cyrilzakka/clinical-trials huggingface dataset:
A Web-based Intervention Study to Reduce High-risk Sexual Behavior by Persons Living With HIV AIDS (PLWH)

This is a CCTG sponsored trial in collaboration with UCSD-AVRC investigators to get more information about the methods that are used on the internet to provide information on how to reduce the risk of giving or getting infections that are often or usually passed from one person to another during sexual or intimate contact (sexually transmitted infection (STI)). STIs include chlamydia, gonorrhea and syphilis. The purpose of this study is to develop methods that will allow someone who is living with HIV an easy way that they can get information and learn of ways on their own that can decrease their chances of getting sexually transmitted infections and ways that they can reduce the chance that they may transmit HIV to others.

Design: CCTG 592 is a randomized, controlled study that will compare the efficacy of web-based intervention to reduce high-risk sexual behavior by persons living with HIV AIDS (PLWH).

Duration: 48 weeks

Sample Size: 200 subjects (100 per arm) that will be randomized

Study Population: HIV-1-infected men who have sex with men (MSM) at least 18 years of age who have a recent history of transmission risk behavior.

Stratification: Subjects will be stratified based upon their baseline antiretroviral use, whether they have a home computer and by site.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infection, as documented by any licensed screening antibody test, such as ELISA, and confirmed by a second antibody test, such as Western blot, or detectable plasma HIV-1 RNA at any time prior to study entry. If an ELISA or Western Blot are not available, HIV infection may be documented by two HIV RNA values \> 2000 copies/mL, drawn at least 24 hours apart. The HIV RNA assays should have been run at a CLIA approved laboratory or equivalent.
* 18 years of age or older.
* Male.
* At least one of the following:
* An HIV negative or unknown status sexual partner in the past three months.
* A sexually transmitted disease in the past 1 year (other than HIV).
* More than 2 male partners in past year.
* Unprotected anal sex in past 3 month.
* Capable of signing written informed consent.
* Read and comprehend English
* Adequate computer skills for study.

Exclusion Criteria:

* Uncontrolled psychiatric condition.
* Drug or alcohol users with use that in the opinion of the investigator, would limit follow-up and adequate consent
Combination Therapy With Atelocollagen in Epidural Nerve Block

"In this study, the investigators plan to evaluate muscle mass and pain relief 4 weeks after performing epidural nerve block and Type I porcine atelocollagen injection into multifidus muscle in patients with chronic low back pain due to degenerative spinal disease for more than 6 months.


Eligibility Criteria:
Inclusion Criteria:

1. Patients scheduled for epidural nerve block for lower back pain
2. Patients over 21 years of age
3. Back pain lasting more than 6 months
4. Patients with ineffective or insignificant effects of conventional drugs and nerve block for back pain
5. Patients with spinal stenosis or disc herniation at the lumbar 4-5 or lumbar 5-sacral 1 level on MRI, and the cross-sectional area of the multifidus muscle at the lesion site is less than 5 cm2 when measured by ultrasound.

Exclusion Criteria:

1. When the degree of low back pain is 3 points or less on the 11-scale numeric rating scale (hereafter NRS)
2. If lower back pain has rapidly worsened within the last week
3. If you have other diseases that may cause low back pain: osteoarthritis of the hip joint, cancer, inflammatory arthritis, spondylitis, fibromyalgia, complex regional pain syndrome, herpes zoster, postherpetic neuralgia, etc.
4. When a diagnostic epidural nerve block is planned
5. In the case of receiving conservative treatment, procedure, or surgery other than oral drugs such as epidural nerve block or proliferation treatment for the treatment of lower back pain within 4 weeks of screening
6. When the low back pain assessed by NRS decreased by more than 50% after epidural nerve block in screening
7. If back surgery is planned within 3 months of the procedure
8. When NRS and ODI measurements cannot be made
9. When collagen injection is contraindicated (eg when allergic to swine)
10. Pregnant women
11. If you cannot read or agree to the consent form
12. If you are unable to sign the consent form yourself
Study to Evaluate the Safety and Tolerability of Tirabrutinib (ONO/GS-4059) Given as Monotherapy in Participants With Relapsed/Refractory NHL and CLL

The primary objective of the study is to evaluate the safety and tolerability of tirabrutinib (formerly ONO/GS-4059) given as monotherapy to participants with relapsed/refractory non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL).


Eligibility Criteria:
Key Inclusion Criteria:

1. Males or females with a confirmed diagnosis of and documented history of relapsed or refractory malignant disease (B-cell lymphoma and/or CLL) for which no therapy of curative or high priority exists and for whom treatment with a Btk inhibitor may be deemed appropriate.
2. Age ≥ 18 years.
3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.

Key Exclusion Criteria:

1. Central nervous system (CNS) lymphoma.
2. Women who are pregnant or lactating.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Decreasing Loneliness to Optimize Pain Care

Loneliness, which is the perceived feeling of insufficient personal relationships, is related to higher risk for inappropriate opioid use and opioid use disorders in patients who are taking opioids long-term. The study seeks to pilot test the evidence-based loneliness interventions of psychological therapy and social navigation in patients on chronic opioids treated in primary care practices to determine if reducing loneliness can lower opioid misuse.

Patients with chronic pain on opioids frequently experience loneliness, which is associated with poorer health outcomes and higher risks for opioid misuse and opioid use disorder. Given that almost half of opioids are prescribed in primary care, a critical need exists for the development and testing of interventions to reduce loneliness in primary care patients at risk for opioid misuse. The long-term goal of the study is to reduce opioid misuse and opioid use disorder by addressing loneliness in primary care with patients on chronic opioids. Interventions addressing maladaptive social cognition through cognitive behavioral therapy and improving social support through social navigation have been shown to be effective in reducing loneliness and improving outcomes in other fields but have not been tested in patients at risk for substance use disorder.

Aims

* To refine both the social navigation and psychological CBT loneliness interventions for patients in primary care on chronic opioids
* To assess the feasibility of implementing a 3-arm pilot randomized clinical effectiveness trial testing a psychological CBT and a social navigation intervention to address loneliness in primary care patients.
* To determine the distribution and variability in the mediating outcome (loneliness), the primary outcome (opioid misuse) and secondary outcomes, including opioid dose, functional status and patient-reported pain outcomes in the pilot randomized clinical effectiveness trial.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* English-speaking
* On chronic opioids (defined as defined as 3 or more months receiving prescribed opioids \[functional definition is 3 or more opioid prescriptions each less than 21 days apart as per our prior studies\])
* With a score greater or equal to 6 on the UCLA Loneliness 3-item Scale
* Have a chronic pain diagnosis

Exclusion Criteria:

* Have cancer-related pain
* Are on palliative care or live in a controlled setting (i.e., assisted living, nursing home or inpatient treatment facility)
* Have an upcoming scheduled surgery
* Severe cognitive impairment or active psychosis
A Research Study to Explore the Impact of GP Support Via Text Messages to Patients With Asthma and/or COPD

A 6-month randomised controlled trial to evaluate the impact of text message support on symptom control and inhaler adherence for patients with asthma and/or COPD

This trial will be a 6-month prospective, randomised controlled trial in which the study population is randomly allocated (1:1) to an intervention or control group. The trial is multicentre and is non-blind. All patients in both groups will continue to receive their usual care for the duration of the study. Randomisation will be at the individual level. Participants will be randomly allocated as per a computer-generated randomisation list using a random number generator as part of the Microsoft .NET framework.

This is a behavioural intervention. The intervention will consist of a series of supportive text messages to patients from their GP practice over a 6 month period. The messages will vary in frequency from 2 or 3 in the first weeks of the trial to only 1 or 2 a month in the final months of the trial. The content of the messages will vary; some will contain information about how to use a preventer inhaler, some will emphasise the importance of using it, and some will provide simple reminders to patients to take their inhaler.

All participants will continue to receive their usual care throughout the duration of the study; the text message intervention with be in addition to their usual care.

Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to provide informed consent and to comply with the study instructions
2. Male and females age 18 or older
3. Confirmed diagnosis of asthma and/or COPD as recorded in the patient's GP medical record
4. Currently prescribed a preventer inhaler
5. Access to a mobile phone
6. Ability to check text messages on phone
7. Ability to read

Exclusion Criteria:

1. Inability to understand the study procedures
2. Inability or reluctance to provide responses to the study questionnaires
3. Inability to receive and respond to text messages
Real Life of Aflibercept in France in Patients Refractory to Ranibizumab: Observational Study in Wet AMD

The aim of the TITAN study is to describe the clinical practices of a cohort of patients with wAMD refractory to ranibizumab (persistence of intra-retinal and/or subretinal fluid) who switch to aflibercept after less than 12 months of ranibizumab treatment.

The study will be conducted in real-life conditions and will allow describing conditions of use of aflibercept in patients refractory to ranibizumab

The study is both retrsopective and prospective to collect local real life data on patients under routine treatment.

The observation periods starts on January 2014. Patients who initiated a treatment by Aflibercept between the 1st of january 2014 and the 31 December 2015 will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Man or woman \> 18 years old
* Patient with wAMD previously treated with ranibizumab (for less than 12 months before initiation of Aflibercept)
* Refractory to ranibizumab (defined by persistent fluid despite a treatment conducted according to the HAS French recommendations with at least 3 loading doses injections)
* Patient who switched to aflibercept (Eylea) between 1st of January 2014 and 30th June 2015
* Written informed consent given

Exclusion Criteria:

* Patient who do not meet the local indication criteria for aflibercept treatment. Contraindications listed in the local SmPC (Summary of Product Characteristics) have to be considered
* Recurrent patients with wAMD previously treated with ranibizumab and switched to aflibercept because of a high recurrence rate (recurrent patients described by Yonegawa et al.in AJO (American Journal of Ophthalmology )2013= exudation suppressed but high rate of injections)
* Patient who have been previously treated by any macular laser Visudyne/PD (Photodynamic therapy)
* Patient with a Visual Acuity (VA) \<1/10
* Patient with Fibrosis involving Macula
* Patient with atrophic AMD
* Patient with any other retinal disease as myopia, diabetic retinopathy, diabetic macular oedema,chorioretinal anastomosis (CRA),, angioid streaks
* Patients taking part in an interventional study at the time of enrolment
Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants (V260-024)

This study will assess the efficacy, safety, and immunogenicity of a 3-dose regimen of RotaTeq™ (V260) in healthy Chinese infants. Approximately 4040 participants at least 6 weeks and up to 12 weeks of age at the time of the first vaccination with V260 or placebo will be enrolled and randomized (1:1) to receive either V260 or placebo. Participants will also receive the routine China Expanded Program on Immunization (EPI) vaccines (oral poliovirus vaccine \[OPV\] and diphtheria, tetanus, and acellular pertussis vaccine \[DTaP\]) either staggered or concomitantly with V260 or placebo. All participants will be followed for efficacy and safety. Immune responses to OPV and DTaP will be evaluated in a subset of participants. The primary hypothesis of the study states that V260 will be efficacious in preventing any severity of rotavirus gastroenteritis as compared with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Healthy infants at least 6 weeks (42 days) and up to 12 weeks (84 days) of age at the time of the first study vaccination
* Parent/legal guardian agrees to participate by giving written informed consent and is willing and able to comply with study requirements

Exclusion Criteria:

* History of congenital abdominal disorders, prior rotavirus gastroenteritis, chronic diarrhea, failure to thrive, or abdominal surgery
* History of intussusception
* Impairment of immunological function, including Severe Combined Immunodeficiency (SCID)
* Acute disease, severe chronic disease, or chronic disease during the acute period
* Uncontrolled epilepsy, encephalopathy, seizure, or other progressive neurological disease
* Hypersensitivity to any component of the rotavirus vaccine, OPV, or DTaP
* Prior receipt of any rotavirus vaccine
* Fever, with an axillary temperature \>=37.5 °C (or equivalent) within 24 hours before study vaccination (study vaccination can be deferred until complete resolution of febrile illness)
* Clinical evidence of active gastrointestinal illness
* Received intramuscular, oral, or intravenous corticosteroid treatment since birth (topical, ophthalmic, and inhaled steroids are permitted)
* Resides in a household with an immunocompromised person
* Receipt of a blood transfusion or blood products, including immunoglobulins
* Participation in another interventional study within 14 days before the first study vaccination or during the study
* Receipt of an investigational or non-registered product other than the study vaccine within 30 days before the first study vaccination or during the study
* For participants in immunogenicity arms: inability to obtain a blood specimen at randomization visit (note: the visit may be rescheduled so that a baseline specimen may be obtained); history of polio, diphtheria, tetanus, or pertussis disease; previous vaccination against diphtheria, tetanus, pertussis, or poliomyelitis
* Any condition which, in the opinion of the investigator, may interfere with the evaluation of the study objectives
A Trial for Patients With Advanced/Recurrent Cervical Cancer

This phase II trial is studying the antitumor activity of single agent pemetrexed 900mg/m2 IV over 10 minutes in patients with recurrent cervical cancer.


Eligibility Criteria:
Inclusion Criteria:

* Recurrent squamous or non-squamous cell carcinoma of the cervix with documented disease progression
* Measurable disease
* Gynecologic Oncology Group (GOG) performance status 0-2
* Patients must have received one prior systemic chemotherapy for persistent or recurrent disease
* Patients with mild to moderate renal insufficiency should avoid taking non-steroidal anti-inflammatory drugs (NSAIDs_ with short elimination half-lives for a period of 2 days before, the day of, and 2 days following administration of pemetrexed.
* All patients taking NSAIDs with longer half-lives, should interrupt dosing for at least 5 days before, the day of, and 2 days following pemetrexed administration.
* Folic Acid (350-1000 ug) must be given daily beginning approximately 5-7 days prior to first does of pemetrexed and continuing daily until 3 weeks after the last dose of study therapy.
* Vitamin B12 (1000 ug) will be administered as an intramuscular injection approximately 1 to 2 weeks prior to first dose of pemetrexed and repeated approximately every 9 weeks until 3 weeks after the last dose of study therapy

Exclusion Criteria:

* Prior Pemetrexed
* Patients who have received radiation to more than 25% of marrow bearing areas
* Any evidence of other malignancy within last 5 years, with exception of non-melanoma skin cancer
Evaluating Safety and Efficacy of Repeat Doses of UB-621in Adult Patients With Recurrent Genital Herpes

To evaluate the efficacy of repeat-dose UB-621 for the recurrent genital HSV-2 infection To evaluate the safety and tolerance of repeat-dose UB-621 for the recurrent HSV-2 infection To evaluate the pharmacokinetics of repeat-dose UB-621 in RGH patients


Eligibility Criteria:
Inclusion Criteria:

1. Age ≧18 years at the time of signing ICF
2. HSV-2 seropositive when screening
3. A history of recurrent genital herpes and experience 6-12 episodes in the past year
4. Negative result of the HIV assay
5. In baseline period, subject have to present at the site within 72 hours after the occurrence of new lesions
6. Keep daily diary during the study period
7. Female subjects: negative serum β-HCG at screening and no beast-feeding.
8. Use contraception during study participation
9. Understanding and willing to fully comply with study interventions and restrictions.

Exclusion Criteria:

1. Any medical conditions that may interfere the assessment of UB-621efficacy, or any medical conditions that may present symptoms in the anogenital regions (such as syphilis, genital warts).
2. History of malignancy, diabetes, auto-immune diseases or immunodificiency diseases.
3. Use of systemic steroids or immunomodulators within 30 days prior to the screening
4. Participating any clinical trials within 30 days prior to the screening, or within 5 half-life of any investigational drugs, take the longer.
5. Vaccination within 30 days prior to the screening.
6. Prior exposure to any HSV vaccines
7. Known hypersensitive to monoclonal antibodies
8. ECG abnormalities with clinical relevance or cardiovascular diseases at screening
9. Serum creatinine \> 1.5 mg/dL at screening
10. AST and ALT \> 2.5 x ULN at screening
11. HBsAg positive or HCT antibody positive at screening
12. Syphilis RPR test positive at screening
13. TB history or documented T-spot positive, or now is under treatment of TB
14. Any other circumstances that are determined to affect the conduct or successful completion of the clinical study
Paclitaxel, Carboplatin, and Topotecan in Patients With Ovarian Cancer

The purpose of this study is to determine whether the triple combination of Carboplatin, Paclitaxel and Topotecan has a superior clinical outcome in the treatment of ovarian cancer compared with the combination of Carboplatin and Paclitaxel.

Carboplatin-Paclitaxel is the current standard in the first-line treatment of advanced ovarian cancer. One option to further improve the therapeutic results is the incorporation of a third, non-cross-resistant drug into first line chemotherapy of advanced ovarian cancer. In two separate, single center phase II studies, a different combination of the three active agents (Carboplatin, Paclitaxel and Topotecan) has been tested. In these studies, Carboplatin and Paclitaxel were given at standard doses and schedules, followed sequentially by Topotecan which was well tolerated at a dose of 1.25 mg/m2/day given for five days and repeated every 21 days. The prolonged therapy is not associated with cumulative toxicity and the compliance of the patients was good.

Study Hypothesis/Comparison: The triple combination (Carboplatin/Paclitaxel/Topotecan) yields superior outcome in the treatment of first-line ovarian cancer compared with the combination of Carboplatin + Paclitaxel

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven epithelial carcinoma of the ovary or of the fallopian tube or extraovarian papillary serous carcinoma with extent to the ovary
* International Federation of Gynecology and Obstetrics (FIGO) stage IIB-IV, regardless of measurable or non-measurable disease
* No prior chemo- or radiotherapy
* Adequate hematologic, renal and hepatic function:

  * ANC ≥ 1.5 x 10\^9/L,
  * Platelet counts ≥ 100 x 10\^9/L,
  * Total bilirubin ≤ 1.5 x upper normal limit,
  * Alkaline Phosphatase ≤ 3 x upper normal limit,
  * Serum creatinine ≤ 1.25 upper normal limit,
  * Estimated GFR ≥ 60 ml/min
* Performance status 0-2 (ECOG)
* Life expectancy must be greater than 12 weeks

Exclusion Criteria:

* Non-epithelial tumors or mixed epithelial/non-epithelial tumors (e.g. mixed Mullerian tumors) or tumors of low malignant potential (borderline tumors)
* Prior treatment with chemo- or radiotherapy
* Administration of other simultaneous chemotherapeutic drugs or hormonal therapy or simultaneous radiotherapy during the study treatment period or planned whole abdominal radiotherapy
* History of congestive heart failure
* Symptomatic brain metastasis
* Complete bowel obstruction
* Dementia
* Active infection or other serious underlying medical condition
* Pre-existing motor or sensory neurologic pathology
Perioperative Family Updates Reduce Anxiety and Improve Satisfaction

This study was a randomized control trial conducted to determine if frequent, standardized updates affect anxiety and satisfaction of family members. Additionally, the investigators aimed to determine if the length of the surgical procedure effects the satisfaction with updates.


Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing inpatient arthroplasty, orthopaedic spine, or orthopaedic trauma procedures

Exclusion Criteria:

* Age under 18
* Non-English speaking patients or families
* Patients with families that would not be waiting in the hospital during the perioperative period