cyrilzakka/clinical-trials huggingface dataset:
Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users (PrEPSteps)

This study will deploy a novel, personalized, smartphone-based intervention (PrEPSteps) that responds to real-time PrEP adherence and nonadherence detected through the use of a digital pill. The PrEPSteps intervention will be developed and refined through a series of focus groups. Participants will be screened at the Screening Visit, and, if eligible, will then begin using the digital pill system at Study Visit 1 for 2 weeks. At Study Visit 2, participants will undergo randomization to using either PrEPSteps + the digital pill, or the digital pill alone to measure PrEP adherence, for 90 days. Participants will then complete 3 monthly study visits (Study Visits 3-5) where the investigators will assess digital pill adherence, conduct manual pill counts, obtain dried blood spots to confirm adherence, provide substance use disorder counseling, and obtain urine drug screens. At Study Visit 5, the investigators will conduct a semi-structured qualitative interview with participants in the PrEPsteps arm, which will be grounded in the Technology Acceptance Model, in order to understand the user response to PrEPSteps and the digital pill. All participants will complete the final follow-up assessment 3 months after Study Visit 5 (Study Visit 6).

PrEPSteps is a novel, smartphone-based behavioral intervention that delivers PrEP adherence messages in response to detected PrEP ingestion via an innovative digital pill. PrEPSteps comprises 1) an adaptation of LifeSteps, an evidence-based medication adherence behavioral intervention, with smartphone-delivered booster sessions, 2) messages of contingent reinforcement and corrective feedback, and 3) stimulant use screening, brief assessment, and referral to treatment. In this K23, the investigators will first refine and inform the specification of PrEPSteps with a series of focus groups. The investigators will next test the feasibility, acceptability and potential for an effect of PrEPSteps to boost PrEP adherence in a pilot randomized controlled trial of men who have sex with men (MSM) with stimulant use. Finally, the investigators will conduct qualitative interviews among participants who used PrEPSteps to understand the participant response to living with the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Cisgender MSM
* Moderate to severe non-alcohol substance use disorder
* Self-reported missed PrEP doses (\> or equal to 2 doses in 1 week over past 3 months)
* HIV negative
* On PrEP or initiating PrEP
* Has qualifying laboratory testing: Cr clearance, HBV, liver function tests
* Owns a smartphone with Android or iOS
* Age 18 or older

Exclusion Criteria:

* Non-English speaker
* HIV positive
* History of Crohn's disease or ulcerative colitis
* History of gastric bypass, bowel stricture
* History of GI malignancy or radiation to abdomen
* Unable/unwilling to ingest a digital pill
* Allergy to gelatin, silver or zinc (components of the digital pill)
* Does not qualify for PrEP (abnormal liver function, or Cr Clearance \<60)
A Study of RO5186582 Treatment on Cytochrome P450 (CYP) 3A4 Activity in Healthy Participants

This is a non-randomized, open-label, five treatment, fixed sequence cross-over study to investigate the effect of RO5186582 treatment on CYP3A activity using midazolam as a probe CYP3A substrate, and also to assess the pharmacodynamic measures of brain electrical activity and sedation to explore the pharmacodynamic interaction between the gama-amino butyric acid (GABA)A negative allosteric modulator RO5186582 and the prototypical GABAA positive allosteric modulator midazolam. The anticipated study duration is up to nine weeks.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants with signed informed consent.

Exclusion Criteria:

* A history of epilepsy, convulsions or significant head injury
* Significant history of drug allergy, as determined by the Investigator, or a known hypersensitivity to any of the ingredients of any of the study treatments
* Use of any drugs or substances, including herbal treatments such as St John's Wort, that are known to be substrates, inducers or inhibitors of CYP3A4 within 30 days of the first dose administration
* Pregnant or lactating
* Any other clinically relevant abnormalities, concomitant diseases or ongoing medical conditions
One MORE for Chronic Pain in Latinos

This study will be a single-site, two-arm randomized controlled trial conducted among Spanish-speaking chronic pain patients. Chronic pain patients will be randomized by a computer-generated randomization schedule with simple random allocation (1:1) to either One MORE or a wait-list control condition (WLC). One MORE will be delivered individually either in-person or via a HIPAA compliant virtual meeting platform.


Eligibility Criteria:
Inclusion Criteria:

* Spanish-speaking
* Age 18+
* Diagnosed with a chronic pain condition
* Average pain in the previous week \> or = 3
* Willingness to participate in study interventions and assessments.

Exclusion Criteria:

* Non Spanish-speaking
* Score of 10 or greater ('high risk') on the suicidality subsection of the MINI
* Psychotic episode within the last 12 months as deemed by the corresponding subsection of the MINI
* Presence of clinically unstable illness judged to interfere with treatment or study procedures
* Unable or unlikely to complete study procedures (e.g., planned major surgery, anticipated move, travel barrier)
* Communication or cognitive impairment that limits participation in treatment or study procedures.
Scar Tissue Analysis After Intraoperative Application of Stromal Vascular Fraction Cells Into Suture Line

The study will evaluate the effect of intradermal injection of stromal vascular fraction into suture line on wound healing and scarring.

Patients undergoing primary or secondary Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction will be included in this monocentric, randomised, controlled, double-blinded study.

After bilateral flank liposuction, the fat will be processed by a special protocol with enzymatic digestion. Stromal vascular fraction will be isolated and injected intradermally just after wound closure into one site of surgical wound (most lateral 5 cm) at the DIEP flap donor site. The other site of DIEP flap donor site (most lateral 5 cm) will serve as a control. Part of stromal vascular fraction will be analysed by flow cytometry for the viability and cell specification. Ten months after DIEP flap surgery the scars at both sites (control and injected site) will be excised and analysed histologically. At that time photographs will be taken and scars will be analysed by Patient and Observer Assesment Scale (POSAS).

Eligibility Criteria:
Inclusion Criteria:

* breast cancer patients scheduled for primary or secondary DIEP flap breast reconstruction

Exclusion Criteria:

* BMI
* age
* immunosuppressive disease
Immunogenicity of Hepatitis B Vaccination Among Drug Users

Uptake, adherence, and completion of vaccination among drug users were low, and their immune function and immune response to hepatitis B vaccination were also suboptimal, indicating that the current practice of hepatitis B vaccination can't protect drug users from HBV infection.

This is a randomized, open-label, blank-controlled trial, conducted among drug users with drug rehabilitation. This study will compare the immunogenicity and safety of three intramuscular 20µg and 60µg recombinant hepatitis B vaccines at months 0, 1, and 6 among drug users

Comparison of 2 vaccination strategy against Hepatitis B in Drug Users

Intervention:

Arm 1 : Receive three intramuscular injections of 60 µg recombinant hepatitis B vaccine at months 0, 1 and 6;

Arm 2 : Receive three intramuscular injections of 20 µg recombinant hepatitis B vaccine at months 0, 1 and 6;

Arm 3 : Receive no vaccination during the study period.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 70 years at the enrolment
* current illicit drug users before drug rehabilitation
* negative for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) at enrollment
* having spent acute physiological detoxification phase

Exclusion Criteria:

* any intolerance or allergy to any component of the vaccine
* ongoing opportunistic infection
* liver disease
* hemopathy
* cancer
* unexplained fever in the last week before the recruiting
Safety Study of a Single Dose of Monovalent High-dose Inactivated Poliovirus Type 2 Vaccine (m-IPV2 HD) in Infants Early in Life

Phase II, observer-blind, randomized study on the safety, reactogenicity, immunogenicity and impact on intestinal shedding of a single dose of monovalent high-dose inactivated poliovirus type 2 vaccine (m-IPV2 HD) or a single dose of standard trivalent inactivated poliovirus vaccine (t-IPV) when given concomitantly with the third dose of bivalent oral poliovirus vaccine (b-OPV) to infants early in life


Eligibility Criteria:
Inclusion Criteria:

1. Age: 6 weeks (-7 to +14 days).
2. Healthy without obvious medical conditions that preclude the subject to be in the study as established by the medical history and physical examination.
3. Written informed consent obtained from 1 or 2 parents or legal guardian as per Panama regulations.

Exclusion Criteria:

1. Previous vaccination against poliovirus.
2. Low birth weight (BW \<2,500 gm).
3. Any confirmed or suspected immunosuppressive or immunodeficient condition including human immunodeficiency virus (HIV) infection.
4. Family history of congenital or hereditary immunodeficiency.
5. Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine).
6. Known allergy to any component of the study vaccines.
7. Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections.
8. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
9. Acute severe febrile illness at day of vaccination deemed by the Investigator to be a contraindication for vaccination (the child can be included at a later time if within age window and all in/exclusion criteria are met.).
10. Member of the subject's household (living in the same house or apartment unit) has received OPV in the last 3 months.
11. Subject who, in the opinion of the Investigator, is unlikely to comply with the protocol or is inappropriate to be included in the study for the safety or the benefit-risk ratio of the subject.
Allogeneic Mesenchymal Stem Cells in Osteoarthritis

This trial is planed to study if allogeneic mesenchymal stem cells would be safe and beneficial in osteoarthritis of knee joint. This is a double blind study. Different doses of stem cells will be used in this study.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females in the age 40 - 70 years (both inclusive)
2. Radiographic evidence of grade 2 to 3 osteoarthritis based on the Kellgren and Lawrence radiographic criteria.
3. History of primary idiopathic osteoarthritis of the knee characterized by pain which requires intake of analgesics.
4. Self-reported difficulty in at least one of the following activities attributed to knee pain: lifting and carrying groceries, walking 400 metres, getting in and out of a chair, or going up and down stairs.
5. Patients who have been on stable medication which may be NSAIDs / Opioid or opiate analgesics, for the past three months.
6. Female patients of childbearing age must be willing to use accepted methods of contraception during the course of the study
7. Ability to provide written informed consent.

Exclusion Criteria:

1. Prior or ongoing medical conditions (e.g., concomitant illness, psychiatric condition, alcoholism, drug abuse), medical history, physical findings, ECG findings, or laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the subject, makes it unlikely that the course of treatment or follow-up would be completed, or could impair the assessment of study results.
2. History of surgery, or major trauma to the study joint
3. Arthroscopy on the study joint in the previous 12 months
4. Signs of active study joint inflammation including redness, warmth, and/or, if qualifying with osteoarthritis of the knee, a large, bulging effusion of the study knee joint with the loss of normal contour of the joint at the screening visit or at the baseline examination
5. Patients who had received intraarticular steroids or hyaluronan within the last three months.
6. Infections in or around the knee.
7. Patients awaiting a replacement knee or hip joint
8. Patients with other conditions that cause pain
9. Patients with deformity of the knee joint.
10. Significantly incapacitated or disabled and would be categorized as ACR Functional Class IV (largely or wholly incapacitated), or unable to walk without assistive devices
11. Patients with other known rheumatic or inflammatory disease such as rheumatoid arthritis
12. Other pathologic lesions on x-rays of knee
13. Positive hepatitis B surface antigen, hepatitis C antibody test, Anti human immunodeficiency virus (HIV) antibody test, or RPR
14. History of Bleeding disorders
15. Known hypersensitivity to Hyaluronan products or animal sera
16. For women of child-bearing potential: positive pregnancy test or lactating \[Females who are planning pregnancy within next one year should be excluded\]
An Evaluation of Yoga Therapy for Cervical Spondylosis

Cervical spondylosis is a chronic degenerative condition, commonly affecting \>40-year-old adults worldwide. Cervical spondylosis is an important cause of neck pain and low back pain, and seriously affects the physical health, mental health, patients quality of life. Yoga has been most commonly used intervention for pain conditions. But its efficacy in cervical spondylosis has not yet been studied in clinical trials. The primary aim of the present study was to assess the efficacy of yoga chikitsa (therapy) compared with control intervention for neck pain caused by cervical spondylosis.


Eligibility Criteria:
Inclusion Criteria:

* Neck pain of CS as per diagnostic criteria of International Classification of Diseases
* CS supported by a physical examination, and cervical radiographic examination
* History of neck pain longer than 3 months
* willing to provide informed consent

Exclusion Criteria:

* History of neck trauma, fracture or surgery,
* Systematic disease of the neck or spine including bones and joints conditions,
* Pregnancy
Method Comparison Study for Measuring Potassium (K) and Ionized Calcium (iCa) in Blood

Method comparison study for Potassium (K) and ionized calcium (iCa).

The objective of this study is to compare the performance of the K and iCa Tests using the IUO i-STAT CG8+ Cartridge on the i-STAT 1 Analyzer to the performance of the K and iCa Tests on the comparator device using capillary whole blood specimens. This objective will be assessed as part of a Method Comparison evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Signed and dated consent form (if required by the IRB)
* ≥ 18 years of age

Exclusion Criteria:

• Prior enrollment in the study
Evaluation of the Position of Promontofixation Prostheses in Perineal Ultrasound

Indirect promontofixation with prostheses is the standard surgical technique for the reference of uterine prolapse. There is no validated examination to control the position of the prostheses postoperatively.

These prostheses are echogenic and perineal ultrasound could be a means of postoperative monitoring. There is no data in the literature on the relationship between prosthesis position and postoperative symptoms


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years of female sex
* Patient with double laparoscopic promontofixation without associated hysterectomy

Exclusion Criteria:

* History of hysterectomy
* Anterior cure (before index intervention) of prolapse with placement of prosthetic material.
Camrelizumab Combined With Apatinib Mesylate or Camrelizumab Alone for First-line Treatment in Subjects With Programmed Death Ligand 1 (PD-L1) Positive Relapsed or Advanced Non-small Cell Lung Cancer (NSCLC)

The study is being conducted to evaluate the efficacy and safety of Camrelizumab (200mg,q2w) combined with Apatinib(250mg qd) in subjects with PD-L1 positive relapsed or advanced non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who have recurrent or advanced (Stage IIIB-IV) non-small cell lung cancer confirmed by histology or cytology.
2. No prior systemic treatment. Subjects who have received prior neo-adjuvant, adjuvant chemotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment free interval of at least 6 months from randomization since the last chemotherapy cycle.
3. Subjects should not have a previously detected activating Epidermal Growth Factor Receptor (EFGR) mutation or Anaplastic Lymphoma Kinase (ALK) fusion oncogene.
4. Subjects must have measurable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria;
5. Freshly acquired samples or archived specimens within 6 months before randomization must be provided.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Exclusion Criteria:

1. Radiologically confirmed central squamous cell carcinoma.
2. Untreated central nervous system metastases (such as brain or meningeal metastases).
3. Pleural effusion, pericardial effusion, or ascites with clinical symptoms that need drainage
4. Past or present with idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, tissue pneumonia (eg bronchitis, occlusive vasculitis), drug-induced pneumonia, active pneumonia during CT screening, or objective evidence of severe impairment of lung function
5. Subjects with an active, known or suspected autoimmune disease. Patients with type I diabetes who are receiving a stable dose of insulin, hypothyroidism who only needs hormone replacement therapy, and skin diseases (such as eczema, vitiligo, or psoriasis) that do not require systemic treatment and do not have acute deterioration within 1 year before the screening period, are allowed.
6. Subjects with suspected active tuberculosis should be examined for chest X-rays, sputum, and ruled out by clinical signs and symptoms.
7. Uncontrolled Cardiac Symptoms or Diseases.
8. Subjects with high blood pressure who cannot be controlled well with antihypertensive drugs (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).
9. Arterial / venous thrombosis events, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, occurred within the first 6 months of randomization.
10. Subjects who have previously received anti-PD-1 / PD-L1 monoclonal antibody, anti-cytotoxic T lymphocyte antigen-4 monoclonal antibody, or vascular endothelial growth factor receptor (VEGFR) small molecule inhibitor therapy.
Skin Sympathetic Nerve Activity and Sympathetic Tone

There are many sympathetic hyperactivity diseases in the investigators' clinical practice. However, the conventional method to measure the sympathetic nerve activity had many limitations such as clinical application, data interpretation and even therapeutic manipulation. Therefore the investigators would like to develop a non-invasive method to record the sympathetic nerve activity in the investigators' study that can help gathering the sympathetic nerve activity easily in the investigators' daily clinical situation. By the determination of sympathetic nerve activity status, the health caregiver can understand the disease more.


Eligibility Criteria:
Inclusion Criteria:

* Sympathetic hyperactivity diseases included: hypertension, heart failure atherosclerotic diseases, arrhythmias, cardiomyopathy, pulmonary hypertension, chronic obstructive pulmonary disease, sleep apnea, pulmonary embolism, hepatitis, liver cirrhosis, hepatopulmonary syndrome, hepatorenal syndrome, renal failure, nephritis, irritable bowel syndrome.
* Healthy Volunteers

Exclusion Criteria:

* Pregnant
Diagnosis and Treatment of Periodontal Disease in Patients With AML

This is a phase 2 randomized controlled trial of pre-chemotherapy periodontal deep cleaning in Acute Myelogenous Leukemia (AML) patients with asymptomatic periodontitis.

Once eligibility is confirmed, participants with periodontitis will be randomized in a 1:1 ratio to undergo treatment by scaling and root planing (SRP, "deep cleaning") (arm A) or receive no periodontal treatment (arm B). We will compare the incidence of Blood Stream Infection (BSI) during chemotherapy between the two arms.

Study participation will continue until day 28 of chemotherapy or discharge from hospital, whichever occurs first.

Bloodstream infection (BSI) is common in patients with acute myeloid leukemia (AML) and causes significant morbidity and mortality. Chemotherapy disrupts oral and intestinal mucosal barriers, facilitating bacterial translocation to the bloodstream.

Baseline periodontitis is associated with higher risk of BSI during chemotherapy. In AML patients, since baseline screening and treatment of asymptomatic periodontitis is currently not a standard practice, the researchers are hoping to (i) personalize supportive care according to patient-specific risk factors; (ii) promote an interdisciplinary approach to supportive care by bringing periodontists into the treatment team; (iii) improve quality of life by reducing hospitalization length; (iv) decrease the incidence of re-hospitalization during future phases of treatment; (v) decrease early treatment related mortality (TRM); and (vi) decrease healthcare costs.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Newly diagnosed or relapsed AML
* Planned intensive chemotherapy (Any regimen expected to require 3-4 weeks of inpatient stay)
* Antibacterial prophylaxis using levofloxacin 500 mg daily
* Sufficient time to perform periodontal examination and treatment by day 1 of chemotherapy

Exclusion Criteria:

* Prior treatment for AML, except hydroxyurea or leukapheresis
* ANC \<0.5 x 10\^9/L at the time of enrollment
* Post-transfusion platelet count \<50x10\^9/L at the time of enrollment
* Unstable for transfer to the School of Dentistry
* Fever at the time of enrollment
* Documented infection at the time of enrollment
* SRP in the last 3 months
* Symptomatic periodontal disease