cyrilzakka/clinical-trials huggingface dataset:
PHAT Life: Peer Versus Adult-Led HIV Prevention for Juvenile Offenders

This application proposes a 2-arm randomized controlled trial comparing the impact of PHAT Life on 350 13-17 year-old offenders' risky sex, STI, substance use, and theoretical mediators when delivered by Youth Representatives (YR) vs. probation staff (PS). 100 facilitators will be recruited to deliver the intervention and participate in the research.

The main objectives of the proposed study are to compare the effectiveness, cost-effectiveness, and sustainability of Youth Representative-led vs. probation staff-led PHAT Life in a real-world juvenile probation setting. The Specific Aims of this study are:

1. To conduct a methodologically-rigorous 2-arm trial comparing the impact of PHAT Life on 350 13-17 year-old offenders' risky sex, STI, substance use, and theoretical mediators when delivered by Youth Representatives (YR) vs. probation staff (PS).
2. To compare the costs and cost-effectiveness of 100 YR-led vs. PS-led PHAT Life with respect to the acquisition of incident STI.

We hypothesize: (a) Compared to teens in PS-led groups, we expect teens in YR-led groups to report less risky sex and substance use at 6-month follow-up, to demonstrate greater improvement on theoretical mediators of risk, and to have fewer incident STI infections; (b) We expect YR-led PHAT Life to cost less and be more cost-effective than PS-led PHAT Life.

Eligibility Criteria:
Inclusion Criteria:

a) male or female gender; b) remanded to a probation program; c) 13-17 years old; d) adolescent is fluent in English; e) are not wards of the Department of Child and Family Services (DCFS); and f) they have not already received the PHAT Life intervention.

Exclusion Criteria:

a) are unable to understand the consent/assent process; b) do not speak English, because instruments are normed for English speakers; c) do not assent; d) legal guardians do not consent to teens' participation; e) are not 13 -17 years old; f) are not on probation or remanded to a probation program; g) are wards of the Department of Child and Family Services (DCFS); and h) they have already received the PHAT Life intervention.
The Effect of Pre-Operative Cryoneurolysis on Post-Operative Narcotic Consumption in Patients Undergoing Autograft ACL Reconstruction

The purpose of the research is to investigate the effect of preoperative Cryoneurolysis of the knee on postoperative pain management in patients undergoing autograft anterior cruciate ligament (ACL) reconstruction (a surgical procedure that makes a new ACL using the patient's own tendon). Cryoneurolysis is an approved process of applying extreme cold temperatures to targeted nerves in order to decrease or eliminate pain. . If you take part in the research, you will be randomly assigned (assigned by chance, like a flip of a coin) to Group A (standard care) or Group B (standard care plus Cryoneurolysis). Participants in both groups will undergo standard ACL reconstruction and receive standard preoperative and postoperative pain management. Participants in Group B only will also receive a standard treatment of Cryoneurolysis to their surgical knee within 7-10 days before their scheduled surgery. Participants in both groups (A \&amp; B) will be asked to bring their remaining postoperative pain medication to their postoperative follow-up appointments for review by study personnel. Participants will also be asked to complete a survey about their knee activity, function and symptoms at these appointments. Your time in the study will last until the completion of the 12-week postoperative follow-up appointment.


Eligibility Criteria:
Inclusion Criteria:

* - Patients aged 14 and over
* Patients who are patients within the PI's practice
* Patients who can speak and read English
* Patients undergoing autograft ACL reconstruction.
* Patients who are opioid naïve

Exclusion Criteria:

* - Under the age of 14
* Non-English speaking/reading patients
* Patients with Reynauds' syndrome
* Patients with skin disorders or hypo-vascularity
* Patients undergoing allograft ACL reconstruction.
* Patients who consistently use opioids preoperatively
TMI With HD Mel in ASCT for R/R Multiple Myeloma (BMT-03)

In this phase I trial, patients with relapsed or refractory multiple myeloma will receive standard autologous stem cell transplant conditioned with high dose melphalan. In addition to Melphalan, the conditioning will include targeted total marrow irradiation (TMI). This is a conventional 3+3 phase I trial with increasing doses of TMI from minimum 3Gy to Maximum 9Gy.

In this phase I trial, patients with relapsed or refractory multiple myeloma will receive standard high dose melphalan with autologous stem cell rescue. In addition the pre-transplant conditioning will include targeted total marrow irradiation (TMI). This conventional 3+3 phase I trial will increase the dose of TMI until the maximum tolerated dose (MTD) is reached. Initial patients enrolled will receive the lowest possible dose of 3Gy. Maximum dose will be 9Gy.

Eligibility Criteria:
Inclusion Criteria:

1. Patients meeting criteria for symptomatic myeloma
2. Patients who have progressive myeloma following initial induction (patients may have received any number of treatment regimens including prior autologous transplant)
3. Patient age 18-75 years at time of enrollment
4. Karnofsky performance status of ≥70
5. Cardiac function: LVEF \>40%
6. Hepatic: Bilirubin \<2x upper limit of normal and ALT and AST \< 2.5x the upper limit of normal
7. Renal: Creatinine clearance of \>30mL/min, estimated or calculated
8. Pulmonary: DLCO, FEV1, FVC \>50% of predicted (after correction for hemoglobin)

Exclusion Criteria:

1. Patients with diagnosis of plasma cell leukemia
2. Patients with truly non secretory myeloma (patients with light chain disease are eligible)
3. Pregnant or breast-feeding
4. Uncontrolled viral, fungal or bacterial infection Note: Infection is permitted if there is evidence of response to medication. Eligibility of HIV infected patients will be determined on a case-by-case basis.
5. Patients who have undergone prior allogeneic stem cell transplant
6. Prior solid organ transplant
7. Patients receiving prior radiation to more than 20% of bone marrow containing areas
Compound Danshen Dripping Pill for Diabetic Microvascular Angina

To investigate the efficacy and safety of Compound Danshen Dripping Pill in patients with diabetic microvascular angina pectoris. Long-term follow-up of 1 year will be performed to evaluate the effect of Compound Danshen Dripping Pill on coronary flow reserve and adverse cardiovascular events in patients with coronary microvascular disease.


Eligibility Criteria:
Inclusion Criteria:

History of type 2 diabetes ≧5 years; Repeated chest pain attacks with typical exertional angina pectoris or resting angina pectoris attacks; Coronary normal or stenosis \<50%; Ischemic depression in ST segment during resting or exercise; Coronary flow reserve (CFR) of the anterior descending coronary artery \< 2.0, or CFR ≧2.0 but acetylcholine activation test is positive; Subjects or their guardians agreed to participate in this study.

Exclusion Criteria:

Previous myocardial infarction or PCI or CABG treatment; Severe arrhythmia; Refractory hypertension or hypertension accompanied by left ventricular wall thickness \> 12 mm; Familial hypercholesterolemia; Takayasu arteritis, Kawasaki disease or coronary artery malformation; Pregnant or nursing, or having the intention to give birth within one year; Hepatic or renal dysfunction; Allergic to contrast agents or traditional Chinese medicines; Patients who participated in clinical research of other drugs within 3 months before being selected.
Influence of Antiretroviral Regimen on Immune Reconstitution in the Female Genital Tract

Increases in cluster of differentiation 4 (CD4)+ T cells in the blood is well documented in human immunodeficiency virus (HIV)-infected individuals after starting antiretroviral therapy (ART), but increases CD4+ T cells in the cervix is variable and not fully understood. Although the amount of HIV in the vagina declines in parallel with those in the plasma when antiretroviral therapy for HIV is started, HIV is still detected frequently in cervical samples from women with undetectable plasma viral loads, suggesting that low level viral replication in the female vaginal tract could lead to both inflammation and incomplete increases in CD4+ T cells. Two classes of HIV medications, nonnucleoside analogue reverse transcriptase inhibitors and protease inhibitors are substantially lower in the female genital tract compared to plasma, whereas concentrations of another class, nucleos(t)ide analogue reverse transcriptase inhibitors are similar or higher to those found in plasma. Thus, many widely used first-line three drug HIV therapies only achieve high concentrations of only two medications in the female genital tract. Importantly, with the recent development of raltegravir (RAL), which achieves concentrations in the female genital tract higher than those in plasma, ART regimens that deliver high concentrations of 3 antiretroviral drugs to the female genital tract are now available. The investigators hypothesize that cervical CD4+ T cell reconstitution is better and inflammatory markers are lower in HIV-infected women on a HIV-therapy including tenofovir (TDF) and emtricitabine (FTC) with RAL versus ritonavir (RIT)-boosted atazanavir (ATZ), and that this is due to therapeutic concentrations of 3 versus 2 antiretroviral drugs in the female genital tract.


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 seropositive women receiving a RAL-based regimen (n=20) and women receiving an atazanavir-based regimen (n=20).
* Women will be recruited to this study from the Denver metropolitan area.
* The women must have a plasma HIV RNA \<48 copies/mL for at least 6 months on the same antiretroviral regimen, and a CD4+ T cell count \> 300 cell/mm3.
* Transient increases of \<=200 copies HIV-1 RNA copies/ mL will be allowed.

Exclusion Criteria:

* Hysterectomy
* No a menstrual cycle for 12 months
* Active substance abuse
* hematocrit (HCT) \<30
* Bleeding diathesis
* Known carcinoma of the cervix
* Using oral glucocorticoids or other immunosuppressive agents
* Current pregnancy
EndoCone Single Port Versus Conventional Multi-port Laparoscopic Approach

Its main objective is to evaluate the clinical outcome (including patient reported outcomes) and health economic assessment (HTA) of a new re-usable system for Single Port Laparoscopic Surgery - ENDOCONE SYSTEM developed by Prof Cuschieri by undertaking a randomised controlled prospective clinical trial (RCT) on specific operations performed (on a random allocation basis) by either the traditional multi-port laparoscopic approach or the Single Port- ENDOCONE system by Karl Storz. To this effect, 300 patients meeting the trial inclusion criteria will be randomised over a three year period to have the operation by either of the two approaches.


Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic gallstone disease
* ASA I/II
* Age between 18 and 80 years

Exclusion Criteria:

* ASA III or more
* significant co-morbid cardiovascular, neurological diseases, diabetics and chronic obstructive airway disease
* patients with previous history of invasive cancer
* patients with previous surgery
* patients requiring urgent/emergency interventions
Fenugreek Wraps in Osteoarthritis of the Knee

This randomised controlled trial aims to investigate the efficacy of fenugreek wraps in the treatment of primary symptomatic osteoarthritis of the knee. 81 patients will be randomised into one of 3 groups and apply fenugreek wraps or diclofenac gel daily for 4 weeks or receive only usual care. Efficacy will be measured using questionnaire on pain, disability,function, quality of life and pressure pain sensitivity.


Eligibility Criteria:
Inclusion Criteria:

* osteoarthritis of the knee, Kellgren Lawrence stadium 2-3
* at least 50% of days with complaints in past 3 months
* initial pain intensity \>45mm on a 100mm visual analoge scale

Exclusion Criteria:

* systemic medication with corticoids or immunosuppressive drugs
* systemic medication with chondroitinsulfate or glucosamine
* secondary arthrosis
* operation on the knee within the past 12 months
* injection within 4 weeks (cortisone) or 6 months prior (hyaluronic acid)
* severe comorbidities (tumor, psychiatric disorders etc.)
* participation in other studies, regarding gonarthrosis
* asthma
* pregnancy, breastfeeding
Assessing an Oral Janus Kinase Inhibitor, AZD4205, in Combination With Osimertinib in Patients Who Have Advanced Non-small Cell Lung Cancer

This study will treat patients with advanced NSCLC who have progressed following prior therapy. This is the first time this drug has ever been tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body and preliminarily assess its anti-cancer activity as monotherapy and in combination with Osimertinib.

A phase I/II, open-label, multicentre study to investigate the safety, tolerability, pharmacokinetics and anti-tumour activity of AZD4205 as monotherapy or in combination with Osimertinib in patients with EGFR mutant advanced stage non-small cell lung cancer (NSCLC). This study includes dose escalation part and dose expansion part.

Eligibility Criteria:
Inclusion Criteria:

1. Obtained written informed consent
2. Patients must have histological or cytological confirmation of activating EGFR mutation positive NSCLC and have failed prior EGFR TKIs treatment.
3. Patients must exhibit Eastern Cooperative Oncology Group (ECOG) performance status 0-1
4. Adequate bone marrow reserve and organ system functions

Exclusion Criteria:

1. Any unsolved toxicity \> CTCAE grade 1 from previous anti-cancer therapy (except alopecia)
2. Active viral or bacterial infections;
3. Active or latent tuberculosis;
4. History of interstitial lung disease (ILD)
5. History of heart failure or QT interval prolongation
6. Immunodeficiency diseases;
7. Active CNS metastases
8. Treatment with an EGFR TKI (e.g., erlotinib or gefitinib) within 8 days or approximately 5 x half-life, whichever is longer, of the first dose of study treatment
The Humanized Monoclonal Antibody Milatuzumab for Refractory Chronic Lymphocytic Leukemia (CLL)

The purpose of this study is to determine whether Milatuzumab is effective in patients with refractory chronic lymphocytic leukemia, and also to find out in which range of doses is a response seen.

The aim of this study is to determine whether the anti-CD74 monoclonal antibody Milatuzumab provides benefit to subjects with CLL in advanced stage or progressive disease. The primary objectives of this study are to assess response rate to the agent, as well as the safety in CLL, using different doses: Overall response (OR), complete response (CR) and partial response (PR) will be determinate according to the NCI criteria.

The secondary objectives are to determine: duration of response, time to progression, overall survival, and the range of doses in which efficacy is seen and MTD not reached.

This study will be done in parallel with other phase I-II studies conducted by Immunomedics.

The study design will take into account that the high levels of circulating CD74expressing cells in CLL may affect both the acute (although probably not long term) toxicity and the efficacy of the study medication. This could translate to a different MTD and a different cumulative dose of Milatuzumab, needed to achieve response.(either a higher dose or longer treatment period.).

The study will be divided into two treatment phases. In the first phase we aim to address whether the dose of 120 mg/m2 is effective in CLL, and also if it is safe. In the second phase we will assess the safety and possible efficacy of higher doses, in those patients that did not achieve a significant response in the first phase. This will be done by gradual dose escalations, not to exceed 600 mg, or the MTD reached in other studies.

In addition, the study will aim at gaining further understanding of the effect of Milatuzumab on the biological in-vitro function of CLL cells.

Eligibility Criteria:
Inclusion Criteria:

* B-CLL confirmed according to NCI criteria
* CLL relapsed or refractory to prior antineoplastic therapy
* Signs of progressive disease; at least one:

  * B symptoms
  * lymphocyte doubling time of \< 6 months
  * symptomatic lymphadenopathy or splenomegaly
  * cytopenias due to bone marrow failure)
* Age \> 18 years, and less then 80
* Serum ALAT, ASAT, bilirubin, creatinine \< 2x upper limit of normal
* Life expectancy \> 6 months
* Patient's written informed consent

Exclusion Criteria:

* Active bacterial or viral infection
* Hypersensitivity to humanized monoclonal antibodies
* Concurrent antineoplastic treatment for CLL or other malignant disease
* Absolute neutrophil count \< 1.5 K/
Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) and Kinesio Taping in Patients With Lateral Epicondylitis

Lateral epicondylitis is the most common condition affecting the elbow and characterized by pain over the lateral epicondyle. The aim of this study was to determine and compare the efficacy of TENS and Kinesio Taping in lateral epicondylitis.

In this prospective-randomized, assessor blinded controlled trial, seventy-eight patients (63 women, 15 men, mean age 47,5 ±7,94 years) with lateral epicondylitis were enrolled. Patients were allocated into 4 treatment groups: Group 1 received TENS and Kinesio Taping, group 2 received TENS+sham Kinesio Taping, group 3 received sham TENS+ Kinesio Taping and group 4 received sham TENS+sham Kinesio Taping. TENS was applied for 10 sessions and Kinesio Taping for 4 times in 10 days. All patients were given a progressive exercise program and were informed about the disease. All patients were told to take paracetamol 500 mg if their pain is severe and to note the number of the paracetamol taken.

Outcome measures were pain-free grip strength, pressure pain threshold and pain severity at rest, night and forced wrist extension test. Patient-rated tennis elbow evaluation (PRTEE) was used to determine functional status. Patients were assessed for outcome measures at screening, after treatment (day 10) and 12th week after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Aged 19 to 72
* Enough cognitive ability to fill clinical assessment forms
* Agreed to participate in the study

Exclusion Criteria:

* Severe or progressive neurological deficits
* Severe psychiatric disease history, substance and/or alcohol dependence,
* Uncontrolled diabetes mellitus, malignancy, osteoporosis
* A history of inflammatory or infectious disease
* A skin allergy story
* Previously undergone physical therapy due to lateral epicondylitis
Safety and Tolerability of a Single Dose of FCM vs. Standard of Care in Treating Iron Deficiency Anemia

The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent


Eligibility Criteria:
Inclusion Criteria:

* Subjects ≥18 years of age and able to give informed consent
* Iron deficiency is the primary etiology of anemia
* Screening Visit central laboratory Hgb indicative of anemia ≤12 g/dL
* Screening Visit ferritin indicative of iron deficiency anemia ≤100 ng/mL or ≤300 when TSAT was ≤30%

Exclusion Criteria:

* Previous participation in a FCM trial
* Known hypersensitivity reaction to FCM
* Requires dialysis for treatment of chronic kidney disease
* Current anemia not attributed to iron deficiency
* Received IV iron, RBC transfusion(s), or antibiotics 10 days prior and during the screening phase
* Anticipated need for surgery requiring general anesthesia 30 days prior to screening or during the study period
* AST of ALT greater than 1.5 times the upper limit of normal
* Received an investigational drug within 30 days of screening
* Pregnant or sexually-active females who are not able to use an effective form of birth control
Efficacy and Safety of Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy (HbA1c 7.0-9.5%)

The present study is designed to evaluate the efficacy and safety of fixed combination therapy of vildagliptin and metformin (25/1000 mg bid) in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* History of T2DM treated with Metformin

Exclusion Criteria:

* FPG \>= 260 mg/dL (14.4mmol/L)

Other protocol-defined inclusion/exclusion criteria may apply
The Success Rate of Cardiopulmonary Resuscitation in Patients Experiencing In-hospital Cardiac Arrest

Cardiac arrest causes the heart to stop functioning to maintain circulation that provides oxygen to the brain. The global incidence of cardiac arrest is 50 to 60 per 100,000 people per year. The incidence of cardiac arrest in Indonesia in 2016 was 350,000 cases, in which 12% were successfully resuscitated, compared to the global success rate of 24.8%.

Cardiac arrest events urgently require CPR action that is useful to save lives in an emergency. The application of Code Blue aims to reduce the mortality rate and increase the rate of return of spontaneous circulation. The Code Blue team itself includes a set of teams who are trained in the handling of cardiorespiratory arrest.


Eligibility Criteria:
Inclusion Criteria:

* Patients with in-hospital cardiac arrest that were treated at Sanglah General Hospital

Exclusion Criteria:

* Patients who upon admission to the hospital already showing cardiac arrest rhythm
* Patients who were DOA (death-on-arrival)
A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain

The primary objective of the study is to determine the analgesic efficacy and safety of ALO-02 extended-release capsules, when compared to placebo, in subjects with moderate to severe chronic low back pain.


Eligibility Criteria:
Inclusion Criteria:

* Moderate-to-severe chronic low back pain present for at least 3 months.
* Require a continuous around-the-clock opioid analgesic for an extended period of time.
* Refrain from taking other opioid and non-opioid medications during the study.

Exclusion Criteria:

* Active or within a past 2 years a history of lumbosacral radiculopathy or chronic low back pain due to other underlying disorders such as spinal stenosis with neurologic impairment, cancer, infection, or post-surgical intervention.
* Documented diagnosis of ongoing pain due to other chronic pain conditions which may interfere with assessment of chronic low back pain.
* Active or ongoing or history of alcohol or drug abuse.