cyrilzakka/clinical-trials huggingface dataset:
Pilot Study for Sedation Interruption in Children

The purpose of this study is to estimate the hypothesized benefit of sedation interruption protocol on mechanical ventilation duration and PICU length of stay. The study will evaluate recruitment rates, and adherence rates of such protocol.

This is a prospective single-center, superiority, open randomized controlled trial comparing sedation interruption protocol and routine continuous sedation in mechanically ventilation (MV) children.

The study will be conducted in the twelve beds Pediatric Intensive Care Unit (PICU) at the Montreal Children's Hospital, a pediatric tertiary care and teaching hospital.

Patients will be enrolled prospectively within 24 hours of intubation and MV. After obtaining written consent patients will then be randomized to interrupted sedation or standard sedation protocol. The investigators will randomize using a computer-generated sequence of random numbers.

A Sedation protocol will be used for both groups to adjust continuous infusions of sedatives/analgesics to a targeted Comfort-Behavior scale. In the intervention group, sedation infusions will be interrupted daily at 8:00 AM, this interruption will be continued until the patient is under-sedated according to the Comfort Behavior scale goals or in the presence of symptoms of hemodynamic instability or respiratory distress. Then the patient will receive a bolus of sedation and the infusion will be restarted at a dose 50% less than the previous dose to return to the Comfort Score goal.

Eligibility Criteria:
Inclusion Criteria:

* Intubated and mechanically ventilated patients due to respiratory failure of multiple etiologies or after major surgical procedures for more than 24 hours.
* Sedation managed by benzodiazepines and opioids infusions

Exclusion Criteria:

* If sedation is required as part of medical management (Pulmonary hypertension, Increase intracranial pressure, Seizures
* Trauma \& burn admissions
* Patients resuscitated from cardiac arrest
* Allergy to sedation (midazolam)
* Allergy to analgesia (fentanyl, morphine)
* Difficult airway including post-operative airway surgeries. (As deemed by ICU physician in charge)
* High frequency oscillator
* Special gas as inhaled nitric oxide, or isoflurane.
* Chronic ventilatory support
* Neuromuscular diseases
* Corrected Gestational age less than 37 weeks.
* Patients not expected to survive to discharge as per attending physician.
* Palliative care patients.
Effect of Melatonin on Palatal Wound Healing (Randomized Controlled Clinical Trial)

The aim of the study is to assess the effect of topical melatonin loaded gelatin sponge on donor palatal site healing, after palatal graft harvesting.

Autogenous soft tissue grafts can be considered the gold standard treatment for many muco-gingival problems. The most common site for harvesting soft tissue grafts is the palate. Many harvesting techniques have emerged, but the epithelialized graft harvesting technique is one of the most reliable and effective techniques as it imparts the superficial section of the connective tissue which contains the highest amount of lamina propria. Unfortunately, it leaves an open palatal wound healed by secondary intention, increasing pain and post-operative morbidity. In order to overcome these inadequacies investigators will cover the donor site with melatonin loaded gelatin sponge and evaluate its effect on the healing process.

Eligibility Criteria:
Inclusion Criteria

1. Patients who have at least one site of natural dentition or dental implants that need to be treated by free palatal graft surgery for indications including progressive recession, planned prosthodontics, presence of a mucogingival deformity, or a lack of keratinized gingiva.
2. Patients who have at least 4 mm thickness of palatal mucosa (at donor site)

Exclusion Criteria:

1. History of smoking.
2. Patients who have any known disease that interfere with periodontal surgery.
3. Patients who have any dermal or autoimmune diseases.
4. Patients who have any previous adverse reactions to the products (or similar products) used in this study.
5. Pregnant and lactating women.
6. Patients who have a palatal infection.
The Relationship Between Root Coverage Procedures and Buccal Vestibular Depth

In this comparative trial, 50 patients with shallow vestibules and Type 1/2 recessions will be treated with either a vertically coronally advanced flap + connective tissue graft or a free gingival graft. At baseline, 3rd-month, 6th-month, and 12th-month visits, the following parameters will be evaluated: buccal vestibular depth, keratinized tissue height, gingival thickness, recession depth, recession width, probing depth, and clinical attachment level. Keratinized tissue change, gingival thickness change, root coverage, clinical attachment gain, and complete root coverage will be calculated. The wound healing index, tissue appearance, patient expectations, aesthetics, and dentin hypersensitivity will be assessed at baseline and at the 6th week.

Buccal vestibule depth was recorded using two different measurement methods. First, the distance between the cementoenamel junction and the deepest point of the vestibule sulcus was measured and recorded as VD1. Then, the distance between the gingival margin and the base of the vestibule sulcus was measured and recorded as VD2.

Eligibility Criteria:
Inclusion Criteria:

* full-mouth plaque and bleeding scores \<15%
* the presence of at least one recession type-1/2 recession and at least one recession with recession depth ≥ 2 mm
* the presence of an identifiable cemento-enamel junction

Exclusion Criteria:

* Vestibule depth \> 6mm
* Smoking \> 10 cigarettes per day
* Any contraindications for periodontal surgery
* Unstable endodontic conditions or presence of any restoration.
Multicentre Trial of Suboxone in Opiate-dependent Subjects in Taiwan

To determine whether Suboxone can be effectively used to treat Taiwanese ethnic subjects with opiate dependence.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, 20 years of age or older at screening visit.
* Subjects must meet DSM-IV/COWS1,2 criteria for opiate dependence. (COWS total score ≥5)
* Subjects must have a positive urine drug screen (dipstick test) for an opiate or morphine at study entry
* Subject is seeking treatment with the desire to discontinue opiate use as an initial goal but willing to consider and accept longer treatment if necessary.
* Subject is in good physical health or, if he/she has a medical condition needing ongoing treatment, must be in the care of a physician who is willing to take responsibility for such treatment and work with the study physician. Study physicians able to manage the subject for his/her general medical condition, may be assigned this role. These same conditions apply in case of subjects with psychiatric disorder(s) needing ongoing treatment.
* Subject is agreeable to and capable of signing informed consent form.
* Females of childbearing potential must have a negative pregnancy test and agree to use a double barrier method or condoms/diaphragm and spermicide contraceptive method during the study.

Exclusion Criteria:

* Women who are pregnant, lactating or breast feeding.
* Subjects have any acute medical condition that would make participation, in the opinion of the treating physician or the principal investigator, medically hazardous (e.g., acute hepatitis, unstable cardiovascular, liver or renal disease).
* Subjects have clinically significant liver disease.
* Subjects who have demonstrated a previous hypersensitivity to buprenorphine or naloxone.
* Subjects who are considered an immediate risk for suicide, are acutely psychotic, severely depressed, or in need of inpatient treatment.
* Subjects who are dependent on alcohol, benzodiazepines or other drugs of abuse (except tobacco) to the point of requiring immediate medical attention.
* Subjects received methadone treatment within the last 30 days since screening visit.
* Subjects have any pending legal action that could prohibit continued participation.
* Subjects have participated in other clinical studies within the past 30 days.
* Subjects who are expecting to leave the clinic geographic area prior to study completion.
A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Japanese Subjects With Palmoplantar Pustulosis

This study will evaluate whether apremilast is better than placebo (inactive substance in the same form as the drug) for the treatment in Japanese subjects with PPP. This study also will evaluate the safety and tolerability of apremilast in Japanese subjects with PPP.CC-10004-PPP-001 is a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 2 study of apremilast in Japanese subjects with PPP and inadequate response to treatment with topical steroid and/or topical vitamin D3 derivative preparations.

The placebo-controlled period will be 16 weeks and patients will receive apremilast or placebo. After the 16-week placebo-controlled period, all subjects will receive apremilast for 16 weeks. All subjects will have their final study visit 4 weeks after stopping apremilast treatment.


Eligibility Criteria:
Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

1. Subject has a diagnosis of Palmoplantar Pustulosis with or without pustulotic arthro-osteitis (PAO) for at least 24 weeks before screening.
2. Subject has a total score of PPPASI: ≥ 12 at screening and baseline.
3. Subject has moderate or severe pustules/vesicles on palms or soles (PPPASI severity score: ≥ 2) at screening and baseline.
4. Subject has inadequate response to treatment with topical steroid and/or topical vitamin D3 derivative preparations prior to or at screening.

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

1. Subject has a diagnosis of plaque-type psoriasis.
2. Subject has the presence of pustular psoriasis in any part of the body other than the palms and soles.
3. Subject has obvious improvement during screening (≥ 5 PPPASI total score improvement during the screening).
4. Subject has received any procedures for focal infection (e.g, tonsillectomy and dental therapy) within 24 weeks of baseline.
5. Subject has periodontitis obviously requiring treatment at screening.
6. Subject has chronic or recurrent tonsillitis or sinusitis requiring any continuous treatment for a month or more at screening.
7. Subject has evidence of skin conditions of hands and feet that would interfere with evaluations of the effect of study medication.
8. Subject is pregnant or breastfeeding.
Online Peer Networked Collaborative Learning for Managing Depressive Symptoms

The goal of this field trial is to tailor and test a web-based intervention in adults 65 years of age or older. Two versions of the web-based intervention have been created and will be tested--one with an online social network and one without an online social network. The purpose of this study is to: pilot a novel intervention, examine methods to improve adherence to web-based interventions (e.g., peer network); collect data on feasibility, acceptability, and efficacy of an web-based intervention for late life depression; and ultimately, to overcome the numerous barriers to treating depression in later life.


Eligibility Criteria:
Inclusion Criteria:

* Has elevated depressive symptoms
* Has a telephone, e-mail account, computer, and broadband access to the Internet.
* Has basic internet skills and is able to access the internet independently
* Is able to speak and read English.
* Is at least 65 years of age.
* Is able to give informed consent.

Exclusion Criteria:

* Has hearing or voice impairment that would prevent participation in psychotherapy
* Has visual impairment that would prevent completion of assessment materials.
* Is diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, current substance abuse, or other diagnosis for which participation in a clinical trial of psychotherapy may be either inappropriate or dangerous.
* Is currently receiving individual psychotherapy or planning to receive psychotherapy during the 8-week treatment phase of the study
* Is planning to be out of town or unavailable for an extended period of time during the study without access to the Internet
* Exhibits severe suicidality, including ideation, plan, and intent.
* Has initiated treatment with an antidepressant in past 14 days. Once patients have been on a stable dose for 14 days and do not have an appointment with a physician or psychiatrist to change this dose, the patient will be eligible based on this criterion.
Pharmacokinetic Assessment of Simultaneous Administration of Clopidogrel and Aspirin

This is a randomized, open-label, single-dose, two-sequence, two-period crossover study to investigate the pharmacokinetics between a tablet containing 75 mg of Clopidogrel and 100 mg of Aspirin and the simultaneous administration of the separate formulations of the two drugs in healthy male volunteers.

Eligibility for participation of this study will be determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 4 weeks before study drug administration. Subjects suitable for this study will be admitted to the Clinical Trial Center of Ajou Medical Center on the day before dosing, and they will overnight-fasted from 10 p.m. of Day -1.

Subjects will be dosed study drug (a tablet containing 75 mg of Clopidogrel and 100 mg of Aspirin, or the simultaneous administration of the separate formulations of the two drugs) orally with 240 mL of water around 8 a.m. of Day 1. Subjects will be performed scheduled pharmacokinetic sampling upto 24 hours.

After 2 weeks of washout period, Subjects will be dosed study drug by crossover manner, and will be performed scheduled pharmacokinetic sampling upto 24 hours.

Study participation will be ended on post-study visit (Day 25).

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects aged 20 - 45 years
* With in 20% of ideal body weight, {Ideal body weight=\[height(cm)-100\]\*0.9}
* Agreement with written informed consent

Exclusion Criteria:

* Clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal disease or mental disorder (Past history or present)
* Subject with symptoms of acute disease within 28 days of starting administration of investigational drug
* Subject with known for history which affect on the ADME of drug Clinically significant active chronic disease
* Inadequate result of laboratory test (especially, Platelet count \< 150,000, Platelet count \> 350,000, AST/ALT \> 1.25 x UNL, Total bilirubin \> 1.5 x UNL)
* Positive reaction in the HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL test
* Taking OTC(Over the counter)medicine including oriental medicine within 7 days
* Clinically significant allergic disease (Except for mild allergic rhinitis and dermatitis seems to be not need for medication)
* Subject with known for hypersensitivity reaction to clopidogrel or aspirin analog
* Not able to taking the institutional standard meal
* Previously make whole blood donation within 60 days or component blood donation within 30 days
* Previously participated in other trial within 90 days
* Continued to be taking caffeine (caffeine \> 5 cup/day), drinking (alcohol \> 30 g/day) and severe heavy smoker (cigarette \> 1/2 pack per day)
* An impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result
Budesonide vs. Mesalazine vs. Budesonide/Mesalazine Suppository Combination Therapy in Acute Ulcerative Proctitis

The purpose of this study is to investigate the efficacy and safety of budesonide suppository for the treatment of acute ulcerative proctitis.


Eligibility Criteria:
Inclusion Criteria:

* Active ulcerative proctitis
* Diagnosis confirmed by endoscopy
* Established disease or new diagnosis

Exclusion Criteria:

* Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, diverticular assoc. colitis, microscopic colitis
* Presence of proctitis of a different origin
* Prior bowel resection
* Presence of symptomatic organic disease of the gastrointestinal tract
* Asthma, tuberculosis, cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract, infection if careful medical monitoring is not ensured
* Local intestinal infection
* Abnormal hepatic or renal function
* Oral/rectal/intravenous corticosteroids therapy
* Existing or intended pregnancy or breast-feeding
* Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial
Novel Synthetic T2W MR Imaging and Spin Parameter Mapping Techniques for Screening Prostate Cancer

This clinical trial studies examines a 3D magnetic resonance imaging (MRI) compared to standard MRI imaging techniques in screening patients with prostate cancer. Diagnostic procedures, such as MRI, may help find and diagnose prostate cancer. Computer systems that allow doctors to create a 3-dimensional (3-D) picture of the tumor may help in planning.

PRIMARY OBJECTIVE:

I. To determine whether the image quality of the novel 3-dimensional (3D) T2-weighted imaging (T2W) synthetic imaging technique without endorectal coil is comparable to the 2-dimensional (2D) T2W imaging technique without endorectal coil.

SECONDARY OBJECTIVE:

I. To evaluate the qualitative diagnostic quality of the T2W images provided by the novel 3D technique, as determined by subjective scoring by experienced readers.

EXPLORATORY OBJECTIVE:

I. To investigate the feasibility of novel 3D synthetic imaging and multi-spin parameter mapping technique of prostate for the detection of clinically significant prostate cancer (csPCa).

OUTLINE:

Patients undergo 3D MRI imaging over 15 minutes with standard of care MRI or at a separate time.

Eligibility Criteria:
Inclusion Criteria:

* Male, age \>= 18
* Untreated, biopsy-proven with intermediate and high-risk adenocarcinoma of the prostate
* Patient is being considered for curative-intent treatment with radical prostatectomy
* Patient has provided written informed consent for participation in this trial
* Patient should be eligible for scanning on a 3T magnet

Exclusion Criteria:

* Low-risk adenocarcinoma of prostate
* Any prior therapy for prostate cancer
* A history of other active malignancy within the last 2 years
* Prostate cancer with significant sarcomatoid, spindle cell, or neuroendocrine small cell components
* Cardiac pacemaker
* Orthopedic hardware in the pelvis and spine
* Claustrophobia
Navigated Transcranial Magnetic Stimulation in Tumor Surgery

Maximizing surgical removal of brain tumors while minimizing neurologic deficits is challenging. Functional brain tissue may reside close to or even within the abnormality, and inadvertent removal or disturbance of such areas can result in neurologic deficits. At present, the gold standard for identifying critical motor areas in tumor surgery is intraoperative invasive direct current stimulation (DCS) through a handpiece. More recently, new non-invasive preoperative method for brain mapping, functional magnetic resonance imaging (fMRI), may be used to identify the eloquent motor areas. fMRI signals used in localization of the motor areas are generated when the brain is activated during the performance of specific motor tasks. However, as fMRI signals are also generated by sensory input, the resulting fMRI map may include sensory as well as motor areas.

Nexstim has developed a Navigated Brain Stimulation (NBS) system that uses TMS with a software based Navigational System that together may have more specific spatial accuracy.

This study aims to determine whether navigated TMS is able to identify the eloquent motor cortical areas in patients with brain tumors and to determine the clinical accuracy of the procedure by comparing it to results obtained by intraoperative DCS and fMRI.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects 18 years of age and over.
* A brain tumor in the vicinity of the central region.
* Mild (BMRC grade 4/5) or no paresis.
* Obscured anatomy of the central region due to the mass effect/infiltrating growth pattern of the lesion
* Scheduled for elective surgery under general or local anesthesia.
* No other known brain abnormalities by history or by structural MRI.
* Mentally and physically able to undergo MR imaging (fMRI, DTI) and navigated TMS studies
* Signed informed consent form.

Exclusion Criteria:

* Implanted metallic parts of implanted electronic devices, including pacemakers, defibrillators, or implant medication pump.
* Pregnant or trying to become pregnant.
* History of alcohol abuse, illicit drug use or drug abuse or significant mental illness
* Hypertensive or hypotensive condition.
* Any condition that would prevent the subject from giving voluntary informed consent.
* An implanted brain stimulator.
* Aneurysm clip or other metal in the head (except mouth
* Enrolled or plans to enroll in an interventional trial during this study.
* Scalp wounds or infections.
* Claustrophobia precluding MRI
* Frequent seizures (\>1/week)
Influence of Plasma Rich in Growth Factors (PRGF) on Healing of Medial Collateral Ligament (MCL) Tear

To evaluate the influence of Plasma Rich in Growth Factors (PRGF) on the healing process of medial collateral ligament (MCL) tear.

Autologous platelet-rich matrices may aid in the healing of ligaments \& tendons by promoting and accelerating tissue healing because of the release of growth factors including transforming growth factor (TGF)-beta1 and platelet-derived growth factor (PDGF) from platelet alpha-granules.

Eligibility Criteria:
Inclusion Criteria:

* age 18-40 years old
* diagnosed MCL tear grade 2/3

Exclusion Criteria:

* pregnancy
* mental or physical disabilities
Clinical Observation of Botulinum Toxin A Treatment in the Treatment of Rosacea

the goal of this study is to study the clinical efficacy and safety of botox in the treatment of rosacea.

The main objective is to collect patients and then use different injection volumes of botulinum toxin intradermal injection for the treatment of rosacea erythema telangiectasia, and then to evaluate the clinical efficacy and safety of the treatment.

Eligibility Criteria:
Inclusion Criteria

* Meeting the diagnostic criteria of mild to moderate erythema telangiectasis rosette acne;
* more than 18 years old;
* to obey the rules of the treatment in the study, and can be followed up for 12 weeks;
* informed consent;

Exclusion Criteria:

* Had received facial cosmetic surgery or botulinum toxin treatment within 6 months before this treatment;
* due to systemic diseases such as autoimmune diseases or menopause facial flush;
* had allergies botulinum toxin;
* pregnant or breastfeeding;
* other facial skin or oral disease therapy, including research before 4 weeks rose acne accept other treatment;
* With basic neuromuscular diseases (such as myasthenia gravis, amyotrophic lateral sclerosis, etc.);
* All landowners 4 weeks before the study whether any oral aminoglycoside drugs, benzodiazepines drugs or muscle relaxants; .Was removed during treatment observation data is not complete, incomplete treatment and patients can't take medication as prescribed.
A Trial of Prostaglandin E2 Tablets Versus Foley Catheter for Labor Induction

A randomized controlled trial comparing labor induction with vaginal PGE2 tablets and foley catheter for cervical ripening.


Eligibility Criteria:
Inclusion Criteria:

* Singleton term pregnancies (\>37 weeks), vertex presentation
* Intact membranes
* Low Bishop score (\<7)
* First, second or third delivery
* Medical indication for induction
* Viable fetus

Exclusion Criteria:

* Contraindication for vaginal delivery, for PGE2 or foley catheter
* Gestational age\<37 weeks, premature rupture of membranes, fetal or uterine malformations, previous cesarean section, uncertain dating, unwilling to participate in trial