cyrilzakka/clinical-trials huggingface dataset:
The Efficacy and Safety of the Combination of Tamsulosin and Tadalafil in Men With Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia and Erectile Dysfunction

The efficacy and safety of the combination of tamsulosin and tadalafil in men with lower urinary tract symptoms due to benign prostatic hyperplasia and Erectile Dysfunction: a randomized, double blinded, parallel design, active controlled, multi-center, phase 3 clinical trial


Eligibility Criteria:
Inclusion Criteria:

Visit1

* Male aged 45 years old or older
* Subjects who have PSA ≤ 4.0 ng/mL Visit2
* Subjects who have Total IPSS score ≥ 13
* Subjects who have IIEF-EF domain ≤ 24 and each point below 3 in question 3 and 4

Exclusion Criteria:

* Subjects who have hypersensitivity to investigational product or sulfa medications
FTIH Study of ECC0509 in Healthy Volunteers

A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single And Multiple Ascending Dose, First-Time-In-Human Study to Assess The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ECC0509 in Healthy Volunteers.

This study will be conducted in up to seven cohorts of Single Ascending Dose (SAD) \&amp; 3 cohorts of Multiple Ascending Dose (MAD). SAD will consist of a staggered dosing approach with a dose range from 1mg to 80mg. Staggered dosing approach will not be deployed for MAD cohorts with a dose range of 8mg to 40mg. In the MAD cohort, the effect of food will also be assessed by comparing the PK profile of Day 10 fed conditions against Day 14 fasted conditions.

Eligibility Criteria:
Key Inclusion Criteria:

1. Healthy male or non-childbearing potential female
2. Age ≥18 and ≤65 years old
3. BMI ≥18.0 and ≤32.0 kg/m2
4. Male participants agree to use contraception
5. No clinically significant abnormal findings in physical examination, 12-lead electrocardiogram (ECG), laboratory tests, or medical history
6. Able to understand and sign informed consent

Key Exclusion Criteria:

1. Significant allergic reactions to any drug.
2. History of significant drug abuse or alcohol abuse within 1 year prior to screening
3. Concomitant participation in any investigational study of any nature
4. Use of any concomitant medication except for the occasional use of acetaminophen (up to 2 g daily)
5. Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to dosing.
6. Any clinically significant abnormal findings in the participant's physical examination, laboratory tests, pregnancy test, urine drug screen, alcohol breath test, or medical history which, in the opinion of the Investigator, would prevent the subject from participating in the study.
Efficacy, Safety and Immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in Neonates

This phase III trial aims to assess the efficacy, safety and immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in neonates, lot-to-lot consistency, and antigen interference with co-administered EPI vaccines

This study is a randomized, double-blind, placebo-controlled study to investigate the efficacy, safety and immunogenicity following three doses of rotavirus RV3 vaccine (Bio Farma) administered as a neonatal schedule

Eligibility Criteria:
Inclusion Criteria:

1. Neonate 0-5 days (0-144 hours) of age at the time of first dose.
2. Neonate is in good health as determined by clinical judgment, including a medical history and physical exam, which confirms the absence of a current or past disease state considered significant by the investigator.
3. The neonate was born full term (minimum of 37 completed weeks and maximum of 42 completed weeks gestation).
4. Neonate birth weight 2500-4000 g inclusive.
5. Parent or guardian has been informed properly regarding the study and signed the informed consent form.
6. Parent or guardian commits to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria:

1. Subject concomitantly enrolled or scheduled to be enrolled in another trial.
2. The subject has direct relatives relationship with the study team.
3. The subject has evolving mild, moderate or severe illness, especially infectious diseases or fever (body temperature 37.5°C) within the 48 hours preceding enrollment.
4. Subject with a known or suspected history of allergy to any component of the vaccines (based on anamnesis).
5. Subject with a biological mother with a known or suspected human immunodeficiency virus (HIV) or Hepatitis B infection.
6. Subject with known or suspected major congenital malformations or genetically determined disease.
7. Subject with intussusception.
8. Subject with a known or suspected disease of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy.
9. Subject with a known or suspected disease of the immune system or those who have received immunosuppressive therapy, including immunosuppressive courses of systemic corticosteroid.
10. Subject who have ever received any blood products, including immunoglobulin, or for whom receipt of any blood product is anticipated during the course of study.
11. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
12. Subject immunized with non-EPI vaccines.
13. Gastroenteritis in the 24 hours preceding dosing (temporary exclusion criteria).
14. Subject planning to move from the study area before the end of the study period.
Efficacy and Safety of a Dolutegravir-based Regimen for the Initial Management of HIV Infected Adults in Resource-limited Settings

Several reports indicate that treatment failure due to HIV resistance or to adverse event-related discontinuation could compromise the effectiveness of scaling-up antiretroviral treatment (ART), especially when lack of access to viral load is a concern. Combined with other nucleoside reverse transcriptase inhibitor, Dolutegravir (DTG) is a very promising alternative to the current first-line non nucleoside reverse transcriptase inhibitor-based regimens.

Initial evaluations of DTG conducted in high income countries showed excellent efficacy and safety and indicated high genetic barrier thus preserving second line treatment. As a consequence, DTG-based regimens have been recently included in the first-line options in the national guidelines for ART of several high-income countries. However, the clinical trials evaluating DTG-based regimens have been conducted in highly controlled conditions, including baseline resistance testing and regular viral load monitoring. Moreover, these trials included a high proportion of men with rare co-morbidities.

There is need to evaluate how a DTG-based regimen will perform in real-world conditions within resources-constrained settings, where viral load monitoring is limited, and where the majority of HIV patients are women with important family planning consideration and NAMSAL trial is a randomized clinical trial which aims to evaluate efficacy and safety over 48, 96 and 192 weeks of DTG + tenofovir disoproxil fumarate/lamivudine versus Efavirenz (EFV) + tenofovir disoproxil fumarate/lamivudine in 606 ART-naïve HIV-1-infected adults in Cameroon. A set of efficacy and safety endpoints will be compared over 48, 96 and 192 weeks between the two arms including the proportion of patients with viral load \<50 copies/mL and incidence of severe adverse events.


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infected
* Age ≥ 18 years
* Abtiretroviral-naïve, including above 7 days of cumulative prior antiretroviral therapy at any time prior to study entry.
* For women of childbearing potential: acceptance to use effective contraceptive methods
* Provision of written informed consent

Exclusion Criteria:

* Infection with HIV-1 group O, N, P
* Infection or co-infection with HIV-2
* Absolute neutrophil count (ANC) \< 500 cells/mm3
* Hemoglobin \< 7.0 g/dL
* Platelet count \< 50,000 cells/mm3
* AST and/or ALT \> 5 x Upper Limit of Normal (ULN)
* Calculated creatinine clearance \< 50 mL/min
* Active opportunistic or severe disease not under adequate control
* For women of childbearing age : Pregnancy/breastfeeding
* History or presence of allergy and/or contraindications to the trial drugs or their components
* Severe psychiatric illness
* Severe hepatic failure Patients co-infected with tuberculosis (TB), receiving a TB treatment and with stable clinical condition will not be excluded.
Nutritional Treatment for the Amelioration of Traumatic Brain Injury

To test the feasibility of administering a commercially available neurotrophic oral nutritional supplement (ONS) for adult patients with acute traumatic brain injury at the Royal London Hospital.

The study will be a randomised controlled non-blinded trial of adult patients with acute traumatic brain injury at the Royal London Hospital.

There will be randomisation to one of two non-blinded trial groups:

1. Usual standard NHS care (control group)
2. Usual standard NHS care plus daily oral dose of Souvenaid® ONS

The trial protocol will commence between 3-7 days after admission. The trial timeline provides a summary of intervention and assessments.

The trial will last 12 months. The first 6 months will be the formal trial with two groups and follow up assessments. This will be performed on intention to treat basis. After this initial phase the investigators will provide an opportunity for all participants from either group (control or treatment) to take Souvenaid® ONS for a further 6 months with a clinical follow up appointment.

Eligibility Criteria:
Inclusion Criteria:

* Adult between 18 yrs and 80 yrs of age
* Acute traumatic brain injury with confirmed radiological features

Exclusion Criteria:

* Allergies to fish oil/milk/soya
* Medical history of galactosaemia
* Non-traumatic aetiology to head injury
* Unable to receive enteral nutrition
* Craniectomy during admission (loss of integrity of skull convexity)
* Concurrent active neurological disease
* Pregnancy or breastfeeding
Tiotropium 18ug Inhalation Capsule Using a Handihaler® Among Korean COPD Patients

This is a descriptive observational open non-comparative study of the safety and efficacy of tiotropium inhalation capsule given at 18mcg once a day for 30 days among Korean patients with COPD. At Visit 1, patients who are diagnosed as COPD will be prescribed tiotropium inhalation capsule at 18mcg once daily (at the same time). Patients' FEV1 will be assessed before start of treatment (Visit 1) and at the end of the 30 day treatment period (Visit 2). Occurrence of adverse events will also be asked from the patient at the end of the 30 day treatment period. Patients will be informed by the attending physicians to immediately report the occurrence of serious adverse events.

Study Design:

Eligibility Criteria:
Inclusion Criteria:

Older than 40 years old Diagnosed as COPD No Previous Spiriva administration No Contraindication for Spiriva according to the product label

Exclusion Criteria:

patients with history of hypersensitivity to atropine and its derivatives (e.g. ipratropium oxitropium or any component of this product).
Pain Clinic Staff Harassed by Patients Pre/Post COVID

Chronic pain may cause psychological or behavioral problems. Chronic pain patients occasionally harass the pain care providers. The COVID-19 pandemic caused major stress for the general population.

Quantitative and qualitative analysis of prospective electronic and clinic diary data. Evaluation of incidents of clinic staff harassment; caused by patients, before and during COVID pandemic. Analysis of causative factors, incident outcome and lessons learned.

Chronic pain may be complicated by mental disease. Some patients have behavioral disorders and occasionally harass the pain care providers. The COVID-19 pandemic caused significant stress for the general population. The stress of the pandemic may aggravate the psychological dysfunction in chronic pain patients.

This is a quantitative and qualitative analysis of prospective electronic and clinic diary data. It is an evaluation of incidents of pain clinic staff harassment; caused by patients, before and during the COVID pandemic. This is an analysis of incident causative factors, incident outcomes, systemic factors and lessons learned. The qualitative information of each incident is presented in a sensitive and careful format.

Eligibility Criteria:
Inclusion Criteria:

* adult chronic pain patients

Exclusion Criteria:

* pediatric chronic pain patients
The Purpose of This Study is to Determine Whether Topical Application of PEP005 is Safe for the Treatment of Common Wart(s)

Verruca vulgaris, otherwise known as the common wart, is caused by the human papillomavirus (HPV). Common warts are generally located on the hands and feet, but can also occur elsewhere (e.g., any areas of frequent contact). Common warts have a characteristic cauliflower-like surface, are typically slightly raised above the surrounding skin and are generally diagnosed by visual inspection.The treatment of warts poses a therapeutic challenge for physicians. No single therapy has been proven effective at achieving complete remission in every patient.This study will aim to evaluate an up-to a three-day course of therapy with 0.05% PEP005 Topical Gel.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients at least 18 years of age.
* A clinically diagnosed, single common cutaneous viral wart (verruca vulgaris) on the dorsal hand.
* Written informed consent has been obtained.
* Agreement from the patient to allow photographs of the common wart(s) treatment area to be taken and used as part of the study package.
Mindfulness Intervention to Study the Neurobiology of Depression

The Pediatric Mood Disorders Program at the University of Illinois at Chicago is conducting a research study examining how mindfulness can help teenagers stay healthy and prevent depression relapse.

Study involves:

* Brain scan using fMRI technology
* Questions about mood and behavior
* Meeting with a clinician
* Possibility of 8 weekly treatment sessions using mindfulness
* Ongoing assessment of depression for next 2 years

Eligible participants will be compensated for their time.

Eligibility Criteria:
Inclusion Criteria:

* between the ages of 12 and 18
* history of major depressive disorder

Exclusion Criteria:

* braces
* afraid of small spaces
Connected Health Care in Exercise Program for Obesity

Many kinds of wearable technology have become available, but the superiority of those devices in weight loss compared to the standard care without them is uncertain. The possible problems are long-term self-motivation, utility and validity of the device, and outcome measures in clinical trials. The connected health care with motivational interviewing as an intervention, and body composition parameters in addition to body weight as outcome measures are employed in the project. The expected outcome is that connected health care, which is more individualized approach by heath care professionals, is more effective compared to self-monitoring using wearable devices. Two types of wearable device are going to be used to monitor 1) body activity and 2) heart rate variables during exercise which reflect fitness level in this study in order to investigate appropriate monitoring parameters to predict outcome measures.

The hypothesis is that addition of connected health system will result in improvement of body composition and fitness level compared to self-monitoring.

Patients with age 18 to 59 years old and body mass index between 30 to 39.9 are to be enrolled at Mayo Clinic in Arizona. All enrolled subjects receive wearable monitoring devices with remote tracking capability and brochure regarding nutrition and physical exercise with basic instruction. Subjects are randomly assigned to connected health care group versus self-monitoring group. Connected health care group will have 2 interviews about physical exercise and 6 communications with individualized instruction and counseling of their exercise including the usage of the monitoring devices. Self-monitoring group will do physical exercise following the initial basic instruction and self-monitor them.

All subjects visit Mayo Clinic to get outcome measures at 0, 12, and 24weeks. Outcome measures will be compared before, at 12 weeks, and after the 24 weeks of the fitness program.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index of 30 to \<40 kg/m\^2

Exclusion Criteria:

* End of organ damage from hypertension
* Diabetes
* Liver disease
* Chronic lung disease
* Neuromuscular disease
* Any conditions that limit exercise
* Currently involved in other weight program
Effect of Camel Milk on Chronic Hepatitis C

Camel milk as the new modality for treatment of chronic hepatitis C. The purpose of this study is to evaluate effectiveness and safety of camel milk in combination with Peginterferon Alfa-2a and Ribavirin in genotype 2,3 chronic hepatitis C virus .

The investigators enrolled 40 patients into the study. Group 1(Intervention ) : received PEGASYS( Peginterferon ) One subcutaneous injection containing 0.5 ml solution with180 mcg per week plus COPEGUS( Ribavirin ) tablets (body-weight adjusted dose: \< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily and 250 ml of raw camel milk will be consumed in 10 minutes orally twice daily for 12 weeks.

Group 2 ( control ): received PEGASYS( Peginterferon ) One subcutaneous injection containing 0.5 ml solution with180 mcg per week plus COPEGUS( Ribavirin ) tablets (body-weight adjusted dose: \< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily for 12 weeks.

Follow up period is 1,2,3 months after treatment. The patients are visited every 4 weeks with biochemistry lab tests. The patients are checked with quantitative HCV RNA (Ribonucleic Acid) on the first months after initiation of the treatment to assess early virologic response and at the end of the study for complete response rate and on the third month after treatment completion for sustained response rate. The patients with undetectable HCV RNA are considered as responders.

Eligibility Criteria:
Inclusion Criteria:

* HCV (hepatitis C virus ) RNA positive
* Age age groups (18 to 70 years)

Exclusion Criteria:

* Ongoing pregnancy or breast feeding
* Hx of HCC(hepatocellular carcinoma )
* Hx of alcoholic liver disease
* Hx of bleeding from esophageal varices
* Hx of hemochromatosis
* Hx of autoimmune hepatitis
* Hx of Suicidal attempt
* Hx of cerebrovascular dis
* Hx of severe retinopathy
* Hx of severe psoriasis
* Hx of scleroderma
* Hx of metabolic liver disease
* Hx of SLE(systemic lupus erythematosus )
Effectiveness of Intravenous Tranexamic Acid in Reducing Blood Loss During and After Cesarean Section

In this study, the efficacy and safety of tranexamic acid in the reducing the blood loss during and after elective LSCS will be investigated.

To state the effectiveness clinically and laboratory and safety of tranexamic acid in reducing blood loss during and after the elective lower segment cesarean section.

Eligibility Criteria:
Inclusion Criteria:

* - Women undergoing caesarean delivery for various elective indications.
* Full term primiparas / multiparas.
* Singleton pregnancy being delivered by LSCS.

Exclusion Criteria:

* - Medical problems involving the heart, liver, kidney and brain .
* Blood disorders.
* Allergy to tranexamic acid.
* History of thromboembolic disorders, abnormal placentation, severe pre-eclampsia, uterine anomalies and pathology.
* Multiple pregnancy, macrosomia.
* Polyhydromnios .
* Patients requiring blood transfusion due to anemia
Reduced Volume of Neck Prophylactic Irradiation in Nasopharyngeal Carcinoma

This is a multi-center, non-inferiority, open-label, randomized controlled phase III clinical trial in primary diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. The purpose of this study is to evaluate the efficacy of reduced neck prophylactic radiotherapy versus conventional neck prophylactic radiotherapy, and compare the radiotherapy-related adverse events and quality of life in two groups.


Eligibility Criteria:
Inclusion Criteria:

* Newly histologic diagnosis of nasopharyngeal non-keratinizing carcinoma (WHO II/III);
* All genders, range from 18-70 years old;
* ECOG score 0-1;
* Clinical stage I-IVa (AJCC/UICC 8th);
* Not received radiotherapy, chemotherapy and other anti-tumor treatment (including immunotherapy);
* No contraindications to chemotherapy or radiotherapy;
* Adequate organ function: white blood cell count ≥ 4×109/L, neutrophile granulocyte count ≥ 1.5×109/L, hemoglobin ≥ 9g/L, platelet count ≥ 100×109/L; alanine aminotransferase or aspartate aminotransferase \< 2.5×upper limit of normal; blood urea nitrogen or creatinine ≤ 1.5×upper limit of normal or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
* Sign the consent form.

Exclusion Criteria:

* Neck lymph nodes exist skipping metastasis;
* Distant metastases;
* Keratinized squamous cell carcinoma or basal cell like squamous cell carcinoma;
* Have or are suffering from other malignant tumors;
* Participating in other clinical trials;
* Pregnancy or lactation;
* Have uncontrolled cardiovascular disease;
* Severe complication, eg, uncontrolled hypertension;
* Mental disorder;
* Drug or alcohol addition;
* Do not have full capacity for civil acts.
The Use of Brazilian Green Propolis Extract (EPP-AF) in Patients Affected by COVID-19.

The COVID-19 pandemic is of grave concern due its impact on human health and on the economy. Propolis, a natural resin produced by bees from plant materials, has anti-inflammatory, immunomodulatory, anti-oxidant properties, and various aspects of the SARS-CoV-2 infection mechanism are potential targets for propolis compounds. Propolis components have inhibitory effects on the ACE2, TMPRSS2 and PAK1 signaling pathways; in addition, antiviral activity has been proven in vitro and in vivo. This is a pilot randomized study that aims to assess the impact of using Brazilian green propolis extract against the deleterious effects of the new coronavirus.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients;
* Positive RT-PCR for SARS-CoV-2;
* 18 Years and older.

Exclusion Criteria:

* Pregnant women;
* People with active cancer;
* Patients undergoing transplantation of solid organs or bone marrow or who use immunosuppressive medications;
* HIV carriers;
* Allergy to propolis or any of its components;
* Bacterial infection at randomization;
* Sepsis or septic shock before randomization;
* Patients unable to use medication orally or via nasoenteral tube;
* Patients with severe chronic liver disease (Child B or C);
* Patients with advanced heart failure;
Safety and Efficacy of Intravenous Ibuprofen for Treatment of Pain in Pediatric Patients Undergoing Tonsillectomy

The hypothesis is that a single, pre-operative dose of intravenous ibuprofen will significantly reduce post-operative fentanyl use compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

1. Patients between 6 and 17 years of age scheduled to undergo tonsillectomy.

Exclusion Criteria:

1. Have inadequate intravenous access
2. Patients with significant cognitive impairment
3. Active, clinically significant asthma
4. History of allergy or hypersensitivity to any component of intravenous ibuprofen, NSAIDs, aspirin (or related products), cyclooxygenase-2 inhibitors, or fentanyl.
5. Have a history of congenital bleeding diathesis (e.g. hemophilia) or any active clinically significant bleeding
6. Any child with obstructive sleep apnea, defined as an Apnea-Hypopnea Index of greater than or equal to 5.0
7. Have taken investigational drugs within 30 days before clinical trial material administration.
8. Inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board \[IRB\]) and agree to abide by the study restrictions. Surrogates will be needed for most patients.
9. Refusal to provide written authorization for use and disclosure of protected health information.
10. Be otherwise unsuitable for the study, in the opinion of the Investigator.