cyrilzakka/clinical-trials huggingface dataset:
Role of Natriuretic Peptides in the Treatment of Acutely Decompensated Heart Failure Patient With Obstructive Airways Disease

Brain natriuretic peptide (BNP) is a useful therapy when treating patients with heart failure. As many of these patients also have airways disease it is important to determine if BNP also has a positive effect on their respiratory condition. The role of BNP in airways disease has never been studied although there is evidence to suggest that it will have a positive effect.

The current study is therefore a proof on concept study which will demonstrate whether BNP (nesiritide) will improve both heart failure and airflow obstruction in patient who have both.

The investigators are looking to enroll 40 patients with heart failure and airways disease who present to hospital emergency departments. Patients who consent and meet the entry criteria will be randomised to receive either nesiritide or placebo in addition to standard therapy. They will receive a bolus of study medication followed by a 4 hour infusion. Before, at hourly intervals and immediately following the infusion the following data will be collected:

* dyspnoea score
* respiratory rate
* FEV1 (if able to be performed)
* peak respiratory flow rates (PEFR, if able to be performed)
* requirement for concomitant bronchodilator therapy
* urinary GMP At all times during the study period and at the conclusion of the study patients will be provided with the best available therapy for their condition at the physicians' discretion.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females
2. Over 18 years of age
3. Confirmed written informed consent.
4. Acute decompensated heart failure based on physicians assessment and requiring treatment as per standard emergency department protocols for this condition.
5. Requirement for intravenous therapy of HF, e.g. diuretic, vasodilator.
6. COAD based on physician's assessment and requiring treatment as per standard emergency department protocols for this condition. Must have at least 2 of the following criteria:

   * history of smoking \> 20 pack years,
   * prior history of PFTs within last 1 year consistent with COAD,
   * history of chronic cough and sputum production,
   * progressive dyspnea, episodes of acute bronchitis over at least 2 yrs

Exclusion Criteria:

1. Women lactating, pregnant or of childbearing potential not using 2 reliable contraceptive methods.
2. Patients who had received an investigational new drug within the last 4 weeks.
3. Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.
4. SBP \<90mmHg
5. Creatinine \>0.25mmol/L
6. Sp02 \< 80% on supplemental oxygen or known cor pulmonale with TR
Toxicities of Cervix and Corpus Uteri Carcinomas Treatment and Evaluation of Impact on Sexual Function

Evaluate the toxicities of cervix and corpus uteri carcinomas treatment

Evaluate the toxicities of cervix and corpus uteri carcinomas treatment on sexual function after treatment (radiotherapy and/or surgery)

Eligibility Criteria:
* Inclusion Criteria:
* Patients whose treatment is provided to Centre Oscar Lambret
* With a corpus uteri adenocarcinoma, no metastatic, treated by:
* Surgery and observation without complementary treatment
* Or surgery and adjuvant radiotherapy
* Or Surgery and curietherapy of vaginal dome
* With a cervix carcinoma, stade IA2 to IIB proximal, treated by :
* External radiochemotherapy and curietherapy
* Or only surgery
* Or pre-surgical curietherapy and surgery
* Age \> 18 years
Clinical Evaluation of Injectable Platelet Rich Fibrin With Connective Tissue Graft for the Treatment of Deep Gingival Recession Defects.

Aim: The aim of this study was to determine whether the combined connective tissue graft (CTG) with injectable platelet rich fibrin (i-prf) with coronally advanced flap (CAF) improved root coverage of deep Miller Class I or II gingival recessions compared to CTG alone with CAF.

Methods: Seventy-two patients with Miller class I and II gingival recessions were enrolled. Thirty-six patients were randomly assigned to the test group (CAF+CTG+i-prf) or control group (CAF+CTG). Clinical evaluations were made at 6 months


Eligibility Criteria:
Inclusion Criteria:

* ≥19 years of age,
* Periodontally and systemically healthy,
* FMPS and FMBS \<15%,
* Presence of deep Miller class I and II gingival recession defect (≥3 mm in depth) at the buccal aspect of incisors,

Exclusion Criteria:

Smoking,

* Contraindications for surgery,
* Presence of recession defects associated with caries, deep abrasion, restoration or pulpal pathology.
Long Term and Permanent Contraceptive

We will study with the different variables that affect the intention to use long- acting and permanent contraceptive methods among married women in Jordan through a cross sectional study. Self- administered questionnaire will be distributed to aid in data collection.

In this cross-sectional study, self-administered pre-made questionnaires. (https://docs.google.com/forms/d/e/1FAIpQLSdjuuQynIxu0AAmIbKHg0-iyZgTW0m5847JaX0OZrnl7v7v1w/viewform ) will be distributed to married women. (Women of childbearing age). The candidates will be selected according to their age (15-49), marital status (married), and pregnancy status (non-pregnant). The data collected through the questionnaires will then be processed and interpreted in order to understand the variables that affect the use of LACM and permanent contraception methods among Jordanian women.

Eligibility Criteria:
Inclusion Criteria:

* females used or currently using long-term contraception

Exclusion Criteria:

* never users of contraception
The Effect of 2 Months Daily Supplementation of Orange Juice With Fibers

The study hypothesis is that 2 Months Daily Supplementation of Orange juice with fibers will effect the weight and the plasma lipids.

This will be a double-blind parallel controlled study. Study population will include 50 subjects, who will be divided randomly into two groups. The first group will get the Orange juice with fibers, and the second group will get Orange juice with out the fibers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers
* Age 60\>18 years
* Written informed consent
* Consumers of orange drinks: freshly squeezed juices, commercial pasteurized juices and / or orange soft drinks
* Regular eating pattern

Exclusion Criteria:

* Patients with chronic disease sach as:

  * diabetes,
  * cancer,
  * C.O.P.D.,
  * metabolic syndrome,
  * over weight,
  * kidney failure,
  * heart disease and
  * osteoporosis.
* Antibiotic treatment in the last 4 weeks
* Subjects on regular probiotic or prebiotic supplementation, unless the subject will do 2 weeks of wash out before commencing the study.
* Subjects with intestinal disorders such as: IBD, IBS, celiac, colon cancer.
* Subjects after intestinal surgery.
* Use of medicines for lowering cholesterol (simvastatin), sugar control
* Pregnancy
* Subjects with abnormal base-line blood test results: liver functions and/or kidney functions, cholesterol level above 200 mg/dL and glucose level above 50 mg/dL (during fast)
The ROB-OSTIAL Study

The purpose of this study is to compare the accuracy of robotic-assisted percutaneous coronary intervention (PCI) using the CorPath GRX® System, versus standard PCI when treating ostial lesions.

CorPath GRX System (the Device) is a robotic-like device that is cleared for the remote delivery and control of heart catheterization devices. It helps doctors insert and move heart catheters (a thin, flexible tube) and similar types of devices inside patients blood vessels to treat the blockage in their heart.

The results will help to evaluate whether procedures using the CorPath GRX result in more accurate stenting (placing of a tube to keep heart vessel open) compared to standard PCI.

To assess accuracy of robotic-assisted PCI in obtaining full ostial lesion coverage and minimal protrusion compared to standard PCI.

Robotically assisted PCI offers the opportunity of performing minimal device movements (up to a minimum of 1 mm) in a stable and reproducible setting. This feature may be of great help when dealing with ostial lesions, whose treatment requires a precise stent positioning to avoid strut protrusion but also geographic miss of the lesion. Robotic-assisted PCI for ostial lesions showed encouraging results in large observational registries, but no study compared this approach with standard PCI.

The aim is to perform a randomized (1:1) study comparing standard (n=33) and robotic-assisted PCI (n=33) in obtaining full lesion coverage when treating ostial lesions (ostial left main will be excluded).

Primary endpoint of the study will be full ostial coverage as assessed by IVUS imaging, while secondary endpoints will be procedural success, vessel damage and number of protruding struts in the donor vessel as assessed by IVUS imaging.

Eligibility Criteria:
Inclusion Criteria:

* Male or nonpregnant female aged ≥18 years
* Coronary OSTIAL lesion suitable for percutaneous coronary intervention (PCI)
* The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria:

* Cardiogenic shock or hemodynamic instability requiring support.
* ST-elevation myocardial infarction.
* Ongoing acute renal failure.
* In the opinion of the investigator, the subject is deemed unsuitable for robotic PCI due to clinical status and/or anatomic characteristics
* More than one lesion to be treated
* Ostial left main disease
A Bioequivalence Study of Tobradex AF

The purpose of the study is to determine the amount of study medication that moves from the front of the eye into the fluid at the front of the inside of the eye.


Eligibility Criteria:
Inclusion Criteria:

* 18 or older
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Under 18
* Other protocol-defined exclusion criteria may apply
Monitoring Patients Who Are Obese Surgery for Gastric By-pass Protein Supplementation and Physical Training (PROMISE)

The purpose of the study is to test whether additional protein intake with or without strength training will help to maintain body composition (fat-free mass) after surgical treatment of obesity by gastric by pass. The main hypothesis is that additional protein intake will limit fat-free mass loss during surgery-induced weight loss, and that strength training will have an additional beneficial effect

Design: Open randomised controlled trial comparing, in obese patients after GBP, an additional oral intake of protein with or without a muscular-strengthening physical training programme (18 weeks) to standard medical and nutritional follow-up after bariatric surgery as control (3 groups). Primary outcome: Variation at 6 months after GBP in total and appendicular fat-free mass as assessed by dual-energy X-ray absorptiometry (DXA). Duration of the study: 36 months. Duration of participation for one patient: 7 months. Number of centers: Monocentric study.

Eligibility Criteria:
Inclusion Criteria:

* Female gender
* Age between 18 and 60 years
* Planned obesity treatment by gastric bypass
* Written informed consent

Exclusion Criteria:

* Subject not affiliated with a social security scheme
* Refusal
* Regular follow-up not feasible
* Participation in a structured physical activity program
* Recent coronary event
* Uncontrolled hypertension
* proliferative diabetic retinopathy or disabling neuropathy, treatment by dialysis, orthopedic problems
* Pregnancy
* Specific food intolerance to protein products
* Abnormal cardiac stress test
Implementation of Nucleic Acid Amplification Testing Screening to Identify Acute and Early HIV Infection

The investigators propose to study the impact of nucleic acid amplification testing (NAT) screening for acute Human Immunodeficiency Virus (HIV) and Hepatitis C (HCV) infections and Less-Sensitive Enzyme linked Immunoassay (LS-EIA) or 'detuned' testing Vironostika, Trinity Biotech BED, or Ortho-Clinical Diagnostic Vistros ECi for early HIV infection in conjunction with routine rapid HIV testing at HIV counseling and testing sites and venues in the San Diego county. The overarching goal of this study is to develop and implement a system to identify, notify and engage into care those individuals with recent HIV infection in order to better define the HIV and Hepatitis C Virus (HCV) epidemics in the San Diego county and to evaluate and characterize HIV transmission dynamics within the San Diego population.


Eligibility Criteria:
Inclusion Criteria:

* Persons presenting for HIV testing to Public Health Department HIV testing site.
* Men and women \>13 years of age.
* Those who are 13 or older and younger than 18 should be an emancipated minor or have consent given by their legal representative.
* Participants 18 and over must be able to provide written consent.
* Participants should be available for follow up for a period of at least 2 weeks after enrollment

Exclusion Criteria:

* Refusal to participate.
* Unable to provide informed consent.
Neuropsychological Profiles of Children With Duchenne Muscular Dystrophy and Its Effects on Motor Functions

This study was planned to determine neuropsychological profiles of children with Duchenne Muscular Dystrophy and investigation of its effects on motor functions \& compare to typically developed peers.

In this thesis, it is aimed to determine the neuropsychological profiles of children with Duchenne Muscular Dystrophy (DMD) and to investigate its effects on motor functions. The study will be carried out with children between the ages of 7 and 16 who have been diagnosed with DMD as a result of genetic testing and who applied to Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Pediatric Neuromuscular Diseases Unit for physiotherapy and rehabilitation evaluation. In addition, considering the primary purpose of the study, typically developed boys between the ages of 7 and 16 with similar physical characteristics will be included in the study and compared with children with DMD. Typically developed boys included in the study will be evaluated only with neuropsychological tests. Evaluating cognitive function from neuropsychological tests; Modified Mini Mental Test, The Controlled Oral Word Association Test,computer-based The Central Nervous System Vital Signs will be applied. To evaluate neurodevelopmental status from neuropsychological tests; Conners' Parent Rating Scale, Child Behavior Checklist, Strengths and Difficulties Questionnaire (SDQ) will be applied. To evaluate the motor functions of individuals with DMD; Brooke Lower Extremity Functional Classification, Motor Function Measurement, Four Square Step Test, Six Minutes Walk Test, Timed Performance Tests (10 meters Walk/Run Test, Gower's (from a supine to a standing position), Right/Left Leg Standing, Ascent/Descent of 4 Steps) will be used. In the study, in which the effect of the mutation region of dystrophin protein isoforms causing DMD on the neuropsychological profile of children will be investigated by comparing them with typically developed boys and the effect of this on motor function will be examined, the statistical significance level will be considered as p\<0.05

Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with DMD by a pediatric neurologist,
* Being between the ages of 7-16,
* Not to have any diagnosed chronic disease,
* Not having lost yet the ability to write and draw as required by neuropsychological assessments,
* Cooperate with the physiotherapist and be able to comply with their instructions.

Exclusion Criteria:

* Inability to cooperate adequately with the physiotherapist who made the evaluations,
* Have had any injury and/or surgery to the lower/upper extremities in the last 6 months, which may prevent the performance of motor function tests.
A Study of Milvexian Using an IV Microtracer With Additional Formulation and Food Effect Comparison in Healthy Participants

The purpose of this study is to evaluate the absolute oral bioavailability (amount of drug entering the bloodstream) of spray-dried dispersion (SDD) milvexian capsules in the fed and fasted states, and to bridge the exposures seen using only the oral solution.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
* Body mass index (BMI) of 18.0 to 32.0 kg/m², inclusive. BMI = weight (kg)/ (height \[m\])²

Exclusion Criteria:

* History of gastrointestinal (GI) disease, upper or lower GI bleeding within 6 months, intracranial bleeding, tumor, aneurysms
* History or evidence of abnormal bleeding or coagulation disorder and/or evidence of coagulopathy, prolonged or unexplained clinically significant bleeding, or frequent unexplained bruising or thrombus formation, or a history of spontaneous bleeding, such as epistaxis, or family history of coagulopathies
* Any acute or chronic medical illness considered clinically significant by the investigator
* History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory, neurological or psychiatric disorder, as judged by the investigator

Other protocol-defined inclusion/exclusion criteria apply
To Evaluate the Safety and Efficacy of Sofosbuvir and Ribavirin in Patients With HCV (Genotype 3) Related Decompensated Cirrhosis

In this prospective randomized trial, A Minimum of 300 consecutive patients of decompensated HCV (Hepatitis C Virus) related cirrhosis, presenting to the Institute of Liver and Biliary Sciences hospital will be included and those patients meeting the entry criteria received treatment with 400 mg of Sofosbuvir, administered orally once daily, and Ribavirin administered orally twice daily, with doses determined according to body weight(600 mg daily in patients with a body weight of ≤60 kg,800 mg daily in patients weighing \>60 and ≤80 kg, and1000 mg daily in patients with a body weight of \>80 kg). Based on the treatment duration, patients would be randomized in either of the 3 treatment groups -

* Group 1 - Sofosbuvir + Ribavirin x 24 weeks
* Group 2 - Sofosbuvir + Ribavirin x 36 weeks
* Group 3 - Sofosbuvir + Ribavirin x 48 weeks


Eligibility Criteria:
Inclusion Criteria:

* Male or Female ≥ 18 yrs
* Baseline HCV RNA \> 1000 IU/ml
* Cirrhosis with current or prior decompensation
* HCV (Hepatitis C Infection) Genotype 3
* Treatment naïve or treatment experienced

Exclusion Criteria:

* HIV or HBV (Hepatitis B Virus) co-infection
* Recent Variceal bleed
* Pregnancy
* Haemolytic anaemia
* Platelet counts \<20,000/ml
* Advanced HCC (Hepatocellular Carcinoma)
* Renal dysfunction, GFR (glomerular filtration rate) \< 30 ml/min
* Haemoglobin \< 10 g/dl
* MELD (Model for End Stage Liver Disease) \>25, CTP (Child-Turcotte-Pugh score) \>12
* Post organ transplant
High Dose BAYA1040_Nifedipine: a Long Term Combination Study

This is a clinical study evaluating the safety and efficacy of long term administration of oral BAYA1040_Nifedipine 80 mg/day (40 mg twice daily) with other antihypertensives in patients with essential hypertension who are not at target blood pressure by the combination of BAYA1040_Nifedipine 40 mg once daily and other antihypertensives.


Eligibility Criteria:
Inclusion Criteria:

* 20 years or older
* Japanese male or female
* Outpatient with essential hypertension
* Patients who are treated with Adalat CR 40 mg od and at least one antihypertensive drug (other than Ca antagonists) for 4 weeks or more before entry in this study

Exclusion Criteria:

* Patients whose sitting diastolic blood pressure (DBP) is 110 mm Hg or more
* Patients with secondary hypertension or hypertensive emergency
Intravenous Tranexamic Acid Versus IV Carbetocin in Abdominal Myomectomy

the aim of the present study is to compare safety and efficacy of intravenous tranexamic acid versus IV carbetocin in reducing blood loss during abdominal myomectomy: a randomized controlled trial


Eligibility Criteria:
Inclusion Criteria:

* women with symptomatic fibroids candidate for abdominal myomectomy with staging of myoma from (3 to 6) according to FIGO staging

Exclusion Criteria:

* women with Myoma FIGO staging (1,2,7 and 8) candidate for laparoscopic or hysteroscopic myomectomy, women with allergy or contraindications to carbetocin or tranexamic acid
Live Music Therapy to Reduce Anxiety, Pain and Improve Sleep in Post-Operative Lung Transplant Patients: a Pilot Study

The purpose of this prospective pilot study is to determine if live music therapy reduces patients' perception of pain and anxiety, reduces benzodiazepine use and pain medication use, length of stay in the ICU, and length of stay in hospital, and improves sleep in post-lung transplant patients.

The purpose and objectives of the study are the following:

* To determine if music therapist delivered patient preferred live music and therapeutic intervention will reduce participant's perceived anxiety in post-lung transplant patients.
* To determine if music therapist delivered patient preferred live music and therapeutic intervention will reduce participant's perceived pain in post-lung transplant patients.
* To determine if music therapist delivered patient preferred live music and therapeutic intervention in post-lung transplant patients will reduce participant's use of benzodiazepine medication for anxiety.
* To determine if music therapist delivered patient preferred live music and therapeutic intervention three times in post-lung transplant patients will reduce participant's use of pain medication.
* To determine if music therapist delivered patient preferred live music and therapeutic intervention in post-lung transplant patients will reduce participant's total time of intubation, length of stay in ICU, and length of stay in the hospital.
* To determine if music therapist delivered patient preferred live music and therapeutic intervention will improve the quality and length of sleep in post-lung transplant patients.


Eligibility Criteria:
Inclusion Criteria:

* All post-lung transplant patients at UTSW Clements University Hospital starting June 1, 2021

Exclusion Criteria:

* Post-lung transplant patients with chests left open directly after OR (before being taken back to the OR and having their chests closed)