cyrilzakka/clinical-trials huggingface dataset:
The Study on the Effectiveness and Safety of Electroacupuncture at ST36 in Treating Primary Premature Ejaculation

A pilot prospective single-arm cohort study on the Effectiveness and Safety of Electroacupuncture at ST36(Zusanli) in Treating Primary Premature Ejaculation

This is a pilot prospective single-arm cohort study to verify the Effectiveness and Safety of Electroacupuncture at ST36(Zusanli) in Treating Primary Premature Ejaculation, based on the result on animal study that daily electroacupuncture at ST36(Zusanli) for 30 days could delay the ejaculation of male SD rats.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 60
2. Heterosexual, with a single, stable partner for more than 6 months
3. Symptoms of primary premature ejaculation: Complaints of IELT ≤ 1 min since the first sexual intercourse, and poor ability to control ejaculation leading to anxiety, annoyance, depression or/and avoidance of sexual life and other negative effects.

Exclusion Criteria:

1. Urinary system infection: Urinary tract infection symptoms (such as urinary tract irritation symptoms, prostatitis symptoms, blood semen, etc.) or urine routine shows abnormal white blood cells and red blood cells
2. Abnormal androgen: sex hormone examination shows abnormal androgen (testosterone)
3. Systemic diseases: ask about medical history of hypertension, diabetes, alcohol dependence, coronary heart disease and mental disorders
4. Organic abnormalities: Abnormal development of external genitalia, bilateral testes, epididymis and spermatic cords with obvious abnormalities on palpation
5. History of surgery and trauma: Dorsal nerve block of the penis, erectile function-related surgery, prostate surgery, pelvic surgery, etc.
6. Influence of drugs: within one month before enrollment, have taken SSRI, tramadol and other drugs to treat diseases
7. Allergy to dapoxetine and lidocaine
8. History of drug, alcohol or substance abuse in the past 6 months
9. Accompanied by erectile dysfunction: International Index of Erectile Function-5 (International Index of Erectile Function, IIEF-5) score ≤ 21 points
International Registry of Congenital Portosystemic Shunt (IRCPSS)

Congenital Portosystemic Shunt (CPSS) is a rare condition important by the multiplicity and severity of associated complications.

CPSS is venous anomaly in which blood coming from the intestines only partially passes through the liver.

This leads to the accumulation of potentially toxic factors that cause systemic effects.

Complications vary among the individuals, and currently, it is challenging to predict which individuals will develop severe complications.

The IRCPSS registry is established with the aim of centralizing detailed clinical follow-up and biological information from participants around the world who suffer from Congenital Portosystemic Shunt (CPSS). A multidisciplinary consortium of experts is collaborating to enhance our understanding of the prevalence, natural history, individual risks, and physiopathology of the disease through the IRCPSS registry.


Eligibility Criteria:
Inclusion Criteria:

Individual with CPSS

Exclusion Criteria:

Secondary shunt without evidence of congenital shunt
A Study Evaluating the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-6620 in Treatment Naïve Subjects With Chronic Hepatitis C Virus Infection

A Double-Blind, Randomized, Placebo-Controlled, Multiple Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-6620 in Treatment Naïve Subjects with Chronic Hepatitis C Virus Infection.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects (18-60 years of age or up to 64 years of age with approval)
* Documented chronic HCV infection to be of at least 6 months duration and plasma HCV RNA ≥ 5 log10 IU/mL at screening.
* HCV treatment naïve
* Estimated creatinine clearance ≥ 80 mL/min,
* QTcF interval ≤ 450 msec, QRS duration \< 100 msec, PR interval \< 220 msec,
* Body mass index (BMI) of 19.0 to 34.0 kg/m2, inclusive.
* Eligible subjects must also be HCV treatment-naïve.

Exclusion Criteria:

* Subjects with prior documentation of cirrhosis, excessive current alcohol intake, any evidence of hepatocellular carcinoma (i.e., α-fetoprotein \> 50 ng/mL or by any other standard of care measure)
* Urine drug screen positive for illicit/illegal drugs
* ALT and AST levels \> 5 times the upper limit of the normal range (ULN)
* Direct bilirubin \> ULN, clinical or other laboratory evidence of hepatic decompensation (i.e., platelets \< 100,000/mm3, prothrombin time ≥ 1.5 × ULN and albumin \< 3.5 g/dL) are not eligible for study participation.
* Subjects with an absolute neutrophil count (ANC) \< 1,000 cells/mm3 (\< 750 cells/mm3 for black or African-American subjects), hemoglobin (Hb) \< 11 g/dL,
* Coinfected with hepatitis B virus (HBV), human immunodeficiency virus (HIV), or another HCV genotype (other than type 1 for Cohorts 1-5 and type 2 or 3 for Cohort 6) are not eligible for study participation.
* Evidence of hepatocellular carcinoma
* Any sign of decompensated liver disease, including prothrombin time ≥ 1.5 X ULN, platelets \< 100,000/mm3 or albumin \< 3.5 g/dL at screening OR current or prior history of clinical hepatic decompensation (e.g., ascites, jaundice, encephalopathy or variceal hemorrhage)
* History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
* History of a primary gastrointestinal disorder that could interfere with the absorption of the study drug or that could interfere with normal gastrointestinal anatomy or motility
Postoperative Epidural Analgesia in Spine Fusion Surgery

we aim to compare the analgesic effect of 0.125% bupivacaine HCL, 0.125% bupivacaine HCL + Morphine sulphate 3 mg, 0.125% bupivacaine HCL + Fentanyl 100 micro gram both at rest and mobilization maneuvers.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing spine fusion surgery.

Exclusion Criteria:

* Drug addiction. Intraoperative dural tear. Uses of opioids drug for any reason in the previous 48 hours. Mental dysfunction. Spinal fusion for any infectious or malignant causes.
Erythropoietin for Infants With Brain Injuries Due to Oxygen Deprivation at Birth

Erythropoietin (Epo) is a hormone normally found in the body that may protect brain cells from damage due to lack of oxygen. This study will evaluate the safety of high-dose Epo in infants who did not get enough oxygen during birth.

Damage to the central nervous system as a result of oxygen deprivation at birth is a major cause of life-long mental and developmental handicaps. When there is not enough oxygen in the blood (hypoxemia) the brain is deprived of oxygen. Some brain cells respond by producing Epo. Epo then binds to oxygen-deprived brain cells. This binding triggers chemical reactions within the brain cell that prevent cell death. Epo also reduces inflammation around the brain cells and acts as an antioxidant. In animal studies, recombinant Epo (rEpo) administration, even up to six hours after oxygen deprivation, reduced subsequent brain injury by 50% to 70%.

Epo has been used by neonatologists to stimulate erythropoiesis (red blood cell production) and reduce the incidence of blood transfusions. Doses of rEpo required for protection of brain cells are considerably higher than those traditionally used by neonatologists.

This study will evaluate the pharmacokinetics, biologic effect, and safety of high dose Epo in neonates with brain injury due to hypoxemia.

Within six hours of birth, each eligible infant will receive one dose of rEpo intravenously. Any infants who require a lumbar puncture during the first week of life will have levels of natural Epo and rEpo in their spinal fluid measured. Blood tests will be used to measure the antioxidant effect of Epo and the impact on red blood cell production. Neurodevelopmental outcome will be measured at 6 and 12 months of age.

Eligibility Criteria:
Inclusion Criteria

* Infant 6 hours of age or less
* Apgar scores less than or equal to 3 at 1 and 5 minutes
* Weight greater than 2500 grams (5.5 lbs)
* Central venous line in place

Exclusion Criteria

* infants are ineligible if they do not meet the inclusion criteria above
Integrative and Complementary Health Practices (PICS)

Complementary medicine, considered an unconventional approach, is performed in conjunction with conventional medicine. In Brazil, Integrative and Complementary Practices in Health have been inserted by the National Ordinance of Integrative and Complementary Practices. The aim of this study is to evaluate the effects of laying on of hands with spiritual connection by the Spiritist Passe about mental and physical health and quality of life of individuals.

Type of study: randomized controlled trial. The sample will consist of cancer and epileptic patients including individuals aged eigtheen years and over. Patients will be referred by health professionals and social workers from Lar da Charidade, Clinics Hospital and attachments, as well as from the general community and will be invited to participate in the study at the Center for Integrative and Complementary Practices of the Clinics Hospital.

Participants will answer the questionnaires before the start of the study, after eight sessions and fiveteen days or the end of the research according to the group. The participants will be submitted to blood collection, when necessary.

Eligibility Criteria:
Inclusion Criteria:

* Cancer patients: diagnosis of neoplasia receiving parenteral chemotherapy.
* Epileptic patients: clinical diagnosis of focal epilepsy

Exclusion Criteria:

* Cancer patients: pregnant women, unable to understand the questionnaires; non-attendance of 3 sessions of therapy application and refusal to sign the consent form.
* Epileptic patients: people unable to understand the questionnaires; non-attendance of 3 sessions of therapy application and refusal to sign the consent form, as well as special groups (pregnant women, newly diagnosed epilepsy).
Composite Health Assessment Risk Model (CHARM) for Older Adults (BMT CTN 1704)

Prospective observational multicenter study of allogeneic Hematopoietic Stem Cell Transplantation (HCT) in recipients 60 years and older to assess important determinants of health status to be combined into a composite health risk model to improve risk assessment of non-relapse mortality (NRM).

At baseline, standardized Geriatric Assessment (GA) tools incorporating subject reported data and bedside testing will be collected. HCT-Comorbidity Index (CI) scores will be assigned and C-reactive protein (CRP) and albumin will be measured locally. Serial measures at 3, 6, and 12 months for frailty, skilled facility admission, and quality of life (QOL) using PROMIS measures for physical function, depression and anxiety will be determined. Graft Versus Host Disease (GVHD) through one year, serious toxicities through day 100, cognitive status at day 100 and causes of death will be captured.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is \> 60.0 years old at time of enrollment.
2. Hematological malignancy as an indication for allogeneic transplantation.
3. Eligible for allogeneic transplantation based on institutional standards
4. First allogeneic transplant planned. Any conditioning regimen and allogeneic donor is acceptable.
5. Able to speak and read English. Spanish, and Mandarin will be acceptable when sites have ability to perform healthcare provider tests in those languages.
6. Written informed consent

Exclusion Criteria:

1. Prior allogeneic HCT
Peer-Led Diet and Exercise Intervention

The majority of older Veterans do not meet the minimum healthy diet or physical activity recommendations, despite known benefits. Identifying novel ways to increase adherence to rehabilitation programs that improve dietary quality and physical activity may reduce the risk of disability in older Veterans. Peer-based interventions may be one method to facilitate lasting behavioral change since peers often share a common culture and knowledge about the problems that their community experiences. The investigators propose to develop and evaluate a novel peer-led diet and exercise intervention that targets older Veterans with multiple chronic health conditions. Successful development and pilot of this intervention will provide the preliminary data for a larger multisite trial focused on the use of peer-led interventions to improve long-term compliance to lifestyle interventions in older Veterans.

Over the next ten years the share of Veterans age 65+ years will increase to over 50% of the total Veteran population. The ability to safely maintain mobility with aging is critical. Older Veterans with multiple chronic health conditions are more likely to experience mobility decline and report reduced physical activity levels and poor dietary quality. While a multitude of interventions have attempted to address poor diet and physical inactivity in older adults; most have utilized resource-intensive professionally led diet OR exercise interventions, and few have focused on the unique needs of older Veterans. Peer support offers a potentially low-cost, easily scalable approach to encourage long-term dietary and physical activity change.

In this proposal the investigators seek to develop and pilot a 12-week peer-led lifestyle intervention that targets older Veterans with multiple chronic health conditions and dysmobility, in two diverse urban areas with a high percentage of underrepresented minority Veteran populations (Baltimore, MD and San Antonio, TX). The investigators will develop a theory-driven, peer-led nutrition and exercise intervention tailored for older Veterans with dysmobility. The investigators will also determine the feasibility and acceptability of the peer-led intervention as well as the estimated magnitude and potential impact on selected outcomes (i.e diet quality and mobility) in older Veterans with dysmobility and multiple chronic health conditions.

Eligibility Criteria:
Inclusion Criteria:

* Self-reported difficulty in at least one of the following activities: Walking quickly across the street, walking one mile, ascending one flight of stairs, rising from a chair without using arms
* Self-reports at least two chronic medical conditions such as hypertension, diabetes, hyperlipidemia, or coronary artery disease
* Speaks English

Exclusion Criteria:

* high cardiovascular risk
* using home oxygen
* contraindications to an exercise intervention
* dementia
* regular exercise participation
* current participation in a weight loss intervention
* acute psychosis, major depression, or behavior that preventions group interaction
Pilot Examination of a Telehealth, Cognitive-behavioral Therapy for Adolescents

This project is designed to refine a 6-week telehealth therapy intervention targeting negative interpersonal beliefs among community-dwelling youth with elevated levels of psychopathology. The study design is a single-arm open trial. The intervention is comprised of weekly teen and parent group cognitive-behavioral therapy, regular check-ins with the youths, and a module embedded throughout treatment that targets negative interpersonal beliefs (i.e., perceived social disconnection, burdensomeness). The goal of the study is to evaluate the feasibility of the treatment and assessment protocol, refine the intervention based on qualitative feedback, and evaluate changes in negative interpersonal beliefs. Youths complete two qualitative interviews about their interpersonal relationships and their feedback about the intervention.


Eligibility Criteria:
Inclusion Criteria:

* 14-17 years of age
* endorsement of perceived burdensomeness (score of greater than 3 on the Interpersonal Needs Questionnaire)
* emotional/behavioral problems broadly defined (Pediatric Symptom Checklist score greater than 14)
* The family being under-resourced (i.e., family is below the US census poverty line; family is receiving economic or medical government aid; child is receiving reduced fee lunch; or primary caregiver is currently unemployed) or living in an under-resourced community (i.e., majority of households in the family's census block lives under the poverty line).

Exclusion Criteria:

* Current need for acute psychiatric care (e.g., inpatient hospitalization)
* autism spectrum disorder
* psychosis
* other condition(s) related to pronounced cognitive impairment (i.e., marked impairment that precludes completion of questionnaires, verbal communication)
* Wards of the state
A Study of Niaspan on Endothelium-Dependent and Endothelium-Independent Vascular Reactivity (0000-093)

A study to evaluate the inter- and intra subject variabilities of flow-mediated dilation (FMD) of brachial artery and nitroglycerin (GTN) induced dilation of brachial artery.


Eligibility Criteria:
Inclusion Criteria:

* Female subjects of reproductive potential test negative for pregnancy and agree to use appropriate methods of contraception throughout the study
* Subject is in good health (other than history of high cholesterol)
* Subject is a non-smoker

Exclusion Criteria:

* Subject has a history of stroke, seizures or major neurological disorder
* Subject has a history of cancer
* Subject is unable to refrain from or anticipates the use any prescription or non-prescription drugs
* Subjects consumes excessive amounts of alcohol or caffeine
Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Correction of Temple Hollowing

This study will evaluate the safety and effectiveness of JUVÉDERM VOLUMA XC injectable gel in adult participants seeking correction of temple hollowing.


Eligibility Criteria:
Inclusion Criteria:

-Has temple hollowing and is seeking restoration in the temple area.

Exclusion Criteria:

* Has temple hollowing due to due to trauma, congenital malformations, or lipodystrophy
* Has received permanent facial implants in the face or neck
* Has undergone fat injections
* Has tattoos, piercings, facial hair or scars that would interfere with visual assessment of the temple
* Has undergone semipermanent dermal filler treatment in the temple or mid-face within the past 36 months
* Has undergone dermal filler injections above the subnasale within the past 24 months
* Has temporal arteritis or history of temporal arteritis
* Has temporomandibular joint dysfunction
* Has eye inflammation or infection
* Has a history of detached retina, retinal vascular occlusion, narrow angle glaucoma, or neovascular eye disease
* Has ever received a facelift, browlift, or facial reconstructive surgery
* Has undergone mesotherapy or cosmetic treatment (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, liposuction, lipolysis, or other ablative procedures) anywhere in the face or neck or botulinum toxin injections within the past 6 months
* Has experienced trauma to the temple within the past 6 months or has residual deficiencies, deformities, or scarring
* Has a tendency to develop hypertrophic scarring
* Has a history of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), hyaluronic acid products, or Streptococcal protein
* Has porphyria or untreated epilepsy
* Has active autoimmune disease
* Has current cutaneous or mucosal inflammatory or infectious processes
* Is on a lidocaine, anticoagulation therapy
Esketamine Combined Pulsed Radiofrequency for Acute/Subacute Zoster-associated Trigeminal Neuralgia

To assess the 1-month effects and safety of esketamine combined PRF and standardized treatment to relieve pain in patients with acute/subacute zoster-related trigeminal neuralgia(ZRTN).

The investigators aim to investigate whether or not esketamine combined PRF and standardized treatment to relieve pain in patients with acute/subacute ZRTN , and seek a safe, and effective treatment for refractory patients with ZRTN

Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years;
2. History of HZ within the last three months;
3. Lesions located in the trigeminal nerve or its branches innervated regions；
4. Numeric Rating Scale (NRS) pain score≥4 (NRS, 0 = no pain, 10= worst possible pain) with pharmacotherapy;
5. Planned to perform CT-guided PRF treatment of the Gasserian ganglion .

Exclusion Criteria:

1. Obstructive sleep apnoea syndrome;
2. Those who receive other invasive treatments, such as spinal cord stimulation;
3. A history of systemic immune diseases, organ transplantation, or cancers;
4. A history of severe cardiopulmonary, hepatic or renal dysfunction;
5. A history of schizophrenia, epilepsy, or myasthenia gravis, delirium;
6. Comorbid hyperthyroidism or phaeochromocytoma;
7. Recent history of drug abuse;
8. Having contraindications to esketamine;
9. Communication difficulties.

Withdrawal criteria

1. Lost to follow-up during the study;
2. Not perform the planned operation;
3. Receiving other treatment regimes during the study period;
4. Not suitable for continuing the study for emerging severe comorbidities or special physiological changes during the study;
5. Voluntary withdrawal from the study.
Sinus Disease in Young Children With Cystic Fibrosis

This is a prospective, observational study examining the impact of highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators on chronic rhinosinusitis (CRS) and olfactory dysfunction (OD) in young children with cystic fibrosis (YCwCF). This study involves two groups: children 2-8 years old, inclusive at initial visit, receiving highly effective modulator therapy (HEMT), and a control group of children 2-8 years old, inclusive at initial visit, not receiving HEMT. Outcomes will include sinus magnetic resonance imaging (MRI) scans, olfactory tests, and quality of life surveys obtained over a two-year period.

This multi-center, prospective, observational study investigates the effects of highly effective modulator therapy (HEMT) on chronic rhinosinusitis (CRS) and olfactory dysfunction (OD) in young children with cystic fibrosis (YCwCF). The study spans two years and includes two distinct groups of children with cystic fibrosis: children ≤ 8 years old receiving HEMT and a control group of children ≤ 8 not receiving HEMT. The study aims to assess the efficacy of HEMT in improving sinus health and olfactory capabilities in this young demographic.

Key assessments include magnetic resonance imaging (MRI) sinus opacification, olfactory bulb volume measured via MRI, objective olfactory testing, and various quality (QOL) surveys. This investigation seeks to characterize the severity of CRS and OD in YCwCF, and to elucidate if early initiation of HEMT improves CRS and OD .

In the HEMT group, participants will have a pre-HEMT assessment followed by 1-year and 2-year post-HEMT evaluations. In the control/non-HEMT group, participants will undergo parallel assessments at baseline, 1-year, and 2-year intervals to track the natural progression of CRS and OD without HEMT.

Eligibility Criteria:
Inclusion Criteria:

HEMT Group:

* Children with documentation of a CF diagnosis
* Age 2-8 years old at first study visit
* CFTR mutation consistent with FDA labeled indication of highly effective modulator therapy (ivacaftor or elexacaftor/tezacaftor/ivacaftor)
* Clinician intent to prescribe ivacaftor or ETI so that enrollment is before start of HEMT

Non-HEMT/Control Group:

* Children with documentation of a CF diagnosis
* Age 2-8 years at first study visit
* Ineligible for highly effective modulator therapy (ivacaftor or elexacaftor/tezacaftor/ivacaftor) based on CFTR mutation or clinical decision not to initiate HEMT if eligible

Exclusion Criteria:

For Both Groups:

* Use of an investigational drug within 28 days prior to the first study visit
* Use of ivacaftor or elexacaftor/tezacaftor/ivacaftor within the 180 days prior to and including the first study visit
* Use of chronic oral corticosteroids within the 28 days prior to and including the first study visit.
* Sinus surgery within 180 days prior to the first study visit