cyrilzakka/clinical-trials huggingface dataset:
Adolescent Blood Pressure Variation and Ventricular Mass

To evaluate possible early neurogenic influence in essential hypertension by monitoring heart growth in adolescents over a two year interval.

BACKGROUND:

Evidence has accumulated suggesting that essential hypertension begins early in life and is potentially preventable. One possible pathogenetic mechanism implicated is a sympathetic nervous system abnormality which is manifested by increased sympathetic drive to the heart. An elevated sympathetic nervous system tone and decreased vagal inhibition is responsible for the hyperkinetic circulation seen in a significant proportion of persons with borderline essential hypertension. Exaggerated blood pressure and heart rate responses to mental stressors have been documented in normotensive children of hypertensive parents. These changes appear to involve sympathetic over-responding to fight-flight stimuli.

Increased blood pressure variability induced by stress might accelerate vascular and other changes leading to essential hypertension. Behavior and environment might chronically elevate sympathetic nervous system tone with damaging cardiovascular consequences. Stressful working conditions, defective anger management and poor interpersonal problem solving skills have been implicated in studies of stress-induced blood pressure increases. These influences may interact with diet and genetic risk to exacerbate pathophysiology. Essential hypertension risk might be reduced by modifying working and living environments and by training young persons at risk to cope with or avoid stressors that elicit defensive over-responding.

DESIGN NARRATIVE:

This longitudinal study tested two different models of sympathetic nervous system influence on the early pathophysiology of essential hypertension. The first neurogenic model was evaluated by determining whether an excessively variable or reactive blood pressure in year 1 gave rise to excessive heart growth or left ventricular hypertrophy over a two year follow-up. The second neurogenic model was evaluated by determining if higher blood pressure exacerbated by personality, stress, and dietary sodium intake led to increased left ventricular hypertrophy at follow-up.

All ninth-graders entering two large Baltimore high schools in year 1 and year 2 of the study were screened to yield the 240 subjects in the cohort. Initial screening included data on blood pressure, height, weight, health habits, personality, medical history, and health care utilization. Baseline exam included data on basal blood pressure, aerobic exercise stress, cognitive stress, interpersonal stress, ambulatory blood pressure, echocardiogram, physical activity, and Type A personality. The parents were also interviewed to assess family blood pressure status, health history, health care utilization and dietary habits including sodium intake. Students were re-examined at twelve and 24 months.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Improving Mental Health and Well-Being Via Awe Walks

Awe is a powerful positive emotion that offsets negative emotion and fosters prosocial behavior. This study examined the effects of awe on health and well-being in healthy older adults. Half of the participants took a weekly "awe walk" while the other half took a weekly walk with no further instructions.

Awe fosters well-being and positive emotions that promote social relationships. Awe shifts attention from ourselves to the outside world and is associated with diminished self-focused attention. We aimed to increase awe in healthy older adults to test whether greater awe experience would lead to gains in other types of positive emotional experience and reductions in negative emotional experience.

Eligibility Criteria:
Inclusion Criteria:

* Stable medical condition for 3 months prior to screening
* Reliant informant with frequent contact with participant who is available to provide observations of participant
* Fluent in English or Spanish
* Age: 40 and above
* Able to complete baseline assessments
* Education or work history sufficient to exclude mental retardation
* Physically acceptable for this study as confirmed by medical history, physical exam, neurological exam and clinical tests

Exclusion Criteria:

* Major memory concerns/diagnosed memory condition
* Korsakoff encephalopathy
* Active substance abuse
* Brain tumor
* Active neoplastic disease (skin tumors other than melanoma are not exclusionary)
* Parkinson's disease
* Multiple sclerosis (untreated)
* Sleep apnea
* History of clinically significant stroke
* Current evidence or history in the past 2 years of epilepsy, focal brain lesion, cancer, steroid use, or DSM-IV criteria for any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse
* Blindness, deafness, language difficulties or any other disability which may prevent the participant from participating or cooperating in the protocol
Comparative Effects of Blow Bottle and Acapella Along With Diaphragmatic Breathing in Patients With Pneumonia

Pneumonia is the inflammation of lung parenchyma involving lungs alveoli and is a leading cause of lower respiratory tract infections and deaths around the globe and the number rises greatly after the Covid-19 pandemic. The Symptoms of Pneumonia is cough, fever, dyspnea, myalgia, altered blood gas ratio, and mental alteration. Treatment and management of this disease varies from patient to patient according to its severity stages .Blow Bottle supports the patient to remove excess secretions to increase pressure in the airways. This opens up the passageways in bronchioles, air behind the mucus push it into the larger airways .It will be easy to remove mucus by coughing or huffing. Hypoximia is a clinical feature of Pneumonia that requires a fraction of inspired oxygen FiO2 of 0.50 to maintain an oxygen saturation of 92%. This research of randomized clinical trial will check the comparative effects of Blow Bottle Technique and Acapella along with Diaphragmatic Breathing in patients with Pneumonia by taking sample of 50 patients through Non Probability convenience sampling and randomly allocating them to two groups A and B out of which A will receive both Blow Bottle and Diaphragmatic Breathing training, B will receive Acapella with Diaphragmatic Breathing upto the duration of 3 days per week for upto 4 weeks. Pre and post training outcomes of pulmonary function will be measured through BCSS ,Oxygen Saturation through Pulse Oximeter, and disease severity through Pneumonia severity index, and Who QOL questionnaire. The data will be analyzed through SPSS 21


Eligibility Criteria:
Inclusion Criteria:

* Patients in the acute pneumonia
* Age40-60 years.
* Both male and female
* Patients with unstable health conditions
* Participants were willing to participate

Exclusion Criteria:

* Patients with physical or cognitive limitations.
* Patients with a history of chronic respiratory conditions such as COPD, bronchitis, or asthma
* Pregnant or breastfeeding women. Individuals with musculoskeletal or neurological conditions
* Patients with contraindications to chest percussion therapy, such as recent surgery or trauma to the chest area.
* Patients with severe Pneumonia requiring immediate care
Development of Three Dimensional Preoperative Planning System for the Osteosynthesis of Distal Humerus Fractures

To reproduce anatomical reduction and appropriate implant placement/choices during osteosynthesis for elbow fractures, a 3D preoperative planning system was developed. To assess the utility of 3D digital preoperative planning for the osteosynthesis of distal humerus fractures, the reproducibility of implant reduction shapes and placements in patients with distal humerus fractures will be evaluated.

3D preoperative planning will be applied for four distal humerus fracture cases . The preoperative planning will be performed in order to determine the reduction, placement and choices of implants. After the operation, the accuracy of the reduction and implants choices and placements will be verified. The reductions will be evaluated with an angle between the diaphysis axis and a line connecting the medial epicondyle with the lateral epicondyle and an angle between the diaphysis axis and the articular surface in the coronal plane and distance between the anterior diaphysis and the anterior articular surface in the sagittal plane for the 3D images of distal humerus. The reproducibility will be evaluated by the differences of the parameters between pre- and post-operative images.

Eligibility Criteria:
Inclusion Criteria:

* Distal humerus fracture patients

Exclusion Criteria:

* Patients with a previous history of traumatic injuries to the elbow
Clinical Study of Neoadjuvant Chemotherapy and Immunotherapy Combined With Probiotics in Patients With Resectable NSCLC

To evaluate the safety and effect of neoadjuvant chemotherapy and immunotherapy combined with probiotics for early resectable NSCLC patients.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed previously untreated non-small cell lung cancer. Patients with stage II, IIIA and potentially resectable stage IIIB (T3N2) disease (according to AJCC 8th edition) are eligible ;
* Eastern Cooperative Oncology Group (ECOG) performance status score 0-1;
* 18 years ≤ Age ≤ 80 years. Signed and dated written informed consent must be provided by the patient prior to admission to the study;
* Patients with appropriate treatment compliance and could be followed-up correctly;
* Patients with measurable or evaluable diseases (according to RECIST 1.1);
* Patients must have the ability to swallow oral drugs;
* Patients with adequate pulmonary function capable of tolerating the proposed lung resection (as determined by the surgeon);
* Signed and dated written informed consent must be provided by the patient prior to admission to the study.

Exclusion Criteria:

* Subjects with known ALK translocations or EGFR mutations.
* Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll;
* Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease;
* Patients with symptomatic ILD (grade 3-4) and/or poor lung function and a history of interstitial lung disease cannot be included. If you have any questions, please contact the trial team;
* Patients with other active malignant tumors currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) or investigational anti-cancer drug;
* Patients who are inability to follow the procedures required in the protocol due to any medical, mental or psychological conditions;
* Prior treatment with an anti-PD-1, anti-PD-L1 or anti-CTLA-4 antibody or any other antibodies or drugs that target T cell costimulation or immune checkpoint pathways;
* Known positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid indicating acute or chronic infection;
* Known history of testing positive for human immunodeficiency virus or known acquired immunodeficiency syndrome;
* Patients with a history of allergy to study drugs or ingredients.
Digital Breast Tomosynthesis Versus Digital Mammography: A National Multicenter Trial

The goal of this study is to determine the value of the new mammography technique called Digital Breast Tomosynthesis (DBT) compared to the current standard technique Digital Mammography for the early detection of Breast Cancer.

DBT is able to compute a three-dimensional image of a breast from several low-dose mammographies taken from different angles while the device is moving around the breast in a circular motion. This should overcome a significant limitation of Digital Mammography arising from the masking of breast cancer in a mammography image caused by overlying normal breast tissue.

This is a study conducted in several Austrian Breast Imaging Centers.

This prospective national multicenter multivendor trial aims at determining the impact of the novel technique Digital Breast Tomosynthesis (DBT) in the assessment and screening for breast cancer. Mammography is the primary imaging modality for the early detection of clinically occult breast cancer.

Despite advances in mammographic technique, mammography is still limited with regard to both sensitivity and specificity. In the majority of cases these limitations arise from the masking of subtle breast cancer lesions by overlapping breast tissue.

DBT is a novel technique that tries to overcome these limitations by performing a 3D-reconstruction of breast tissue from multiple low-dose digital mammographic images acquired in several planes in a 15 to 50 degree angle.

Early studies indicate an advantage of DBT compared to the standard Full Field Digital Mammography (FFDM) in terms of an improvement of specificity without cutback in sensitivity.

Controversy continues over the use of DBT in combination with FFDM or as a standalone screening method without concomitant 2D imaging. Unfortunately, the peer-reviewed publications evaluating DBT are limited and consist of single institution studies with a small number of participants.

The purpose of this study is to evaluate the novel technique of DBT compared to routine FFDM in a clinical large sample study (600 participants) to provide the path to implementation of this new technique into clinical and screening routine.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 25 years (40 years or older for Screening Cohort)
* No history of breast cancer
* Written informed consent
* Asymptomatic women in follow up for early detection of breast cancer or
* Patients with a recent positive mammography (BI-RADS 3-5)

Exclusion Criteria:

* Pregnant and breast feeding women
* Unable to tolerate breast compression
* Breast implants
* Unable to understand or execute written informed consent
Eliminating HCV Infection Among PWUD

Identify 300 PWUD with chronic, viremic HCV infection and engage them in a multidisciplinary, generalizable model of care and initiate HCV treatment


Eligibility Criteria:
Inclusion Criteria:

1. Ability to review, sign and date the IRB/IEC approved informed consent form
2. Age ≥19 years
3. Documented HCV RNA positive for 6 months or more, with any HCV genotype
4. Active PWUD (ongoing drug use or documented use within the previous 6 months) OR active enrolment in an opiate substitution program

Exclusion Criteria:

1. Previous DAA-based HCV treatment
2. Pregnant or breast-feeding
3. Indications of decompensated liver disease
4. Diagnosis of active hepatocellular carcinoma
5. Positive test at the time of screening for hepatitis B surface antigen (HBsAg)
6. Frequent injecting drug use that is judged by the treating physician to compromise subsequent HCV treatment safety
7. Inability or unwillingness to provide informed consent or to actively engage in care leading to the initiation of HCV treatment
EU: A Multicenter Compassionate Use Program of Daclatasvir (BMS-790052) in Combination With Sofosbuvir With or Without Ribavirin for the Treatment of Subjects With Chronic Hepatitis C

The primary objective of this program is to provide Daclatasvir in combination with Sofosbuvir with or without Ribavirin to subjects with chronic Hepatitis C who are at a high risk of liver decompensation or death within 12 months if left untreated and who have no available therapeutic options.


Eligibility Criteria:
This program is conducted in the EU (Germany, Austria, Norway, The Netherlands, Sweden and United Kingdom only)

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Patients chronically infected with Hepatitis C
* Patients at a high risk of liver decompensation or death within 12 months if left untreated and who have no available therapeutic options

Exclusion Criteria:

* Patients who are \<18 years old
* Patients who have contraindications to either Daclatasvir (DCV) or Sofosbuvir (SOF)
* Patients who are pregnant
* Creatinine clearance (CrCl) ≤ 30 mL/min (as estimated by Cockcroft and Gault formula)
* Patients who are pregnant or Women of Child Bearing Potential who are not using required contraception
Side Effects of Q-Switched Ruby Laser for the Treatment of Lentigines in Light and Dark Skin Types

The purpose of this study is a comparison of efficacy and side effects of Q-switched Ruby laser treatment for solar lentigines in two different skin types II and IV.

It has been widely accepted that dark colored individuals are prone to develop laser induced side effects especially post inflammatory hyperpigmentation(PIH) and it could be a limiting issue in selecting dark colored individuals.

We designed this study to evaluate the difference of efficacy and side effects in light and dark skinned individuals.

Eligibility Criteria:
Inclusion Criteria:

* Solar Lentigines
* Fitzpatrick skin type II and IV

Exclusion Criteria:

* Pregnancy
* Age above 80
* Photosensitivity
* Concern for malignancy
* Active Infection
Evaluation of a Video-based Internet Intervention as Preparation for Inpatient Psychosomatic Rehabilitation

The purpose of this study is to determine the effect of an internet-based preparation on the outcome expectancy and treatment credibility of rehabilitants concerning inpatient psychosomatic rehabilitation. Both study groups receive the usual written information for preparation (TAU). The patients of the experimental group have access to various videos on the study website until their inpatient rehabilitation begins, the patients of the placebo group receive no special treatment. The investigators hypothesize that the experimental group gains more positive outcome expectancy and treatment credibility compared to the control group.


Eligibility Criteria:
Inclusion Criteria:

* Authorized inpatient rehabilitation in one of the cooperation clinics
* Internet access

Exclusion Criteria:

* None
Uterine Artery Blood Flow in Pregnant Women With PCOS Treated With Metformin

FlowMet study is a "sub-study" of the PregMet study (registered in 2005).

The aim of the FlowMet study is to register the possible effect of metformin on the blood flow of the uterine artery in pregnant PCOS women. The participants will be examined with ultrasound Doppler in gestational week 10-13:

1. before and 3h after the first tablet intake of metformin/placebo
2. and 10-14 days after inclusion in the trial
3. blood flow in the umbilical artery and fetal cerebral artery in gestational week 24.


Eligibility Criteria:
Inclusion Criteria:

* Same as in the PregMet study. As this study is a sub-study/extended study of the PregMet study, ONLY those included in the PregMet study (NCT00159536) can participate.

Exclusion Criteria:

* Same as in the PregMet study
A Prospective Observational Study of the Clinical Performance of Zarin in Madagascar

This one-year observational study will monitor the contraceptive effectiveness, safety and acceptability of Zarin during the first year of use after the method has been approved for public use in Madagascar. It will be implemented by Marie Stopes Madagascar with technical support from Marie Stopes International and FHI. 300 women of reproductive age who selected Zarin as their primary method of contraception will be enrolled in the study at the MSM outreach sites and static clinics.

This one-year observational study will monitor the contraceptive effectiveness, safety and acceptability of Zarin during the first year of use after the method has been approved for public use in Madagascar. It will be implemented by Marie Stopes Madagascar with technical support from Marie Stopes International and FHI. 300 women of reproductive age who selected Zarin as their primary method of contraception will be enrolled in the study at the MSM outreach sites and static clinics.

Eligibility Criteria:
Inclusion Criteria:

* be a participant of the MSM service evaluation and continue using Zarin at 3 months
* agree at the time of Zarin insertion to be contacted regarding an opportunity to participate in more research related to the implant

Exclusion Criteria:

-
A Study of LY3209590 in Japanese Participants With Type 2 Diabetes Mellitus

The main purpose of this study is to evaluate the safety of a study drug known as LY3209590 in Japanese participants with type 2 diabetes. Side effects and tolerability will be documented. Blood samples will be taken to compare how the body handles the drug and how it affects blood sugar levels. The study will last almost five months for each participant.


Eligibility Criteria:
Inclusion Criteria:

* Have type 2 diabetes mellitus (T2DM) for at least 1 year
* Have received a stable daily dose of basal insulin at screening
* Have hemoglobin A1c (HbA1c) greater than or equal to (≥)6.5 percent (%) and less than or equal to (≤)10.0% at screening
* Have a body mass index greater than (\>)18.5 and ≤40.0 kilograms per square meter (kg/m²) at screening

Exclusion Criteria:

* Have received a total daily dose of insulin \>1.2 units per kilogram (U/kg) of body weight at screening
* Have received insulins except for basal insulins
* Have received sulfonylurea at more than half of the maximum approved dose level
* Have a history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction or history of significant atopy
* Have had more than 1 episode of severe hypoglycemia within 6 months before entry
Finding the Optimal Location for Saturation Measurement During Flexible Bronchoscopy

An observational comparison of different locations of saturation measurements during Flexible Bronchoscopy

The study group will include 100 patients undergoing flexible fiberoptic bronchoscopy (FFB).

The patients will receive sedation with Midazolam, Fentanyl and Propofol. All patients will receive supplemental oxygen via nasal cannula (2-4 L/min) before the beginning of the procedure.

In all cases, patients will be monitored using continuous electrocardiography, pulse oximetry (on patients finger), and transcutaneous carbon dioxide and saturation (on patients earlobe), and automated noninvasive blood pressure recordings every 5 minutes. All parameters will be recorded from accepting patient to bed of procedure until 10 minutes after removal of FFB from nasopharynx.

The saturation will be measured in 3 different locations (one pulse is added in other earlobe). additionally, A blood gas sample will be taken during discrepancy between different measurements.

Immediately after the end of procedure, the measurements from 3 different monitors will be printed, and the blood sample be taken to a gas sample machine by the investigator.

Desaturation value and time will be compared between the different locations. The blood arterial saturation will be compared to other measurements taken at the same time.

Eligibility Criteria:
Inclusion Criteria:

* informed consent

Exclusion Criteria:

-
Clinical Trial to Evaluate the Efficacy and Safety of Nexpowder™ for Diverticular Bleeding in the Lower Gastrointestinal Tract

Clinical Trial to Evaluate the Efficacy and Safety of Nexpowder™ for Diverticular Bleeding in the Lower Gastrointestinal Tract


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 19 years or older at the time of screening
* Patients diagnosed with diverticular bleeding

Exclusion Criteria:

* Patients diagnosed with upper gastrointestinal bleeding