cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole in Subjects With Recurrent Vulvovaginal Candidiasis

The purpose of this study is to evaluate the Efficacy and Safety of SHR8008 capsule In Subjects With Recurrent Vulvovaginal Candidiasis


Eligibility Criteria:
Inclusion Criteria:

1. Females, ≥18 and ≤75 years old.
2. Have a history of RVVC at screening.
3. Suitable for oral therapy and able to swallow capsules intact.
4. Subjects of childbearing potential must use highly effective contraceptive measures throughout the study.
5. Willing to sign the informed consent form to participate in this study.

Exclusion Criteria:

1. Presence of concomitant vulvovaginitis caused by other pathogens.
2. Have a history of cervical cancer, or "cervical intraepithelial neoplasia or malignancy" or "atypical squamous cells of undetermined significance (ASCUS)" as indicated by Pap test or other tests reported within 1 year before screening (not applicable to subjects with a history of total hysterectomy).
3. Any condition that, in the opinion of the investigator, could impact drug absorption, distribution, or elimination.
4. Moderate to severe hepatic and/or renal disorders.
5. Significant laboratory abnormality at screening.
6. QTc interval greater than 470 ms or other clinically significant ECG abnormality at screening.
7. Have received systemic or vulvovaginal antifungal drugs, antibacterials, antitrichomonal, CYP3A4 substrates or inducers or inhibitors, and vulvovaginal corticosteroids within 7 days prior to randomization.
8. Have received any estrogen replacement therapy or vaginal topical products.
9. Have received systemic corticosteroid therapy within 30 days or systemic immunosuppressant therapy within 90 days prior to randomization;
10. Have planned surgery or other medical procedures that may impact compliance with the protocol;
11. Known history of hypersensitivity or intolerance to azole antifungal drugs.
12. History of narcotic or drug abuse or alcoholism, or any other medical, psychiatric or social condition that in the investigator's opinion could preclude compliance with the protocol.
13. Women who are pregnant or lactating, or planning to become pregnant during the study period.
14. Have received VT-1161 study medication in a previous study or received any investigational medicinal product (IMP) in a clinical study within 5 half-lives of that IMP prior to screening (if the half-life is unknown, 60 days prior to screening);
15. other conditions unsuitable for participation in the study.
Adolescent Coordinated Transition Nigerian HIV+ Youth

The purpose of this study is to evaluate the comparative effectiveness of a comprehensive, coordinated transition protocol which includes an early introduction to the adult provider, an integrated case management team and a peer-facilitated organized support group on retention in care, viral suppression and psychosocial wellbeing among adolescents living with HIV.

Using a two-arm cluster randomized design, our proposed study will evaluate the comparative effectiveness of ACT, a coordinated protocol for transitioning adolescents living with HIV (ALHIV) from pediatric to adult care (Intervention Group; IG) versus the usual abrupt transfer to adult care (Control group; CG) on rates of retention in care and viral suppression, and differences in perceived psychosocial wellbeing. Twelve health facilities, two in each of the six geopolitical zones of Nigeria will be pair-matched and randomly assigned to either IG (N=6 health facilities) or CG (N=6 health facilities). A total of 216 ALHIV will be enrolled in the study over a 36-month period. The primary outcome will be the difference in the rate of retention between the groups. Secondary outcomes will be difference in the rate of viral suppression and the difference in perceived psychosocial wellbeing. Additionally, the investigators will conduct mediation/moderation analysis to examine the role of intermediate variables such as transition readiness, perceived mental health, social support, health locus of control, self-esteem and sexual risk behavior self-efficacy on the primary outcomes. Implementation factors will be assessed using the hybrid 2 model.

Eligibility Criteria:
Inclusion Criteria:

* Documented HIV infection
* Aware of HIV diagnosis
* Currently on ART

Exclusion Criteria:

* Medically unstable
Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery

Individuals who undergo spine surgery often have a significant loss of blood and may require multiple blood transfusions. Research has shown that epsilon-aminocaproic acid (EACA) may reduce the amount of blood lost during surgery, which would decrease the number of blood transfusions required. This study will evaluate the safety and effectiveness of EACA at reducing blood loss and the need for blood transfusions in individuals undergoing spine surgery.

Spine surgery is often required to correct a number of diseases, including spondylosis, pseudoarthrosis, scoliosis, or other spinal deformities. Spine surgery is often associated with significant blood loss and individuals may require multiple blood transfusions during and following surgery. Blood transfusions are expensive and carry an increased risk of health complications, including fever, allergic reactions, or infections. Preliminary research has shown that EACA may be beneficial for individuals undergoing spine surgery. In addition, EACA appears to be safer and less expensive than other medications typically used to treat serious bleeding. The purpose of this study is to evaluate the safety and effectiveness of EACA at reducing the number of blood transfusions required during and following spine surgery in adults.

This study will enroll individuals who are undergoing spine surgery at Johns Hopkins Hospital. Prior to surgery, participants' demographic data and medical history will be collected. Participants will then be randomly assigned to receive either EACA or placebo intravenously during surgery and for 8 hours following surgery in the intensive care unit (ICU). While in the hospital, participants will have blood drawn frequently for laboratory testing. They will receive blood transfusions as needed and will be closely monitored for blood loss and any medical, surgical, or transfusion complications. Outcome measurements related to the amount of transfused blood required and postoperative complications will be collected on the 8th day following surgery. Study participation will end on the day of hospital discharge or the day of a necessary second surgery.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of spondylosis, pseudoarthrosis, kyphoscoliosis, or acquired or congenital spine deformity
* Willing to undergo elective spinal surgery by a participating surgeon; eligible procedures include the following: spine osteotomy, arthrodesis, instrumentation and/or corpectomy, surgery for lumbar spinal stenosis, or surgery for degenerative disc disease

Exclusion Criteria:

* Requires urgent or emergent surgery
* Has kidney failure that requires dialysis
* Has a known bleeding diathesis, defined as a documented history of an inherited bleeding disorder (e.g., hemophilia or von Willebrand's disease) OR prothrombin time ratio greater than 1.5 seconds OR a documented previous arterial or venous thrombosis within 1 year of study entry
* Pregnant
Effect of Acute Exercise on Cognitive Functions

To determine whether acute aerobic exercise versus resistance exercise effects cognitive function among older adults.


Eligibility Criteria:
Inclusion Criteria:

* Exercise at least 2 times a week Able to sign informed consent Able to perform ergometric exam Above 40 years old

Exclusion Criteria:

* Smoking
* Suffering psychiatric or neurologic illness
* No medication for chronic illness that could effect cognitive function
* Problems with cognitive functioning after head trauma
* Long-term hospitalization within the past 3 months
* Inability to use computer because of vision or motor problems
* Pregnancy
Sequential Intrathecal Injection of Fentanyl and Hyperbaric Bupivacaine

56 Parturients, aged 18-40 year, undergoing elective CS were randomly assigned to receive sequential intrathecal injection of fentanyl and hyperbaric bupivacaine at the same rate (normal sequential) NS or a rapid intrathecal injection of fentanyl followed by slow injection of hyperbaric bupivacaine (rapid sequential) RS. Time of first rescue analgesia, Dose of rescue analgesics, degree of postoperative pain, incidence of hypotension, hypotension duration, ephedrine dose, spinal anaesthesia related complications and failed block were recorded.

56 ASA physical status I, II Parturients, aged 18-40 year, undergoing elective CS were randomly assigned to receive sequential intrathecal injection of fentanyl and hyperbaric bupivacaine at the same rate through a 5ml syringe each (NS (normal sequential), n 28) or a rapid intrathecal injection of fentanyl through an insuline syringe followed by slow injection of hyperbaric bupivacaine through a 5ml syringe RS (rapid sequential), n 28). Onset of sensory block (T6 level), highest level of sensory block, time of first rescue analgesia, Dose of rescue analgesics, degree of postoperative pain by VAS 6H postoperative, Onset of motor block (Bromage scale0\>3), duration of motor block (return to Bromage 0), incidence of hypotension, hypotension duration, ephedrine dose, spinal anaesthesia related complications as nausea, vomiting, pruritis, shivering and failed block were recorded.

Eligibility Criteria:
Inclusion Criteria:

* ASA I, II
* Parturients aged from 18-40 years old
* scheduled for elective CS

Exclusion Criteria:

* parturients with complicated pregnancy as (preeclampsia, pregnancy induced HTN, gestational Diabetes, abnormal placenta (placenta previa), multiple gestation),
* BMI greater than 35 or less than 22,
* major systemic disease (cardiac, renal, liver),
* need for emergency CS,
* having allergy to drugs used in the study,
* having contraindication for spinal anaesthesia or
* refused regional anaesthesia
Treating Smokers With Mental Illness

This is a smoking cessation study that will enroll smokers who have been diagnosed with a severe mental illness. The study will use a combination of intensive tobacco treatment counseling and nicotine replacement therapy to assist smokers in cutting back on and quitting smoking over the course of six months.

At the baseline measurement visit, participants will be asked to complete a survey and an interview. They will be randomly assigned to either the intervention or control group. Both groups will receive a smoking cessation manual and list of resources. The intervention group will also receive smoking cessation counseling and nicotine replacement therapy. Both groups will be seen for in-person assessments again at 8 weeks and 6 months post baseline.

Eligibility Criteria:
Inclusion Criteria:

* have a severe mental illness diagnosis
* be a daily smoker
* be willing to reduce the number of cigarettes smoked per day leading to a quit attempt
* want to try to quit smoking
* be willing to use nicotine replacement therapy
* be able to communicate in English

Exclusion Criteria:

* anyone who has had an active psychotic episode or been hospitalized due to suicidal ideation in the last six months
* pregnancy
* taking Chantix or Clozapine
* having a terminal illness
Economic Aspects Associated With the Implementation of an Orthogeriatric Setting in a General Hospital

The economic and social burden of hip fractures is expected to increase dramatically, but financial resources remain limited. This calls for the investigation of innovative new forms of organization and integration of medical, surgical and rehabilitation services for these patients.

The study will investigate economical aspects associated with implementation of a comprehensive orthogeriatric ward for elderly hip fracture patients in a general hospital, compared with the classic model of orthopedic treatment followed by rehabilitation period.


Eligibility Criteria:
Inclusion Criteria:

* hip fracture

Exclusion Criteria:

* Patients admitted for elective hip surgery
* Patients with multi-trauma injuries
Suitability of 11C-ORM-13070 as a PET Tracer

The purpose of the study is to evaluate the suitability of 11C-ORM-13070 as a positron emission tomography tracer.


Eligibility Criteria:
Inclusion Criteria:

* Good general health ascertained by detailed medical history and physical examination
* Males between 18 and 45 years
* Body mass index (BMI) between 18-30 kg/m2
* Weight 55-95 kg (inclusive)

Exclusion Criteria:

* Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastro-intestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease as judged by the investigator
* Any condition requiring regular concomitant medication including herbal products or likely to need any concomitant medication during the study.
* Regular consumption of more than 21 units of alcohol per week (1 unit = 4 cl spirits, about 13 g of alcohol)
* Current use of nicotine-containing products more than 5 cigarettes or equivalent/day
* Inability to refrain from using nicotine-containing products during the stay in the study centre
* Inability to refrain from consuming caffeine-containing beverages during the stay in the study centre e.g. propensity in getting headache when refraining from caffeine-containing beverages
* Blood donation or loss of significant amount of blood within 3 months prior to the screening visit
* Abnormal 12-lead electrocardiogram (ECG) finding of clinical relevance
* Any abnormal value of laboratory, vital signs, or physical examination, which may in the opinion of the investigator interfere with the interpretation of the test results or cause a health risk for the subject if he takes part into the study
* Anatomical abnormality in MRI which may in the opinion of the investigator interfere with the interpretation of PET results
* Participation in a drug study within 3 months prior to the entry into this study
* Participation in a prior PET study
Benefits of Diving Training on Recovery for Veterans Suffering of Chronic PTSD: an Exploratory Study

Patients suffering from Chronic Posttraumatic Stress Disorder (PTSD) have difficulties in executive cognition that hinder their quality of life and make it difficult to recovery and to reintegrate them socially and professionally. These difficulties are particularly important for soldiers suffering from chronic PTSD.

The literature suggests that diving may be a complementary approach to improving cognition, in addition to its benefits on the quality of life of patients with chronic PTSD. It appears to be an intervention of interest to improve the successful recovery for veterans with PTSD compared to a multi-sport practice.

A French military rehabilitation program proposes the broadening of the relationships between recovery and reintegration by incorporating approaches in the field of positive psychology for soldiers with chronic PTSD. This program was organized for a group of 10 veterans for 10 days. Each morning, from 9 am to 12 pm, participants had sporting activities: mountain walking, mountain biking, climbing, canyoning and collective orienteering running. From 3 pm, they had individual and collective practical workshops based on PTSD psychoeducation, human resources competences and coaching, including a curriculum vitae workshop.

The investigators aims to compare this program included multisport practice with the same praogram included diving instead of multi-sport to evaluate the impact to recovery at one year

Eligibility Criteria:
Inclusion Criteria:

* veterans
* having a chronic PTSD evaluated by a psychiatrist All soldiers included in this study were on sick leave for at least 6 months due to chronic PTSD and were waiting for a military invalidity committee pension. They were all engaged in the first step of the Omega project and had a nine-day HRT training session planned

Exclusion Criteria:

* the psychiatrist did not consider the clinical state appropriate enough to take part in the omega project
Comparison of Lidocaine and Remifentanil for the Effect on Responses to the Endotracheal Tube During Emergence From General Anesthesia

Target concentration infusion(TCI) of remifentanil (2.0ng/ml) suppresses the cough induced by endotracheal tube more effectively than intravenous administration of lidocaine (1.5mg/kg).


Eligibility Criteria:
Inclusion Criteria:

* Females older than 20 years old

Exclusion Criteria:

* Patients with acute or chronic respiratory disease, hypertension, gastro-esophageal reflux disease, having preoperative sedatives or mucolytics, and current smoker.
A Phase III Study of Entecavir vs Lamivudine in Adults With Chronic Hepatitis B Infection and Negative for Hepatitis B e Antigen

The purpose of this clinical research study is to assess the safety and effectiveness of entecavir, as compared to lamivudine, in the treatment of adults with chronic hepatitis B infection who are hepatitis B e antigen negative.


Eligibility Criteria:
* Male and female subjects =/\> 16 years of age (or minimum age required in a given country) with history of chronic hepatitis B infection;
* HBeAg negative, anti-HBeAb positive;
* Absence of coinfection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis D virus (HDV);
* Absence of other forms of liver disease e.g., alcoholic, autoimmune, biliary disease;
* Less than 12 weeks prior therapy with nucleoside or nucleotide analogue antiviral agents with activity against hepatitis B (e.g., adefovir, famciclovir and lamivudine)
Improving Physical Activity and Mobility Via Live Online Exercise Sessions for Older Adults

The COVID-19 pandemic has undoubtedly resulted in an increased level of personal anxiety, reduced access to support services, and as a secondary complication, increased physical inactivity. Older people appear to be at higher risk of several secondary complications and long-term negative health outcomes. These complications include declines in physical health and mobility, social isolation, and worsening mental health. There is strong evidence in older persons that supports the role of exercise and physical activity in: the alleviation of strength and mobility declines, reducing anxiety and depression, and alleviating cognitive declines. Exercise-based intervention trials have also been shown to reduce social isolation and loneliness. This study will compare an online exercise program delivered via Zoom and a waitlist control group in healthy older persons.

This study will examine the impacts of an online exercise program in healthy older persons compared to a waitlist control group. Briefly, participants (healthy persons, age 65-80 years old) will participate in an online group exercise program (designed to meet Canada's Physical Activity Guidelines) via Zoom delivered by Registered Kinesiologists and Physiotherapists for a total of 8 weeks. Participants will be randomly assigned to the exercise group or the waitlist control group. Participants' will undergo assessments of physical activity, life-space mobility, nutrition, loneliness, depression, and anxiety at baseline, end of study, and 8-weeks following the end of the intervention.

Eligibility Criteria:
Exclusion Criteria:

1. Experience any physical conditions which may prevent them from engaging in moderate-intensity physical activity including using assistive walking devices (e.g. cane or walker), or injuries;
2. Have a history of neuromuscular conditions or muscle wasting diseases;
3. Are currently participating in physical activity, ≥150 minutes of moderate-to-vigorous physical activity per week;
4. Are not eligible to participate in regular physical activity according to the Canadian Society Exercise Physiology Get Active Questionnaire;
5. Do not have access to the internet at home via a personal smartphone, tablet (e.g., iPad), or computer.
Comparison of Hearing Aid Fitting Outcomes Between Self-fit and Professional Fit for MDHearing Smart Hearing Aids

Hearing aids are commonly used to help people with hearing loss hear better in daily listening environments. MDHearing Smart hearing aids are designed to use the MDHearing app to adjust hearing aids to each individual's hearing loss. This study intends to show whether the MDHearing Smart hearing aids can be fitted by each user reliably and if each user can use the MDHearing app on their smartphone or tablet to make adjustments to achieve good aided benefit, which will be compared to those fitted by audiology professionals. This study includes three components: human factor study, self-fit study, and professional-fit study. The information obtained will be useful for both audiology professionals and people with impaired hearing.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* At least one air conduction threshold above 15dB HL.
* All air conduction thresholds must be under 60dB HL

Exclusion Criteria:

* Signs of outer or middle ear pathology
* Greater than 60db HL hearing loss at any frequency.
Effect of Cervical Mobilization on Rotator Cuff Tendinitis

this study aimed to investigate the effect of 3 types of cervical mobilization on the strength of shoulder abductors, external rotators and pain level in patient with rotator cuff tendinitis. the measurement will be made immediately, 10 minutes, and 30 minutes after mobilization

subjects will be allocated according to the inclusion and exclusion criteria from outpatient clinic at El sahel teaching hospital. they will be assigned randomly into 3 groups, each group will receive certain type of cervical mobilization. the outcome measures will be measured before, immediate, 10 minutes, and 30 minutes after treatment

Eligibility Criteria:
Inclusion Criteria:

* patients will be included if they have rotator cuff tendinitis

Exclusion Criteria:

* Patients will be excluded if they had recent neck trauma or acute whiplash disorder ,any intra articular injection in the gleno-humeral joint during last three months, patients with musculoskeletal disorder (any type of fracture), any history of surgery on that shoulder and tendon calcification, cervical rib, rotator cuff tear.
A Comparison of the Effectiveness of Two Types of Myofunctional Appliances

A randomized clinical trial is set out to compare the effectiveness of two types of functional appliances in the correction of a Class II malocclusion. (Class II malocclusions are where upper front teeth bite significantly further forward in relation to lower front teeth).

It is a multicenter randomized clinical trial with two arms parallel group. The patients will be randomly divided into two groups, group one: Myobrace appliance will be used while, and group two Twin-block appliances will be used. Cephalometric x-ray will be taken before starting the treatment (T1) and at the end of treatment (T2) at 9 months. The effectiveness of the two appliances will be assessed and measured comparing the difference in the cephalometric X-ray before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Growing children who need myofunctional appliance.
2. Cl II div. 1 malocclusion.
3. No previous orthodontic or orthopaedic treatments.

Exclusion Criteria:

1. Patients with systemic involvement.
2. Congenital malformations such as cleft lip and palate.
3. Facial deformities.
4. Finger sucking habit will be excluded