cyrilzakka/clinical-trials huggingface dataset:
Prevention of Post-Operative Shivering

Shivering and vasoconstriction are thermoregulatory mechanisms that are required to increase core body temperature (BT) in patients with core hypothermia.

paracetamol is an antipyretic drug that has been in clinical use for a long time.

It can lower the BT of febrile and nonfebrile patients. A previous study demonstrated that orally administered paracetamol can suppress in a dose-dependent manner the increase in the BT of patients with acute ischemic stroke. However, few studies have evaluated the effects of paracetamol on postoperative shivering.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients between 18-40 years.
* ASA physical status I and II
* Both genders
* Patients scheduled for elective mega-liposuction surgery under combined general epidural anesthesia

Exclusion criteria

* Patients who refused to participate in the study,
* ASA physical status more than II,
* any contraindications to regional anesthesia,
* surgical duration less than two hours or exceeding six hours,
* giving history of any of the following; allergy to the study medications used, system impairment, alcohol abuse, any endocrine disease affecting body temperature such as thyroid disorders,
* any psychiatric or neurological disorders, convulsions, patient receiving vasodilators or medications likely to alter thermoregulation,
* Finally if their body temperature was recorded to surpass 37.5ºC or \<36.5°C before enrolment.
Plasma TMAO (Trimethylamine N-oxide) as a Predictive Marker in Coronary Disease Patients

The primary aim of the current research project is to determine whether the TMAO concentration in the blood can serve as a prognostic indicator of myocardial infarction.

The hypothesis is that in patients with recent myocardial infarction, TMAO concentration in blood is higher than in patients undergoing scheduled coronarography.

To the study will be included volunteers - patients with stable angina (SA), who were scheduled for conventional coronary angiography, and patients with acute coronary syndrome (ACS) who were admitted to the hospital with chest pain and undergoing coronography surgery. Blood samples will be taken from volunteers once - before the coronography surgery by qualified medical personnel.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed stable angina (SA) or acute coronary syndrome (ACS) and planned coronography

Exclusion Criteria:

* unconscious patient
Development and Validation of a Novel Stereoacuity Test Using Head-mounted Display

This prospective study investigated the validity and test-retest reliability of stereopsis test using head-mount display (HMD). Contour-based circles (crossed disparity: 1,960 to 195 arc of seconds(arc secs)) were generated as separate images on a high resolution phone display (Galaxy S7; Samsung, Suwon, Korea) using a HMD (Galaxy Gear VR; Samsung, Suwon, Korea). Two images were independently projected to each eye as graded circles with random dot background. While the position of the stimulus changed from among 3 possible locations, the subjects were instructed to select the circle with disparity by pressing the corresponding position on a keypad. The results of the new HMD stereotest were compared to those from standard Randot and TNO stereotests.


Eligibility Criteria:
Inclusion Criteria:

1. The subjects who want or need to visual acuity test or to test for a prescription for glasses visited the hospital. 2. The Subjects' ages ranged from 19 to 60 years in the study.

Exclusion Criteria:

1. Ocular alignment was assessed with cover-uncover and alternate prism cover testing at distance and near. Significant exodeviation included exophoria was considered to be ≥6 prism diopters were excluded.
2. Subjects with a history of ocular surgery within 3 months of the study were excluded.
3. Foreigners or subjects who are unable to understand informed consent were excluded.
4. Subjects with a history of eye problems, including infection, inflammation, cataract, vitreous opacity or retinal diseases were excluded.
5. Subjects with corrected visual acuity of 20/32 in bad eye were excluded.
6. Subjects with significant refractive error considered to be ≥2.00 diopters of anisometropia were excluded.
7. A female who is pregnant, may be pregnant, or is lactating was excluded.
PROS Brief Smoking Cessation Counseling in Pediatric Practice to Reduce Secondhand Smoke Exposure of Young Children

The investigators' long-term goal is to improve the quality of services targeting the prevention of secondhand smoke (SHS). Their specific aims are to:

* refine components of office systems and counseling interventions for parental tobacco control in pediatric outpatient settings; and
* pilot test the feasibility and efficacy of a parental tobacco control randomized controlled trial in pediatric office settings using 5 intervention and 5 comparison pediatric practice sites.

The investigators hypothesize that:

* clinicians in intervention practices (compared to those in control practices) will more often implement successful office systems, screen for parental smoking, advise parents to quit and to prohibit smoking and SHS exposure at home, recommend pharmacotherapy, provide adjuncts, and refer parents to cessation programs; and
* parents who smoke in intervention practices (measured by 3-month follow-up telephone surveys) will be more likely than those in control practices to have received cessation services, use pharmacotherapy, make lasting quit attempts, and institute rules to prohibit smoking and limit SHS exposure at home.

The investigators' long-term goal is to improve the quality of services targeting the prevention of secondhand smoke (SHS). Their specific aims are to:

* refine components of office systems and counseling interventions for parental tobacco control in pediatric outpatient settings; and
* pilot test the feasibility and efficacy of a parental tobacco control randomized controlled trial in pediatric office settings using 5 intervention and 5 comparison pediatric practice sites.

The investigators hypothesize that:

* clinicians in intervention practices (compared to those in control practices) will more often implement successful office systems, screen for parental smoking, advise parents to quit and to prohibit smoking and SHS exposure at home, recommend pharmacotherapy, provide adjuncts, and refer parents to cessation programs; and
* parents who smoke in intervention practices (measured by 3-month follow-up telephone surveys) will be more likely than those in control practices to have received cessation services, use pharmacotherapy, make lasting quit attempts, and institute rules to prohibit smoking and limit SHS exposure at home.

Eligibility Criteria:
Inclusion Criteria:

* PROS practices will be eligible to participate if they are located in a community-based setting with a non-institutionalized population.
* Physicians are eligible if they are able and willing to provide informed consent and have a patient flow of several children per week, and are not currently participating in another PROS study. They also must be able to read and speak English.
* Eligible parents will:

  * be parents or guardians age 18 or older;
  * be parents of a child aged 0-6;
  * have access to a telephone; and
  * be able to speak/read English.
Factors Involved in Obesity-related Inflammation and Insulin Resistance

In this project, we propose to recruit lean and obese subjects with different ethnic background (African Americans and Caucasians) to study the alterations of lipid and carbohydrate metabolism and determine whether these disturbances are linked to genetic, inflammatory, oxidative stress, and/or nutritional factors. Because systemic inflammation and insulin resistance are frequent features of obesity, we postulate that an unbalanced diet with high saturated- and low omega 3-fatty acids is linked to obesity-related inflammation and insulin resistance. We propose to investigate fatty acid metabolism and determine the links between fatty acid composition and oxidative stress in tissues of lean and obese subjects. We propose the following aims:

Specific Aim 1: Evaluate nutrient intake in lean and obese subjects using the standard NHANES Food Questionnaire.

Specific Aim 2: Evaluate the fatty acid composition, including omega-3, in adipose tissue depots, blood monocytes and skeletal muscle, and examine the relationship between omega-3 content and inflammatory and oxidative stress markers.

Specific Aim 3: Compare the effects of omega-3 and saturated FA supplementation on inflammatory and oxidative stress markers in vitro in adipose tissue explants, preadipocytes and monocyte culture.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age
* Undergoing elective abdominal or bariatric surgery

Exclusion Criteria:

* Intercurrent infections
* Active cancer diagnosis within 5 years
* Use of medications for diabetes or hyperlipidemia
* Use of glucocorticoids or anti-inflammatory drugs
Multicenter Pilot Study to Describe the Performance of a New Device in Patients With Colostomy

The study evaluates the efficacy of a new 2-piece appliance in patients with colostomy.


Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 years old
* Patient having a colostomy with a diameter less than 30 mm for users of Ø 55 mm pouches or having a colostomy with a diameter less than 40 mm for users of Ø 65 mm pouches
* Patient having a colostomy for at least 1 month
* Patient using currently the two-piece flat ostomy appliance Flexima®/Softima® 3S for at least 2 weeks and being satisfied
* Patient having a stoma protusion smaller than or equal to 1.5 cm
* Patient capable to apply and remove the appliance himself or with the help of a caregiver (except health care professional)
* Patient having a mental capacity to participate to the study (i.e. to understand the study and to answer to the questions)
* Patient agreeing to test the new appliance during the training phase (5±3 days) and during the study device usage phase (14±3 days)
* Patient covered by social security

Exclusion Criteria:

* Patient experiencing repeated leakages with the usual pouching system
* Patient currently suffering from peristomal skin complications (bleeding or red and broken skin at the time of inclusion)
* Patient receiving or having received, within the last month, chemotherapy, radiotherapy or corticotherapy
* Patient already participating in another clinical study or who have previously participated in this investigation
* Pregnant or breast-feeding woman
The Effect of Two Different Approaches on Palatal Donor Site

An epithelialized gingival graft will be harvested from the palate for the treatment of various mucogingival deformities. The donor site will be treated with either a combination of a collagen sponge, cyanoacrylate and suspending sutures or a collagen sponge, cyanoacrylate, suspending sutures and coconut oil.

After epithelialized gingival graft harvesting, intraoperatively, measurements will be taken for palatal tissue thickness, graft dimensions, working time, and primary bleeding time. Data regarding pain perception will be gauged using a visual analog scale, and the number of analgesics, secondary bleeding, epithelization level, and color match will be assessed prospectively. These outcomes will be evaluated on the first 7 days and subsequently on the 14th, 21st, and 28th days. Patient-reported outcomes will be recorded using the Oral Health Impact Profile-14 questionnaire.

Eligibility Criteria:
Inclusion Criteria:

age ≥18; mucogingival surgical treatment indication that needs connective tissue graft in the anterior mandible; stable periodontium after phase I therapy; full-mouth plaque and bleeding scores \&lt;15%

Exclusion Criteria:

* previous palatal harvesting history; unstable endodontic conditions; tooth mobility at the surgical site; systemic disease; pregnancy; use of medications with potential adverse effects on periodontal tissues
Standard Balloon Angioplasty Versus Angioplasty With a Paclitaxel-eluting Balloon for Femoral Artery In-stent Restenosis

Comparison of recurrent-restenosis rates 6 months after angioplasty of in-stent restenoses or in-stent reocclusions in the superficial femoral artery (SFA) using either a standard balloon (Admiral Xtreme, Invatec) or a paclitaxel-eluting balloon (In.Pact™ Admiral, Invatec).


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 21 years old.
2. Patient must sign informed consent form.
3. Patient must agree to participate in the study and comply with follow-up requirements.
4. Clinically, all patients must be in Rutherford category 2 to 4.

   Angiographic Inclusion Criteria:
5. Planned angioplasty of in-stent restenoses (degree of stenosis 70-100%) within the SFA. The target lesion must not extend beyond the stent margins. In cases of two or more stenotic regions within the stented segment, these are considered separate lesions if there is a nonstenotic or only mildly stenotic (\< 30%) segment of at least 2 cm in length between them. Otherwise, they are considered a single lesion. In case of separate lesions, only the proximal lesion will be taken as the target lesion!
6. The length of the in-stent lesion should be at least 1 cm and maximally 20 cm (measurement by radiopaque ruler).
7. The degree of target lesion stenosis must be determined by pre-interventional duplex ultrasound.
8. The target lesion region starts at the origin of the SFA and ends distally at the femoropopliteal crossover (crossing by SFA of medial rim of femur in the PA projection).
9. Patency (\< 50% stenosis) of popliteal artery and at least 1 infragenicular artery.

Exclusion Criteria:

General:

1. Patient is currently participating in another clinical trial.
2. Pregnancy or pregnancy planned during study duration.
3. Life expectancy less than 1 year.
4. Co-morbidities preventing study participation.
5. Severe coagulation disorders.
6. Current treatment with anticoagulants other than aspirin, ticlopidine, clopidogrel or prasugrel.
7. Active gastric ulcer or gastrointestinal bleeding.
8. Thrombotic occlusion of the target vessel within previous 4 weeks.
9. Treatment of target lesion with laser or atherectomy devices.
10. Dialysis dependency.
11. Manifest hyperthyreosis.
12. Known allergy against contrast agent that cannot be adequately controlled by usual premedication.
13. Known heparin intolerance.
14. Known paclitaxel intolerance.

    Angiographic:
15. Target lesion extends into the popliteal artery.
16. Symptomatic untreated inflow lesion \> 50% in ipsilateral iliac arteries. Pretreatment of iliac stenoses is possible.
17. SFA lesions \> 50% stenosis proximal and/or distal to the target lesion that require treatment.
18. Target lesion extends beyond the stent margins.
Perioperative Analgesia After Knee Arthroplasty

The purpose of this study is to compare two accepted methods of pain control in knee arthroplasty surgery.The first method combines the periarticular injection of ropivacaine with continuous blockade of the femoral nerve.The second method uses periarticular infiltration of ropivacaine in combination with an bolus of ropivacaine into an intraarticular catheter placed intraoperatively followed by a continuous intraarticular infusion of ropivacaine. All patient will also receive a sustained-release oral opioid and oral rescue opioids determined by pain severity using the Visual Analog Scale (VAS)


Eligibility Criteria:
Inclusion Criteria:

* Elective primary knee arthroplasty
* ASA I,II,\&III patients
* Spinal Anaesthesia

Exclusion Criteria:

* Patients refusing consent
* Contraindications to regional anaesthesia
* Preexisting neurological disease
* Alcohol or drug abuse
* Inability to use the outcome assessment tools
* Wheel chair or walker dependent
* Pregnancy
Safety and Targeting of Anti-hk2 Antibody in mCRPC

This is an imaging trial, to develop h11B6 as a therapeutic radiopharmaceutical for men with mCRPC.

This imaging study will be conducted to confirm the safety and estimate the mass amount of antibody h11B6, and confirm in vivo tumor targeting of the antibody, using Indium-111 (111In) radiolabeled h11B6 in subjects with advanced prostate cancer. This study will also provide the dosimetric information crucial for Phase 1 therapy.

It is the intent to develop h11B6 as a therapeutic radiopharmaceutical for men with mCRPC. This Phase 0 study will be conducted to confirm the safety, estimate the mass amount, and confirm in vivo tumor targeting of the antibody. This study will use Indium-111 (111In) radiolabeled h11B6 in subjects with mCRPC to image known sites of disease and identify a favorable mass amount of antibody for satisfactory tumor targeting with minimal/no accumulation off-target. In cohort 1, In-111 labeled h11B6 will remain fixed at 2 mg, and additional h11B6 will be added in 2 sub-cohorts (8 mg and 18 mg respectively); up to 6 patients may be entered into a sub-cohort. Additional patients (up to 6) will be studied once the most favorable mass and imaging time point have been established, to establish targeting of antibody to known disease.

This study will provide the dosimetric information crucial for Phase 1 therapy.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with mCRPC will be eligible if they meet the following criteria:
* Eastern Cooperative Oncology Group (ECOG) ≤ 1
* Histologically or cytologically confirmed adenocarcinoma of the prostate
* Castrate levels of testosterone (\<50 ng/dL \[1.74 nmol/L\])
* Metastatic disease documented by imaging
* Documented progressive mCRPC with androgen involvement as defined by - Prostate Cancer Working Group 3
* Acceptable laboratory parameters
* At least 28 days since administration of any therapeutic radioactive isotope
* Able to tolerate the conditions required to perform imaging studies (e.g., lying flat for at least 1 hour).

Exclusion Criteria:

* Known hypersensitivity to proteins, or other allergic diathesis that, in the opinion of the investigator, makes an immune response to humanized antibody likely
* Radiotherapy or immunotherapy within 30 days, or single fraction of palliative radiotherapy within 14 days of administration of study agent
* Any condition that, in the opinion of the Investigator, would impair the subject's ability to comply with study procedures and required study visits
* Active, symptomatic, or untreated brain metastases.
Breastfeeding Study

The purpose of this study is to evaluate the stool consistency and microbiota composition of healthy breastfed infants.

This is a prospective, observational, non-interventional study. The purpose of this study is to evaluate the stool consistency and variability in fecal microbiota composition, diversity, and abundance of defined taxa in 75 healthy, term, exclusively breastfed infants. All enrolled infants will participate in the trial for approximately 169 days.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Infants whose parent(s)/LAR who have reached the legal age of majority in the Philippines
* Infants whose parent(s)/LAR are willing and able to comply with study requirements
* Infants whose parent(s)/LAR who are able to be contacted directly by telephone throughout the study
* Healthy term, singleton infant at birth
* Between 21 to 26 days post-natal age at enrollment visit
* Weight-for-length and head circumference-for-age z-scores are ≥ -3 and ≤ +3 according to WHO Child Growth Standards
* Infants of parent(s)/LAR who have previously made the decision to breastfeed their infant at the time of enrollment

Exclusion Criteria:

* Infants with conditions requiring infant feedings other than those specified in the protocol
* Infants receiving weaning foods or liquids
* Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results
* Infants who are presently receiving or have received medications that could interfere with the interpretation of study results
* Infants or infants whose parent(s)/LAR who cannot be expected to comply with the protocol or with study procedures
Efficacy and Safety of LAS 34273 in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease(COPD)

To evaluate the efficacy and safety of LAS 34273 compared to placebo in patients with moderate to severe COPD during one year of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged ≥ 40 years with a clinical diagnosis of moderate to severe stable COPD

Exclusion Criteria:

* History or current diagnosis of asthma, recent respiratory tract infection or acute COPD exacerbation, life expectancy of less than 1 year, known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma
Evaluation of Postoperative Pain After Using 3MIX-TATIN Versus Calcium Hydroxide Iodoform Paste In Necrotic Primary Molars Treated by Lesion Sterilization and Tissue Repair Therapy

The aim of the current study is to compare a newly introduced material which is a combination of triple mix antibiotics paste and anti-hyperlipidemia drug simvastatin, the new material is named 3MIX-TATIN \& will be compared to triple antibiotic paste for management of necrotic primary molars by using lesion sterilization and tissue repair LSTR technique.

3Mix-tatin will prepared by mixing three commercially available antibiotics with simvastatin. After removing the coating materials, 3 types of antibiotics are pulverized by porcelain mortars and pestles to achieve fine powders. A total of 100 mg ciprofloxacin, 100 mg metronidazole, and 100 mg cefixime will be mixed in a ratio of 1: 1: 1. Two milligrams of simvastatin will be added to the drugs blend to form 3-Mix-tatin. Preparation of 3Mixtatin will be trained and supervised by an expert pharmacist. 3Mixtatin will be stored in a tightly capped porcelain container, adding a small amount of silica gel in a bag inside the container to maintain low humidity. This powder will be mixed with normal saline to form a creamy paste of 3Mixtatin at the time of application.

Local anesthesia using mepivicaine hydrochloride 3% (septodont, saint-maurdesFosses, France) will be administered.

Rubber dam isolation.

Access cavity will be prepared with a fissure bur in a high-speed handpiece, necrotic pulp tissue will be removed using a sterile sharp spoon excavator.

The canal orifices will be enlarged with a round bur (one mm diameter and two mm depth) to create medication receptacles.

Cotton pellet moistened with 2.5% sodium hypochlorite (NaOCl) will be placed in the pulp chamber for 1 minute.

Bleeding, if present, will be controlled by applying sterile cotton pellet moistened with 10% sodium hypochlorite against the pulp stumps and will be maintained for 1 min.

The 3-Mix-Tatin will be mixed with saline to obtain a creamy mix and placed over the canal orifices and the pulpal floor.

The access opening will be sealed with a glass ionomer cement , and the tooth will be restored with a stainless steel crown.

Eligibility Criteria:
Inclusion Criteria:

* Children age range from 5-8 years.
* Children free from any systemic diseases or medical problems.
* Primary molar with necrotic pulp, with pain, gingival abscess, fistula openings, or clinical mobility not exceeding grade two.
* Radiographic evidence of non-perforating internal resorption, external resorption not exceeding 1\\3 of the root, furcation or periapical radiolucency.

Exclusion criteria:

* Non-restorable molars or beyond repair, for example: decay reaches to bifurcation, a hard gingival margin cannot be established or infection cannot be eradicated by other mean (Balaji, 2007).
* Patient with known allergy to any type of antibiotics or anti-hyperlipidemia drugs.
* Patient with facial cellulitis or lymphadenopathy
* Lack of patient/parent compliance and cooperation.
* Refusal of participation or failure to obtain an informed consent.