cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Inhibitory Effect of 5 Anti-Histamines in Urticaria

The antihistamines with inhaled steroids are the cornerstone on the symptomatic therapy in the management of patients with rhinitis and the first line of treatment in patients with urticaria. Currently, the use of antihistamines has become popular due to its excellent safety profile and clinical efficacy, however to the investigators knowledge, there are no studies about the pharmacokinetic and pharmacodynamic effects of these drugs in patients of tropical Latin America. The investigators main interest is to evaluate if skin test inhibition correlates with the clinical effect of five anti-histamines.

This was a randomized, double-blind, study that was conducted in six health care centers from Medellín and Bogotá (Colombia). This study was conducted in compliance with the ethical principles of the Declaration of Helsinki and with Good Clinical Practice guidelines. Written informed consent was obtained from all subjects or they parents in patients under 18 years. Ethical committee of University of Antioquia (Medellín, Colombia) approved the protocol. Considering the large number of articles that demonstrate the efficacy of antihistamines as first-line treatment in patients with urticaria, the ethics committee request that all participants would receive an antihistamine during the two months of the study because a placebo group would provide little information for the principal objective and the high risk of airway angioedema. Thirty heath subjects were used as a control group to evaluated the characteristics of the wheal in the prick test with histamine.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of persistent allergic urticaria.
* Age over 12 years and at least one year with the disease
* Informed consent filled.
* Be resident of the metropolitan area of Medellin.

Exclusion Criteria:

* • Use of immunosuppressive drugs
An Observational Study Evaluating the Productivity and Health-Related Quality of Life of People With HER2 Positive Breast Cancer

The purpose of this study is to compare productivity (in terms of work or daily activity) and generic and disease-specific health-related quality of life of participants with HER2 positive early breast cancer currently receiving adjuvant treatment (with chemotherapy and/or targeted HER2 therapy), with participants who have completed adjuvant parenteral therapy, and participants with HER2 positive metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with early stage or metastatic (Stage IV) HER2-positive breast cancer (confirmed by the study site physician). \[HER2-positive is defined as ImmunoHistoChemistry (IHC3+) and/or in situ hybridization (ISH) ≥2.0\]
* Able to provide written, informed consent.
* Early Stage Breast Cancer (eBC) patients must have received at least 1 cycle of adjuvant anti-cancer therapy following surgery; metastatic breast cancer (mBC) patients must have received at least 1 cycle of treatment for their metastatic disease.

Exclusion Criteria:

* Unwilling or unable to consent.
* Unable to complete written quality of life questionnaires
* Partcipants with Eastern Cooperative Oncology Group (ECOG) Performance Status ≥3
Phase IV Study of FDA Approved, Once-Daily GRALISE™(Gabapentin) Tablets for the Treatment of Postherpetic Neuralgia

Study objective is to assess the safety and effectiveness of once- daily GRALISE in clinical practice

Open Label, single arm, 2wk titration, 6 wk stable dosing, 8 wk of total treatment, 1wk dose tapering

Eligibility Criteria:
Inclusion Criteria:

* Men or Women 18 years or older who are suffering from PHN

Exclusion Criteria:

* Patient is Pregnant or a nursing mother
* Patient has hypersensitivity to gabapentin
* Patient has an estimated creatinine clearance of \<30 mL/min or is in hemodialysis
Open Label, Adaptive, Parallel Group PET Study Using RO7017773 And [11C] RO15-4513

This is a single dose (SD), non-randomized, open-label, adaptive, parallel group study with the purpose of investigating the occupancy of alpha5-containing GABAA receptors by RO7017773 in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy (absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemisty, serology, and urinalysis), as judged by the Investigator.
* Males and women of non-childbearing potential (WONCBP)

Exclusion Criteria:

* History of convulsions (other than benign febrile convulsions of childhood) including epilepsy, or personal history of significant cerebral trauma or CNS infections
* Clinically significant abnormal finding from the MRI performed after the initial screening examination
* Abnormal blood pressure, i.e, systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg
* Abnormal pulse rate, resting pulse rate greater than 100 or less than 40 bpm
* History or presence of clinically significant ECG abnormalities before study drug administration or cardiovascular disease
* Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
* Positive result on hepatitis B (HBV) or hepatitis C (HCV), presence of hepatitis B surface antigen (HBsAg) or positive hepatitis C antibody test result at screening or within 3 months prior to starting study treatment
TI-001 (Intranasal Oxytocin) for Treatment of High Frequency Episodic Migraine and Chronic Migraine

This study evaluates the use of oxytocin, given as a nasal spray, for treatment of high frequency episodic migraine and chronic migraine.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women, aged 18 to 65 years with primary diagnosis of high frequency episodic migraine or chronic migraine.

Exclusion Criteria:

1. Known allergy to oxytocin
2. History of addictive behavior (eg, alcoholism, drug abuse) or severe mood disorder
3. History of clinically significant, functionally impairing cardiovascular or pulmonary disease or any other disease that might confound study results
4. Have basilar or hemiplegic migraines
5. Have substantial cognitive or memory impairment due to any cause (eg, Alzheimer's or dementia)
6. Have a nasal obstruction due to any cause
7. Are pregnant or breast feeding
8. Require ongoing use of steroidal or nonsteroidal anti-inflammatory drugs
9. Are unable or unwilling to provide informed consent or to follow study procedures
Perioperative Use of Atosiban for Ultrasound-indicated Cerclage to Reduce Spontaneous Preterm Birth(sPTB)

After ultrasound-indicated cerclage, some pregnant women still experience sPTB, and there is controversy regarding the use of tocolytic agents during the perioperative period to reduce the incidence of sPTB. In this study, the investigators employed a randomized double-blind method to investigate whether the use of atosiban during the perioperative period can reduce the incidence of sPTB before 34 weeks.


Eligibility Criteria:
Inclusion Criteria:

* (i) Viable singleton gestation between 14 0/7 and 23 6/7 weeks of gestation.
* (ii) Previous history of miscarriage or preterm labor in mid-pregnancy.
* (iii) Transvaginal ultrasound examination showed that the cervix is 25mm or less at gestations less than 24 weeks.

Exclusion Criteria:

* (i) Women with uterine contractions.
* (ii) Vaginal bleeding.
* (iii) Symptoms of chorioamnionitis.
* (iv) Medically indicated PTB (severe preeclampsia, placental abruption, preterm premature rupture of membranes).
* (v) Major structural or chromosomal abnormalities.
* (vi) Contraindication to atosiban.
* (vii) Had received atosiban or any tocolytic agents within 7 days before their presentation.
Comparison of FDG and FAPI in Patients With Various Types of Cancer

To evaluate the potential usefulness of 68Ga-DOTA-FAPI-04 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer, compared with 18F-FDG PET/CT.

Subjects with various types of cancer underwent contemporaneous 68Ga-DOTA-FAPI-04 and 18F-FDG PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FDG and 68Ga-DOTA-FAPI-04 PET/CT were calculated and compared to evaluate the diagnostic efficacy.

Eligibility Criteria:
Inclusion Criteria:

* (i) adult patients (aged 18 years or order); (ii) patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include magnetic resonance imaging (MRI), CT, tumor markers and pathology report); (iii) patients who had scheduled both 18F-FDG and 68Ga-DOTA-FAPI-04 PET/CT scans; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

* (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
TRIGEN SURESHOT™ Distal Targeting System Study

The objective of this study is to quantitate the amount of radiation both subjects and surgeons are exposed to during intramedullary nailing of the femur using the TRIGEN SURESHOT Distal Targeting System versus Standard nailing instrumentation.

The TRIGEN SURESHOT™ Distal Targeting System was designed to be an intraoperative image-guided localization system to aid with drill positioning for screws during intramedullary nailing distal interlocking. It is hypothesized that this system will aid in identification of the distal holes leading to reduced exposure to radiation. The SURESHOT System provides information to the surgeon that is used to place surgical instruments utilizing electromagnetic tracking data obtained intraoperatively. It is indicated for long bone fractures treated with intramedullary nailing in which the use of stereotactic surgery may be appropriate. The hypothesis is that using the TRIGEN SURESHOT™ Distal Targeting System will allow accurate distal locking while effectively decreasing the amount of radiation exposure compared to the standard instrumentation process.

Eligibility Criteria:
Inclusion Criteria

* Unilateral femoral shaft fracture requiring intramedullary nailing in which the use of stereotactic surgery may be appropriate.
* Subject is between 18-80 years of age.
* Subject is skeletally mature
* Subject is of legal age and capable of providing legal consent.
* Subject is suitable for current Intramedullary Nailing procedure
* Subject willing to accept randomization either to the TRIGEN SURESHOT Distal Targeting System or TRIGEN standard instrumentation.

Exclusion Criteria

* Femur shaft fracture not amenable to intramedullary nailing in which the use of sterotactic surgery may be inappropriate.
* Fracture with vascular injury (Gustilo Type IIIC) requiring repair
* Open fractures where open wound is in communication with distal targeting holes and therefore would influence duration of locking procedure (i.e. potentially no need for incisions for locking screw placement).
* Fracture of the Metaphyseal distal femur with intraarticular comminution
* Known Pathological Fracture
* Subject is a prisoner
* Operative procedure for closed fracture is scheduled for greater than 2 weeks for closed fractures
* Subject has cognitive issue/mental status conditions that preclude intramedullary nailing in the judgment of the investigator.
* Contralateral femoral shaft fracture
BF2.649 in Patients With OSA and Treated by CPAP But Still Complaining of EDS

Multicenter randomized double blind study versus placebo during 12 weeks with at first, an escalating dose period followed by stable dose period at the selected dose.

This double-blind period can be followed by a 9 months open-label period if the patient wishes to continue with the study product.

The first period (12 weeks double blind period) will aim at demonstrating the efficacy and safety of BF2.649 by verifying whether the results of BF2.649 are superior to those of placebo.

The aim of the second period (open label extension phase) will be to assess the long-term tolerance, as well as the maintenance of the BF2.649 efficacy.

Eligibility Criteria:
Inclusion Criteria:

* patients with OSA treated by nCPAP but still complaining with EDS
* ESS score \> or = 12

Exclusion Criteria:

* patient suffering from insomnia without OSA
* co-existing narcolepsy
* patient with sleep debt not due to OSA
* acute or chronic severe disease
Integrated Management of Pronation Deformity in Cerebral Palsy

Pronation deformity is a very common problem in children with cerebral palsy. This deformity is usually has neural and non-neural aspects. In this clinical trial the aim is to show the importance of combine treatment approach with pharmacological and non-pharmacological modalities. .

Spasticity is not only the most common motor disorder but also the main cause of slowly developing contractures in children with cerebral palsy. Pronation deformity which is a very common problem in children with cerebral palsy is primarily due to spasticity of the pronator muscles. Reduced strength and loss of control of the supinator muscles and soft tissue and joint contractures usually coexist with spasticity of pronator muscles. There is very limited information about how to treat this deformity in the current literature.

In this prospective, randomized, controlled clinical trial the aim is to show the effectiveness of twister, and home exercise program in an integrated approach with BoNT-A injections on spasticity, and passive range of motion (pROM) of children with CP having pronation deformity.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cerebral palsy
* MAS score of pronator muscles at least 2
* Gross Motor Functional Classification Scale level of I-IV
* Scheduled to receive botulinum toxin injections to pronator teres and/or -pronator quadratus muscles besides other spastic upper extremity muscles

Exclusion Criteria:

* Severe cognitive or behavioural problems
* Less than 40 degrees of available passive range of motion in pronation
* Severe dystonia in the affected upper limb
* Received orthopedic surgery to affected upper limb
Randomized Controlled Trial on Uptake of NHS Health Checks

The National Health Service (NHS) Health Check is a significant part of the strategy to tackle premature mortality and promote healthy lifestyles. Public Health England aspires to an uptake rate of 75% but national uptake is less than 50%. This study aims to assess the impact of two new behaviourally informed NHS Health Check leaflets on the uptake of NHS Health Checks, by randomizing patients in Lewisham and North East Lincolnshire to the different leaflets and comparing patient-level uptake data. The study will test whether a shorter risk-framed leaflet or a shorter benefits-framed leaflet will be more effective than the current national leaflet at encouraging uptake of the NHS Health Check.


Eligibility Criteria:
Inclusion Criteria:

* due to be invited for an NHS Health Check
* aged 40-74

Exclusion Criteria:

* have an existing Cardio-Vascular Disease-related medical condition
* have had an NHS Health Check in the last five years
Noninvasive Methods to Monitor Graft Survival in Kidney Transplant Patients

The purpose of this study is to test noninvasive methods to monitor the health and condition of new kidneys in people who have received kidney transplants.

Innovations in kidney transplantation have improved short-term outcomes for transplant patients. However, organ rejection remains as an important threat to the long-term survival of the transplanted organ. If clinicians could better monitor the condition of the organ after transplantation, they may be able to improve the chance of graft survival. Noninvasive ways to monitor the condition of the transplanted organ need to be developed and tested. This observational study will investigate whether certain blood and urine tests are useful in monitoring the health of transplanted kidneys.

This trial will involve 14 post-transplant study visits over the course of 2 years. A physical exam, medication history, adverse events assessment, and blood and urine collection will occur at all visits. Kidney biopsies will occur at study entry prior to transplantation and at Month 6, in adult participants only. Protocol biopsies are optional in the pediatric substudy group. Additional visits may be required if organ rejection is suspected.

Eligibility Criteria:
Inclusion Criteria:

* Candidate for deceased donor or living donor kidney transplant
* Negative Crossmatch
* Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

* Clinically significant liver disease
* Other illnesses that, in the opinion of the investigator, may interfere with the study
* Recipient of multiple organ transplants
* Inability or unwillingness to comply with the study protocol
Effects of Self-myofascial Release on Hamstring Flexibility in Patients With Non Specific Low Back Pain

The aim of this preliminary study suggest the addition of self myofascial release to a therapeutic exercise program in reducing hamstring flexibility and would have additional effects on decreasing pain intensity in individuals with non specific low back pain.

There are different treatments that can affect the facial tissue, but MFR techniques have shown promising effects in reducing pain, improving flexibility and daily activities, these techniques involve specifically guided load long-duration mechanical forces to manipulate the myofascial complex (16). Fascia is part of a body-wide tensional force "transmission system" as facial system is innervated by mechano receptors, that when manual pressure is applied may create a range of response via myofascial pathway by transmitting tensional force and decreasing muscle tension that facilitate movement and reduce pain, However in reviewing the literature, there is still theory and hypothesis in relation to the exact mechanism underlying the efficacy of facial manual therapy Self myofascial release (SMR) works under the same principle as myofascial release technique in which individual use their own body mass to exert pressure on soft tissues by tennis ball to the plantar surface of the foot and is widely used to increase flexibility and range of movement further along the posterior muscles of a proposed anatomy train.

Eligibility Criteria:
Inclusion Criteria:

* Patients with nonspecific low back pain for at least 3 months.
* \>20 degree active knee extension loss with hip in 90 degree of flexion
* NPRS \>3
* Patients willing to participate and take treatment.

Exclusion Criteria:

* Patients having severe orthopedic, neurological disease
* Patients having specific diagnose cause of low back pain (infection, tumor, lumbar spine fracture, radicular pain, cauda equina syndrome)
* Involvement in regular flexibility yoga program
* Recent(\<6 months) lower limb, spinal or soft tissue injuries
* Any integumentary contraindication to MFR
The Impact of a Short Intervention During RSV Prophylaxis on Influenza Vaccination Rate.

Premature infants (born before 34 wk) are routinely vaccinated against RSV but vaccination rate against influenza are low in spite of national programs. Study goal is to evaluate the effectiveness of short intervention during RSV prophylaxis visit, planned to educate parents about the importance of influenza vaccination.


Eligibility Criteria:
Inclusion Criteria:

* Infants coming for RSV prophylaxis

Exclusion Criteria:

* Already vaccinated against influenza
* Contraindication for influenza vaccination
Toric Trifocal IOL Treatment With High Astigmatism and Hyperopia vs SMILE Enhancement After Trifocal IOL Treatment

The aim of this study is to assess visual and refractive outcomes after Toric Trifocal lens implantation and visual outcomes after laser vision correction (LVC) - ReLex Smile to correct residual refraction after 6 months of Toric Trifocal (IOL) implantation.

The current state of the art for the correction of aphakia and presbyopia after lens extraction and refractive lensectomy is the implantation of multifocal intraocular lenses (IOL). In this study, the trifocal IOL types AT LISA TRI 839MP and AT LISA TRI TORIC 939MP (Carl Zeiss Meditec, Germany) were assessed.

In this prospective non-randomized study patients with spherical hypermetropia of \>4 D in combination with high astigmatism of \>3.0 D were treated. The first group of 40 eyes of 20 patients underwent refractive lensectomy, followed by implantation of the diffractive trifocal IOL type AT LISA TRI 839MP (Carl Zeiss Meditec, Jena, Germany) and 6 months later SMILE surgery. In 40 eyes of 20 patients in the second group IOL type AT LISA TRI TORIC 939MP were implanted. All patients were adequately consulted preoperatively about this type of IOLs and they were verbally consented. The study is adherent to the tenets of the Declaration of Helsinki. All patient are between 20- 45 years old.

The current study demonstrates that both the non-toric and toric versions of the trifocal IOL evaluated here provide excellent functional vision to patients, with good distance, intermediate and near uncorrected VA, a wide range of vision and good contrast sensitivity.

Before SMILE,Yag-Laser capsulotomy should be performed on all patients, regardless of posterior capsule ossification, in pseudophakic patients with residual refraction. When the Yag-Laser is applied after the Smile, there will be a diopter change.

Relex Smile surgery in pseudophakic patients with trifocal IOL was safe, effective, and predictable in a large cohort of patients. It is noteworthy that the decision for a treatment strategy (toric IOL or non-toric IOL with SMILE in s second step) should be made carefully, to select the appropriate method for the patient. During phaco surgey the positions of incisions should be determined according to the angle of the highest K value of the patient. For high astigmatic patients, toric trifocal IOL is highly effective.

Eligibility Criteria:
Inclusion Criteria:

1. High spherical hypermetropia
2. Astigmatismus \>2 D or higher
3. Amblyopia
4. Strabismus (accomodative esotropia)

Exclusion Criteria:

1. Glaucoma
2. Retinal detachment
3. Corneal disease
4. Macular degeneration
5. Advanced Retinopathy