cyrilzakka/clinical-trials huggingface dataset:
Pre-emptive Infiltration of the Scalp with Diprospan Plus Ropivacaine for Pain After Craniotomy in Children

At present, pediatric postoperative analgesia has not been fully understood and controlled, particularly craniotomy surgery. On the one hand, professional evaluation of postoperative pain for young children is difficult; on the other hand, the particularity of craniotomy adds (such as consciousness obstacle, sleepiness, et al) disturbance to the pain assessment in children. Although opioids administration is regarded as the first-line analgesic for post-craniotomy pain management, it may be associated with delayed awakening, respiratory depression, hypercarbia and it may interfere with the neurologic examination. For the avoidance of side-effects of systemic opioids, local anesthetics administered around the incision have been performed clinically. However, some studies revealed that the analgesic effect of local anesthetics was unsatisfactory due to its short pain relief duration, steroid as adjuvant can enhance postoperative analgesia and prolong postoperative analgesia time. As is reported that postoperative pain of craniotomy is mainly caused by skin incision and reflection of muscles, preventing the liberation of inflammatory mediators around the incision seems to be more effective than simply blocking nerve conduction. Researchers have clarified that the addition of diprospan to local infiltration of analgesia could provide significant analgesic effects and significantly prolong the duration of analgesic effects without obvious complications for various types of surgeries. To date, no studies have evaluated the addition of diprospan to local infiltration for patients receiving craniotomy.

Thus, investigators suppose that pre-emptive scalp infiltration with steroid (Diprospan) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in children.


Eligibility Criteria:
Inclusion Criteria:

* An elective craniotomy under general anesthesia; American Society of Anesthesiologists (ASA) physical status of I or II; Participates with an anticipated fully recovery within 2 hours postoperatively; Informed consent by parent(s) and/or legal guardian.

Exclusion Criteria:

* History of allergies to any of the study drugs; Drugs with confirmed or suspected sedative or analgesic effects; receiving any painkiller within 24 h before surgery; children who received steroids; Psychiatric disorders; Uncontrolled epilepsy; Chronic headache; Peri-incisional infection; Body mass index exceeded the 99th percentile for age; Children who must use a patient-controlled analgesia (PCA) device; Children who cannot understand an instruction of pain scales before surgery
A Study of Quilizumab Versus Placebo in Patients With Refractory Chronic Spontaneous Urticaria

This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will assess the efficacy and safety of additional quilizumab therapy in adult patients with Chronic Spontaneous Urticaria resistant to antihistamine treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CSU refractory to H1 antihistamines with/without LTRAs, as defined by the following:
* The presence of itch and hives for \> 6 consecutive weeks at any time prior to enrollment despite use of H1 antihistamines during this time period
* UAS7 score greater than 16 and itch component of UAS7 greater than 8 during 7 days prior to Day 1. Patients must have been on daily stable doses of H1 antihistamine for at least 3 consecutive days immediately prior to the screening visit and must document current use at screening
* CSU diagnosed for more than 6 months
* Patients must have a minimum diary compliance (6 out of 7 consecutive days) prior to Day 1

Exclusion Criteria:

* Treatment with an investigational agent within 30 days of screening, and previous treatment with monoclonal antibody therapies used to treat CSU 9 months prior to screening
* Chronic urticarias other than CSU, including the following: Acute, solar, cholinergic, heat, cold, aquagenic, delayed pressure or contact.
* Other diseases and conditions with symptoms of urticaria.
* Routine doses of the following medications within 30 days prior to screening: systemic or topical corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide
* IV immunoglobulin G (IVIG), or plasmapheresis within 30 days prior to screening
* Patients with cancer, history of cancer considered uncured or in complete remission for \< 10 years, or currently under work-up for suspected cancer except non-melanoma skin cancer that has been treated or excised and is considered resolved
* History of anaphylactic shock without clearly identifiable avoidable antigen
* Presence of clinically significant cardiovascular, neurological, psychiatric, metabolic or other pathological conditions.
* Medical examination or laboratory findings that suggest the possibility of decompensation of co-existing conditions for the duration of the study.
* Evidence of current drug or alcohol abuse
* Nursing women and women of childbearing potential, unless using effective contraception as defined by protocol
Study of the Effect of Magnetic Stimulation Repetitive Transcranial on Impulsivity in Cocaine Dependence

In a randomized, double-blind controlled trial the investigators will evaluate the efficacy of rTMS in reducing impulsivity for cocaine addicts through - Quantitative and qualitative analysis - such behavior and possible behavioral consequences related.

reduction of the rating impulsivity

Eligibility Criteria:
Inclusion criteria:

1. Diagnosis of the cocaine dependence syndrome, alone or in combination with abuse of alcohol and nicotine dependence (DSM IV, 1994; SCID-P, 1994).
2. 20 days or less withdrawal
3. 18-35 years old.
4. If female, to be using contraception (barrier, oral contraceptive, IUD, surgical sterilization).
5. Fixed residential address in Sao Paulo

Exclusion criteria:

1. Other Mental Disorders (DSM IV, 1994; SCID-P, 1994).
2. organic brain disease, neurosurgery to implant metal clip or epilepsy.
3. severe uncontrolled clinical comorbidity.
4. use current or within last six months of psychotropic drugs in general, except for Clonazepam dose of up to four mg / day.
5. Changes clinically significant laboratory findings. 13
6. Condition or situation to which in the opinion of the investigator put the patient at risk significant, which may confound the results, or interfere substantially in individual's participation in the study.
7. Mandate that mandating the judicial treatment for cocaine dependence
Improve Detection and Management of Gestational Diabetes Through the Primary Health Care Level in Morocco

A situational analysis on gestational diabetes conducted in 2015 in two districts in Morocco revealed difficulties in accessing screening for gestational diabetes (GDM) and delays in receiving appropriate care. Based on the results of the situational analysis, the investigators developed this proposal in close collaboration with the Moroccan research group on gestational diabetes composed of representatives of the Ministry of Health, researchers, members of professional organizations and specialists in the domains of endocrinology, gynecology, neonatal health and nutrition. The investigators opted for an hybrid implementation effectiveness trial to evaluate both clinical effectiveness of the proposed screening and initial management strategy and its implementation at the first level of care.

The objectives of this study are thus to evaluate the feasibility of a decentralized strategy of screening for GDM and the initialization of GDM treatment already through the primary level of care and to assess its potential for scaling-up. Specific objectives of this study are to augment universal access to screening and management of gestational diabetes and to increase the competencies of health care providers at first level health care facilities to detect, start initial treatment and to improve follow-up of affected women. By comparing active screening and treatment initiation through first line health facilities with the existing practices, the investigators would like to explore the effect of the new model on maternal and newborn outcomes such as weight gain in pregnancy, occurrence of delivery complications and birth weight. The investigators will further assess the acceptability of screening and initial management of GDM through first line health services by health care providers and by pregnant women diagnosed with GDM and the impact of two different screening approaches on the lifestyle of affected mothers.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women attending ANC (screening)
* Women diagnosed with GDM (follow-up)
* Informed consent

Exclusion Criteria:

* Pregnant women with pre-existing diabetes type 1 or 2
* No informed consent
Dexmedetomidine for Laryngeal Mask Airway Insertion

The investigators attempted to determine the optimal dose of dexmedetomidine required for the successful insertion of LMA during propofol induction without a neuromuscular blocking agent.

After a predetermined bolus dose of dexmedetomidine was injected over 2 min, anesthesia was induced with propofol 2.0 mg/kg. After confirming the loss of eyelash reflex and the bispectral index (BIS) score decreased below 60, the insertion of LMA was attempted.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II patients undergoing general anesthesia for short elective surgery (\<1 hr)

Exclusion Criteria:

* G-E reflux
* obesity (BMI\>30)
* anticipated difficult airway
MiniTightRope Suspensionplasty Compared With LRTI for the Treatment of Basilar Thumb Arthritis

This prospective randomized trial aims to ascertain differences in outcome measures for the operative treatment of basilar thumb arthritis by comparing the two most common surgical treatments: LRTI and mini tightrope suspensionplasty. The Investigators will evaluate both subjective and objective data to determine if a particular surgical method offers more favorable outcomes.

The study will be a prospective randomized-controlled trial comparing LRTI and mini tightrope suspensionplasty for the surgical treatment of basilar thumb arthritis. Patients meeting operative criteria who present to Level One Orthopaedics at Orlando Health will be consented for study participation. Subsequently, consented patients will be randomized into one of three treatment arms: LRTI, suspensionplasty with one-suture construct and suspensionplasty with two-suture construct. The patient will be blinded prior to the procedure; however, the performing surgeon will not be able to be blinded. The patient will become un-blinded postoperatively when the performing surgeon informs them which method was used. The investigators will then follow the patients for 5 years to assess the primary and secondary outcomes (see below) and analyze the data with an intention-to-treat method before publishing the conclusions. Follow-up visits will occur at two weeks, one month, three months, six months, one year, and five years. Outcome measures will incorporate subjective and objective measures and will include the SF-36 and Disabilities of Arm, Shoulder \& Hand (DASH) questionnaires, pinch/grip strength, visual analog pain scale, patient satisfaction and postoperative complications.

Eligibility Criteria:
Inclusion Criteria:

* Radiographically diagnosed Stage II-IV basilar thumb arthritis as described by the Eaton and Littler classification system on either the right or left hand.

Exclusion Criteria:

* To have a history of prior surgical intervention for basilar thumb arthritis, trauma to the hand or wrist, or debilitating injury to the upper extremity.
* Patients under the age of 18 or with a history of a debilitating neurologic injury, either acute or chronic, to the upper extremity will be excluded.
* Patients that are non-operative candidates due to medical comorbidities will also be excluded.
Novel Approaches in Linkage Analysis for Complex Traits

To develop new statistical methods to explore genetic mechanisms that contribute to the development of hypertension.

BACKGROUND:

Hypertension affects 50 million Americans and is the single greatest risk factor contributing to diseases of the brain, heart, and kidneys. There is a strong evidence that hypertension has a genetic basis. The study will develop novel approaches to better understand the genetic mechanisms contributing to measures of blood pressure (BP) level, diagnostic category (hypertension versus normotension) and correlated traits.

DESIGN NARRATIVE:

This genetic epidemiology study will develop novel approaches to better understand the genetic mechanisms contributing to measures of blood pressure (BP) level, diagnostic category (hypertension versus normotension) and correlated traits. The first aim is to localize genes influencing measures of blood pressure levels, diagnostic category and their correlates. This will be done by applying genome-wide multivariate linkage analyses based on the variance components approach and utilizing clusters of traits correlated with measures of blood pressure and/or diagnostics category. The second aim is to develop exploratory diagnostic tools for linkage analysis of complex traits to further enhance our ability to localize genes influencing measures of blood pressure, diagnostic category and their correlates. This will be done by extending the diagnostic tools used in regression analysis to the variance components approach used for linkage analysis of quantitative traits. In this study for example, it can be used to identify outlier families since previous studies have shown that families with outlier values yield false-positive results. Tree-structure models will also be extended to pedigree data. Tree-based modeling is an exploratory technique for uncovering structure in the data. The use of tree-structure models is advantageous because no assumptions are necessary to explore the data structure or to derive parsimonious model. These models are accurate classifiers (binary outcome) and predictors (quantitative outcomes). All these tools will be incorporated in the S-Plus software as a function. S-Plus was selected due to its capability and flexibility for analyzing large data sets.

Eligibility Criteria:
No eligibility criteria
A Study Evaluating a Urinary Catheter With Different Activation Times for the Wetting Solution, in Healthy Male Volunteers.

The primary purpose of this study is to compare the subject's perception (separately for each randomized catheter) of practicing catheterization when using catheters with sodium chloride in wetting solution (using two different activation times) with a standard reference catheter. The hypothesis is that the subjects' perception of catheterization is the same or more positive when using the test catheters compared to the reference catheter.

The study is designed as a randomized, single-blind, cross-over, single-centre, study in healthy male volunteers.

All subjects will first be catheterized with a reference catheter, which is proven to be well tolerated by most subjects. This catheter will be used as a reference catheter to be compared with the randomized catheters. One more reason for this first test is to withdraw subjects who cannot tolerate catheterizations. Subjects will qualify for the randomized part of the study only if the first catheterization could be performed without significant discomfort.

When the subject is randomized he will be catheterized with two urinary catheters in a randomized order during one day. The activation times for the wetting solution will be 5 seconds and 24 (± 2h) hours.

During each catheterization, the friction at withdrawal will be measured for the catheter using a Tension Test System.

The subjects will be blinded. 25 healthy volunteers will be recruited from a single centre in Sweden.

Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent
* Healthy volunteer
* Male aged 18 years or over

Exclusion Criteria:

* Known or suspected, current impairment of and/or decreased urethral sensibility
* History of urethral morbidity
* History of urinary tract infection within three months, or ongoing symptomatic urinary tract infection
* Use of medications that may affect the urethra´s dryness (anti-cholinergic drugs or cortisone)
* Current drug, alcohol or other substance abuse
* Other significant disease or condition (e.g. benign prostate hypertrophy, other prostatic lesions), which may interfere with treatment and/or evaluation
* Allergy to antibiotics suspected poor compliance with the protocol during the complete study period
Immunogenicity and Safety of Pentaxim as 3 Doses Primary Vaccination Followed by a Booster Dose at 18 Months

As per request by the Heath Authorities, the present clinical study will assess the immunogenicity and safety of sanofi pasteur's DTacP-IPV// PRP\~T combined vaccine (PENTAXIM™) as a three-dose primary vaccination at 2, 3, and 4 months of age or 3, 4 and 5 months of age followed by a booster dose at 18-20 months of age as compared to commercially available DTacP, Hib conjugate (Act-HIB™) and IPV (IMOVAX Polio™) monovalent vaccines in order to meet the requirements for registration of the product in People's Republic of China.


Eligibility Criteria:
Inclusion Criteria :

* Aged 2 months (60 to 74 days) inclusive on the day of inclusion
* Born at full term pregnancy (³36 weeks) with a birth weight ≥ 2.5 kg
* Informed consent form signed by the parent(s) or other legal representative
* Able to attend all scheduled visits and to comply with all trial procedures

Exclusion Criteria :

* Participation in another clinical trial in the 4 weeks preceding the trial inclusion
* Planned participation in another clinical trial during the present trial period
* Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
* Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances
* Chronic illness at a stage that could interfere with trial conduct or completion
* Blood or blood-derived products received in the past
* Any vaccination performed or planned in the 4 weeks preceding the first trial visit (except BCG and Hepatitis B, which can not be given within 8 days before the first study visit)
* Vaccination planned in the 4 weeks following any trial vaccination (except BCG and Hepatitis B, which can not be given within 8 days before or after the study vaccine(s) administration)
* History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b infection (confirmed either clinically, serologically or microbiologically)
* Clinical or serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or HIV infection
* Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenzae type b infection with the trial vaccine or another vaccine
* Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
* History of/current seizures
* Febrile illness (axillary temperature ≥ 37.1°C) or acute illness on the day of inclusion
Per-operating Use of a Probe for Detection of β+

The objective of the study is to evaluate the sensibility of the probe Forimtech to detect β+ emission in vivo in humans and its usefulness during elective surgical procedure Hypothesis:The probe Forimtech is able to allow per-surgery detection of tumoral lesions sensible to 18F-FDG and to help in the realization of guided biopsies, minimally invasive surgery or complement of resection of tumors.

The β+ emission detected by the probe Forimtech is correlated to the emission γ detected by the 18F-FDG.PET/CT

Patients with a malignant neoplasic lesion known or suspected for which a surgery is planned will be presented with the protocol. If inclusion/exclusion criteria are fulfilled all the procedures will be planned. A 18F-FDG PET/CT will be done. Surgery will be conducted within 3 hours after the I.V. injection of 18F-FDG according to the standard procedure applied in the visceral surgery department. During the surgery, emission of β+ from the lesion (s) seen during the PET/CT will be detected with the probe.

Resected pieces will be analysed histologically.

Eligibility Criteria:
Inclusion Criteria:

* Age \< 80 years old;
* Karnofsky index ≥80% ;
* Informed consent signed
* Patients with an indication of thoracic, visceral, or ENT surgery with the aim of a diagnostic biopsy, of an invasive minimal treatment, or an initial or complementary resection

Exclusion Criteria:

* Pregnancy
* Enable to sign informed consent
ADDITIVE BENEFITS of KALTENBORN SUSTAINED STRETCH JOINT MOBILIZATION with RESISTANCE EXERCISE TRAINING in KNEE OSTEOARTHRITIS

to determine the supplementary effects of Kaltenborn sustained stretch mobilization when combined with resistance training in the management of knee osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

Grade I-III knee OA Both male and female nee osteoarthritis for at least 3 months knee pain no more than 8/10

Exclusion Criteria:

Malignancy Any additional Inflammatory disorders Infection Knee trauma lower limb fracture Lumbar radiculopathy or myelopathy knee surgery Intra-articular steroid therapy in the last 2 months Total knee replacement (TKR). Total hip replacement (THR). Any neurological disorder Any cardio-pulmonary complications Rheumatoid arthritis Septic arthritis Recent history of trauma Osteoporosis or osteomyelitis Grade IV osteoarthritis

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Safety & Effectiveness Study of the Hydrus Microstent for Lowering IOP in Glaucoma Patients Undergoing Cataract Surgery (HORIZON)

This clinical trial is a prospective, randomized, controlled, multicenter, study. After informed consent is obtained, patients will be evaluated for eligibility based on glaucoma severity, eye health, and visual acuity. Following successful screening, use of all topical glaucoma medications will be stopped for a period of "washout" to establish a qualifying medication-free intraocular pressure (IOP) value. Clinical follow up will be scheduled over the course of the 24 month study, and examinations will be repeated to monitor eye health. At the 1 and 2 year follow up, those patients on ocular hypotensive medications will be instructed to washout, and then have the diurnal (IOP taken in the morning, mid-day, and afternoon in the same day) IOP evaluation. Annual follow up will occur up to 5 years. The primary effectiveness endpoint is a decrease in diurnal IOP from baseline compared to the 24 months diurnal IOP following medication washout.


Eligibility Criteria:
Inclusion Criteria:

* An operable age-related cataract
* A diagnosis of POAG treated with 1 to 4 hypotensive medications
* Medicated IOP ≤ 31 mmHg
* Diurnal IOP ≥ 22 mmHg and ≤ 34 mmHg

Exclusion Criteria:

* Congenital or developmental glaucoma
* Previous argon laser trabeculoplasty
* Ab-interno or ab-externo device implanted in or through Schlemm's Canal
* Use of oral hypotensive medication for glaucoma for treatment of fellow eye