cyrilzakka/clinical-trials huggingface dataset:
Enhancing Linkage to HIV Care for Newly Detected HIV-positive Persons in Ukraine

This study proposes to assess whether a modified Antiretroviral Treatment Access Study intervention, proved to be effective in the U.S. and based on the nurse case management approach, can impact the enrollment in HIV care of recently detected HIV-positive patients in specialized health care clinics in three regions in Ukraine, using the existing local infrastructure. The proposed study addresses a significant public health issue of non-/late enrollment of HIV-positive persons in HIV care and treatment.

Individual, parallel, two-arm, 1:1 RCT. The study participants were recruited between October 2015 and December 2016 at 9 clinics located in Dnipropetrovsk region (Dnipropetrovsk Regional Narcological Dispensary; Dnipropetrovsk Regional Dermatovenereologic Dispensary; Kryvyi Rih Infectious Disease Clinic No. 1), Mykolaiv region (Mykolaiv Regional Narcological Dispensary; Mykolaiv Regional Dermatovenereologic Dispensary; Mykolaiv Regional Infectious Disease Clinic), and Odesa region (Odesa Regional Dermatovenereologic Dispensary; Odesa Infectious Disease Clinic; Odesa Regional Center of Mental Health). These three types of clinical sites (treating addiction, sexually transmitted infections \[STIs\], and infectious diseases \[IDs\]) were located in the regions with the highest HIV prevalence in Ukraine, but were not co-located with HIV care facilities. Participants assigned to the standard of care (SOC) arm and the MARTAS arm received referrals to the local AIDS Centers (Dnipropetrovsk Regional AIDS Center, Kryvyi Rih AIDS Center, Mykolaiv Regional Center for Palliative Care and Integrated Services (former Mykolaiv AIDS Center), and Odesa Regional AIDS Center) or their departments ("Trust" offices) located in each study region. Investigators affiliated with The Ukrainian Institute on Public Health Policy (UIPHP) were responsible for all aspects of study design, management, and analysis.

Eligibility Criteria:
Inclusion Criteria:

* Age 18+ years;
* Tested HIV-positive
* Fluent in Russian or Ukrainian;
* Able to read/understand and sign an informed consent

Exclusion Criteria:

* Enrolled in HIV care;
* Plan to move out of the study region before the end of their follow-up period
* Cognitive impairment
* Have pending legal issues, independent of their lifetime history of incarceration
* Subject is a part of another intervention or/and research study with similar linkage-to-care objectives
Long-term Follow-up Study to Evaluate the Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD Inj

A multi-center, open, long-term follow-up study to Evaluate the Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD inj. for Moderate to Severe Chronic Atopic Dermatitis: 5-year Results from the K0104 Extension Study


Eligibility Criteria:
Inclusion Criteria:

1. Subject who enrolled K0104 Clinical Trial(parent study).
2. Subjects who understand and voluntarily sign an informed consent form

Exclusion Criteria:

1. Subjects who are expected to be unable to perform at least one follow-up during this study (K0104-E)
2. Subjects who has received/administered clinical trial drugs or medical devices by participating in other clinical trials until the first visit of this trial (K0104-E) after the completion of K0104 clinical trial
3. Subjects who are judged to be unsuitable for other researchers to participate in the research
Drug-drug Interaction Study with TS-142 in Healthy Adult Subjects (concomitant Administration of Itraconazole)

This is an open-label, single-center, single-sequence study to evaluate the concomitant effects of the potent CYP3A inhibitor itraconazole on the single-dose pharmakokinetics, safety and tolerability of oral TS-142 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Japanese male age 20 to 39 years at the signing of informed consent
* Subjects whose body mass index (BMI) within the range 18.5 - 25.0 kg/m2, exclusive of 25.0
* Subjects who judged by the principal investigator(s) or subinvestigator(s) to be appropriate as a subjects of this study based on the results of screening tests and the tests obtained prior to the administration of the investigational drug. (Those who have no abnormal findings in the physical examination, vital signs, and standard 12-lead ECG in the screening test and the test obtained prior to administration of the investigational drug, and whose clinical test results are within the standard values of the clinical trial site. However, if who showed abnormal findings but not clinically significant, they can be enrolled in clinical trials based on comprehensive consideration of medical viewpoints by the principal investigator(s) or subinvestigator(s).)
* Subjects who understand, and have willingness and ability to read and sign, the informed consent form

Exclusion Criteria:

* Subjects who have any disease and are judged not to be healthy based on the medical viewpoints by the principal investigator(s) or subinvestigator(s)
* Subjects who have an inappropriate history for participation in this study, including hepatic, renal, cardiovascular, hematological, endocrinological, metabolic, respiratory, gastrointestinal, dermatological, neurological, urological, immunological, psychiatric abnormalities or diseases
* Subjects who have any history of drug or food allergies
* Other protocol defined exclusion criteria could apply
Pediatric Asthma Study Using Stepwise Treatment With Two Food And Drug Administration Approved Asthma Medications

This study was designed to evaluate if, in children with asthma, a stepwise treatment (five levels varying from once daily fluticasone propionate 100mcg until twice daily a fixed combination of salmeterol and fluticasone propionate 50/500 mcg) based on symptom scores alone results in a sub-optimal treatment when compared to treatment based on cumulative symptom scores and bronchial hyperresponsiveness (PD20 methacholine).


Eligibility Criteria:
Inclusion criteria:

* Children with a documented history of asthma.
* Using inhaled steroids from 100 mcg up to 500 mcg twice daily for at least 1 month before study start.
* Must be able to perform reproducible lung function tests.
* Must have a positive RAST or skin prick test.
* During the treatment period, the patient has to be hyperreactive (defined as PD20 methacholine \< 150 mcg) and/or have a cumulative symptom score of 14 based on the daily record card filled in during the last 2 weeks of the run-in period.

Exclusion criteria:

* History of an acute upper or lower respiratory tract infection, middle ear, or sinus infection 4 weeks prior to visit 1.
* Admitted to hospital due to a respiratory disease 4 weeks prior to visit 1.
* Received oral corticosteroids within 4 weeks prior to visit 1.
* Existence of any disorder that affects growth.
* Clinical or laboratory evidence of a serious systemic disease, or suspected hypersensitivity to corticosteroids, lactose or short/long acting B2-agonists.
A Clinical Study on the Whole-course Management (BCD-KPD-AutoHSCT) Scheme for Patients With RIMM

Multiple myeloma (MM) is still an incurable hematological tumor, and renal involvement is the main factor of poor prognosis. The recovery of renal function can partially reverse its poor outcome. Although the 5-year survival rate of MM patients has significantly improved after entering the era of new drugs, patients with severe renal insufficiency still have a high early mortality.The purpose of this study is to investigate whether early intensive chemotherapy can reverse the proportion of renal insufficiency, is to investigate the treatment effect of RIMM patients with different renal pathological types, and is also to investigate whether autoHSCT can further partially save renal function in RIMM patients.

For patients with multiple myeloma with renal impairment, the same disease stage and the same treatment regimen have different therapeutic effects. In the era of new drugs, studies have shown that early reduction of the free light chain in serum is the key to reversing renal function. The International Myeloma Working Group recommends the following drugs for the treatment of RIMM patients: 1. regimens based on proteasome inhibitors; 2. regimens based on immunomodulators. Here, we explore a clinical study on the Whole-course Management (BCD-KPD-AutoHSCT) scheme for patients with RIMM.

Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 18 years or older
2. Confirmed diagnosis of symptomatic myeloma with renal impairment
3. Confirmed myeloma-associated nephropathy (e.g. light chain cast nephropathy, AL amyloidosis, MIDD etc.) on renal biopsy
4. Willingness and eligibility for autologous hematopoietic stem cell transplantation

Exclusion Criteria:

1. Pre-existing chronic kidney disease unrelated to myeloma, such as diabetic nephropathy or hypertensive nephropathy
2. Plasma cell leukemia or extramedullary plasmacytoma
3. Contraindications or prior severe allergic reactions to study medications
4. Co-existing malignancy
5. Co-existing medical conditions unsuitable for enrollment as determined by researchers, such as recent cardiovascular event, active infection etc.
Inhaled NO for the Treatment of COVID-19 Caused by SARS-CoV-2 (US Trial)

The purpose of this open label, randomized, study is to obtain information on the safety and efficacy of 80 ppm Nitric Oxide given in addition to the standard of care of patients with COVID-19 caused by SARS-CoV-2.

Nitric Oxide (NO) is a small endogenously produced molecule recognized to play a critical role in the function of several body systems including the vasodilatation of smooth muscle, neurotransmission, regulation of wound healing and inhibition of pathogens. In-vitro studies have shown that NO inhibits the replication cycle of the severe acute respiratory syndrome coronavirus (SARS CoV) in vitro. The suggested mechanisms of actions of NO on SARS are an effect on the fusion between the S protein and its cognate receptor, ACE2, and reduction in viral RNA production in the early steps of viral replication. The primary aim of this feasibility study is to investigate the safety of intermittent NO, delivered via inhalation, in hospitalized patients with COVID-19. The primary endpoint in the study will be time to deterioration of respiratory symptoms determined by escalation to either non-invasive ventilation (NIV), high-flow nasal cannula (HFNC), or intubation.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment within 24 hours of hospital admission of patients diagnosed with COVID-19
* Patients with oxygen saturation less than 93 % on room air
* Shortness of breath, with symptom onset within the previous 8 days.
* Female subjects of childbearing potential should take adequate measures to avoid pregnancy
* Signed informed consent by the subject

Exclusion Criteria:

* Patients who are treated with or require high flow nasal cannula, CPAP, intubation, mechanical ventilation, or tracheostomy
* Diagnosis of acute respiratory distress syndrome
* Subjects diagnosed with immunodeficiency, with history of congestive or unstable heart disease, left ventricular dysfunction or myocardial damage, severe pulmonary hypertension and/or unstable hypertension
* Patients receiving drugs that have contraindications with NO.
* Breastfeeding or pregnancy as evidenced by a positive pregnancy test.
* Patients with active pulmonary malignancy or lung transplant
* Patients with a history of frequent epistaxis or significant hemoptysis
Myfortic in Heart Transplant Patients With Gastrointestinal (GI) Symptoms

Stable heart transplant patients on Mycophenolate Mofetil (MMF) will sign a screening consent form in order to be evaluated with the gastrointestinal symptom rating scale (GSRS) questionnaire. Those who score three or more on at least two questions are eligible for the study. Once they sign a study consent they are randomized to one of two arms. It is thought that the severity of GI side effects will be reduced over time in patients who are in the Myfortic arm versus the severity of GI side effects over time in patients who remain on MMF treatment. Patients are evaluated by GSRS, The Psychological Well-Being Schedule, and the IT01/02 Checklist for the evaluation of GI symptoms and followed for one year (visits 1 month, 3 months, 6 months, 12 months).


Eligibility Criteria:
Inclusion Criteria:

* Stable dose MMF for at least 4 weeks
* Over 18 years of age
* Heart transplant at least three months prior to study

Exclusion Criteria:

* GI symptoms known not to be caused by MPA therapy
* Acute rejection episode in past 4 weeks
* History of malignancy since transplant
* Pregnancy
A Study of ALM-488 to Highlight Nerves in Patients Undergoing Head & Neck Surgery

Phase 1/2 study of ALM-488 to highlight nerves in patients undergoing head \& neck surgery.

This study will evaluate the safety, tolerability, and efficacy of ALM-488 administered as an intravenous (IV) infusion to patients undergoing head \& neck surgery. The study will also characterize the pharmacokinetics of ALM-488 in this subject population and determine the dose of ALM-488 needed to generate a fluorescence signal in nerve tissue to enable fluorescence recordings and image analysis with an imaging system. The study will also evaluate the effect of timing of ALM-488 administration, relative to surgery, on fluorescence characteristics.

Eligibility Criteria:
Inclusion Criteria:

1. A neoplasm located in the head and neck.
2. Primary surgical treatment is by parotidectomy, or thyroidectomy, or cervical neck dissection.
3. Can understand and is willing to sign a written informed consent document.
4. ≥18 years of age.
5. Life expectancy of at least 6 months.
6. Normal liver and kidney functions.
7. If of childbearing potential, must have a negative urine or serum pregnancy test and be using a medically acceptable form of contraception (e.g., hormonal birth control, intrauterine devices, double-barrier method) or abstinence. The subject, if male, must use a medically acceptable form of contraception (e.g. condom) or abstinence.
8. Plans to undergo head and neck surgery.

Exclusion Criteria:

1. Prior radiation or chemotherapy for any prior head and neck neoplasm.
2. Open surgery in the ipsilateral head and neck within 1 year.
3. Abnormal cardiac rhythm not controlled with medication, history of stroke, coronary events and/or heart failure within 1 year.
4. Current evidence of renal disease.
5. Pregnant or breastfeeding.
6. Unresolved acute toxicity from prior anti-cancer therapy.
7. History of fluorescein allergy.
8. Any other criteria deemed by the Principal Investigator that may prevent the patient from successfully completing the trial.
A Study of IMR-687 in Subjects With Sickle Cell Disease

A Study to Evaluate the Safety and Efficacy of IMR-687 in Subjects with Sickle Cell Disease

A phase 2b, randomized, double-blind, placebo-controlled, multicenter study of subjects with sickle cell disease (SCD; homozygous sickle hemoglobin \[HbSS\], sickle-β0 \[HbSβ0\] thalassemia, or sickle-β+ \[HbSβ+\] thalassemia) to evaluate the safety and efficacy of the phosphodiesterase type 9 (PDE9) inhibitor, IMR-687, administered once daily (qd) for 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed diagnosis of SCD (HbSS, HbSB0 thalassemia, or HbSB+ thalassemia)
2. Hemoglobin of \>5.5 and \<10.5 g/dL; Hb values within 21 days post-transfusion will be excluded.
3. Subjects must have had at least 2 and no more than 12 documented episodes of VOCs in the past 12 months at the time of informed consent signing and at randomization (Day 1).
4. Subjects receiving HU must have received it continuously for at least 6 months prior to signing informed consent, and must have been on a stable dose for at least 3 months prior to signing the informed consent, with no anticipated need for dose adjustments during the study including the screening period, in the opinion of the investigator.
5. Female subjects must not be pregnant or breastfeeding and be highly unlikely to become pregnant. Male subjects must be unlikely to impregnate a partner.
6. Must be willing and able to complete all study assessments and procedures, and to communicate effectively with the investigator and site staff.

Exclusion Criteria:

1. Hospital discharge for sickle cell crisis or other vaso-occlusive event within the 4 days prior to randomization (Day 1).
2. Subjects participating in a chronic/prophylactic RBC transfusion program (i.e., regularly scheduled RBC transfusions); any transfusions within 21 days of screening or baseline Hb measurements
3. Subjects with HbF \>25% at screening.
4. Significant kidney disease (eGFR \<45mL/min) and liver dysfunction: alanine aminotransferase or aspartate aminotransferase \>3x upper limit of normal.
5. Body mass index (BMI) \<17.0 kg/m2 and a total body weight \<45 kg; or a BMI \>35 kg/m2.
6. Subjects with known active hepatitis A, hepatitis B, or hepatitis C, with active or acute event of malaria, or who are known to be positive for human immunodeficiency virus (HIV).
7. Stroke requiring medical intervention within 24 weeks prior to randomization (Day 1).
8. Prior exposure to IMR-687.
9. Subjects taking direct acting oral anti-coagulants (apixaban, dabigatran, rivaroxaban, edoxaban, or ticagrelor) or taking warfarin unless they stopped the treatment at least 28 days prior to randomization (Day 1).
10. A history of use of crizanlizumab (Adakveo®) or voxelotor (Oxbryta®) within 6 months prior to signing the informed consent.
11. Receipt of erythropoietin, luspatercept (Reblozyl®)or other hematopoietic growth factor treatment within 3 months of signing the ICF or anticipated need for such agents during the study.
12. Prior gene therapy.
Study of BC3402 in Combination With Azacitidine in Patients With MDS and CMML

The study is to evaluate safety, pharmacokinetics, pharmacodynamics and efficacy of BC3402 in combination with azacitidine (AZA) in subjects with Myelodysplastic Syndrome (MDS) and Chronic myelomonocytic leukemia (CMML)


Eligibility Criteria:
Inclusion Criteria:

1. MDS and CMML subjects with higher risk;
2. Age ≥ 18 years old;
3. Eastern Cooperative Oncology Group score of 0\~2;
4. Not suitable for or refuse to receive hematopoietic stem cell transplant(HSCT);
5. Subjects should take effective contraceptive measures
6. Must sign the Informed Consent Form (ICF), and be able to follow all study procedures.

Exclusion Criteria:

1. Prior exposure to anti-TIM-3 therapy at any time
2. Previous HSCT
3. Live vaccine administered within 4 weeks prior to start of treatment
4. Current use or use within 7 days prior to start of treatment of systemic steroid therapy (\> 10 mg/day prednisone or equivalent) or any immunosuppressive therapy. Topical, inhaled, nasal, ophthalmic steroids are allowed.

Other protocol-defined Inclusion/Exclusion may apply.
Studies of Psychiatric Predisposing Factors, Treatment-related Cardiovascular Effects, and Prognostic Factors Associated With Antimuscarinic Drug (Tolterodine) for Female Overactive Bladder Syndrome

Overactive bladder syndrome (OAB) affects around 17 % of female population. However, the etiology of OAB was complicated and unclear in many aspects. In particular, the research about psychiatric aspect of etiology in OAB was paucity. Besides, research about prognostic factors and impact of cardiovascular system of OAB treatment was also paucity. Therefore the aims of the investigators study were (1) to analyze the etiology of OAB in psychiatric aspects; (2) to analyze the prognostic factors associated with tolterodine treatment; (3) to analyze the differences of cardiac conduction and heart rate variability before and after tolterodine treatment; (4) to analyze the differences of arterial stiffness between non-OAB and OAB female patients, and before and after tolterodine treatment.


Eligibility Criteria:
Inclusion Criteria:

* all cases are female patients with lower urinary tract symptoms
German Evaluation of the Effectiveness of the Psychological Intervention Managing Cancer and Living Meaningfully (CALM)

Purpose of this randomized controlled trial is to test the efficacy of the individual psychotherapeutic intervention Managing Cancer and Living Meaningfully (CALM) in a German sample of patients with advanced cancer. The interventions aim is to reduce depression and distress and support psychological well-being.

Principal hypothesis: The manualized psychotherapeutic intervention (CALM) will result in a significantly greater reduction in depression and psychological distress compared to a non-manualized supportive psycho-oncological intervention. Secondary hypothesis: The manualized psychotherapeutic intervention (CALM) will further result in a significantly improve psychological well-being, quality of life and sense of meaning compared to a non-manualized supportive psycho-oncological intervention.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Fluency in German
* No cognitive impairment indicated in the medical record or by the attending oncologist
* Confirmed diagnosis of solid tumors with UICC (Union Internationale Contre le Cancer) stages III/IV/ metastasized cancer (all with expected survival of 12-18 months)
* PHQ-9 depression score \>=9 or Distress thermometer score \>=5

Exclusion Criteria:

* Major communication difficulties (including language barriers)
* Inability to commit to the required 3-6 psychotherapy sessions
* A score \<20 on the Short Orientation-Memory-Concentration (SOMC) test, indicating cognitive impairment unless deemed suitable at recruiter's discretion
* A score \<70 on the Karnofsky-Performance Status Scale, indicating high physical symptom burden impeding study participation
* Being in psychotherapy
Genomics of Primary Sclerosing Cholangitis (PSC)

Primary Sclerosing Cholangitis (PSC) is a progressive liver disorder of unknown cause. Current evidence suggests that genes, the genetic material we inherit from our parents, in combination with environmental factors, likely play an important role in the development of PSC.

This study is being done to investigate whether genes make people more likely to develop PSC. Discovery of these genes will help us to better understand how PSC developes and subsequently, to apply new approaches for its prevention, diagnosis and treatment.


Eligibility Criteria:
Inclusion Criteria:

* Men, Women, and Children between the ages of 5-90 with a history of PSC.
* PSC patients who have had a liver transplant are eligible.
* Family members (1st degree relatives) of enrolled PSC patients are eligible.

Exclusion Criteria:

* Individuals with no history of PSC or those unable to provide consent.
Music Therapy Model "The Bonny Method of Guided Imagery and Music" on Patients with Rheumatoid Arthritis

The aim of this study is to investigate the effect of music therapy and in particular of the model "The Bonny Method of Guided Imagery and Music (GIM)" in patients with rheumatoid arthritis (RA) in relation to both chronic pain relief and other psychosocial parameters, as well as the effect of the method on caregiver burden.


Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid arthritis (RA)
* Over 18 years of age

Exclusion Criteria:

•None