cyrilzakka/clinical-trials huggingface dataset:
The Effect of BMS-986165 Combined With an Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Patients

The purpose of this study is to investigate the effect of BMS-986165 in combination with an oral contraceptive in healthy female patients.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive,
* Weight ≥ 50 kg
* Negative result for tuberculosis (TB) as evidenced by a QuantiFERON-TB Gold Plus test at screening, or documentation of a negative result within 4 weeks before Cycle 1, Day 1
* Women of childbearing potential with intact ovarian function, on a stable regimen of combination birth control containing EE without evidence of clinically significant breakthrough bleeding or spotting for at least 2 consecutive months prior to Cycle 1 Day -1
* Subjects aged 21 years or older must have a normal Pap smear result within 3 years before Cycle 1 Day 1 (a Pap smear may be performed at screening if no result is available); a finding of abnormal squamous cells of unknown significance (ASCUS) is allowed provided it is an initial finding and not a follow up from an initial finding of ASCUS

Exclusion Criteria:

* Exposure to an investigational agent within 12 weeks before Cycle 1 Day 1
* Subjects who are pregnant or breastfeeding
* Any significant acute or chronic medical illness including infection, any active infection, febrile illness within 7 days before Cycle 1, Day 1, or any condition that could predispose the subject to infection
* History of recurrent or chronic sinusitis, bronchitis, pneumonia, urinary tract infection (recurrent or chronic urinary tract infection is 2 episodes within 6 months)
* Any serious acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening
* Known or suspected autoimmune disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the subject's immune status (eg, history of splenectomy, primary immunodeficiency, etc)

Other protocol defined inclusion/exclusion criteria could apply
Translation and Reliability of FAAM-U

This study is designed to translate and validate the FAAM questionnaire to the Urdu language, to interpret its psychometric properties, and to determine the reliability of scores obtained from the population of Pakistan. The translated version of the gold standard tool will be used by the local population as well as Urdu-speaking immigrants across the globe to better understand and report the severity of their symptoms. Hence, to improve quality of life across cultures, there is a need of standard outcome measures in Urdu language.


Eligibility Criteria:
Inclusion Criteria:

* Ankle and foot disorders, referred by a general physician or surgeon,
* Conscious
* Ambulatory
* Able to write and read Urdu language

Exclusion Criteria:

* inflammatory disease
* vascular diseases
* neural diseases
* cancer
Nitrate Supplementation During Final Examination Stress

The purpose of the present study is to explore the effects of a dietary nitrate supplement on immunity, mood, cardiovascular activity, and lung function during and following final exam stress in both healthy and asthmatic individuals.

Past research has demonstrated significant changes in immune response and airway inflammation during times of stress. Specifically, significant decreases in the fraction of exhaled nitric oxide (FeNO) in both healthy and asthmatic undergraduate students have been found during times of final exam stress. Additionally, research suggests that dietary supplementation of nitric oxide may have beneficial cardiovascular effects which may offset the physiological consequences of stress.

This research study explores the effects of a dietary supplement on immunity, mood, cardiovascular and respiratory function during and following final exam stress. In this study, investigators monitor changes in respiratory infection incidence, airway nitric oxide, mood, blood pressure, and lung function in students with and without asthma during the time of final exams and a comparable time of low stress during the term. There are three assessments in the laboratory, as well as two additional brief questionnaires on separate days. During the final exam period, half of the participants are randomly assigned to the experimental group which is provided with a dietary supplement (beetroot juice drink) of which they are asked to take one dose every day in the morning for seven days. The three assessments periods include two during the week of final exams and one during a period of low stress scheduled up to two weeks to two months before that time. For the final exam period, the first of the two sessions takes place on the day before the second of these exams, and the second assessment takes place on a subsequent day after second exam. A follow-up assessment of cold symptoms takes place online 7 days after the final exam period.

Eligibility Criteria:
Inclusion Criteria:

* Lung healthy or physician diagnosis of asthma
* Undergraduate student with at least 3 final examinations

Exclusion Criteria:

* Current smoker
* History of seizures
* History of stroke
* History of heart attack or heart disease
* History of thyroid problems
* History of head injury or neurological disorder
* Diabetes
* Any kind of lung disease (other than asthma)
* Corticosteroids within the past month
* Antibiotics within the past month
A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Allogenic Hematopoietic Cell Transplantation (HCT) Participants.

The main purpose of the study is to evaluate the efficacy and safety of mRNA-1647 compared to placebo to prevent first clinically significant cytomegalovirus infection (CS-CMVi) in the period following cessation of CMV prophylactic treatment (for example, letermovir) on Day 100 post-HCT through Month 9 post-HCT.


Eligibility Criteria:
Inclusion Criteria:

* Receipt of an allogeneic HCT.
* CMV-seropositive, defined as a documented positive test for anti-CMV IgG.
* High-risk for CMV: HCT from related, unrelated, or haploidentical donor with post-transplant cyclophosphamide for graft-versus-host-disease (GVHD) prophylaxis; or HCT from related or unrelated donor with at least one mismatch at any of the following human leukocyte antigen (HLA) gene loci (HLA-A, B, C, and DRB1); or HCT from related or unrelated donor with myeloablative conditioning.
* Persons of nonchildbearing potential or of childbearing potential with negative urine or serum pregnancy test on the day of first study injection.
* Persons of childbearing potential who have practiced adequate contraception or have abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose.
* Persons of childbearing potential who have agreed to continue adequate contraception or abstain from all activities that could result in pregnancy through 3 months after last study injection.
* Persons who are not currently breast/chestfeeding.
* Willingness to comply with study procedures and provide written informed consent.

Exclusion Criteria:

* History of a diagnosis or condition that, in the judgment of the Investigator, may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.
* A documented positive human immunodeficiency virus (HIV) test.
* Treatment with alemtuzumab (Campath®), antithymocyte globulin (ATG), or any equivalent in-vivo T cell depleting agent within 12 months.
* HCT with ex-vivo T cell depletion.
* Low risk for CMV: HCT from related or unrelated donor with reduced intensity conditioning (RIC) and no other high-risk features.
* History of prior hematopoietic cell transplantation within 12 months.
* Receipt of prior investigational CMV vaccines or participation in another CMV therapeutic study that may interfere with study outcome measures as determined by the Investigator.
* Suspected or known allergic reaction to any component of any mRNA vaccine or its excipients.
Multimodal Outcome CHAracterization in Comatose Cardiac Arrest Patients Registry and Tissue Repository

Cardiovascular disease remains the leading cause of death in the United States. Mortality rates of cardiac arrest range from 60-85%, and approximately 80% of survivors are initially comatose. Of those who survive, 50% are left with a permanent neurological disability, and only 10% are able to resume their former lifestyle. Early prognosis of comatose patients after cardiac arrest is critical for management of these patients, yet predicting outcome for these patients remains quite challenging.

The primary study objective of MOCHA is to develop an accurate and reliable assessment algorithm for determining neurologic prognosis in patients initially unconscious (no eye opening, GCS-M\<6 and not following commands) post-cardiac arrest, using multiple prognostic modalities at standardized time points.

The investigators will conduct a prospective, international, observational study of cardiac arrest survivors using guideline-recommended prognostic assessment tools with central adjudication of results, while avoiding premature withdrawal of life-sustaining therapy (WLST). The investigators will prospectively collect data on demographics, premorbid characteristics, details of cardiac arrest and resuscitation, post-cardiac arrest care, detailed neurological examination findings, electrophysiologic studies, chemical biomarkers and neuroimaging at standardized time points, and will assess functional outcomes at discharge, 6- and 12-month follow-up, as well as annually up to 5 years. The international cohort will have a derivation subset that will be used to create a multimodal outcome prediction model (using regression analysis), which will then be confirmed by the validation subset. A substudy of MOCHA will also explore the impact of the practice of WLST in the prediction model by analyzing its performance in a pooled cohort of subjects unexposed to WLST originating from countries where this practice is not common.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older (no upper age limit)
* Initially unconscious following cardiac arrest from any non-perfusing rhythm (i.e., ventricular tachycardia, ventricular fibrillation, pulseless electrical activity, asystole)
* Sustained return of spontaneous circulation (ROSC) as defined by maintained spontaneous circulation for at least 20 minutes after cardiopulmonary resuscitation.

Exclusion Criteria:

* Subjects younger than 18 years of age
* Isolated respiratory arrest without concomitant or ensuing cardiac arrest
Intraocular Pressure During Spine Surgery

This study will compare the effect of two intravenous solutions on eye pressure during spine surgery in the following groups:

Group A - Lactated Ringer's replacement for blood loss and placebo eye drops

Group B - Lactated Ringer's replacement for blood loss and brimonidine eye drops

Group C - Albumin replacement for blood loss and placebo eye drops

Group D - Albumin replacement for blood loss and brimonidine eye drops

Patients will be administered either brimonidine eye drops, or placebo eye drops, preoperatively, on the day of surgery and during surgery. Eye pressure will be measured before surgery, every 30 minutes throughout your surgery and every hour for 4 hours following surgery. Subjects will be evaluated before surgery and on days 5, 8, 15 after surgery. During these evaluations, the subject will be asked questions about recovery and his/her eyes will be checked by an ophthalmologist and vision will be tested.

Eligibility Criteria:
Inclusion Criteria:

* Spine surgery with instrumentation in prone position expected to last at least 5 hours;
* Anticipated blood loss ≥ 1L
* Age 18-80 years old;
* ASA physical status I-III.

Exclusion Criteria:

* History of increased intraocular pressure or glaucoma;
* Diabetic retinopathy;
* Heart failure or serious left ventricular dysfunction;
* Abnormal preoperative fundus examination;
* Creatinine \> 2 mg/dL;
* Patient refuses blood transfusion or albumin administration
Safety Study of 90Y-hMN14 to Treat Pancreatic Cancer

The purpose of this trial is to determine the safety of 90Y-hMN14 at different dose levels in the treatment of pancreatic cancer.


Eligibility Criteria:
Disease Characteristics:

* Patients with a documented histologic or cytologic diagnosis of a pancreatic malignancy
* Patients with recurrent, advanced and/or metastatic disease, who have either failed standard therapy or are not eligible for any alternate therapies of higher therapeutic priority.
* Patients with at least one identified (confirmed) and measureable tumor site.

Prior/Concurrent Therapy:

* Surgery: Patients are excluded if they have had major surgery either during or within four weeks prior to study entry.
* Chemotherapy: Patients must have failed standard therapy or are not eligible for any alternate therapies of higher therapeutic priority.
* Biologic Therapy: Patients who have received a chimeric, CDR-grafted (humanized), or human IgG will be eligible provided pre-study evaluations demonstrate no significant reactivity with hMN14 IgG (i.e., HAHA)
* Radiotherapy: No prior radiotherapy within four weeks of study entry. No prior external beam irradiation to a field that includes more than 30% of the red marrow. No prior radiation to maximal tolerable levels for any critical organ (e.g., 3,000 cGy for the liver; 2,000 cGy for the lungs and kidneys).
* Other: Any experimental therapy (i.e., drugs, biologics, procedures) for the primary malignancy, either during or within four weeks prior to study entry.

Patient Characteristics/Inclusion Criteria:

* Performance Status: Patients with a Karnofsky performance status \> 70% (or equivalent, ECOG 0-1) and an expected survival rate of at least 3 months
* Hematopoietic: Hemoglobin \> 10g/dL; WBC \> 3000 per mm3; Granulocyte count \> 1500 per mm3; platelet count \> 100,000 per mm3
* Hepatic: Total bilirubin \< 1.5 times the institutional upper limit of normal (IULN); AST or ALT \< 2 X IULN
* Renal: Creatinine \< IULN
* Cardiovascular: Patients with LVEF \>/= 50% by required MUGA/2D-ECHO study
* Pulmonary: Patients with DF and FEV1 \>/= 60 % by required Pulmonary Function Tests
* Gastrointestinal:Patients with severe anorexia or other related symptomology are excluded
* Central Nervous System: Patient with known metastatic disease to the CNS are excluded
* Other: Patients who have had a prior imaging study with a murine antibody may be included. Patients agreeing to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be preformed on each premenopausal female of childbearing potential immediately prior to entry into the study. Patients able to understand and give written informed consent.
Ketosis Impact on Signs & Symptoms of Schizophrenia and Bipolar disorderS

The goal of this clinical trial is to learn if a ketone drink can improve signs and symptoms of patients with a schizophrenia-spectrum disorder (SSD), or a bipolar-spectrum disorder (BD).

The main questions it aims to answer are:

Does a ketone drink improve information processing in patients with SSD/BD?

Other questions it aims to answer are:

Does a ketone drink improve cognitive functioning in patients with SSD/BD? Does a ketone drink improve metabolism and inflammation in patients with SSD/BD? Does a ketone drink affect circadian rhythm in patients with SSD/BD?

Research will compare the effects of the ketone drink with that of an isocaloric carbohydrate drink in the same patients ('cross-over').

Participants will:

1. drink a ketone drink and (after a wash-out period) an isocaloric control drink (randomized order); after each drink:

   * EEG/EMG to determine information-processing parameters (PPI and P300)
   * cognitive tests
   * visual analog scale of mood, energy levels, ability to focus
   * indirect calorimetry to determine use of energy substrate
   * blood draws
2. for 5 consecutive days:

   * wear a continuous glucose monitor (CGM)
   * wear a non-invasive passive sweat biomarker sensor (EnLiSense device)
   * register a diet and nicotine diary
   * saliva sampling (max. 5x/day)


Eligibility Criteria:
Inclusion Criteria:

* Patients with a first-episode psychosis (underlying schizophrenia-spectrum disorder), or patients with a (hypo)manic or depressive episode (underlying bipolar disorder)
* Age \>= 18 years old
* Receiving standard care (including antipsychotic and mood stabilizing medication)
* Mentally competent to give informed consent:

Exclusion Criteria:

* Substance use as cause of psychosis or (hypo)mania
* Substance use (other than nicotine) in the week prior to study onset
* Intellectual disability
* Diabetes mellitus (type 1 or type 2)
* Metabolic disease impacting ketone metabolism (NB: these are rare disorders diagnosed during childhood)
* Liver disease
* Kidney disease
* Cardiovascular disease
* Pregnancy
* Breastfeeding
Vitamin C Chewing Gum, Pregnancy Nausea and Vomiting

Although there are studies in the literature examining the effects of chewing gum or using vitamin C on nausea and vomiting symptoms, no study has been found examining the effect of vitamin C gum on the severity of nausea and vomiting during pregnancy. This study aimed to investigate the effect of vitamin C gum on the severity of pregnancy nausea and vomiting.

One of the problems that occur during pregnancy, the etiology of which is not fully known, is nausea and vomiting experienced during early pregnancy (Taşkın, 2019). Meta-analysis studies indicate that the prevalence of nausea and vomiting during pregnancy is between 35% and 91% (Matthews et al., 2015; Sridharan and Sivaramakrishnan, 2018). Nausea and vomiting usually occur on days 4-6. It starts in weeks 9-16 of pregnancy. It peaks in the following weeks (Matthews et al., 2015). Risk factors for nausea and vomiting during pregnancy are not known precisely. While the increase in human chorionic gonadotropin hormone and estrogens in the blood seems to be the possible cause, hormonal factors such as prostaglandin E2, thyroxine and prolactin are probably added to this (Bustos et al., 2017). There are many pharmacological and non-pharmacological methods with proven effects in the treatment of pregnancy nausea and vomiting. Pharmacological treatments include antiemetics, anticholinergics, antihistamines, dopamine antagonists, vitamins (B6 and B12), H3 antagonists or combinations of these substances (Erişen et al., 2021). Non-pharmacological methods include some interventions such as acustimulation, acupuncture, chamomile, ginger, peppermint oil, lemon oil, and vitamin B6 (Matthews et al., 2015). Pregnant women with nausea and vomiting generally do not want to receive pharmacological treatment due to concerns about the negative effects of drugs on the fetus. It is stated that various vitamin-based products such as B6, B12 and herbal treatments such as ginger, mint, peppermint oil and lemon are effective and safe in pregnancy nausea and vomiting (Sarecka-Hujar and Szulc-Musioł, 2022).

Eligibility Criteria:
Inclusion Criteria:

* 18 years and over,
* At least primary school graduate,
* married,
* Those who are younger than the 16th week of pregnancy,
* Those who complain of nausea and vomiting during pregnancy,
* Those who agreed to participate in the study.

Exclusion Criteria:

* Those who have a health problem that may cause nausea and vomiting in their current pregnancy,
* Those receiving any antiemetic treatment,
* Smokers.
The Effects of Glucomannan on Weight Loss

The purpose of this study is to determine if the herb, Glucomannan, is an effective non-pharmacological appetite suppressant for overweight or Class I obese patients. The study design will not include any other lifestyle changes which enhance weight loss in order to completely isolate the effects of Glucomannan as a non-pharmacological appetite suppressant.


Eligibility Criteria:
Inclusion Criteria:Subjects will be recruited based upon the category of them wanting to lose 50 pounds.

Subjects must be able to swallow the capsule whole with water.

Exclusion Criteria:

1. Self-reported use of prescription medication other than hormonal birth control (such as medication for diabetes, hypertension hypothyroidism, heart disease, cancer, etc.)
2. Pregnancy
3. Age younger than 21 or older than 60 years of age.
4. Screening for hypertension during the first laboratory visit that reveals a systole greater than 120 and a diastole greater than 90.
5. BMI calculations based upon height and weight measurements at the first laboratory visit that reveal a BMI less than 25 or greater than 35.
6. Self-reported iron-deficiency anemia, osteoporosis, and hypoglycemia.
Electrical Nerve Stimulation of the Ulnar Nerve

Cubital tunnel syndrome is caused by compression of the ulnar nerve at the elbow. This leads to symptoms such as chronic hand weakness, numbness and pain. This is usually treated with a surgical procedure where the nerve is decompressed. Research has shown that nerve simulators speed up the recovery of nerves following injury. The purpose of our research is to examine the difference in patient outcomes after the nerve decompression surgery with and without nerve stimulation.

Our research questions is: What are the differences in long term functional outcomes of patients that have ulnar nerve decompression surgery with and without nerve stimulation?

1. Patients will be seen in University of Chicago clinics, if they are diagnosed with Cubital Tunnel Syndrome, they will be approached to be enrolled in our study
2. If they fit inclusion and exclusion criteria, failed conservative management, and consent to be part of the study, they will be scheduled for Cubital Tunnel Surgery and randomized into intervention/non-intervention group
3. Patients will have pre-operative subjective pain and upper extremity function surveys and objective hand strength/sensation measurements done by a blinded Occupational Therapist in University of Chicago Occupational Therapy Clinic. Patient will also have a pre-operative EMG done.
4. Patient will be discharged following surgery and followed up at 6 weeks, 3 months, 6 months, 12 months. EMG will be done at 3 months and the same outcome measurements (Pain scores, PRUNE evaluation, QuickDash Questionnaire, Michigan hand Questionnaire, grip strength, sensation measurements) will be taken at each postoperative visit by the same blinded occupational therapist
5. Data will be compared pre and postoperatively

Eligibility Criteria:
Inclusion criteria

* EMG confirmed ulnar nerve neuropathy at cubital tunnel with or without these symptoms:

  * Paresthesia or numbness of the small finger and/or ring finger
  * Complaints of hand weakness
  * Exam shows positive flexion compression test at elbow and/or positive tinel's sign at the cubital tunnel
* Failed conservative management for 6 weeks

  ○ Has completed a combination of these for 6 weeks and still has symptoms
  * Night splinting in 45-60 degrees of flexion and forearm neutral
  * Padding of elbow with an elbow pad during the day
  * Daily NSAIDs if able to take them
  * Cubital tunnel steroid injection
* Age restriction: 18--65years old

Exclusion criteria

* Psychiatric conditions
* Workman's compensation patients
* Neurologic conditions (ex. MS)
* Inflammatory rheumatologic conditions (Connective tissues disease, RA... etc)
* Associated elbow and upper extremity fractures
* Previous Cubital Tunnel Surgeries
* Previous C-Spine Surgeries
* Pregnancy