cyrilzakka/clinical-trials huggingface dataset:
Assessment of Safety, Tolerability, Systemic Exposure and Efficacy of GPB Cream in Adolescents With Severe Primary Hyperhidrosis

The aim of this study is to evaluate the safety, tolerability and systemic exposure (in a subset of patients) of topical administration of 1% GPB in adolescents with severe primary axillary hyperhidrosis.


Eligibility Criteria:
Inclusion Criteria:

* Medical diagnosis of severe primary axillary hyperhidrosis with a PRHS score of ≥5 with symptoms for at least 3 months before Screening
* At least 50 mg of sweat production in each axilla measured gravimetrically over a period of 5 minutes at room temperature along with a humidity consistent with the normal climate in that area (patients have to acclimatize to that room for at least 30 minutes before the measurement)
* Adolescents of both sexes aged 12 to 17 years (until study completion) with a body mass index percentile ≥10 and ≤90 (according to Kromeyer-Hauschild et al 2001)
* Local tolerability assessment (skin reaction) score = 0

Exclusion Criteria:

* Secondary hyperhidrosis, ie, hyperhidrosis that is secondary to other underlying diseases such as (but not limited to) hyperthyroidism, lymphoma, and malaria
* Previous surgical treatment of hyperhidrosis including sympathectomy, surgical debulking of the sweat glands, subcutaneous tissue curettage, ultrasonic surgery, microwave treatment (miraDry), or laser treatment
* Botulinum toxin treatment for the treatment of axillary hyperhidrosis in the previous 4 months
* Hypersensitivity to glycopyrrolate, or to any of the excipients of the investigational medicinal product (IMP)
Evaluation of the Educational Program of Diabetes Mellitus: Focus on Empowerment

With health education, patients will have knowledge of the disease and may modify their attitudes to diabetes. Have a different behavior, will perform self-management of their health. Will adhere to physical activity, the better control of the disease and have quality of life. Empower the patient through the educational practices.

In this sense, from the perspective that the routine monitoring of users with type 2 diabetes should be performed at the primary health care, which has the structural axis the family health team, and that education is fundamental to the self-management of diabetes mellitus care, applying a evaluative research based on an educational program to check before and after clinical, anthropometric data and validated instruments can provide an effective means of control and prevention of disease.

The purpose of randomization is to compare the effects and values of the dependent variables ( knowledge about diabetes mellitus, psychological attitudes, adherence to practices related to physical activity and diet self-care, empowerment for self-care in diabetes mellitus and control of clinical indicators ) in the experimental group with the group control, which are associated with the independent variable ( educational program). For the experimental group an educational systematized process, to evaluate the scope for enhancing the educational process with emphasis on Diabetes empowerment to provide self-care, thereby improving disease control will be performed. Have the control group will maintain the traditional care through individual consultations and information about the disease, through leaflets that could assist in the educational process for self-management of care. All subjects in the experimental group and the control group will be questioned in the pre -test and post - test by related instruments: (1) knowledge of the diabetes mellitus, (2) attitudes toward the psychological aspects, (3) self-care (medication adherence, diet and physical activity), (4) empowerment for self-care in diabetes mellitus and (5) clinical indicators.

Eligibility Criteria:
Inclusion Criteria:

* users from 30 years of age diagnosed with type 2 diabetes mellitus,
* degree of education above the fourth grade of elementary education and
* ability to attend the education program.

Exclusion Criteria:

* users with reading disability and
* chronic complications (defined as kidney failure, blindness, amputation of limbs, etc.).
Long-Term Safety and Efficacy Study of Avanafil in Men With Erectile Dysfunction

This open-label study is being conducted to evaluate the long-term safety, tolerability, and efficacy of avanafil in men with mild to severe erectile dysfunction. Approximately 400 subjects will be enrolled and treated with avanafil for up to 52 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Successfully completed the entire treatment period in a qualifying study (TA-301 \[NCT00790751\] or TA-302 \[NCT00809471\]);
* Demonstrated compliance with the study protocol, including drug administration, diary completion, and scheduled study visits, during the qualifying trial;
* Made at least 4 attempts at intercourse during the last treatment period of the qualifying trial;
* Agree to make at least 4 attempts at intercourse each month through the course of this study;
* Agree not to use any other treatments for erectile dysfunction during participation in this study.
* Provide written informed consent;
* Willing and able to comply with scheduled study visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Subjects who, in the opinion of the investigator, have developed one or more comorbidities during the qualifying study that would pose a safety concern to their continuation on treatment in study TA-314;
* Subjects requiring treatment with an excluded medication.
EuroPainClinicsStudy XI (Cryo vs RF MB Z Joints)

Determine the efficacy of lumbar medial branch neurotomy by radiofrequency and cryoablation in patients with chronic low back pain

Description of the clinical state:

Facet joint pain encompasses a significant portion of the possible sources of pain in patients with vertebrogenic algic syndrome. A typical symptom caused by facet joint irritation of the medial branch nerve is a back pain with intermittent irregular patchy pain spreading to the legs. The cause of this pain is irritation of the medial branch of the dorsal nerve root which innervates a facet joint. Confirmation of the source of the pain involves local anaesthetic blocks of the medial nerve branches in several adjoining vertebral areas. If this test is positive, then the patient's condition is indicated for radiofrequency ablation or cryoablation of the nerve branches.

Description of interventional procedures:

Patients with chronic low back pain with confirmed zygapophysial joint pain after previous two medial branch nerve blocks with positive results are indicated for radiofrequency medial neurotomy or alternative cryoablation neurotomy. Navigation with probes in both cases is arranged and directed according to fluoroscopic imaging.

Eligibility Criteria:
Inclusion Criteria:dsds

* patients aged between 20 and 80
* positive two medial branch nerve blocks with pain relief over 80% during the first 12hours after nerve block application
* positive patient history for facet joint pain
* patients with chronic low back pain for at least 6 months with back pain and leg pain (VAS \>=5)
* those who (only if a signature was obtainable), or whose legal guardian, fully understood the clinical trial details and signed the informed consent form

Exclusion Criteria:

* patients with a history of other spinal diseases (compression fracture, spondylitis, tumor)
* women with positive a pregnancy test before the trial or who planned to become
* pregnant within the following 3 years
* other patients viewed as inappropriate by the staff
* disagreement with participation in the study
BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery

The purpose of this study is to learn if BMS-562247 can prevent blood clots in the legs and lungs in men and women following unilateral total knee replacement surgery. The safety of this treatment will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing elective unilateral total knee replacement surgery.
* Willing and able to undergo bilateral ascending contrast venography.
* Able to inject (by self or caregiver) study medication subcutaneously.

Exclusion Criteria:

* Women of childbearing potential.
* Women who are pregnant or breastfeeding.
* Under some conditions, subjects weighing more than 300 lbs. (136kg) and/or Body Mass Index (BMI) \>=35 kg/m2
Development of an Online Program to Help Manage Chronic Pain in Children and Teenagers

This research seeks to develop an internet-based program to help teenagers manage pain at home using a variety of techniques from physiotherapy, medicine, psychology and nursing. This study uses interviews to investigate what content and features teenagers and their parents want to see in an online intervention for managing chronic pain in teenagers.

This research seeks to develop an internet-based programme to help teenagers manage pain at home using a variety of techniques that mirror clinical practice. This includes content from medicine, physiotherapy, nursing and psychological techniques, such as relaxation.

The study will use interviews (one semi-structured interview and one 'think-aloud' interview per participant) to explore the question: What content and features do young people with chronic pain, and their parents want to see in an online pain management intervention?

The study seeks to recruit a group of teenagers from Great Ormond Street Hospital, as well as a group of parents. After the first round of interviews, participants have the option to be contacted about the second round.

Recruitment for the first round of interviews will continue up until the point where no additional insights are found by adding new data to the analysis ('point of saturation'). We anticipate 30 teenagers and 30 parents will be sufficient. We hope to recruit young people with a mixture of ages and sexes, as well as a mixture of different pain diagnoses, and parents with varying backgrounds and sexes where possible.

The insights gathered from this study will help develop a new program for managing chronic pain in teenagers, which we aim to make available through the NHS. The internet-based intervention hopes to contribute to successful chronic pain management at home, and may be used as an adjunct to clinical services, such as the Pain Control Service at Great Ormond Street Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents aged 12 to 17 years
* Adolescents experiencing chronic pain of any type (minimum duration of three months).
* Parents or legal guardians of adolescents, aged 12 to 17 years, who are experiencing chronic pain of any type (minimum duration of three months).

Exclusion Criteria:

* Unable to communicate in fluent, spoken English.
* Adolescents aged 18 years or over.
* Adolescents with chronic cancer pain that are continuing to undergo treatments to eradicate their primary cancer or have received these treatments in the last three months (maintenance therapies are acceptable).
Clinical Evaluation of Bulk-fill Alkasite Restoration Versus Resin Modified Glass Ionomer in Adult With Class V Carious

Cention N will have the same clinical performance as resin-modified glass ionomer in cervical carious lesions. Evaluation of restorations will be done at baseline, six months, and one year according (USPHS) criteria.

In this study, Class V carious lesions were restored using two different restorative materials either resin modified glass ionomer or Cention N restorative materials. This study will be held in the restorative clinic at Future University in Egypt. Patients will be assessed for medical and dental histories first. Then an examination of the patients will be done using visual inspection by using a dental mirror and probe. Eligible patients according to inclusion and exclusion criteria will be informed about all procedures with follow up time if they accept, 12 their signature on written informed consents will be obtained. Eligible participants will be randomly divided into two groups according to the type of restoration they will be received. The first group (A) will be received resin modified glass ionomer restorative material and the second group (B) will be received Cention N restorative materials. Each restoration will be evaluated for clinical parameters after finishing and polishing at baseline and regular recalls of 6 months and one year.

The restorations will be clinically examined according to modified USPHS criteria in terms of marginal adaptation, anatomic form, color match, marginal discoloration, secondary caries, postoperative sensitivity and retention. The information that will be obtained will be collected and statistically analyzed

Eligibility Criteria:
Inclusion criteria:

* Patients with High caries risk.
* Patients with poor oral hygiene.
* Patients with untreated cervical caries lesion.
* patient aging ≥18 years.
* Absence of tooth mobility
* Absence of abnormal occlusion.
* Patients with good likelihood of recall availability.

Exclusion criteria:

* Patients with cervical caries lesions need crown restoration.
* Non-vital teeth.
* Evidence of parafunctional habits.
* Teeth supporting removable prosthesis.
* Periapical Abscess or Fistula.
* Patients with systemic disease.
* Patients with xerostomia.
* Participants with a history of allergy to any component of restorations will be used in the study.
Adjuvant Therapy With CytoSorb in Refractory Septic Shock

This prospective randomized single center study investigates to what extent the removal of elevated cytokine levels by hemoadsorption has a positive effect on the treatment of patients in septic shock by stabilizing the circulatory situation.

The term "sepsis" refers to a clinical syndrome in which a dysregulation of the host's inflammatory reaction to infection leads to a life-threatening of organ dysfunctions. Sepsis and septic shock are major causes of death in intensive care units worldwide.

The clinical picture of septic shock, the most severe form of sepsis, leads to uncontrolled production and release of a large number of proinflammatory cytokines and mediators, the "cytokine storm". Septic shock is accompanied by a massive increase in mortality of up to 60%.

This high mortality rate is due to a lack of current treatment options. The early recognition of the disease and its immediate treatment are decisive for successful therapy and the survival of those affected. The most important therapeutic steps, apart from focus control by antibiotics and surgical intervention, are the stabilization of the affected organ systems, in particular the circulatory system and the respiratory system. As an extracorporeal and non-specific procedure for the interruption of the cytokine storm, hemoadsorption by means of CytoSorb adsorbers may be an intervention, which has already demonstrated its basic effectiveness in the treatment of septic and cardiosurgical patients.

Eligibility Criteria:
Inclusion Criteria:

* Refractory septic shock
* Need for Norepinephrine ≥ 0.25 µg/kg/min
* IL6 ≥ 1000 ng/l
* Indication for CRRT

Exclusion Criteria:

* Sepsis due to pulmonary or urogenital causes
* Onset of septic shock longer than 36 hours
* Liver cirrhosis Child Pugh C
* "do not resuscitate"-order
* expected survival \< 14 days
* participation in another interventional trial
* Pregnancy or breastfeeding
* Lack of consent
Effectiveness of Pulpotomy in the Management of Mature Permanent Tooth With Irreversible Pulpits

This study is to evaluate the effectiveness of pulpotomy in mature permanent tooth with irreversible pulpits, and compare the clinical efficacy of pulpotomy and root canal therapy.

At present, root canal therapy ( RCT ) is still the main treatment for mature teeth diagnosed as irreversible pulpitis, but the teeth after RCT become non-vital, losing the immune defense mechanism and regeneration potential of pulp, which is not conducive to the long-term preservation of teeth. The traditional view is that mature permanent teeth with irreversible pulpitis are not indications for pulpotomy. However, with the deepening of pulp biology research and the availability of new pulp capping materials, the effect of pulpotomy is more predictable. Recent studies have shown that pulpotomy for irreversible pulpitis teeth can achieve good results, however, there is a lack of high-quality randomized controlled clinical studies, and the effect of pulpotomy compared with RCT studies rarely reported. Therefore, this project intends to explore the curative effect of pulpotomy on mature permanent teeth with irreversible pulpitis, and analyze the influence of age, tooth position and other factors on its curative effect, broaden the indications of pulpotomy, and establish the indications and standardized operation process of pulpotomy for mature permanent teeth with irreversible pulpitis.

Eligibility Criteria:
Inclusion Criteria:

Intended to participate with this study, and provide informed assent/consent. Aged 18 and 59 years. At least one mature permanent teeth diagnosed as acute pulpitis or chronic pulpitis, and the teeth was in Nolla stage 9 and above by radiographic examination.

To be prepared to appear for follow-up.

Exclusion Criteria:

Allergic to any medications or materials necessary to complete the procedures. The teeth with severe coronal defect that find to be non-restorable. The teeth with full crown restoration. The teeth with root fracture or vertical root fractures. Patients with periodontitis. Patients who are undergoing orthodontic treatment. Patients with dental dysplasia or other oral genetic disorders. Women who are pregnant or lactating, or women who plan to become pregnant in the subsequent 2 years.

Patients with mental disorders. Patients with a history of systemic diseases that may alter immune function.
Beta-alanine Supplementation and CrossFit Performance

This study will randomize CrossFit participants to receive beta-alanine or placebo supplementation for 3 weeks. The study will be double-blind. Performance on the "Fran" test will be completed at baseline and after the 3 week intervention. Respiratory exchange ratio will also be assessed during the performance test at baseline and after 3 weeks.

Beta-alanine is a nutritional supplement often consumed by people involved in high-intensity sports that involve substantial lactic acidosis. If consumed on a regular basis, it improves muscle buffering capacity and exercise performance during high-intensity moderate-duration events. CrossFit involves competitions that are high in intensity and moderate duration and many elite CrossFit athletes have reported taking beta-alanine as a supplement. It has never however been evaluated in a research study for its affect on CrossFit performance. The purpose of the study is therefore to assess the effects of beta-alanine supplementation on CrossFit performance. A maximum of 30 CrossFit participants will participate in this randomized double-blind parallel groups study. Participants will be randomized to receive 6.4 g/d beta-alanine or maltodextrin placebo for 3 weeks. At baseline and after the intervention, participants will complete a "Fran" test, which involves performing sets of repeated dumbbell thrusters alternating with chin-ups. The performance measure is the time to complete the test. During the test, respiratory exchange ratio will be assessed to indirectly assess acidosis.

Eligibility Criteria:
Inclusion Criteria:

* Minimum of one year of CrossFit experience and doing CrossFit training at least twice a week

Exclusion Criteria:

* Having consumed beta-alanine in the past six months
* Having changed the dose of any other nutritional supplement within the past month
* Having suffered a major physical injury in the past six months
Exploring Functional Paralysis with Advanced Magnetic Resonance Modalities

In functional neurological disorder (FND), neurological symptoms are present, such as paralysis, weakness and disturbed sensation of limbs, although clinically no abnormalities can be found. It is a poorly understood disorder with uncertain diagnosis, treatment and prognosis. In this study, the subtype functional paralysis is investigated with advanced neuroimaging techniques that go beyond standard clinical examinations. In previous research on FND, healthy volunteers have generally been used as a control group. However, since people with functional paralysis have similar symptoms to people with spinal cord injuries (SCI), it is intended to compare the three groups to find similarities and differences. With the proposed methods, the goal is to gain a detailed understanding of FND regarding nerve cell metabolism, diffusion pathways and neuronal networks involved in cognitive processes such as motor inhibition (reaction or no reaction depending on situation). Neurophysiological data, clinical assessments and questionnaires are carried out in addition to Magnetic Resonance Imaging (MRI).

The aim is to enrol 75 participants in this study, i.e. 25 people with FND, 25 people with SCI and 25 healthy control subjects.

The overall goal of the study is to find markers for FND for use in future studies to improve diagnosis and individualise therapy recommendation for both people with SCI and people with FND. Therefore, this study is a relevant step to understand FND and to diagnose this specific disease using objective MRI based diagnostic tools.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-65

Exclusion Criteria:

* Contraindication for magnetic resonance examinations (e.g. cardiac pacemaker, pregnancy, etc.)
* history of mental or neurological illness (addiction, central nervous system tumour and severe craniocerebral trauma)
* unable to hold a pen due to paralysis
To Evaluate Safety and Effectiveness of RovatitanTab.

To evaluate the safety and effectiveness of a fixed-dose combination containing valsartan and rosuvastatin (Rovatitan® Tablet) in patient with hypertension and hypercholesterolemia

* Effectiveness: the ratio of patients who reach target BP or LDL-cholesterol
* Safety: we will collect safety data

Eligibility Criteria:
Inclusion Criteria:

* Patients who have hypertension and hyperlipidemia and older than 19 years
* Patients who undertstand purpose and method of study, agree with study

Exclusion Criteria:

* Patients who have been administered Rosuvastatin/Valsartan as a anti- hyperlipiddemic/anti-hypertensive drugs
* Uncontrolled hypertension (SBP\>=180mmHg or DBP\>=110mmHg)
* Patients who participated another clinical study or observational study 3 months ago.