cyrilzakka/clinical-trials huggingface dataset:
HIV Prevention in Very High Risk Men Who Have Sex With Men

The purpose of this study is to pilot test an innovative program development project in an open trial format an 8-session, individual, cognitive-behavioral therapy based, intervention on ten (10) HIV-infected men who have sex with men who report very high levels (\>10 episodes) of sexual transmission risk behavior (unprotected anal intercourse with serodiscordant partners).

This is an innovative program development project that will, over the next year, pilot test, in an open trial format an 8-session, individual, cognitive-behavioral therapy based, intervention on ten (10) HIV-infected men who have sex with men who report very high levels (\>10 episodes) of sexual transmission risk behavior (unprotected anal intercourse with serodiscordant partners). That is, to pilot test a novel prevention intervention designed to effect reductions in sexual transmission risk behavior among the riskiest men in the largest HIV risk group in the US. Effecting even modest reductions in the mean number of risk acts in this group will likely have substantial public health significance through the number of averted new HIV infections. Traditional secondary HIV intervention strategies (e.g., Information, Motivation, Behavior change (IMB)) models only have modest effects for HIV-positive MSM and there is evidence to suggest that these effects tend to diminish over time.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years old or older
* Self-reports as a man who has sex with men (MSM)
* Self-reports being HIV-infected
* Reports engaging in 10 episodes or more of unprotected anal intercourse (receptive or insertive) in the past three months with male partners who are not HIV-infected or whose serostatus is unknown.
* Is capable of completing and fully understanding the informed consent process and the study procedures and assessments in English

Exclusion Criteria:

* Unable or unwilling to provide informed consent
Different Epidural Initiation Volumes

The aim of this study is to compare the effect of different epidural initiation volumes on postoperative pain scores, local anesthetic requirements, and motor block in patients who undergo patient controlled epidural analgesia for postoperative pain after cesarean section.

90 minutes after combined epidural spinal catheter insertion, three different volumes (5 mL, 10 mL, and 20 mL) are administered with a patient-controlled epidural analgesia (PCEA) device through the epidural catheter. For each group, 0.625% bupivacain + 2 μg/mL fentanyl, is administered.

The visual analog scale, first analgesic demand time, the number of PCEA requirement per hour, morphine requirement, nausea-vomiting, itching, motor block, hypotension, and total consumed analgesic, and ephedrine amounts of the patients are recorded in the recovery room and at postoperative 2, 4, 6, 12 hours.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology risks classification II
* Term pregnant

Exclusion Criteria:

* Multiple pregnancy
* Diabetes mellitus
* Hypertension
* Coagulopathy
* Severe cardiac, neurological and pulmonary disease
* Allergy to the study drugs
* Difficulty in understanding the use of the patient controlled analgesia device
Japanese Coronary Intervention Using Drug Eluting and Perfusion Therapy for Left Main Disease (JDEPTH-LM Registry)

JDEPTH-LM Registry is a prospective, observational, multi-center study designed for the efficacy and safety of Double-effect kissing balloon technique (W-KBT) in left main (LM) bifurcation percutaneous coronary intervention (PCI) using Perfusion balloon (PB) and Drug coated balloon (DCB) in patients with left main coronary artery disease (LMD) with left circumflex artery (LCx) ostium stenosis.

JDEPTH-LM Registry is a prospective observational multi-center study. The investigators will enroll and treat patients in the registry who meet the selection criteria under usual care and for whom PCI with W-KBT following on crossover stenting for LMT-LAD direction, proximal optimization technique (POT), and conventional kissing balloon technique (C-KBT) is the optimal treatment. The operators shall obtain oral or written consent from patients who meet the criteria before performing PCI, indicating the intention to perform PCI with W-KBT, and shall keep records. The investigators will continuously register cases attempting PCI with W-KBT according to the protocol and evaluate its efficacy and safety using data from this multi-center registry.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Patient with stable coronary artery disease, non-ST-elevation myocardial infarction, or unstable angina
3. Left main disease confirmed by coronary angiography or coronary CT angiography
4. Clinical and anatomical eligibility for PCI as agreed by the local Heart Team
5. Patient with consent prior to undergoing PCI
6. Left main Medina classification (1,1,1), (1,0,1), (0,1,1), (0,0,1) confirmed by coronary angiography
7. De novo target lesion in LMT-LAD amenable for crossover stenting with provisional side-branch approach as determined by PCI operator
8. De novo ostial LCx lesions
9. Lesion indicated in No. 8 with a length of less than 10 mm or a stenosis of less than 70% confirmed by coronary angiography

Exclusion Criteria:

1. Inability to provide written informed consent
2. Patient with a history of ST-elevation myocardial infarction within the previous 1 week
3. Patient in a state of cardiogenic shock
4. Patient with a history of coronary artery bypass grafting
5. Patient with malignant tumors or other conditions with a life expectancy of less than one year
6. Patient considered suitable for stent placement in the ostial LCx from a medical perspective
7. Patient considered unsuitable for anti-thrombotic therapy after PCI
8. Other patient whom the investigator deems unsuitable for the safe conduct of LM-PCI, including W-KBT
Day 3 Fresh Transfer Followed by Day 3 or Day 5 Vitrification of Supernumerary Embryos

This monocenter academic study aims to evaluate the effectiveness and cost effectiveness of two different strategies: fresh Embryo Transfer (ET) on day 3 followed by cryopreservation of cleavage-stage (Day 3) embryos versus blastocyst-stage (Day 5) embryos.

The primary outcome is the cumulative pregnancy rate after all transfers (fresh and/or frozen embryo transfer cycles which might take about 1 year), up to two sequential cycles. The secondary outcome concerns a cost analysis of both strategies from the healthcare payer's perspective.


Eligibility Criteria:
Inclusion Criteria:

* subfertile women planned for the first or second oocyte retrieval for in vitro fertilisation (IVF)/Intracytoplasmic sperm injection (ICSI) treatment
* who are older than 18 and less than 38 years old
* who have normal Follicle Stimulating Hormone (FSH) and normal Anti-Mullerian Hormone (AMH) levels

Exclusion Criteria:

* treatment with donor oocytes or donor embryos
* patients planned for Pre-implantation Genetic Diagnosis (PGD)
* Patients with BMI\>30
* patients with endometriosis grade III-IV
BASET Scoring: A Novel Simple Biometric Score and Potential Tool for Diagnosis and Grading of Obstructive Sleep Apnea Syndrome (OSAS) Patients

this study aims to assess the validity of BASET scoring as a new potential tool for diagnosis and grading the severity of OSAS patients and as screening of the risk factors of OSAS.

The study will be conducted on one hundred twenty-six patients attending to sleep disorders breathing Unit, Chest Department at Mansoura University Hospital confirmed by polysomnography

Eligibility Criteria:
Inclusion Criteria:

* All adult patients after having full night polysomnography.

Exclusion Criteria:

* Pregnant patients
A Pilot Feasibility Study Comparing Smartphone Home-based Rehabilitation Program Against the Usual Hospital and Outpatient Physiotherapy Care on Clinical and Cost Effectiveness for Total Knee Replacement Patients

Knee osteoarthritis (OA) is a common, chronic, and costly condition whilst total knee replacement (TKR) is a common orthopaedic surgical intervention. In Singapore, after TKR surgery, nearly all patients who are home discharged are referred to hospital-based outpatient rehabilitation. Although outpatient rehabilitation attendance is associated with better functional outcomes, access to rehabilitation care is limited as outpatient rehabilitation is costly and inconvenient for patients and their caregivers, resulting in suboptimal adherence.

A smartphone home-based rehabilitation program provides the best access to rehabilitation care and is a potential alternative for the majority of patients who do not require intensive "hands-on" rehabilitation therapy.

The primary aim of this randomized controlled trial is to compare patient functional outcomes and cost-effectiveness of this innovative smartphone home-based exercise program versus that of currently standard, hospital-based outpatient rehabilitation program among post TKR patients in the Department of Physiotherapy, Singapore General Hospital.

Thirty patients undergoing TKR for knee OA will be randomly assigned to receive either smartphone home-based rehabilitation program or hospital-based rehabilitation program following surgery for a rehabilitation period of 24 weeks. The primary patient functional outcome will be fast gait speed. Outcomes will be assessed preoperatively, at 12-week and 24-week after surgery by an assessor masked to group allocation.

If shown to be non-inferior to the standard outpatient rehabilitation, smartphone home-based exercise program can be recommended as a cost effective treatment option for patients with TKR.

Eligibility Criteria:
Inclusion Criteria:

1. Primary unilateral total knee replacement
2. Age \>= 45 years
3. Under the Enhanced Recovery After Surgery (ERAS) programme (discharge on post-operative day 0/1)
4. Able to ambulate independently without an assistive device
5. Willingness to be randomized to either smartphone home-based rehabilitation program or outpatient rehabilitation
6. Ability to provide informed consent
7. Able to operate phone application and use online platform
8. Able to read and understand English or Mandarin

Exclusion Criteria:

1. Rheumatoid arthritis and other systemic arthritis
2. Significant back or other non-knee pain
3. A previous history of stroke and other major neurological conditions
4. An intention to transfer to step-down care facilities post-operatively
Advanced Telemonitoring of Patients With Heart Failure in Home Environment

Heart failure is currently not only a major medical but also a socio-economic problem. Its prevalence is estimated at 1-2% of the population with an exponential increase in older age groups. A very important part of the treatment of heart failure is the gradual uptitration of therapy to the maximum tolerated doses. Properly conducted therapy titration requires more frequent patient contact. Thanks to the introduction of telemedicine techniques, the investigators can communicate more effectively with the patient, reach the target doses of heart failure medication faster and subsequently reduce the number of hospitalizations due to worsening of heart failure.

This study investigates effect of advanced telemonitoring of patients with heart failure in home environment.


Eligibility Criteria:
Inclusion Criteria:

* LVEF ≤ 40%
* exclusion of obstructive coronary artery disease
* NTproBNP ≥ 125pg/ml
* ≥ 60 years of age
* Informed written and verbal consent
* Able to participate in study activities

Exclusion Criteria:

* LVEF ≥ 40%
* Ischaemic ethiology of cardiomyopathy
* NTproBNP ≤ 125pg/ml
* Severe psychological disturbances
* Absence of collaboration (informed consent)
* BP ≤ 110mmHg without hypertensive medication
Addressing Financial Hardship in Adolescent and Young Adult Cancer Survivors

This study seeks to develop, test, and revise an intervention designed to address financial hardship (FinFit) among adolescent and young adult (AYA) cancer survivors.

PRIMARY OBJECTIVE:

I. To synthesize CHAT and LIFT to create FinFit, an intervention to address the unique, multilevel determinants of financial hardship among AYAs treated in community oncology practices.

OUTLINE: This is an observational study.

STEP 1: CHAT participants complete an in-depth interview on study.

STEP 2: LIFT participants complete a focus group or an interview on study.

STEP 3: Participants from steps 1 and 2 complete member-checking processes on study.

Eligibility Criteria:
Inclusion Criteria:

- Adults (ages 18 years of age or older) with perspectives on CHAT, LIFT, FinFit's proposed forms, and those from any community-based practices that were originally part of CHAT or LIFT administration are eligible for inclusion in Aim 1 interviews.

Exclusion Criteria:

- Those not involved in any of the preliminary programs, not familiar with the proposed forms of FinFit, or not involved in the proposed implementation sites will not be eligible for participation.
Immunogenicity and Safety of Vaccine Against Tetanus and Diphtheria.

A single blind, randomized, comparative, multicentre clinical trial of the immunogenicity and safety of booster immunization with bivalent vaccine against tetanus and diphtheria CLODIVAC (IBSS BIOMED S.A.) and Td-Impfstoff Mérieux (Sanofi Pasteur) in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

1. Approved informed consent.
2. Men and women aged 18- 65 years.
3. Written confirmation on previous immunization against diphtheria and tetanus not older than 16 years and not younger than 4 years.

Exclusion Criteria:

1. Subject with acute infectious diseases.
2. Subject allergic to any of the substances of the IMP administered in clinical trial.
3. Subject with Guillain-Barré syndrome or neuropathy, an anaphylactic or other allergic reactions after previous vaccination against tetanus or diphtheria.
4. Subject with primary or secondary immunodeficiency (e.g. congenital immunodeficiency, HIV infection, organ or bone marrow transplantation, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, generalized malignancy, drugs or other causes induced immunodeficiency).
5. Subject with progressive or unstable neurological disorder.
6. Subject with severe thrombocytopenia or any coagulation disorder not allowing the intramuscular administration.
7. Subject with blood product treatment, including immunoglobulins within the last 90 days prior to study entry.
8. Subject vaccinated less than 14 days inactivated or live vaccine prior to study entry.
9. Pregnant woman and breastfeeding (anamnestically).
10. Subject incapable of cooperation.
11. Alcohol or drug abuse.
12. Subject currently participating in another clinical trial or in drug evaluation, within 4 weeks prior to study entry.
13. Subjects requiring vaccination against tetanus after severe injury.
14. Any other condition that in the Investigator's opinion may affect the safety of the test participant or the integrity of data obtained during the study.
PPA Tele-Savvy: A Pilot Study of an Online Intervention for Caregivers of Persons Living With PPA

The primary goal of this pilot project is to adapt an evidence-informed on-line psychoeducation program (Tele-Savvy) to address the unique challenges facing informal caregivers of those living with PPA and geared toward achieving caregiver mastery in this population.

The primary goal of this pilot project is to develop an evidence-informed on-line psychoeducation program (Tele-Savvy) based on the well-established Savvy Caregiver program to address the unique challenges facing informal caregivers of those living with Primary Progressive Aphasia (PPA) and to help these caregivers achieve mastery. Key elements of the adaptation process are to identify and adapt mechanistic elements of the Tele-Savvy intervention (increasing self-efficacy, mastery of new skills, increased knowledge of disease-specific symptoms and trajectories, problem-solving skills). We will engage PPA caregivers in the process of adapting the existing Tele-Savvy program to fit their needs and then pilot test the adapted PPA Tele-Savvy program.

Eligibility Criteria:
Inclusion Criteria:

Aim 1:

Informal (family or friends) caregivers of persons living with or deceased from PPA.

Age 18 or over Providing or have provided at least 2 hours per day of unpaid assistance, on average, for a person in the early-middle stage of PPA.

Must have access to a computer with adequate internet connection. Able to use a videoconferencing platform and receive email. Participants must be able to read, speak and understand English and have no uncorrectable vision or hearing deficits that might impede participation.

Aim 2:

Informal (family or friends) caregivers of persons living with PPA. Age 18 or over Providing at least 2 hours per day of unpaid assistance, on average, for a person in the early-middle stage of PPA.

Must have access to a computer with adequate internet connection. Able to use a videoconferencing platform and receive email. Must be able to read, speak and understand English and have no uncorrectable vision or hearing deficits that might impede participation.

Exclusion Criteria:

-
Study on the microRNA Expression Level in Postmenopausal Osteoporosis

The miRNA plays an important regulation role in gene expression, and also closely related to bone metabolism. Previous research found that postmenopausal osteoporosis with kidney Yin deficiency syndrome (POP) is associated with CLCF1 gene. This project proposed by bioinformatics prediction CLCF1 targeted regulation of miRNAs, and use the 3 'UTR dual luciferase report system for target validation, aimed at the miRNA levels to explore postmenopausal osteoporosis molecular mechanism with kidney Yin deficiency syndrome.


Eligibility Criteria:
Inclusion Criteria:

* The Participants who volunteer to be test subjects, and can accept experimental drugs, and promise to finish the course should sign the informed consent.
* Female ages 45 to 75 had gone through natural menopause before two years
* In accordance with the western medicine diagnostic criteria of osteoporosis and belong to kidney Yin deficiency syndrome differentiation of traditional Chinese medicine certificate;
* In accordance with the western medicine diagnostic criteria;
* In accordance with TCM diagnostic methods; .If any of the above answers are no, The subjects couldn't in the study.

Exclusion Criteria:

* Do not accord with standard of the western medicine diagnosis and TCM diagnostic methods
* Age: \<44 and \> 76 years old;
* With hyperparathyroidism, osteomalacia, rheumatoid arthritis, multiple myeloma and other serious complications such as secondary osteoporosis; Late or deformity, disability, loss of labor;
* With cardiovascular, cerebrovascular, liver, kidney and hematopoietic system and other serious primary diseases;
* Psychosis or alzheimer's patients;
* Nearly three months, the use of hormone replacement therapy (HRT) and taking calcitonin, nearly six months has used double phosphonic acid salt for 15 days, etc.;
* This medicine allergic constitution or composition of known to have allergies;
* In a critical condition, It's difficult to make exact evaluators to efficacy and safety of the new drugs;
Treatment With Nivolumab at the Fixed Dose 40 mg (Nivo40) in Patients With Relapsed/Refractory Hodgkins Lymphoma

A phase I/II trial to evaluate the safety and efficacy of nivolumab at the fixed dose 40 mg in patients with relapsed or refractory Hodgkins lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis: Histologically confirmed Hodgkins lymphoma
* Relapsed or refractory disease after at least two prior lines of treatment
* Age 18-70 years old
* Signed informed consent
* No severe concurrent illness

Exclusion Criteria:

* Uncontrolled bacterial or fungal infection at the time of enrollment
* Requirement for vasopressor support at the time of enrollment
* Karnofsky index \<30%
* Pregnancy
* Somatic or psychiatric disorder making the patient unable to sign informed consent
* Active or prior documented autoimmune disease requiring systemic treatment.
ICG- Livertest Versus New Biomarkers as Prognostic Markers in Critically Ill ICG- Livertest Versus New Biomarkers as Prognostic Markers in Critically Ill

ICG- Leberfunktionstest versus "neue" Biomarker als prognostischer Marker bei intensivmedizischen Patienten


Eligibility Criteria:
Inclusion criteria: Gruppe 1:

* Intensiv-Patienten mit Verbrennungen \> 10% der Körperoberfläche
* Alter \> 18

Gruppe 2:

* Intensivpatienten nach grossen chirurgischen Eingriffen
* Alter \> 18

Gruppe 3:

* Polytraumatisierte, intensivpflichtige Patienten
* Alter \> 18

Exclusion criteria: • Alter \< 18

* Schwangerschaft
* Einschluss in eine andere Studie
* Moribunde Patienten
* Patienten, die kein Deutsch verstehen
* Jodunverträglichkeit
Homoharringtonine and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia

Phase II trial to study the effectiveness of homoharringtonine and interferon alfa in treating patients with chronic myelogenous leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with interferon alfa may kill more cancer cells.

OBJECTIVES:

I. Determine the efficacy of homoharringtonine administered simultaneously with interferon alpha in achieving complete cytogenetic response in patients with chronic myelogenous leukemia in chronic phase.

OUTLINE:

Single-Agent Chemotherapy plus Biological Response Modifier Therapy. Homoharringtonine, HH, NSC-141633; plus Interferon alfa (Schering), IFN-A, NSC-377523.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Chronic myelogenous leukemia (CML) in chronic phase
* Clonal evolution (i.e., the presence of clones other than the Ph chromosome) allowed Ph chromosome variants or complex Ph chromosome translocations are not considered disease acceleration
* Ineligible for known therapy of higher efficacy or priority
* Allogeneic bone marrow transplantation should be considered priority therapy for CML patients with a matched related donor
* No blastic phase CML (30% or more blasts in peripheral blood or bone marrow)
* No accelerated phase CML, defined as any of the following: 15% or more peripheral or marrow blasts or 30% or more blasts and promyelocytes 20% or more peripheral or marrow basophils
* Thrombocytopenia (platelets less than 100,000) unrelated to therapy
* Documented extramedullary disease outside of liver or spleen

PATIENT CHARACTERISTICS:

* Age: 15 and over
* Performance status: Zubrod 0-2
* Life expectancy: Sufficient to fully evaluate the effects of 2 courses of therapy
* Bilirubin no greater than 2.0 mg/dL
* SGOT less than 300
* Creatinine less than 2.0 mg/dL OR creatinine clearance at least 60 mL/min
* No severe heart disease (class III/IV)
* No pregnant or nursing women
* Effective contraception required of fertile women

PRIOR CONCURRENT THERAPY:

* No prior interferon alpha
* At least 2 weeks since antileukemic therapy, with recovery required
* Patients who received hydroxyurea within the past 2 weeks and have WBC greater than 50,000 may enter protocol after discussion with the primary investigator