cyrilzakka/clinical-trials huggingface dataset:
Safety Study of Feeding With Ginger Extract in Acute Respiratory Distress Syndrome

An enteral diet supplemented with ginger extract in acute respiratory distress syndrome (ARDS) patients may be beneficial for gas exchange and could decrease duration of mechanical ventilation and length of stay in intensive care unit (ICU).

Rationale: Clinical ARDS occurs primarily as the result of inflammatory injury to the alveoli producing diffuse alveolar damage.

Objective: To evaluate the effects of an enteral diet enriched with ginger extract on inflammatory factors, respiratory profile and outcome of patients with ARDS.

Methods: In this single center, randomized, controlled double blind study, 32 patients with ARDS were randomized to receive a high protein enteral diet enriched with ginger extract or placebo.

Measurements and Main Results: Serum levels of IL-1, IL-6, TNF-α and LTB-4, oxygenation, measured as PaO2/FiO2, static compliance measured on days 0, 5 and 10.

Patients fed enteral diet enriched with ginger extract had significantly lower serum levels of IL-1, IL-6, TNF-α and LTB-4 on days 5 and 10 compared to control group (P\<0.05). Significant improvement in oxygenation was observed on day 5 (P=0.02) and 10 (P=0.003) in ginger extract group compared to control group. Static compliance was also increased significantly on day 5 (P=0.01) in ginger extract group compared to control group. A significant difference was found in duration of mechanical ventilation (P0.02) and length of ICU stay (P=0.04) in favor of ginger extract group. We did not find any difference in barotraumas, organ failure and mortality between the study groups.

Conclusions: An enteral diet supplemented with ginger extract in ARDS patients may be beneficial for gas exchange and could decrease duration of mechanical ventilation and length of stay in ICU.

Eligibility Criteria:
Inclusion Criteria:

* Required positive pressure ventilation via endotracheal tube or tracheostomy and were on enteral nutrition support.
* Also they had to have an acute onset of significantly impaired oxygenation with a PaO2 to FiO2 ratio equal or less than 200, bilateral pulmonary infiltrates on frontal chest radiograph and no clinical evidence of left atrial hypertension according to the American-European Consensus Conference on ARDS .
* Patients had to be enrolled within 48 hours of developing these criteria.

Exclusion Criteria:

* Age younger than 18 years
* Participation in other interventional trials in the previous 30 days
* Neurological conditions that could impair weaning from ventilatory support,
* Severe chronic respiratory disease
* Pregnancy
* Lactation
* Active bleeding
* Head trauma
* Intracranial hemorrhage
* Peptic ulcer
* HIV infection
* Food allergy
* Morbid obesity
* Malignancy or other irreversible conditions for which 6 months mortality was estimated to be 50% or more and who were receiving nonsteroidal anti inflammatory drugs or ketoconazole.
Health Care Use and Costs of Functional Somatic Disorders

The goal of this observational case-control study is to learn about direct healthcare use and costs of functional somatic disorders.

The aim of the proposed study is to investigate the use and costs of direct healthcare for individuals with functional somatic disorders.

Researchers will compare direct healthcare use and costs of individuals with functional somatic disorders and compare them with that of healthy controls and individuals with other severe physical disease, respectively.

Functional somatic disorders (FSD) are common conditions characterized by persistent patterns of physical symptoms that cannot be better explained by other physical or mental conditions. The conditions may cause severe impairment for the patients who are often characterized by impaired physical and mental health, lower social status, and poor labour market association.

In 2005, it was estimated that FSD accounted for 3% of hospitalizations and 10-20% of health care expenses in Denmark, and a newer Danish primary care study has shown patients with FSD to have higher annual health care costs compared with conventionally-defined conditions. In foreign nations, studies in clinical samples have shown increased direct and indirect health care costs of FSD which showed a dose-response relationship with severity of the FSD. One Canadian population-based study found increased health care use and costs in children, adolescents, and young adults with a first health record diagnosis of somatic symptom and related disorders. Even though these previous studies provide valuable knowledge to the field of FSD, their methodology may give rise to bias, i.e. inclusion of highly selected patient samples, the use of various diagnostic criteria for defining FSD, and the establishment of FSD by means of self-report. Evidently, studies investigating the socioeconomic burden in terms of direct health care use and costs of FSD in a randomly obtained population-based sample using solid methodology such as validated symptom criteria and diagnostic interviews for establishing FSD are highly lacking.

The objectives of this proposed study are:

To describe and investigate the healthcare use and healthcare costs for individuals with FSD and compare them with

1. individuals without FSD, and
2. individuals with severe physical disease

Eligibility Criteria:
Inclusion Criteria:

* None

Exclusion Criteria:

* not born in Denmark
* not being a Danish citizen
* pregnancy.
Accelerating Post-exercise Muscle Glycogen Resynthesis in Humans: Impact of Combined Nutrient Intake and Intermittent Pneumatic Compression or Heat Therapy

To determine if modalities designed to improve blood flow combined with post-exercise nutrient intake will improve replenishment of muscle glycogen better than nutrient intake alone. A secondary objective is to compare the effectiveness of heat therapy and intermittent pneumatic compression on glycogen replenishment.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects will be male and female participants in good health
2. 18-35 years of age
3. Currently performing cardiovascular or intermittent exercise at a moderate to high intensity at least 5 days per week for 60 minutes or longer per day.
4. Understanding of the procedures to be undertaken as part of the study
5. Willingness to participate in exercise testing and follow instructions provided by the experimenter
6. Informed, voluntary, written consent to participate in the study

Exclusion Criteria:

1. History of deep vein thrombosis
2. Obesity (BMI \> 30 kg/m2)
3. Hypertension (resting SBP \> 140/90 mmHg)
4. Smoking
5. Pregnant, planning to become pregnant, or lactating
6. Supplements containing antioxidants including vitamin C and E and N-acetyl cysteine
7. Any medication
8. Lactose intolerance
9. Participation in another study within the previous 30 days or in a PepsiCo funded study within the past 6 months.
Non-invasive Preimplantation Genetic Testing for Aneuploidies Using Cell-free DNA in Spent Culture Media

Analysis of embryonic cell-free DNA (cfDNA) present in the spent culture media (SCM) is a non-invasive alternative for preimplantation genetic testing for aneuploidies (PGT-A) that avoids the technical challenges and limitations of biopsy. Initial studies investigating this non-invasive PGT-A (niPGT-A) method reported variable concordance between cfDNA in SCM and the trophectoderm sample (\~ 30%-86%) and indicated a contribution from both the inner cell mass and trophectoderm to the cfDNA in SCM.

This study aims to evaluate the use of the embryo culture medium as a source of genetic material for PGT-A and validate a niPGT-A protocol using cfDNA in SCM.

Multiple studies have demonstrated the ability to detect and amplify cfDNA from SCM, at different stages of embryonic development, with varying rates of amplification success. Differences in analytes, timing of SCM collection and the duration of embryo culture within the collected medium, performance of assisted hatching (AH), whole genome amplification methods, comprehensive chromosome screening methods and next generation sequencing (NGS) platforms, bioinformatic analyses and strategies for identifying maternal contamination all contribute to the ultimate performance of niPGT-A.

This study aims to validate a noninvasive PGT-A (niPGT-A) method utilizing cfDNA released from the human blastocyst into the SCM.

Patients undergoing a fertility treatment with PGT-A due to secondary infertility will be recruited. On day 6 post fertilization, SCM will be collected prior to blastocyst biopsy. The SCM is normally discarded at this stage. Trophectoderm biopsy and sample collection will follow the IVF laboratory's standard practices for clinical PGT-A.

Three aneuploidy screening kits, relying on different whole genome amplification methods followed by NGS on the Ion GeneStudio™ S5 Prime System (ThermoFisher Scientific), will be compared. The concordance between cfDNA and trophectoderm biopsies will be evaluated for approximately 150 blastocysts with the best performing niPGT-A protocol.

Selection of the embryo(s) for transfer will be based solely on the PGT-A result from the biopsied cells. The patient's IVF+PGT-A treatment plan and timeline will not be altered.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing fertility treatment with PGT-A (Recombinant FSH antagonist protocol with dual trigger)
* Secondary infertility
* BMI 18- 35 kg/m2
* Sperm: fresh ejaculated sperm (abstinence: 2-3 days)
* At least one blastocyst biopsied on day 6

Exclusion Criteria:

* High progesterone on day of trigger (\>1.5ng/ml)
* Vitrified oocytes
* Frozen sperm
* Indications for PGT-SR and PGT-M
WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation

This is a multi-center, prospective, randomized study, stratified by center, comparing the WATCHMAN device to long term warfarin therapy, demonstrating that the treatment arm is non-inferior to the control arm. This study was amended to allow for a non-randomized arm and increased enrollment.

The WATCHMAN device is designed to be permanently implanted distal to the ostium of the left atrial appendage (LAA) to trap potential emboli before they exit the LAA.

Eligibility Criteria:
Inclusion Criteria:

* Patient has paroxysmal, persistent or permanent non-valvular atrial fibrillation (AF)
* Eligible for long term warfarin
* CHADS score \>= 1 \[congestive heart failure (CHF), history of high blood pressure, 75 years of age or older, diabetes, prior stroke or transient ischemic attack (TIA)\]

Exclusion Criteria:

* Contraindicated for warfarin
* Contraindicated for aspirin or clopidogrel (Plavix)
* Congestive heart failure (CHF) Class 4
* Implanted mechanical valve
* Atrial septal or Patent Foramen Ovale (PFO) device
* Platelets \< 100,000 or hemoglobin \< 10
* Left ventricular ejection fraction (LVEF) \< 30%
Nasal Packing Versus Intravenous Dexmedetomidine in Turbinate Surgeries

Comparing of nasal packing DEX and IV DEX for controlling the intraoperative bleeding after turbinate surgery.

Dexmedetomidine (DEX) is a highly selective α2 adreno-receptor agonist with higher affinity to a2 adreno-receptor than clonidine, and this makes DEX primarily sedative and anxiolytic. The elimination half-life of DEX (t1/2b) is 2 h and the redistribution half-life (t1/2a) is 6 min, and this short half-life makes it an ideal drug for intravenous titration. Potentially desirable effects include decreased requirements for other anesthetics and analgesics.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65 years
* Both sexes
* American Society of Anesthesiologists (ASA) physical status classification I or II.
* Undergo turbinate surgery

Exclusion Criteria:

* Patients with a body mass index \> 30 kg/m2 existing or recent significant disease.
* Contraindications to the use of dexmedetomidine .
* History or presence of a significant disease significant cardiovascular disease risk factors.
* Significant coronary artery disease or any known genetic predisposition.
* History of any kind of drug allergy,
* Drug abuse.
* Clinically significant abnormal findings in physical examination, electrocardiographic (ECG) or laboratory screening.
* Known systemic disease requiring the use of anticoagulants,
* Patients with a history of previous turbinate surgery.
Stroke Caregiver Empowerment

The purpose of this study is to refine STROKE-CARE for caregivers and explore changes in caregiver and care-recipient outcomes

Individuals with disabilities rely heavily on unpaid family caregivers to help perform necessary occupations. The emotional and physical demands of caregiving often contribute to caregivers experiencing burden. Caregivers with burden are at-risk for poor health and a heightened risk of mortality. This is likely, in turn, to negatively impact care-recipient quality of life. The proposed study refines a behavioral intervention that teaches caregivers to facilitate problem solving over the course of daily activities. The long-term goal for this project is to establish an effective rehabilitation intervention that promotes caregiver health and well-being, which ultimately influences care-recipient health. This study will use an open-case series and a single-arm clinical trial to refine the intervention and examine caregiver and care-recipient response to the intervention. This research applies to the priorities and objectives of this research initiative through examination of a caregiver-centered, standardized intervention that is based on occupational theories and principles, investigating outcomes experienced by caregivers of individuals with cognitive deficits after stroke. Data from this pilot project will be used to design and obtain federal funding for a randomized controlled trial to examine the efficacy of the refined intervention on caregiver and care-recipient health outcomes.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Primary caregiver for an individual post-stroke
* Live with the care-recipient
* Provide 1 hour of caregiving per day
* Subjective caregiver burden

Exclusion Criteria:

* non-English speaking
* Active treatment (chemotherapy, radiation therapy) for cancer
* Imminent placement of care-recipient into a nursing home or with another caregiver (within 6 months)
* Involvement in another clinical trial for caregivers
Sublobar Resection for Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section (ECTOP-1019)

This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1019. The goal of this clinical trial is to confirm the therapeutic effect of sublobar resection for AIS/MIA diagnosed by intraoperative frozen section.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who sign the informed consent form and are willing to complete the study according to the plan;
2. Aged from 18 to 80 years old;
3. ECOG equals 0 or 1;
4. Not receiving lung cancer surgery before;
5. Resectable peripheral cT1N0M0 tumors;
6. Single lung nodules with ground-glass dominant or pure ground-glass on CT, or multiple lung nodules with the major lesion being the aforementioned nodules;
7. Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section
8. Not receiving chemotherapy or radiotherapy before.

Exclusion Criteria:

1. Not cT1N0M0;
2. Cannot be completely resected by sublobar resection;
3. Invasive lung adenocarcinoma or not lung adenocarcinoma diagnosed cytologically or pathologically;
4. Receiving lung cancer surgery before;
5. Receiving radiotherapy or chemotherapy.
Comparison of Triple Antibiotic Paste With Combination of Chitosan and Calcium Hydroxide as a Root Canal Disinfectant

Investigators observed the clinical and radiographic healing of periapical lesion using Chitosan mixed with calcium hydroxide and compared it with triple antibiotic paste when used as intracanal medicament in 3months, 6 months and 12 months.

Aim: To evaluate and compare the healing of periapical lesions using chitosan mixed with calcium hydroxide or Triple Antibiotic Paste at 3,6 and 12 months.

Methodology:

20 adult patients having periapical lesions in single rooted teeth were selected in this study after being assessed using the PAI index. Patients were randomly assigned to: Group - I (n=10) Chitosan with Ca (OH)2 and Group -II (n=10) Triple Antibiotic paste (TAP)

After access opening and cleaning and shaping were done in the first visit, the pertinent intracanal medicaments were placed depending on the patient group. After 4 weeks, on the second visit, the medicament was removed andobturation was done in the asymptomatic teeth. Both clinical and radiographic endodontic evaluation was done at 0, 3, 6 and 12months using the same parameters.

Radiographic evaluation was done using the PAI Index and was compared at 0, 3, 6, and 12 months after treatment, Z Test.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 40 years Periapical lesion (not more than 5mm) radiographically.on single rooted teeth
* Roots with closed apex.
* Systemically healthy patients.

Exclusion Criteria:All patients who respond positive to allergic patch test \[triple antibiotic paste\] and drugs.

* Teeth with previous endodontic therapy performed.
* Patients with a history of any systemic diseases.
* Pregnant and lactating women.
* Tooth associated with vertical root fracture and coronal perforation.
* Tooth affected with calcific degeneration.
* Presence of external or internal root resorption.
* Blunderbuss apex.
Rational Approach to a Unilateral Pleural Effusion

Recurrent unilateral, non-infectious pleural exudate is suspicious for primary or secondary pleural malignancy. Both conditions are associated with 5-year survival of 10%. Work-up is difficult, as the pleural surface is large and \<33% of pleural malignancies shed malignant cells to the pleural fluid. Even so, additional tissue biopsies are needed for establishing mutation status for targeted therapies.

Optimal imaging to guide tissue sampling is pivotal. PET-CT has higher sensitivity than conventional CT for detecting malignant lesions \>10mm. However, no randomised trial has investigated differences in diagnostic accuracy, time-to-diagnosis, or economics. Falsely PET-positive lesions in e.g. colon, however, lead to more derived tests than do CT alone.

Gold standard for pleural tissue sampling is the surgical (VATS) thoracoscopy, allowing direct visual guiding of tissue sampling from all pleural surfaces. Yet, globally the medical (pleuroscopy) thoracoscopy is more widely used: cheaper, outpatient procedure, but allows only sampling from the parietal pleura. To date, no randomised studies have compared medical and surgical thoracoscopy concerning diagnostic hit rates, adverse events, or economics.

Investigators will perform two randomized studies to investigate whether

1. PET/CT is comparable to CT alone
2. VATS is comparable to pleuroscopy concerning hit rate, total investigations performed, time-to-diagnosis.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with recurrent pleural effusion of unknown origin after a first pleural tap according to BTS guidelines.
2. Indication for thoracoscopy according to BTS guidelines.
3. Patients accept further investigation according to Danish and BTS guidelines.
4. Have received oral and written consent and agreed.
5. At the time of inclusion, above 18 years of age.

Exclusion Criteria:

1. Female patients: pregnancy or breastfeeding.
2. Lack of language comprehension.
3. Legally incompetent patients.
4. Life expectancy less than 3 month.
5. Contraindications to pleural tissue sampling.
Three Different Modalities for Treatment of Inflammatory Punctal Stenosis

This study aimed to compare the efficacy of three various modalities of treatment of inflammatory punctal stenosis (Punctal dilatation alone, combined punctal dilatation with topical medications, or peri-punctal injection of Triamcinolone acetonide)

Acquired punctal stenosis is a condition in which the external opening of the lacrimal canaliculus, located in the nasal part of the palpebral margin, is narrowed or occluded. This condition results from chronic inflammation of the external punctum, leading to gradual fibrotic changes in the ostium, followed by progressive occlusion of the duct.

Different modalities were described for the treatment of acquired punctual stenosis. Repeated dilatation of the stenotic punctum is a simple procedure that may provide temporary improvement of the symptoms, but restenosis is common unless additional procedures are performed. Many other methods were used to augment punctual size, including 1-snip, 2-snip, and 3-snip punctoplasty, supplemented with adding sutures or Mini-Monoka insertion and punch punctoplasty.

Eligibility Criteria:
Inclusion Criteria:

* Age from 33 to 75.
* Both sexes.
* Patients with inflammatory punctal stenosis or occlusion complaining of symptomatic epiphora.

Exclusion Criteria:

* Subjects with previous lacrimal surgeries.
* Subjects with lid margin malposition such as ectropion, entropion, or lid retraction.
* Subjects with medial lid masses obscuring the punctum.
* Subjects with a history of ocular trauma involving the medial aspect of the lid margin.
Efficacy of Polyglucosamine Long Term Treatment

The polyglucosamine, specification L112, is a medical device and in this clinical trial used for weight reduction in moderately obese participants following a long term treatment lasting 12 months. The rationale for this study is to show that overweight can be reduced by taking 2 times daily 2 tablets with the main meals.

Two groups of subjects were compared. A comparable diet condition, consisting of 10 % reduction of caloric intake was followed, according to a questionnaire based on the weekly number of servings. No modification of physical activity was requested.

One group had to take the polyglucosamine tablets and the other group placebo tablets for at least 12 months. It is known, that polyglucosamine is a fat binder acting in a physical-chemical manner, the positive charged fiber is bound to the negative charged dietary fat and this complex is unable to pass the gut wall into the body but is naturally excreted,hence this energy is not available. Therefore, this medical device should show a measurable reduction in body weight.

Eligibility Criteria:
Inclusion Criteria:

* BMI \>30 and \< 35
* waist circumference of more than 88 cm for women and greater than 102 for men

Exclusion Criteria:

* pregnancy or breast-feeding
* alcohol abuse
* drug abuse or drug addiction
* inability to fulfill the criteria of the trial protocol
* cancer diseases
* malignant tumors
* pre-existence of chronic intestinal disease
* known hypersensitivity reactions to crustaceans
Lifestyle Intervention in Obese Arab Women

The study protocol aims to test the hypothesis that a lifestyle intervention program aimed to increase leisure-time physical activity and reduce body weight will improve the parameters of the metabolic syndrome and quality of life among obese, non-diabetic Arab women

200 obese non-diabetic Arab women, 35-54 years old, with one or more parameters of the metabolic syndrome (NCEP-III criteria) will be randomized to either conventional or intensive treatment. The intensive intervention arm will include group meetings with physical education instructor (twice a month),group meetings with a dietician (once per month) and personal dietary counselling (once per month). The targets to be achieved will be at least 7% reduction of the initial body weight and engagement in leisure-time sports activity for at least 150 min/week.Evaluation before enrollment and at the end of the trial will include: information on dietary and physical activity habits, quality of life parameters, anthropometric and blood pressure measurement, blood lipid profile, and fasting and post oral glucose load blood glucose and insulin levels. Duration of the intervention: 12 month.

Eligibility Criteria:
Inclusion Criteria:

* Obesity (BMI: 30-40 kg/squared meter)
* Female Gender
* Being 35-54 years old

Exclusion Criteria:

* Diabetic

A contraindication for physical activity