.

Nitrous oxide/oxygen in varying concentrations has been successfully used for many years to provide sedation and analgesia for a variety of painful procedures in children. The use of nitrous oxide as a sedative agent is very common in pediatric dentistry. In concentrations up to 50% it is considered as mild sedation and it is very safe. It is usually used for mild or moderate anxiety state because it is not so potent in concentrations up to 50 %. Despite its safety and widespread of its use nitrous oxide is not a potent drug and many times dentists fail to gain cooperation in moderate or high anxious children, and the alternatives are to use moderate sedation with drugs such as Midazolam, Atarax or general anesthesia. Nitrous oxide 50% is the most common concentration in use but the results of the sedation does not always provide a satisfactory cooperation, higher concentration was not conducted in Pediatry densitery. The aim of this study is to compare the effectivity and safety of providing nitrous oxide at increasing concentrations 60%, 70% with 50% parameters, sedation depth, adverse events and cooperation of the child during the dental treatment.Our hypothesis is that nitrous oxide in concentrations higher than 50% up to 70% is a safe and effective sedation method in dental treatment of children.

Eligibility Criteria:
Inclusion Criteria:

* Children evaluated by a senior pediatric dentist and require a wide treatment of caries, with a high score of anxiety unable to accept dental treatment with nitrous oxide /oxide of 50% in combined with behavioral management in the pediatric dental clinic.

Exclusion criteria:

* Children with high potential risk of sedation, snoring, stridor, sleep apnea, maxillofacial malformation, history of airway difficulty, gastro esophageal reflux, reactive airway disease or acute runny nose, cardiac disease, altered mental status, inadequate fasting time.
* Parental refusal for conscious sedation.
Phase 2 Study of Ambrisentan for Liver Function Test Rescue in Pulmonary Arterial Hypertension

This Phase 2 study was to determine the incidence of increased serum aminotransferase concentrations (alanine aminotransferase \[ALT\] and/or aspartate aminotransferase \[AST\]), as well as the overall safety and tolerability of ambrisentan, in participants with pulmonary arterial hypertension (PAH), idiopathic PAH (IPAH), or familial PAH (FPAH) who had previously discontinued ERA therapy (bosentan or sitaxsentan) due to increased serum ALT or AST concentrations.


Eligibility Criteria:
Summary of Inclusion Criteria:

* Males and Females between 12 and 75 years of age
* Current diagnosis of IPAH, FPAH, or PAH associated with collagen vascular disease, congenital systemic-to-pulmonary shunts, anorexigen use, HIV infection
* Must have previously discontinued bosentan or sitaxsentan therapy due to serum aminotransferase (ALT and/or AST) concentrations \> 3 x ULN
* Must have normal (\< 1 x ULN) serum ALT and AST concentrations at screening
* Six-minute Walk distance of at least 150 meters at screening
* If receiving sildenafil or a clinically approved prostanoid for PAH, must have been on stable therapy for at least 4 weeks prior to screening
* Subjects with a diagnosis of HIV must have stable disease status during the screening period
High Flow Nasal Cannula as a Treatment for Obstructive Sleep Apnea

A single center, prospective study to assess the efficacy of high flow nasal cannula (HFNC) in improving obstructive sleep apnea (OSA) parameters in patients with reduced tolerance to continuous positive airway pressure (CPAP) treatment.

A single center, prospective study. The study would include 30 patients diagnosed within the past 2 years with moderate to severe OSA (AHI\>=15) at the Rabin Medical Center (RMC) sleep lab, and who are intolerant to CPAP treatment. Following signing an informed consent form, these patients would undergo polysomnography (PSG) while treated with HFNC. The HFNC PSG outcome measures will be compared to the baseline PSG done within the past 2 years and to an additional PSG while connected to a CPAP device.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years
* Confirmed diagnosis of obstructive sleep apnea, diagnosed at RMC sleep lab in the past 2 years
* Apnea Hypopnea Index (AHI)≥15
* Patient has difficulties to adjust or comply with CPAP treatment
* Signed Informed Consent Form

Exclusion Criteria:

* Patients who need bilevel positive airway pressure (BIPAP)
* Known carbon dioxide (CO2) retainers
* Weight change\>10% compared to time of OSA diagnosis
* Clinically unstable patients
* Pregnant women or special populations (e.g. children or patients unable to give informed consent)