cyrilzakka/clinical-trials huggingface dataset:
Dolutegravir/Lamivudine Dual Therapy for ART-naïve People With HIV and TB Receiving Rifampin-based TB Treatment

This will be a Phase IIIb Clinical Trial, an international multicenter, randomized, three-arm, non-comparative trial of efficacy, safety, and tolerability of the dual therapy regimen dolutegravir plus lamivudine either twice daily or DTG/3TC ( Dovato) in the morning +dolutegravir (DTG) in the evening, versus standard of care (SOC) twice-daily dolutegravir plus 2 once-daily Nucleoside reverse-transcriptase inhibitors (NRTIs) tenofovir disoproxil fumarate /lamivudine (TDF/3TC), among antiretroviral therapy (ART)-nave individuals with HIV-1 receiving rifampin-based TB therapy

Tuberculosis (TB) is the most common cause of death in people with HIV worldwide. Among patients with HIV, the incidence of TB per year is about 5-10%. The two diseases are now always treated concurrently in co-infected individuals, as there is a survival benefit for starting antiretroviral therapy (ART) soon after TB treatment initiation. Current Brazilian guidelines suggest that for patients with a cluster of differentiation 4 (CD4) \< 50, ART should be started within 2 weeks of starting TB treatment; for patients with a CD4\>50, ART should be started within 2 months of starting TB treatment. World Health Organization guidelines suggest ART initiation within 2 weeks of TB diagnosis regardless of CD4 count (provided there are no signs of TB meningitis), but most programs defer ART until 6-8 weeks in patients with CD4 \>50 to reduce the risk of immune reconstitution inflammatory syndrome (IRIS).

The option of dual therapy for HIV (i.e., complete regimens to treat HIV composed of only 2 drugs) is of increasing interest and can lower costs for patients, payors, and programs while lowering cumulative lifetime exposure to ART (with potential resultant lessened burden of cumulative toxicities) and maintaining high antiviral efficacy. Based on the GEMINI, TANGO, and SALSA clinical trials, a regimen of 50 milligram (mg) DTG combined with 300mg lamivudine (3TC) has been shown to be a highly effective stand-alone option for the treatment of HIV-1 in ART treatment-naïve or virologically suppressed individuals through 48 weeks (SALSA) and 144 weeks (GEMINI and TANGO).

Eligibility Criteria:
Inclusion Criteria:

* Documentation of HIV-1 status: HIV-1 infection, documented by any licensed rapid HIV test or HIV-1 enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, or plasma HIV 1 RNA viral load. Two or more HIV-1 RNA viral loads of \>1,000 copies/mL are also acceptable as documentation of HIV-1 infection.
* CD4+ cell count ≥50 cells/mm3 obtained within 30 days prior to study entry
* HIV-1 viral load ≥1000 copies/mL
* ART-naïve.
* Documentation of pulmonary TB

Exclusion Criteria:

* Pregnant, or plans to become pregnant.
Retigabine Efficacy and Safety Trial for Partial Onset Refractory Seizures in Epilepsy

This Phase 3 study is being conducted to evaluate the efficacy and safety of retigabine dosed at 900 mg/day and 600 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are receiving up to three established antiepileptic drugs (AEDs).

This Phase 3 study is being conducted in Europe, Israel, Australia, and South Africa to evaluate the efficacy and safety of retigabine dosed at 900 mg/day and 600 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are receiving up to three established antiepileptic drugs (AEDs). The primary objective is to demonstrate a superior change in total partial seizure frequency for four weeks from baseline to the double-blind period. The proportion of responders (greater than or equal to 50% reduction in seizure frequency for four weeks from baseline to the double-blind period) will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of refractory epilepsy with simple or complex partial onset seizures with or without secondary generalization
* 28-day partial seizure frequency rate of four or more partial seizures over the 8-week baseline phase
* Currently treated with up to three established AEDs
* Vagal Nerve Stimulator may be included

Exclusion Criteria:

* Existing medical or psychiatric condition which could affect patient's health or compromise ability to participate in the study
* Clinically significant abnormalities on physical exam, vital signs, ECG, or liver function tests
* Impaired renal function (creatinine clearance less than 50 mL/minute)
* Evidence of progressive central nervous disease, lesion, or encephalopathy
* History of primary generalized seizures
* History of clustering or flurries or status epilepticus within 12 months of study entry
Does Training on a Virtual Reality Bronchoscopy Simulator Improve Performance of Bronchoscopic Intubation in Patients?

The aim of the study is to study whether training by residents or anesthesia assistants, on a recently introduced virtual-reality bronchoscopic simulator (ORSIM) improves performance of fiberoptic intubation in patients.

Traditionally, fiber optic bronchoscopy (FOB) intubation has been taught in a see one, do one basis. Modern training method in skill acquisition involves the use of simulators. Recently a portable, computer based, bronchoscopic simulator (ORSIM) was developed. The investigators hypothesized that operators trained with the ORSIM simulator will be more proficient in performing asleep FOB intubation than those trained with didactic teaching alone.

This randomized trial involves 34 consented residents or anesthesia assistants (AAs). In preparation, each consented person will view a teaching video of FOB intubation and tips. They will then perform an asleep FOBI in the OR under a staff anesthesiologist's supervision who's familiar with the study. Those who are randomized to the ORSIM group with undergo simulator training of 30-60 min. Those in the Didactic group will not undergo further training. Within about a week, the resident/AA will perform another asleep FOB intubation.

The study results will impact on how FOB intubation will be taught effectively in the future.

Eligibility Criteria:
Inclusion Criteria:

Subject:

* anesthesia/surgery/emergency/critical care residents or anesthesia assistants who have performed less than 5 Fiberoptic intubations

Exclusion Criteria:

* experience with bronchoscopy simulator or 5 or more FOB intubations

Patient:

* Anticipated difficult airway
* Mallampati Grade (MPG) \>III
* Body Mass Index (BMI) \>30
Aspirin and Thienopyridine Resistance in Peripheral Arterial Disease

This study evaluates the effects of Aspirin and thienopyridine resistance in relation to clinical cardiovascular outcomes as the genetic predictors of, and outcomes associated with aspirin and thienopyridine resistance in patients with peripheral arterial disease (PAD) currently remain unknown.

Although anti-platelet therapy is a cornerstone of PAD treatment, the investigators know very little about the prevalence, genetic determinants and clinical relevance of aspirin and thienopyridine resistance in PAD patients. The investigators expect to report on the prevalence of, and impact on outcomes from aspirin and/or thienopyridine (eg. clopidogrel) resistance, in patients who undergo peripheral arterial angiography/interventions (including carotid angiography/interventions) and operations. This study will provide important information on the utility of testing for aspirin and thienopyridine resistance and improve understanding of the genetic and pathophysiologic basis of anti-platelet therapy resistance in patients with cardiovascular disease, including PAD. Most importantly, this study will serve as the basis for a subsequent randomized prospective trial of different treatment options in PAD patients with aspirin/thienopyridine resistance.

Eligibility Criteria:
Inclusion Criteria:

* patient undergoing PAD (carotid or lower extremity) angiography or intervention
* greater than or equal to 18 years of age

Exclusion Criteria:

* patient unable to take aspirin and thienopyridine for any reason (not excluded if take at least one of either medication)
* hematocrit less than or equal to 30%
* hematocrit greater than or equal to 52%
A Study of DC-CIK to Treat Hepatocellular Carcinoma

The purpose of this study is to evaluate the efficacy of Dendritic and Cytokine-induced Killer Cells (DC-CIK) for hepatocellular carcinoma (HCC).

About 60 patients with HCC, who had received complete resection or TACE and got Complete remission (CR) or partial response (PR), will be randomly divided into group A (receive DC-CIK treatment) or group B (just regularly follow up), and the randomize ratio will be 1:1. Patients in group A will receive 2-3 cycles of DC-CIK cells treatment (every 4 weeks). Patients in group B will have no anti-tumor therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients \> 18 years of age;
2. Hepatocellular carcinoma with histological or imaging and AFP diagnose, and had received complete resection or TACE and got CR or PR by imaging studies;
3. Patients who have a life expectancy of at least 12 weeks;
4. Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1;
5. The bone marrow functioned normally (WBC \> 4.0×109/L, Hb \> 120 g/L, PLT \> 100×109/L);
6. The ECG results were normal, and the liver and kidney were functional.

Exclusion Criteria:

1. Patients who had distant metastases;
2. Patients with uncontrolled infection; underlying disease that was severe or life-threatening;
3. Patients who were pregnant or lactating;
4. ECOG perform status ≥ 2;
5. Patients who are suffering from auto immune diseases or patients who need to accept glucocorticoid treatment.
Radiation Therapy, Plasma Exchange, and Immunotherapy (Pembrolizumab or Nivolumab) for the Treatment of Melanoma

This early phase I trial investigates how well radiation therapy, plasma exchange, and pembrolizumab or nivolumab work in treating patients with melanoma. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Plasma exchange (also known as "plasmapheresis") is a way to "clean" or "flush out" the blood. Immunotherapy with monoclonal antibodies, such as pembrolizumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Plasma exchange may help to improve the effect of standard radiation therapy and immunotherapy treatment on tumor cells of patients with melanoma.

PRIMARY OBJECTIVE:

I. To determine the kinetics of soluble (s)PD-L1 removal and regeneration by plasma exchange in patients with melanoma.

SECONDARY OBJECTIVES:

I. To observe response at 3 months after plasma exchange plus immunotherapy. II. To observe ongoing response at approximate 3 month intervals after plasma exchange plus immunotherapy.

CORRELATIVE RESEARCH OBJECTIVES:

I. To determine the effects of plasma exchange on immune cell function. II. To observe the kinetics of extracellular vesicles (EVs) after plasma exchange in patients with melanoma.

OUTLINE:

Patients undergo radiation therapy daily on days 1-5 (weekdays). Patients then undergo therapeutic plasma exchange over 1-2 hours on the first session starting on the last day of radiation therapy and the last session ending prior to immunotherapy. Beginning day 5, patients receive pembrolizumab intravenously (IV) or nivolumab IV. Treatment with pembrolizumab continues every 3 weeks or treatment with nivolumab continues every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study and standard of care (SOC) computed tomography (CT), positron emission tomography (PET), and/or magnetic resonance imaging (MRI) scans as clinically indicated during follow-up.

After completion of study treatment, patients are followed up at 3 weeks and then for up to 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Histological confirmation of melanoma. Patients may have completed biopsy outside of Mayo Clinic, but there must be an internal review done to confirm diagnosis prior to confirming eligibility
* Measurable or non-measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\< 3
* sPD-L1 levels \> 1.7 ng/ml by enzyme-linked immunosorbent assay (ELISA)
* Negative pregnancy test done =\< 7 days prior to radiation therapy, for women of childbearing potential only
* Provide written informed consent
* Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
* Willing to provide blood samples for correlative research purposes

Exclusion Criteria:

* Persons taking a biotin supplement
* sPD-L1 level \< 1.7 ng/ml by ELISA
* Pregnant or nursing women
* Men or women of childbearing potential who are unwilling to employ adequate contraception
Long Term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101

This was a long-term follow-up study of participants who completed Kythera-sponsored trials of ATX-101 (06-03, 07-07, 09-15)

No study medication was administered in this study.

Eligibility Criteria:
Inclusion Criteria:

* Any subject who successfully completed a Kythera-sponsored clinical trial of ATX-101 (06-03, 07-07, 09-15)
* Signed informed consent
* Willingness to comply with schedule and procedures of the study

Exclusion Criteria:

* Subjects who have had or are undergoing treatment that may affect the evaluation of the submental area will be excluded
Mechanical Modalities vs. Standard Care for Edema and Pain Management After DRF Fixation

This single-blinded, randomized controlled trial (RCT) will evaluate the added benefit of mechanical modalities (continuous passive motion (CPM) and intermittent pneumatic compression (IPC)) when integrated into standard therapy for managing postoperative edema and pain in patients undergoing distal radius fracture (DRF) fixation. The primary outcomes are edema volume (measured via volumeter) and pain intensity (Numeric Pain Rating Scale, NPRS) at 6 weeks post-operation. Secondary outcomes include wrist/forearm range of motion (ROM), grip strength, Patient-Rated Wrist Evaluation (PRWE), and adverse events.


Eligibility Criteria:
Inclusion Criteria:

Adults aged 18 years or older. Undergoing surgical treatment for distal radius fracture with stable internal fixation.

Able to initiate formal rehabilitation approximately 2 weeks postoperatively. Willing and able to attend in-clinic therapy sessions at the outpatient hand therapy center.

Exclusion Criteria:

Unstable fixation or need for further surgical intervention. Pre-existing conditions that would significantly affect upper limb function (e.g., severe arthritis, neurological disorders).

History of skin conditions or allergies that contraindicate the use of mechanical devices.

Any contraindication to mechanical modalities (for example, severe peripheral vascular disease).

Inability to comply with study procedures or follow-up visits. Pregnant or breastfeeding individuals.
The Effect of Caffeine in Elderly Citizen Following Eight Hour Abstinence From Caffeine Containing Drinks & Foods

The study investigated the effect of caffeine on physical performance in healthy citizens aged over 70 years following eight hours of abstinence from caffeine containing drinks and foods. The main hypothesis was that 6 mg/kg caffeine would improve cycling endurance at 65% of expected maximal heart rate.

It is well documented that caffeine ingestion increases the endurance of young people exercising at 60%-85% of their maximal oxygen uptake (13;15;47). It also seems to improve endurance as measured by repeated sub-maximal isometric contraction (42), and decreases the rate of perceived exertion during exercise (6;9;46). Typically, doses of approximately 6 mg/kg caffeine were used in these studies.

With a growing number of elderly with a physical active lifestyle and many elderly participating in rehabilitation programs the endurance enhancing effect of caffeine is of increasing interest in this age group. We therefore conducted a study of healthy 75 year old citizens to investigate whether 6 mg/kg caffeine improved physical performance and reduced the perceived effort during work in healthy citizens aged ≥ 70 years. The main hypothesis was that caffeine would improve cycling endurance at 65% of expected maximal heart rate. The study showed that compared to placebo caffeine increased endurance by 25 % (p\<0.0001) and isometric sub-maximal strength with 54 % (p\<0.0001), reduced perceived exertion after 5 minutes of biking by 11 % (p=0.002), but in 21 of 30 participants there was reduced postural stability (with eyes open). In the above described study participants abstained from caffeine containing drinks and foods for 48 hours prior to each test. Half of the participants reported withdrawal symptoms. Such a long caffeine abstinence period would infer with daily life for many people. We therefore invited the participants from the above study to a repetition of the above study to test whether similar results would be obtained if participants only abstained from caffeine containing drinks and foods for 8 hours prior to each test.

Eligibility Criteria:
Inclusion Criteria:

* Healthy elderly individuals aged over 70 years (Primarily those who previously have participated in an identical study with 48 hour caffeine abstinence)

Exclusion Criteria:

* Dementia or invalidating psychiatric disease
* General debility, angina, or other diseases that would render participation in the test program impossible
* Treatment with beta receptor blocking drugs, calcium-channel blocking drugs, digitalis, or nitroglycerine
* Acute disease and injury
* Diabetes
* Conditions that would contraindicate caffeine ingestion or participation in the test program
* Treatment with medication that interacts with caffeine
* Ingestion of caffeine containing drinks and foods 8 hours before each session
Study of the Treatment of Burn Wounds With Antimicrobial Topical Soaks

Determine effectiveness of various antimicrobial solutions on burn wounds (infections, wound healing, length of hospital stay).

Patients were treated with both Sulfamylon soaks and Silver nitrate soaks on different burn areas. These two areas were then compared for incidence (percentage) of infections.

Eligibility Criteria:
Inclusion Criteria:

* Burn Injury requiring excisional therapy
* Hospitalization required until wounds are closed

Exclusion Criteria:

* Known hypersensitivity to products
* Outpatient treatment for burn injury
The Analgesic Effect of Transversus Abdominis Plane (TAP) Block Following Radical Prostatectomy

This study is conducted to evaluate different analgesic treatments effect following operation where the prostate gland is surgically removed.

The different treatments the investigators wish to investigate is:

1. Transversus Abdominis Plane (TAP) block.

   The TAP block is a rather new method, where a local anaesthetic is deposited between the two inner abdominal muscles. Between these muscles, the nerves that innervates the anterior part of the abdominal wall is situated.
2. Wound infiltration

   In this method you deposit a local anaesthetic in the edges of the wound.
3. Placebo

No active local treatment is given.

All patients who wish to participate will be allocated to one of three different treatment groups.

Group 1:

Will receive TAP block with a local anaesthetic and wound infiltration with saline.

Group 2:

Will receive wound infiltration with a local anaesthetic and TAP block with saline.

Group 3:

Will receive TAP block with saline and wound infiltration with saline.

Beside this local treatment all patients will be given systemic Paracetamol (tablet) and Ibuprofen (tablet).

In addition all patients will be given a pump containing morphine. The pump is connected to a button which the patient can activate when they experience pain. This enables the patient to control how much morphine he needs, following the operation.

The hypothesis is that the TAP block is superior in reducing pain and thereby reducing morphine consumption compared to wound infiltration and placebo.


Eligibility Criteria:
Inclusion Criteria:

* BMI \> 18 and \< 35
* Patients who have given their informed consent and have fully understood the nature and limitations of the study
* Patient who is planned for radical prostatectomy

Exclusion Criteria:

* Not able to cooperate to complete the study
* Is not able to speak and understand danish
* Allergy towards the drugs which is used in the study
* Daily use of strong opioids
* Infection at the injection area
The Effect of Ethnic on Moxifloxacin Induced QT Interval Prolongation in Korean and Japanese Healthy Subjects

The Effect of Ethnic on Moxifloxacin Induced QT Interval Prolongation in Korean and Japanese Healthy Subjects

The purpose of this study is to explore the ethnic and gender difference in the Moxifloxacin induced QT interval prolongation between Japanese and Korean subjects.

Eligibility Criteria:
Inclusion Criteria:

- 1) Subjects in Japan and Korea deemed healthy as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, or clinical laboratory determinations.

2) Body Mass Index (BMI) of 17.6 to 26.4 kg/m2, BMI = weight (kg)/ \[height (m)\]2.

Exclusion Criteria:

* 1) Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population.

  2) Any of the following on 12-lead ECG prior to study drug administration, confirmed by repeat.
* Heart rate ≤ 45 bpmmsec or Heart rate ≥ 100 bpmmsec
* PR ≥ 210 msec
* QRS ≥ 120 msec
* QT ≥ 500 msec
* QTcF: male ≥ 450 msec, female ≥470msec
* Iincomplete right bundle branch block
* Marked Sinus Arrhythmia
* Wondering pacemaker
* Atrial rhythm
Romanian Entropy Clinical Study Network

The critically ill patient is one of the most complex cases with regard to the optimization of the anesthesia, as well as postoperative management. One of the most important steps in the complex management of such patients is the modulation of anesthesia for every patient needs. We start with the assumptions that the optimization of anesthesia should depend on each patient, being conducted in an individual manner. We also believe that by individualizing the anesthesia by monitoring the entropy it is possible to obtain an appropriate management regarding hemodynamic complications during anesthesia including tachycardia, bradycardia, hypotension and hypertension.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I, II, III;
* written consent accepted to be enrolled in the study; in polytrauma patients in the operation theatre who are brought directly through the emergency department, written consent is obtained from the relatives, in accordance to the national law number 206, of 2004, for a good and correct scientific research, in the situation where the patient is no capable to sign or give the written consent;

Exclusion Criteria:

* cardiac pacemaker;
* atrial fibrillation at the time of presentation in the operation theatre;
* any subject with epidural catheter, placed pre-operatively;
* allergy to Propofol or another anesthetic drugs;
* pregnancy;
* presence of neuromuscular disease;
* presence of neurologic disease;