cyrilzakka/clinical-trials huggingface dataset:
An Assessment of Long Term Safety of the Combination of Aliskiren / Amlodipine in Patients With High Blood Pressure

To assess the long-term (6 month and 12 month) safety of the combination of aliskiren 300 mg / amlodipine 10 mg in patients with essential hypertension (Mean Sitting Diastolic Blood Pressure \[msDBP\] ≥ 90 mmHg and \< 110 mmHg).


Eligibility Criteria:
Inclusion Criteria:

* Outpatients 18 years of age or older
* Male or female patients are eligible
* For newly diagnosed/untreated patients with essential hypertension defined as msDBP ≥ 90 and \< 110 mmHg at Visit 1 and Visit 4
* For previously treated patients with essential hypertension defined as msDBP ≥ 90 and \< 110 mmHg after 2 to 4 weeks of washout (Visit 4)

Exclusion Criteria:

* Severe hypertension
* History or evidence of a secondary form of hypertension
* History of Hypertensive encephalopathy or cerebrovascular accident.

Other protocol-defined inclusion/exclusion criteria may apply
Effect of Abdominal Massage on Excretory Activity and Pulmonary Function Tests in Patients After Surgery

This study is aimed to determine the effect of abdominal massage on excretory activity and pulmonary function tests (PFT) in patients undergoing PKP.

Methods: The research will be carried out with 78 patients who underwent partial hip replacement. Patients were assigned to study (abdominal massage) and control groups by randomization. Abdominal massage will be applied to the patients at least 30 minutes after the morning and evening meals (08:30 in the morning, 20:30 in the evening) for 15 minutes, similar to the literature. Patients' data will be collected 15 minutes before and after the application of abdominal massage. Within the scope of the patient's data, information on pulmonary function test values, intra-abdominal pressure value and excretory activities will be collected. Abdominal massage will start in the evening of the day the patient is transferred to the clinic (20:30), and will be terminated when the patient defecates. No treatment will be applied to the patients in the control group. The data recorded before and after the abdominal massage in the study group will be recorded in the Excretory Activity Form and the Pulmonary Function Test Form as a result of the measurements made at the same time in the control group.

Eligibility Criteria:
Inclusion Criteria:

* Having a urinary catheter for at least one day after surgery,
* Discharged at least 48 hours after surgery,
* Do not have any condition for which abdominal massage is contraindicated (inflammatory bowel disease, presence of abdominal tumor, surgical intervention or radiotherapy to the abdominal region, presence or suspicion of ileus, and pregnancy),
* No diagnosis of chronic constipation made by a physician,
* Who has not developed any respiratory tract complications (atelectasis, pneumonia, etc.) due to surgical intervention,
* No chronic respiratory disease (chronic obstructive pulmonary disease, pulmonary hypertension, sleep apnea syndrome, asthma, chronic bronchitis, cystic fibrosis, occupational lung diseases, etc.),
* Patients who do not have problems in transition to oral feeding and who can be fed orally will be included in the study.

Exclusion Criteria:

* Urinary catheter removed within the first day after surgery,
* Discharged before 48 hours after surgery,
* Any condition in which abdominal massage is contraindicated (inflammatory bowel disease, presence of abdominal tumor, surgical intervention or radiotherapy to the abdominal region, presence or suspicion of ileus, and pregnancy),
* Having a diagnosis of constipation made by a physician,
* Having any respiratory complications (atelectasis, pneumonia, etc.) developed due to surgical intervention,
* Having chronic respiratory disease (chronic obstructive pulmonary disease, pulmonary hypertension, sleep apnea syndrome, asthma, chronic bronchitis, cystic fibrosis, occupational lung diseases, etc.),
* Patients who have problems in the transition to oral feeding and cannot be fed orally will not be included in the study.
COVID-19 Convalescent Plasma for Mechanically Ventilated Population

The purpose of this study is to see if this plasma can be safely used in humans with COVID-19 and to see if it can improve patients' health when they are sick with COVID-19.

This open-label, single arm, phase 1 trial will assess the safety and efficacy of convalescent plasma in severely ill, mechanically ventilated participants with pneumonia due to COVID-19. This study will enroll adults 18 years old and older, including pregnant women. A total of 50 eligible participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19. Participants will receive convalescent plasma on Study Day 1 in addition to standard of care. Participants will be assessed daily while hospitalized and then on Study Days 15, 22, 29, and 60. All participants will undergo a series of safety, efficacy, and laboratory assessments. Blood samples will be collected on Days 1 (prior to plasma administration), 3, 5, 8, 11, 15, 29, and 60. Oropharyngeal or endotracheal samples will be collected on Days 1 (prior to plasma administration), 3, 5, 8, 11, and 15.

Eligibility Criteria:
Inclusion Criteria:

1. Adult ≥18 years of age
2. Laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other authorized or approved assay in any specimen collected within 72 hours prior to enrollment. Note - An exception must be requested to the Sponsor if≥72 hours since positive test.
3. Hospitalized, on invasive mechanical ventilation or ECMO, consistent with a clinical status assessment 8-point ordinal scale severity score of 7.
4. Documentation of pneumonia with radiographic evidence of infiltrates by imaging (e.g., chest x-ray or CT scan).
5. Patient or proxy is willing and able to provide written informed consent and comply with all protocol requirements.

Exclusion Criteria:

1. Contraindication to transfusion (e.g., severe volume overload, history of severe allergic reaction to blood products), as judged by the investigator.
2. Clinical suspicion that the etiology of acute illness (acute decompensation) is primarily due to a condition other than COVID-19
3. Receipt of other investigational therapy as a part of another clinical trial. a. Note: investigational therapies used as part of clinical care, (eg, remdesivir, hydroxychloroquine) are permissible.
The Effect of Clove Oil on Labor Pain

The study has two groups. one of them is experimental group that is given massage with clove oil. The other one is control group that is given standard midwifery care. Each group consists of 30 women. We will evaluate their labor pain scores by using Visual Analogue Scale before and after massage application.

Labor is a painful process. That's why there are lots of nonpharmacological methods to reduce labor pain. Especially most clinical guide suggests giving massage to pregnant who has labor pain. In the literature, there are a lot of study examining effectiveness of massage techniques. However there is no study about massage application with clove oil on labor pain. The investigators would like to give a massage with clove oil to pregnants to reduce their labor pain. Hereby the investigators will evaluate effectiveness of clove oil.

Eligibility Criteria:
Inclusion Criteria:

* All of volunteer and pregnant women is 18-35 years old.

Exclusion Criteria:

* The pregnant women has any obstetrical complications.
Bioequivalence Study of Zidovudine 300 mg Tablets, USP Under Fed Conditions

The objective of this study was to assess the single-dose relative bioavailability of Ranbaxy and GlaxoSmithKline (Retrovir ®) 300 mg Zidovudine tablets, under fed conditions

This was an open label, randomized, single dose, 2-way crossover, comparative bioavailability study performed on 68 healthy adult volunteers. In each period, subjects were housed from at least 10 hours before dosing until after the 12 hour blood draw. Single oral dose 300 mg Zidovudine doses were separated by a washout period of 7 days.

A total of sixty-eight (68) healthy adult subjects (29 males and 39 females) were enrolled in the study, of which sixty five (65) subjects (29 males and 36 females) completed the clinical portion of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult male or female volunteers, 18-55 years of age
2. Weighing at least 52 kg for males and 45 kg for females within 15 % of their ideal weights (table of 'Desirable weights of Adults', Metropolitan Life Insurance Company, 1983)
3. Medically healthy subjects with clinically normal laboratory profiles, vital signs and ECGs
4. Females of child bearing potential were either sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or were using one of the following acceptable birth control methods:

   Surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum; IUD in place for at least 3 months; Barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the first dose and throughout the study Surgical sterilization of the partner (vasectomy for 6 months minimum) Hormonal contraception for at least 3 months prior to the first dose of the study Other birth control method deemed acceptable
5. Postmenopausal women with amenorrhea for at least 2 years
6. Given voluntary written informed consent to participate in this study.

Exclusion Criteria:

1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease
2. In addition history or presence of alcoholism or drug abuse within the past year, or hypersensitivity or idiosyncratic reaction to Zidovudine or to any other nucleoside analogue
3. Female subjects who were pregnant or lactating
4. Subjects who tested positive at screening for HIV, HBsAg or HCV
5. Subjects who have used any drugs or substances known to be strong inhibitors of cyp enzymes (formerly known as cytochrome p 450 enzymes) within 10 days prior to the first dose
6. Subjects who have used any drugs or substances known to be strong inducers of cyp enzymes (formerly known as cytochrome P 450 enzymes) within 28 days prior to the first dose and throughout the study
7. Subjects who through completion of the study would have donated in excess of 500 mL of blood in 14 days, 1500 mL of blood in 180 days or 2500 mL of blood in 1 year
8. Subjects who have participated in another clinical trial within 28 days prior to the first dose.
Radiation Field, Dose and Fractionation Related to Mandibular Complications

Radiotherapy is inhibiting the healing capacity of the mandibular bone. Late complications as bone exposure, fracture of the jaw, osteoradionecrosis might be a consequence of this vulnerability. A factor that could be involved in the development of complications is field of radiation. There are limited number of studies investigating this relation.

Retrospective analysis of a head and neck oncology register with prospectively included patients will be performed. Patients will be related to the University hospitals in Lund, Umea, Orebro, Stockholm. A thorough analysis of the medical journals in this group of patients will be performed. Included patients have been treated with combination of surgery and radiotherapy to treat malignancies in the head and neck region. At least 12 months follow up period is needed for inclusion.

The scientific aim is to investigate weather the field of radiation and fractionation is crucial for developing the formentioned complications.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of the head and neck malignancy
* Must have recieved radiotherapy as primary treatment alone or combination treatment together with surgery

Exclusion criteria

* less than 12 months follow up
* Under 18 years of age
Effects of Perioperative Intravenous Dexamethasone on the Severity of Persistent Postsurgical Pain After Total Knee Arthroplasty : A Prospective, Randomized, Double-blind, Placebo-controlled Trial

To compare the effects of perioperative intravenous Dexamethasone with a placebo on the severity of persistent postsurgical pain after total knee arthroplasty.

It is not clear whether perioperative intravenous Dexamethasone has an effect on severity of persistent postsurgical pain (PPSP) after total knee arthroplasty (TKA). The research hypothesis is that TKA patients experience less severe PPSP after administration of perioperative intravenous Dexamethasone.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 40 years (45)
* Primary knee osteoarthritis diagnosed using the American College of Rheumatology criteria (46)
* Undergoing elective, primary and unilateral total knee arthroplasty
* American Society of Anesthesiology (ASA) physical status class 1-3
* BMI \< 40 kg/m2

Exclusion Criteria:

* History of active rheumatic diseases
* History of previous musculoskeletal injury of the same knee for excluding patients with secondary knee osteoarthritis
* History of previous surgery on the same knee
* History of adverse effects from medications to be used in this study
* Contraindication to spinal anesthesia
* History of psychiatric disorders or cognitive impairment
* Contraindication to corticosteroid agents
* Poorly controlled diabetes mellitus (HbA1C \> 7.5)
* Poorly controlled hypertension
* History of ischemic heart disease or peripheral arterial disease or cerebrovascular disease
* Hepatic insufficiency (Child-Pugh score \> 5)
* Renal insufficiency (Creatinine clearance \< 30 mL/min)
* History of cataracts or glaucoma or ocular hypertension
* History of steroid or immunosuppressive drug use within 6 months of surgery
Clinical Evaluation of ASP Health's Automated ROSE System for Bronchoscopic Applications

Prospective comparison of cytology slides (bronchoscopically derived fine needle aspiration samples of lymph nodes at the time of rapid intraprocedural on site evaluation) created with the ASP Health's specimen preparation system to slides made by existing conventional methods.

Rapid On-Site Evaluation (ROSE) has dramatically improved patient care during Fine Needle Aspiration procedures by providing adequacy feedback to the proceduralists. In the case of endobronchial ultrasound (EBUS) procedures, the samples that are collected from the patients are reviewed to determine adequacy of samples to ensure diagnostic quality samples are being processed. If the amount of specimen is found to be adequate, the interventional pulmonologists make additional passes to collect more specimen sample. While the existing ROSE method performed by smearing the samples on the glass slide and staining the slides has dramatically improved patient outcomes, it has several challenges/drawbacks. Some of the challenges of ROSE slide preparation include: (i) high variability in sample quality, (ii) cumbersome process in the procedure room and (iii) possibility of cross contamination between samples, (iv) slow specimen preparation and staining process which leads to extended procedure time and (v) the cost of the personnel to prepare slides. The goal of this study is to conduct a trial of a novel automated sample preparation system from ASP Health that combines both the specimen deposition and staining in a compact/mobile unit. This automated system is expected to improve the workflow of the cytotechnologists and cytopathologists by ensuring reproducibility and efficiency.

ASP's sample preparation instrument: The instrument is an integrated device with a short processing time (measured in 2 to 3 minutes) that distributes cells from limited volume samples (measured in microliters). The process involves a novel aerosolization technique that transfers liquid sample to a glass slide via a burst of air. After the sample is deposited on the glass slide, the automated system uses an integrated heating strip to heat the specimen slide. This process is similar to using a hair dryer to dry the specimen slide in the current ROSE setting. After drying the slide, the system uses series of pumps to dispense microliters of stain reagent onto the slide to stain the cells. Currently, the system is configured to perform DiffQuik staining, which is commonly used in the ROSE process. In the future, the staining capability will be broadened to include other staining processes such as Rapid PAP, H\&E staining etc.

The early prototype of this instrument has been successfully tested at Cleveland Clinic on residual of EBUS samples, serous body fluids, and bench top FNAs with high diagnostic concordance.

Eligibility Criteria:
Inclusion Criteria:

* Anyone who is undergoing EBUS procedure for diagnosis or staging of lung diseases.

Exclusion Criteria:

-
EASE TRICUSPID Expertise-based Assessment Study on Clinical Efficacy of Contour 3D® in TRICUSPID Valve Annuloplasty

Few clinical evidence for the Contour 3D Tricuspid Annuloplasty Ring exists; therefore, in order to position this product on the market, a post-market release study was completed. The purpose of this study was to evaluate the hemodynamic performance of the Contour 3D® Tricuspid Annuloplasty Ring following Tricuspid Valve (TV) repair in a post-market environment.

The EASE TRICUSPID Clinical Trial was a prospective, non-randomized, non-interventional, post-market release study. The purpose of this study was to evaluate the hemodynamic performance of the Contour 3D® Tricuspid Annuloplasty Ring following Tricuspid Valve (TV) repair in a post-market environment. Therefore, the primary objective of the EASE Tricuspid Study was to evaluate the hemodynamic performance of the Contour 3D® Tricuspid Annuloplasty Ring (Contour 3D ring) in subjects with tricuspid regurgitation who had a clinical indication for TV repair in a post-market use. Secondary objectives included the evaluation of the effect of TV repair with the Contour 3D ring on the right ventricular function, as well as the assessment of the effect of TV repair with the Contour 3D ring on the functional status in subjects undergoing TV repair in a post-market environment. Subjects eligible for TV repair and compliant with the enrollment criteria were considered by the Investigator for inclusion in the study. To minimize bias, enrolled subjects were followed by their own physician in accordance with the center's established practice for routine follow up. Follow-up sessions were planned at the physician's discretion. To meet the intended goals, appropriate clinical data were collected at baseline (pre-surgery), during the surgical procedure, at discharge and during the follow-up period at 6 months. Experienced echo-cardiologists evaluated the echos. At the time of enrollment it was not certain if the subject would receive a Contour 3D ring, since the surgeon might have decided during surgery that another treatment was more beneficial to the subject. In this case, the subject was terminated from the study.

Eligibility Criteria:
Inclusion Criteria:

* Willing to sign and date the Patient Informed Consent (PIC)
* Indicated for a concomitant surgical repair of the TV
* Willing to return to the hospital, where the implantation originally occurred, for a 6 month follow-up visit

Exclusion Criteria:

* Patients with a degenerative TV condition
* Patients with primary TV regurgitation
* Previous TV repair or replacement
* Stand-alone TV repair
* Already participating in another investigational device or drug study, possibly leading to bias and jeopardizing the scientific appropriate assessment of the study endpoints
* Life expectancy of less than one year
* Pregnant or desire to be pregnant within 12 months of the study treatment
* Under 18 years or over 85 years of age
* Patients with active endocarditis
* Patients with valvular retraction with severely reduced mobility
* Patients with a heavily calcified TV
Elevated Lipoprotein(a) in Hospital Staff

The objective of this study is to investigate the prevalence of elevated Lp(a) in the working general population.

The objective of this study is to investigate the prevalence of elevated lipoprotein(a) concentrations and distribution of lipoprotein(a) in a working general population. This is a prospective study investigating the association of lipoprotein(a) with cardiovascular markers and outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Any healthcare workers working in healthcare settings (regardless of PHI and/or private setting) aged 21 and above OR family member such as father, mother, siblings, grandparents, spouse and children aged 12 and above of recruited staff with high Lpa ≥120nmol/l
2. Study team members can also be recruited because we are trying to find the prevalence of elevated Lp(a)

Exclusion Criteria:

1. Inability to provide informed consent.
2. Pregnant women.
3. Prisoner
Comparison of Full Robotic Instrumentation and Assistant-Controlled Laparoscopic Instrumentation in Robotic Distal Gastrectomy

This pilot study aims to provide valuable insights into the optimal surgical approach for robotic distal gastrectomy. By comparing full robotic procedures with assistant-controlled techniques, the results may guide future practice, enhancing surgical efficiency, reducing costs, and improving patient outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically confirmed gastric adenocarcinoma prior to surgery.
2. Patients who have undergone a complete (R0) resection.
3. Patients with an ASA (American Society of Anesthesiologists) score of 3 or below.
4. Patients undergoing robotic radical distal gastrectomy.

Exclusion Criteria:

1. Patients under 19 years of age.
2. Patients who have received preoperative chemotherapy or radiotherapy.
3. Patients diagnosed with stage IV gastric cancer due to distant metastasis.
4. Patients diagnosed with malignancies other than gastric cancer.
5. Patients scheduled to undergo total gastrectomy.
6. Patients requiring total omentectomy.