cyrilzakka/clinical-trials huggingface dataset:
Black Cohosh for Host Flashes Due to Androgen Deprivation Therapy

This is a randomized, placebo-controlled crossover study. Participants will be actively participating in the study for 6 months, and enrolled in the study for up to 1 year. During the first phase of the study, the participants will be randomized into either the placebo group or treatment group for 8 weeks following 1 week of baseline data collection (no treatment). Following this first phase, a no-treatment washout period of at least 3 weeks will be implemented for all participants. After the washout period, the randomized groups will switch from treatment to placebo group, or placebo to treatment group for an additional 8 week period. Hot flash frequency and severity will be documented using a daily hot flash diary and calculated using the Hot Flash Score questionnaire. The impact on quality of life will be documented by weekly Hot Flash Related Daily Interference Scale (HFRDIS) questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Able to understand English or be wiling to use a trained interpreter
* Diagnosis of prostate cancer
* Receiving either Leuprolide or Degarelix,for prostate cancer treatment
* Currently experiencing a minimum of 3 self-reported hot flashes within a 24 hour period
* Eastern Cooperative Oncology Group (ECOG) performance status score \< 2
* Life expectancy \>3 months.
* No grade 3 or higher toxicity from prior cancer therapies unless judged by the principal investigator to be clinically irrelevant to study procedures
* At least four (4) weeks following prior major surgery
* Serum testosterone concentration below castrate level (\< 30 ng/dL) at time of recruitment
* Willing to provide written informed consent for participation in the study

Exclusion Criteria:

* Concurrent severe illness effecting ECOG performance status or life expectancy as determined by the principal investigator
* Hormone refractory patients. Patients taking Enzalutamide or Abiraterone.
* Active infection
* Psychiatric illness or social situation that would limit safety and compliance with study requirements
* Currently taking any pharmaceutical medications that have potential interactions with black cohosh as determined by the principal investigator
* Currently taking any supplements that have potential interactions with black cohosh as determined by the principal investigator
* Currently receiving any treatment for hot flashes or planning to initiate any treatment for hot flashes other than with study supplementation
* ALT, AST, or Bilirubin \> 2 times their normal laboratory values in the past 3 months
* Inability to complete the informed consent process or adhere to the protocol treatment plan.
Process Validation in Dermatology: Assessing Methods for UV Exposure (Artificial Source vs. Sunlight) and Efficacy Evaluation of Anti-Tanning Agents

The rationale of this study is to establish a robust method for assessing sun protection product efficacy in preventing erythema and tanning. Employing both artificial ultraviolet-A Irradiation and natural direct sunlight exposure, the investigation seeks to provide a reliable methodology, ensuring reproducibility and enabling a direct comparison between these methods. Meticulously determining optimal UV dosages, the study prioritizes inducing skin responses for evaluation while avoiding adverse effects like blistering. The localized validation of UV exposure techniques, tailored to the Indian population, contributes significantly to the field by addressing diverse skin types and environmental conditions. By incorporating both artificial and natural (direct sunlight) UV exposure methods, the study aspires to enhance the safety and effectiveness of future dermatological investigations, benefiting both the scientific community and the broader population.


Eligibility Criteria:
Inclusion Criteria:

1. 06 Healthy adult subjects aged between 18 to 45 years (both inclusive).
2. Healthy adult male and non-pregnant\|non-lactating females.
3. Female of childbearing potential have self-reported negative urine pregnancy test.
4. Subjects with Fitzpatrick skin types III to V will be included. Alternatively, subjects with a Skin colorimetric Individual Typology Angle (ITA) value ranging from 20° to 41° at the application site (forearms) to be included to ensure a diverse representation of skin tones.
5. Absence of known photosensitivity disorders to maintain the integrity of the study outcomes.
6. Subjects must exhibit a willingness to comply with study plan, including follow-up visits and product applications.
7. No history of skin cancer to or any adverse skin conditions, and not under any medication(s) likely to interfere with the study results.
8. Subjects willing to follow study direction and willing to give written informed consent for the participation.

Exclusion Criteria:

1. Active skin diseases, such as eczema or psoriasis, that could potentially influence skin reactions.
2. Use of photosensitizing medications that interfere with UV-induced skin responses.
3. Pregnancy or breastfeeding status, as hormonal changes during these periods can affect skin reactions.
4. Individuals with a history of severe adverse reactions to skincare or cosmetic products, ensuring participant safety.
5. Presence of open wounds, infections, or cuts at the application sites to prevent complications during the study.
6. Subjects with a history of significant sunburns in the past three months, minimizing the potential for confounding effects.
Feasibility of Appropriate Smartphone Position During Video-assisted Cardiopulmonary Resuscitation

There is a gap in our knowledge regarding whether video-assisted cardiopulmonary resuscitation (V-CPR) is feasible when a lay responder is alone at the scene. The feasibility of V-CPR was measured in a simulated cardiac arrest scenario when a lay responder was alone with the patient.

There is a gap in our knowledge regarding whether video-assisted cardiopulmonary resuscitation (V-CPR) is feasible when a lay responder is alone. The feasibility of V-CPR was measured in a simulated cardiac arrest scenario when a lay responder was alone with the patient. A pilot study was conducted to measure the appropriate smartphone position and placement time when a lay responder is alone. Two simulated cardiac arrest locations were prepared: a living room and yard.

The performance of the participants were recorded. After that, the quality and assessability of the videos were evaluated by five experts (experienced in CPR teaching and evaluation).

Eligibility Criteria:
Inclusion Criteria:

* layperson or health care professional, who is phisically and mentally able to do a simulated CPR scenario (participants in the scenario)
* expert in CPR training (assessors)

Exclusion Criteria:

* technical issue during data collection
The EMBRACE Study The EMBRACE Study

Cardiomyopathy is a condition that affects the heart muscle, whereby it becomes enlarged, thick or rigid. When the heart muscle becomes involved, it affects the pumping action of the heart. This condition can affect as many as 10% of all patients after undergoing anthracycline cancer drug therapy and unfortunately carries the worst prognosis of all cardiomyopathies. To date, there is no effective intervention that will prevent a patient from developing this condition. The research conducted will look to see if an energy imbalance in the heart predates the onset of detrimental changes to the pumping function of the heart, if this is detected then we can act earlier to prevent the pumping function deteriorating.

There is emerging cellular and experimental evidence that cardiac energetic status is reduced after anthracycline treatment, however, this has not been tested in the human heart. The researchers hypothesize that cardiac energetic status is reduced in the human heart after administration of anthracycline therapy in breast cancer patients, inline with the evidence available from all other types of cardiomyopathies. The researchers propose to use in vivo 31Phosphorus cardiac spectroscopy to measure the cardiac energetic status at the beginning and at the end of the cycles of chemotherapy in the hearts of breast cancer patients who are administered epirubicin (the most modern anthracycline to date) and compare this with the cardiac energetic status of age and gender matched healthy controls. Further, the researchers wish to explore if the myopathy-induced effect of anthracyclines extends to the skeletal muscle as well, by examining skeletal muscle biopsies in these patients.

Eligibility Criteria:
Inclusion Criteria:

* A patient who has been diagnosed with breast cancer and has been scheduled for a first cycle of anthracycline therapy.
* Participant who is willing and able to give informed consent for participation in the study.
* Healthy (gender and age matched) volunteers willing to give informed consent for participation in the study.

Exclusion Criteria:

* Contraindication to magnetic resonance scanning such as an implantable cardiac device.
Validation of a Noninvasive Automated Blood Pressure Device

The investigator's objective is to validate the novel automated blood pressure device against the requirements set forth in the AAMI_ISO 81060-2:2010 standard in voluntarily consented study participants.

A new prototype blood pressure cuff has been designed for the higi SH llc health stations. This new cuff accurately captures blood pressure (BP) by emulating a fitted cuff which is used in conjunction with a mercury sphygmomanometer, the accepted gold standard for measuring BP values in most clinical facilities. The cuff is driven by a motor and gearhead to automatically "wrap" the cuff around a user's arm when they initiate a BP test. A BP measurement is then taken by an Original Equipment Manufacturer (OEM) BP module using an algorithm developed for use with a fitted cuff; the same module one would expect to find in a clinic or doctor's office. For the device to pass the AAMI_ISO 81060-2:2010 standard statistical requirements and thus, be considered a valid device for measuring BP it will need to meet the standards criteria 1 and 2.

Eligibility Criteria:
Inclusion Criteria:

* between the ages of 12 to 92 years of age.
* generally healthy but can be on medication for blood pressure regulation.

Exclusion Criteria:

* heart disease is present such as, coronary artery disease, cardiomegaly, irregular heart rhythm, atrial fibrillation, heart valve disease, congenital heart disease, cardiomyopathy, pericardial effusion, Marfan syndrome, and heart murmurs.
* using a pacemaker to maintain a suitable heart rate.
* missing their natural left arm.
* exhibit a musculoskeletal disorder that may prevent them from sitting upright for a period of time (\~40min) or prevent a BP reading taken from the left arm.
* Special populations, for example pregnant women and patients with known arrhythmias.
Prevention of Postpartum Hemorrhage With Tranexamic Acid

Postpartum hemorrhage is a significant contributor to maternal morbidity and mortality and is worldwide. TXA has recently been proven to reduce mortality when given to women in setting of diagnosed PPH. US obstetricians and anesthesiologists are hesitant to use TXA in the peripartum period especially for prevention of PPH due to uncertainty of an optimal dose and safety profile. The purpose of this study is to characterize the pharmacokinetics of TXA when given prophylactically at time of delivery. In addition investigators will determine the pharmacodynamics of TXA in the peripartum period.

Conduct a prospective, open-label, dose finding PK study in 30 pregnant 3rd trimester women scheduled for non-emergent cesarean section who are at risk for hemorrhage. Three doses of the drug will be administered in an escalating fashion by cohort with the lowest dose first. A maximum of 1 gram will be administered. TXA serum levels at several time points after delivery will be assayed. A PK model will be constructed for determining the optimal TXA dose administered at parturition.

Eligibility Criteria:
Inclusion Criteria:

* Women who are undergoing medically indicated cesarean section at greater than 34+0 weeks gestation or women undergoing elective cesarean section at 39+0 weeks gestation in accordance with recommendations from the American Congress of Obstetricians and Gynecologists
* Pregnant women with normal serum creatinine (serum creatinine \< 0.9)
* Women between the ages of 18 and 50 years old

Exclusion Criteria:

* Patients younger than 18 or older than 50
* women with active thrombotic or thromboembolic disease
* Women with a history of arterial or venous thromboembolic event
* Women with inherited thrombophilia or preexisting conditions that predisposes them to thromboembolic events (i.e. lupus, antiphospholipid syndrome)
* Women with a subarachnoid hemorrhage
* Women with acquired defective color vision
* history of seizure disorder
* known renal dysfunction
* multiple gestations (Twin or triplet pregnancies)
* Hypersensitivity to Tranexamic acid or anti-fibrinolytic therapy
* History of liver dysfunction
Stem Cell Therapy for Vasculogenesis in Patients With Severe Myocardial Ischemia

Mesenchymal stem cells from the bone marrow can be stimulated to differentiate into endothelial cells and participate in the development of new blood vessels in ischemic tissue.

The aim of the study is in a phase I/II safety and efficacy study to evaluate the clinical effect of autologous mesenchymal stem cell therapy in patients with severe chronic myocardial ischemia.

Mesenchymal stem cells from the bone marrow can be stimulated to differentiate into endothelial cells and participate in the development of new blood vessels in ischemic tissue.

The aim of the study is in a phase I/II safety and efficacy study to evaluate the clinical effect of autologous mesenchymal stem cell therapy in patients with severe chronic myocardial ischemia.

4o patients with reversible ischemia on a SPECT will be treated with direct intramyocardial injections of autologous isolated and expanded mesenchymal stem cells.Clinical and objective evaluations will be performed at baseline and during 12 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Age 30 to 80 years Reversible ischemia on a stress SPECT Angina pectoris CCS class \>_ 2 Reduced exercise time \< 10 min No further revascularization options

Exclusion Criteria:

* Pregnant Present or history of cancer Proliferative retinopathy Systemic severe disease LVEF \< 25 % NYHA \> II
Predictive Assays In Cervix Cancer

The experiments outlined in this proposal will compare a number of currently available techniques for assessing hypoxia and interstitial fluid pressures in patients with cervix cancer. The aim of these experiments is to establish the relationship of the clinically relevant outcome measures of tumour control and survival following radiation therapy with these biological characteristics of carcinoma of the cervix relevant to tumour hypoxia. These characteristics will be assessed in patients undergoing treatment using techniques which have reached an appropriate level of development for clinical evaluation and aim to determine the best technique for determining these parameters of the tumour microenvironment. A number of novel strategies directed at the microenvironment are undergoing or soon will be undergoing clinical evaluation and selection of appropriate patients for these trials is of great importance.


Eligibility Criteria:
Inclusion Criteria:

1. Histologic diagnosis of cervix cancer
2. A decision to treat using radiation therapy according to the existing treatment policies of the PMH Gynecology Group
3. Clinical stage IB-IV with grossly evident cervical disease
4. No distant metastases
5. No cytotoxic anti-cancer therapy for cervical carcinoma prior to study entry
6. Signed informed consent

Exclusion Criteria:

-
Surgical Valvuloplasty for Congenital Mitral Insufficiency

Congenital mitral insufficiency is one of the most common valvular diseases in the pediatric population worldwide, carrying a high morbidity and mortality risk if not treated immediately and properly. Given that mitral replacement likely increased risk of cardiac dysfunction and mitral reoperation, mitral repair is the currently preferred surgical strategy in the majority of pediatric patients with mitral insufficiency. Unfortunately, previous evidences demonstrated the long-term hemodynamic alteration in response to significant mitral regurgitant might lead to a reversible or irreversible pulmonary vascular remodeling regardless of concomitant other cardiac malformations, which is associated with increased risk of morbidity and mortality following the surgery. Currently available researches mainly focused the association of pulmonary vascular pressures with risk of mortality and morbidity on adult rheumatic or degenerative mitral insufficiency; however, knowledge is still lacking regarding pediatric population with congenital mitral insufficiency. The investigator wil assess the relationship between baseline sPAP and risk of operative morbidity and mortality.


Eligibility Criteria:
Inclusion Criteria:

* evidence of normal or preserved left ventricular systolic function (defined as left ventricular ejection fraction \[LVEF\] \>50%);
* native mitral regurgitation of grade moderate or greater;
* with or without systemic-to-pulmonary shunting necessitating concomitant surgical repairs, regardless of pulmonary arterial pressure or pulmonary artery wedge pressure.

Exclusion Criteria:

* functional single ventricle;
* rheumatic mitral diseases;
* Eisenmenger syndrome;
* aortopathy, transposition of the great arteries, obstructions of ventricular outflow tract, malignant arrhythmias, cardiomyopathy, microbiological identification of infective endocarditis;
* a history of pericardiotomy or intervention therapy.
Trial Evaluating the Efficacy of Remimazolam in Endobronchial Ultrasound Guided Transbronchial Needle Aspiration

Study to evaluate the efficacy and safety of remimazolam in patients undergoing endobronchial ultrasound-guided transbronchial needle aspiration

Primary Outcome Evaluate and compare the success of the procedure in patients undergoing EBUS-TBNA (Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration) when administered with remimazolam in the experimental group, versus Real world midazolam (Control Group 1), and On label midazolam (Control Group 2).

Secondary Outcome In patients undergoing EBUS-TBNA, compare the following aspects when administered with remimazolam in the experimental group versus Real world midazolam (Control Group 1) and On label midazolam (Control Group 2): Procedure start time, Time taken to achieve full alertness, Need for flumazenil administration, Total dose of fentanyl used, Scale of coughing/discomfort/convenience, Changes in vital signs, Complications related to the procedure.


Eligibility Criteria:
Inclusion Criteria:

1. Adult males and females aged 18 and above
2. ASA 1-3
3. BMI 18.5\~30.0
4. Saturation pulse oximeter (SpO2) ≥ 90% in ambient air or with no more than 2 liters/min of O2 support
5. Patients who can comply with the procedures according to this clinical study protocol and who have voluntarily signed the consent form themselves

Exclusion Criteria:

1. Patients undergoing radial EBUS or electromagnetic navigation bronchoscopy (ENB) simultaneously
2. ASA 4 or higher
3. Mallampati score 4
4. BMI \< 18.5, BMI \>30.0
5. Known sensitivity to benzodiazepines, flumazenil, opioids, naloxone, or a medical condition in which these agents
6. Bronchoscopy outside the bronchoscopy unit
7. chronic kidney disease on dialysis
8. Patients with a current active acute infection or uncontrolled chronic inflammatory lung disease
9. Patients considered inappropriate for the study at the investigator's discretion
A Phase 1/2 Study Evaluating AMG 337 in Asian Subjects

This is a multicenter, Phase 1/2 study. The study will evaluate the tolerability, safety and activity of AMG 337 in Asian subjects who have advanced solid tumors (Phase 1) or subjects with MET amplified tumors with a focus on gastric/gastroesophageal junction/esophageal adenocarcinoma (Phase 2).

This is a Phase 1/2, multicenter, single arm, open-label study to assess the safety, efficacy and pharmacokinetics of AMG 337 in solid tumors. In the Phase 1, approximately 3 to 45 subjects enrolled in a 3+3+3 dose escalation scheme evaluating two dose levels. In the Phase 2, approximately 140 subjects will be enrolled to either Cohort 1 (subjects with MET amplified /gastroesophageal junction/esophageal (G/GEJ/E) adenocarcinoma with measurable tumor) or Cohort 2 (subjects with MET amplified solid tumors with measurable tumor and subjects with MET amplified G/GEJ/E adenocarcinoma with non-measurable tumor). All subjects will self-administer AMG 337 daily until disease progression or other protocol specified end of treatment criteria are met. Tumor assessment by RECIST 1.1 will be followed during study treatment.

Tumor tissue, biomarkers, pharmacokinetics and Patient Reported Outcomes will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Able to self administer daily AMG 337 as a whole capsule
* Male or female 20 years of age or over
* Phase 1: Subjects must have a pathologically confirmed, advanced solid tumor for which the subjects have received prior therapy for advanced disease, for which no standard therapy exists, or the subject refuses standard therapy.
* Phase 2: Subjects must have a pathologically confirmed, advanced G/GEJ/E adenocarcinoma (cohort 1) or other solid tumor (cohort 2) for which the subjects have received prior therapy for advanced disease, or for which no standard therapy exists, or the subject refuses standard therapy.
* Tumor MET amplified by protocol-specified centralized testing (phase 2 only).
* Phase 1: Measurable or non-measurable disease per RECIST v1.1
* Phase 2: Measurable disease per RECIST v1.1 guidelines. Cohort 2 may include subjects with advanced MET amplified G/GEJ/E adenocarcinoma with non-measurable tumor per RECIST v1.1.
* (ECOG) Performance Status of 0, 1, or 2
* Other protocol defined inclusion criteria may apply.

Exclusion Criteria:

* Known central nervous system metastases.
* Subject is a candidate for curative surgery or definitive chemoradiation.
* Peripheral edema \> grade 1.
* Subjects who have persistent gastric outlet obstruction, complete dysphagia or are dependent upon jejunostomy for feeding. Significant gastrointestinal disorder(s) that in the opinion of the Investigator may influence drug absorption.
* Currently receiving any anti-tumor treatments, or less than 14 days prior to enrollment since ending anti-tumor treatment.
* Prior treatment with small molecule inhibitors of the MET pathway.
* Other protocol defined exclusion criteria may apply.