cyrilzakka/clinical-trials huggingface dataset:
Olanzapine for the Treatment of Refractory Chronic Nausea and Vomiting

Prospective, observational study evaluating the effect of olanzapine for the treatment of refractory chronic nausea and vomiting.

Patients will be identified who are seen in the Johns Hopkins Gastroenterology Clinic, suffer from chronic nausea and vomiting that is refractory to both prokinetic and antiemetic medications, and are being prescribed olanzapine for treatment of nausea and vomiting. Patients who meet criteria will be enrolled and their gastrointestinal symptoms, quality of life, and psychological symptoms will be assessed by various questionnaires and followed over the course of 3 months.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age
* Able to communicate in English without aid of interpreter
* Have chronic refractory nausea, meeting each of the following criteria:

  1. Baseline nausea and vomiting score on VAS of 25mm or greater
  2. Duration symptoms of at least 6 months (does not have to be contiguous)
  3. Intolerance to or inadequate response to prior treatment with both 1) ondansetron or another serotonin (5HT3) antagonist and 2) metoclopramide or domperidone

Exclusion Criteria:

* History of chemotherapy within the last year
* Current diagnosis of cancer
* Pregnant or breastfeeding
* For females, active efforts to conceive/become pregnant during the time of the study
* Chronic opioid use (3 times a week or greater use)
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation of greater than 2x upper limit of normal (within 3 months of enrollment)
* Cirrhosis
* Unable or unwilling to stop using metoclopramide while using olanzapine
* Concomitant use of other antipsychotics (e.g., haloperidol)
* Prolonged corrected QT interval (QTc) (\>470ms for men and \>480ms for women)
* History of life-threatening arrhythmia
* Hypokalemia (potassium \<3.1) or hypomagnesemia (magnesium \<1.2)
* Metabolic syndrome, defined as per Adult Treatment Panel III criteria
* Granulocytopenia (absolute neutrophil count \<1500)
* History of tardive dyskinesia
* History of acute dystonic reaction to medications
* History of neuroleptic malignant syndrome
Registry on the Effectiveness and Safety of the 9-month MDR-END Treatment Regimen in Korean Patients with FQ-sensitive MDR-TB (MDR-END Registry)

This study is to evaluate the effectiveness and safety of a 9-month MDR-END regimen as a treatment for fluoroquinolone-sensitive multidrug resistant pulmonary tuberculosis in the real-world clinical setting.

It will be conducted as a non-interventional, prospective, single group, multicenter design.

Subjects who are considered to meet the inclusion /exclusion criteria will receive MDR-END regimen for 9 months (or 12 months) during the treatment period according to the 5th edition of the Korean Guidelines for Tuberculosis, and will be followed-up for 12 months after the end of treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 19 years or older who have been diagnosed with multidrug resistant pulmonary tuberculosis
2. Adults prescribed MDR-END regimen according to the Korean Guidelines for Tuberculosis after being informed of this study from the investigator and signing an informed consent form

Exclusion Criteria:

1. Patients with confirmed quinolone resistance
2. Patients with hypersensitivity to one or more of the following drugs: Delamanid, Linezolid, Levofloxacin, and Pyrazinamide
3. Patients who are found to have contraindications according to the approved labels of Delamanid, Linezolid, Levofloxacin, or Pyrazinamide
4. Patients with or with a history of optic neuritis or peripheral neuritis
5. Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
6. Pregnant or lactating women
7. Women of childbearing potential who are unwilling to use appropriate contraception during the study treatment
Remote-delivered MBCT for SCAD Survivors

Spontaneous coronary artery dissection (SCAD) is an important cause of cardiac events, primarily affecting young healthy women with no cardiovascular risk factors. The 10-year recurrence rate is 30%, but SCAD recurrence cannot be predicted. Approximately half of SCAD survivors struggle with significant anxiety and fear of recurrence (FOR), which contributes to poor sleep and physical inactivity and, thereby, increased risk of recurrence. Mindfulness-Based Cognitive Therapy (MBCT) is an 8-week group intervention with evidence to improve FOR and health behaviors (sleep, physical activity), through psychological mechanisms that directly target key FOR processes (interoceptive bias, intolerance of uncertainty). I adapted MBCT to target FOR, sleep, and physical activity in cardiac event survivors via group videoconferencing delivery (UpBeat-MBCT), however this intervention has not yet been targeted to SCAD survivors. I propose an open pilot trial to test the feasibility, acceptability, and changes in psychological and behavioral health variables in SCAD survivors participating in UpBeat-MBCT (N=16). Participants will be recruited from the MGH SCAD Program and asked to complete self-report surveys and actigraphy before and after the intervention. The primary outcomes are feasibility and acceptability of the intervention and research procedures. Exploratory outcomes are changes in psychological and behavioral variables and their inter-correlations. This project would be the first and only behavioral intervention for SCAD survivors and would provide preliminary data for an NIH Stage II efficacy trial to develop an accessible and efficacious intervention for a vulnerable group of SCAD survivors, with generalizability to survivors of other cardiac events.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Cardiologist-confirmed diagnosis of SCAD in the past 1-12 months
* English-speaking and reading
* Internet access (via computer or mobile device).

Exclusion Criteria:

* Terminal illness with life expectancy \<1 year
* Severe mental illness requiring urgent psychiatric intervention (e.g., active suicidal ideation) or past-year psychiatric hospitalization)
* Significant cognitive impairment preventing informed consent determined by study staff or medical record review (e.g., medical history of cognitive impairment)
* Deemed unable to complete research procedures (e.g., group sessions or surveys) per clinical judgment of study staff
* Unavailable for intervention sessions (e.g., schedule conflicts)
Tobacco Control Among Business Process Outsourcing (BPO) Employees

The Business Process Outsourcing BPO industry has been rapidly expanding in India over the last 10 years. There is a concern regarding issues of health and safety that are unique to this new and developing industry. The lack of reliable and relevant information on which to base the response to this concern poses a challenge for safeguarding the health of BPO employees. Elevated stress levels, shift duties, high work targets, lofty income may force many towards addictions to keep them going.

Use of tobacco, which is very common addiction in India, is associated with several health hazards. Anecdotal evidence suggests that smoking and other forms of addictions are at its peak in the BPO industries. We are conducting a research on the tobacco habits among Business Process Outsourcing (BPO) employees to understand the prevalence of different forms of tobacco addiction and the reasons for initiation and continuation of the habit. We will also offer different interventions as a measure of tobacco cessation.

This is a four arm randomized controlled trial among Business Process Outsourcing (BPO) employees working in four different BPO units. The trial is undertaken with the objective to explore the prevalence of tobacco use in its various forms along with factors responsible for initiation and continuation of the habit. This trial also aims to study the change in the knowledge, attitudes and practices among BPO employees after intervention with different tobacco cessation strategies.

Four BPO units with work force of approximately 200 employees each, with the management and employees that consent to participate in the study will be selected for the trial. The aim and purpose of the study will be explained and a written informed consent form in English will be offered. The employees who are willing to participate in the trial, will be recruited after signing the informed consent form.

The subjects involved in the research will be expected to answer a few questions about their socio-demographic, occupational, medical, risk factor history and some questions to assess their knowledge, attitude and practice regarding tobacco use. Following this the tobacco users will be offered one of the tobacco cessation interventions to help them quit tobacco.

Regular follow-up visits will be conducted through out the period of the study. The same questionnaire as the pre intervention will be repeated post intervention, ten months later to assess change in their knowledge, attitude and practice regarding tobacco use.

Eligibility Criteria:
Inclusion Criteria:

* The study participants will be apparently healthy males and females above 18 years of age working in the selected BPO units in Mumbai.

Exclusion Criteria:

* There will be no minors.
Fluid Responsiveness Using Forehead Sensor in Children

Forehead sensor can predict the more accurate fluid responsiveness than finger sensor in children

The investigator hypothesized that the forehead sensor can predict the fluid responsiveness more accurate than the finger sensor in pediatric patients.

Eligibility Criteria:
Inclusion Criteria:

* pediatric patients undergoing general anesthesia for neurosurgery, major abdominal surgery, and cardiac surgical procedures.

Exclusion Criteria:

* preoperative Ejection fraction \<30%
* underlying lung disease
* cardiac arrhythmia
Study to Assess Safety, Tolerability and Pharmacokinetics After Single Doses of AZD2516 to Healthy Volunteers

The primary purpose of this study is to assess the safety and tolerability of AZD2516 following administration of a single dose.


Eligibility Criteria:
Inclusion Criteria:

* Healthy white males or non-fertile females between 20 to 45 years and 65 to 80 years old.
* Weight between 50 to 100 kg and a body mass index (BMI) between 19 to 28 kg/m2

Exclusion Criteria:

* History of previous or ongoing psychiatric disease.
* Abnormalities in ECG that may interfere with interpretation of data.
Pharmacogentic Screening of Coumarine Based Oral Anticoagulant Using Next Generation Seguencer

As drug response is a complex trait in the majority of cases using an optimal starting dose for an individual may reduce the time taken to reach a stable INR, and reduce the risk of having either a high INR (with a risk of bleeding) or a low INR (with a risk of thrombosis)

The results of this project will benefit in (1) Identification of novel features or mutation types in warfarin resistance genomes. (2) To determine whether other polymorphisms in noncoding regions or their unique haplotype combinations contribute to the variability in the maintenance dose of warfarin, and (3)personalization of the drug and deciding the correct dose from the start.

Eligibility Criteria:
Inclusion Criteria:

* Patients with thrombosis and warfarin resistance

Exclusion Criteria:

* less than 18 years
Allogeneic Multipotent Stromal Cell Treatment for Acute Kidney Injury Following Cardiac Surgery

The purpose of this trial is to determine if the administration of allogeneic MSCs at defined doses is safe in patients who are at high risk of developing significant Acute Kidney Injury (AKI) after undergoing on-pump cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* Documented ischemic coronary heart and/or valvular heart disease:Acceptable candidate for elective CABG and/or Cardiac Valve Surgery
* Patients at high risk for post-op AKI:Age 18 or older if at high risk for post-op AKI because of underlying Diabetes mellitus (type I or II), CHF, COPD Chronic Kidney Disease (CKD) stage 1-4
* Patients at high risk for post-op AKI :age \> 65 or combinations
* Patent femoral artery without aortic aneurysm
* Ability to give informed consent.

Exclusion Criteria:

* Presence of ongoing local or systemic infection
* Younger than 18
* Participation in another clinical trial
* Pregnancy
* Contraindication to general anesthesia
* Prisoner
* Dialysis patient (CKD-6) or patient with CKD-5
* History of malignancy except non-melanoma skin cancer
* Occluded Groin arteries
* Uncontrolled Diabetes mellitus (HbA1c \> 10, history of diabetic ketoacidosis or osmolar coma within the last three months)
* Non-healing foot ulcers.
* Clinical evidence of severe peripheral vascular disease (ABI \< 0.3)
* Coronary Angiogram \< 7 days before surgery
* Inadequate pre-operative time to obtain baseline kidney function data due to urgent/emergent surgery
* Unstable myocardium (evolving myocardial infarction), cardiogenic shock
Determine the Effect of the Fourth Ventricle Compression Technique on Physiological Variables

This study aims to analyze the influence of the fourth ventricle compression technique in heart rate, respiratory rate, blood pressure, conductivity and thermal variability of the skin in healthy young adults.

The fourth ventricle compression technique (CV-4) is one of the most important techniques in the treatment of cranial osteopathy.

During the present study, the effects of CV-4 technique will be analyzed in the following variables: heart rate, respiratory rate, blood pressure, conductivity and thermal variation of the skin.

According to the literature, CV-4 technique will cause changes in all of the studied variables, except the respiratory rate, through the activation of the brain stem, namely the parasympathetic nerve centers.

Regarding the respiratory rate, it is justified by the fourth ventricle and the respiratory centers proximity.

Concerning heart rate and respiratory rate, during the CV-4 technique the literature describes a decrease in the values of this variables. However, other studies refer that the technique does not produce relevant effects in the heart and respiratory rates variation, probably because there was no stipulated time to finish the technique, ending subjectively compared to previous ones.

When it comes to blood pressure, a decrease in systolic blood pressure values is noticed by some authors.

In which concerns the variation in body temperature, according to the literature, there were no significant results obtained when performing CV-4.

During the performed literature analysis,there were not found any studies concerning the influences of the CV-4 technique in the thermal conductivity variable.

Eligibility Criteria:
Inclusion Criteria:

* Healthy participants aged between 18 and 33 years.

Exclusion Criteria:

* Cognitive deficits that can possibly compromise the understanding of the study instructions;
* Any type of medication taken that may have influences at the variables under study in the previous 7 days;
* Cranio-cervical injuries, surgery to the skull and /or spine in the last 12 months;
* Chronic cardiorespiratory, renal, systemic, neurological, musculoskeletal, oncological and psychiatric pathologies;
* Headaches, migraines, dizziness and / or nausea while performing the techniques;
* Caffeine and / or alcohol intake in the 6 hours prior to the data collection;
* Tobacco consumption in the 30 minutes prior to the data collection;
* Practice of intense physical exercise in the 90 minutes prior to the data collection;
* Pregnant women or menstruating;
* Participants who were submitted to manual therapy treatments during the past month;
* Osteopathy students of 3rd year or higher degree, in order to prevent the participant from recognizing which group they belong to.
Effect of Oral Contraceptives After Administration of Semaglutide in Subjects With Type 2 Diabetes

This clinical trial is conducted in Europe. The purpose of the trial is to investigate the influence on the pharmacokinetics (the rate at which the trial drug is eliminated from the body) of an oral contraceptive combination drug after multiple administration of semaglutide in female subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained by a physician before any trial-related activities
* Postmenopausal women: a. With at least 12 months of spontaneous amenorrhoea with serum follicle stimulating hormone (FSH) above 40 mIU/mL and oestrogen deficiency (estradiol levels less than 30 pg/mL, or a negative gestagen test) or b. Bilateral oophorectomy (surgical removal of both ovaries)
* Type 2 diabetes treated with either diet and exercise alone or with metformin (monotherapy) having a glycosylated haemoglobin (HbA1c) of 6.5 -10% (both inclusive)
* Stable treatment of diabetes, either diet and exercise only or a stable dose level of metformin, for at least 3 months
* BMI (Body Mass Index) between 18.5 - 35.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Known or suspected hypersensitivity to trial products or related products
* Previous participation in this trial. Participation is defined as being dosed with either drug
* Treatment with antidiabetic drug other than metformin within the last 3 months
* Use of hormone replacement therapy within 4 weeks prior to starting dosing with the trial product
* Presence or history of cancer or any clinically significant diseases or disorders, considered by the physician to have influence on the results of this trial
* Subjects who are known to have hepatitis
* Positive human immunodeficiency virus (HIV) antibodies
* Uncontrolled treated/untreated hypertension (systolic blood pressure above 160 mmHg and/or diastolic blood pressure above 100 mmHg)
* History of alcoholism or drug abuse during the last 3 months
* History of chronic or idiopathic acute pancreatitis
* Family or personal history of multiple endocrine neoplasia type 2 (MEN2), or family history of medullary thyroid cancer (FMTC)
* Personal history of non-familial medullary thyroid carcinoma
* Subjects who are considered at increased risk of thrombosis formation, such as deep vein thrombosis, pulmonary embolism, infarction or apoplexy (as judged by the trial physician) and subjects who are smokers
* Blood or plasma donation within the last 3 months prior to first dosing
* Participation in any other trial investigating other products or involving blood sampling within the last 3 months prior to first dosing
* Inability or unwillingness to perform self-injection (with placebo medium) at trial start
Biomarkers of Ovarian Reserve and Correlation With IVF Treatments

Retrospective study to evaluate the correlation between AFC, FSHb, AMH and IVF outcomes of 347 cycles performed with three different protocols.

347 IVF cycles (236 patients) analyzed for a retrospective study to evaluate the correlation between the biomarkers of ovarian reserve (antral follicles count, antimullerian hormone, basal follicle stimulating hormone) and number of oocytes and mature oocytes (MII) retrieved during the pick up. For the stimulation were used three different protocols: long luteal, antagonist with daily administration of gonadotropins and antagonist with depot administration of gonadotropins.

Eligibility Criteria:
Inclusion Criteria:

* women with primary or secondary infertility underwent ovarian stimulation for in vitro fertilization.

Exclusion Criteria:

* women who underwent ovarian stimulation for cryopreservation in the presence of neoplastic disease.
Prospective Study on the Incidence of Adrenal Crisis in Patients With Chronic Adrenal Insufficiency

Prospective study to evaluate incidence, causes and potential risk factors for adrenal crisis in patients with chronic adrenal insufficiency.

This is a prospective study following patients with chronic adrenal insufficiency by contacting them every 6 months via questionnaires and telephone. QUestionnaires assess incidence and causes of adrenal crisis, frequency of hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* chronic primary or secondary adrenal insufficiency requiring glucocorticoid substitution therapy

Exclusion Criteria:

* adrenocortical carcinoma
* long term glucocorticoid treatment above 7.5 mg prednisone equivalent dose for other reasons than adrenal insufficiency
* age \< 18 years
Pharmacokinetics and Pharmacodynamics of Different Nicotine Salt Concentration Vape System Pods and Free-base Nicotine

Comparison of the pharmacokinetics and pharmacodynamics of two different nicotine salt concentrations and free-base nicotine using an open vape pod system

On each study day, one puff will be taken with the assigned product every 30 seconds (total of 10 puffs). Blood samples will be collected to measure nicotine 15 minutes before vaping and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff. Heart rate and blood pressure will be measured 15 minutes before and 2, 10, 15, 30, 60, 120, and 180 minutes after the last puff. Post-use withdrawal, craving, reward, and satisfaction will be assessed 10 minutes and 1 and 3 hours after the last puff using the modified Minnesota Nicotine Withdrawal Scale (MNWS), the Tiffany Questionnaire on Smoking Urges (QSU), and the Positive and Negative Affect Schedule (PANAS) questionnaires. Respiratory symptoms will be assessed at baseline and 5 minutes after the last puff. Ten minutes post-use, the direct effects of the assigned product (e.g. satisfying, calming, pleasant, vape another one right now) will also be assessed using visual analog scales.

Eligibility Criteria:
Inclusion Criteria:

* Men or women, age 18 or older at screening, who have used electronic cigarettes and/or smoked at least 5 cigarettes per day in the past 30 days
* Saliva cotinine of \> 50 ng/mL at screening
* No clinically significant findings on the physical examination at screening
* Ability to communicate well with the investigator and to understand and comply with the requirements of the study
* Women of child-bearing age: willingness of using a reliable contraception method during the study
* Signed informed consent

Exclusion Criteria:

* Known hypersensitivity/allergy to a content of the e-liquid
* Pregnancy or breast feeding
* BMI \< 18 or \> 28 kg/m2 at screening
* History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening
* Loss of ≥ 250 ml of blood within 3 months prior to screening, including blood donation
* Treatment with an investigational drug within 30 days prior to screening
* Treatment with prescribed or over-the-counter (OTC) medications with potential influence on CYP2A6 function within 1 week prior to screening (with the exception of contraception)
* History or clinical evidence of any disease (e.g. gastrointestinal tract-disease) and/or existence of any surgical or medical condition, which in the opinion of the investigator might interfere with the absorption, distribution, metabolism or excretion of the study drugs, or which might increase the risk for toxicity
* Legal incapacity or limited legal capacity at screening
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol