cyrilzakka/clinical-trials huggingface dataset:
A Healthy Volunteer Study Evaluating the the Safety, Tolerability, and Pharmacokinetics of RT234

The objective of this two part study was to demonstrate safety, tolerability, and pharmacokinetics of RT234 in healthy volunteers.

This study is also known as Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 1 (VIPAH-PRN 1) study

This study was designed to evaluate safety and tolerability and to characterize the PK profiles of single and repeated doses of inhaled vardenafil as RT234. In addition, vardenafil PK after single 0.6 mg doses of RT234 was compared to that following administration of a single 20 mg dose of oral vardenafil tablets.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or female, 18 to 45 years of age (inclusive at time of informed consent)
2. Normal heart, lung, kidney, and liver function based on physical examination
3. Systolic blood pressure of 100-145 mmHg, diastolic blood pressure of 50-90 mmHg, and a resting heart rate of 40-100 bpm at Screening
4. A body mass index (BMI) of ≤18 to ≥30 kg/m2 at Screening
5. Must be a non-smoker or ex-smoker with less than a 5-pack year history of smoking (including the use of electronic cigarettes) and have ceased smoking ≥1 year prior to Screening; or a social smoker (defined as less than 10 cigarettes in the previous 12 months)

Exclusion Criteria:

1. Has serum transaminase (i.e., alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], or gamma-glutamyl transferase \[GGT\]) levels greater than three times the upper level of normal
2. Abnormal orthostatic vital signs (at screening) defined as a decrease of ≥20 mmHg in systolic blood pressure and/or a decrease of ≥10 mmHg in diastolic blood pressure and/or \>25 bpm increase in heart rate within 3 minutes of standing, or with symptoms of light-headedness, dizziness, or fainting upon standing.
3. History of hypotension including fainting, syncope, orthostatic hypotension, and/or vasovagal reactions
4. History of retinitis pigmentosa
5. Vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION) or other optic perfusion impairment
6. History of priapism or anatomical deformation of the penis
7. History of sudden sensorineural hearing loss (SSHL), need for hearing aids, and/or other documented hearing loss
8. A corrected QT interval using Fridericia's formula (QTcF) \>450 msec
9. Has evidence of significant obstructive lung disease on spirometry. Subjects with any of the following criteria will be excluded:

   1. FEV1 \<60% (predicted) (pre-bronchodilators); or
   2. FEV1/FVC \<65% (pre-bronchodilators)
Developing and Testing a Spanish-Language Intervention to Reduce Cancer-Related Sleep Disturbance

The purpose of this study is to learn about how to provide treatment to cancer survivors who have difficulty sleeping.


Eligibility Criteria:
Inclusion Criteria:

* Located in the Southern Puerto Rico area
* Able to speak and read Spanish
* Have no documented or observable disabilities that would interfere with study participation
* Has completed primary treatment for breast cancer (e.g., surgery, chemotherapy, radiation)
* Has clinically significant sleep disturbance (i.e., \>/= 8 on the Insomnia Severity Index)
* Is at low risk of other sleep disorders that are not amenable to treatment with cognitive-behavioral therapy
* Has access to the Internet and a digital device (e.g., smartphone) capable of using videoconference software

Exclusion Criteria:

* Not able to read and speak Spanish
Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers

The primary objectives of the study are to evaluate the safety and tolerability of multiple doses of BIIB061 administered to healthy adults. The secondary objective is to determine the multiple-dose PK profile of BIIB061 in this study population.


Eligibility Criteria:
Key Inclusion Criteria:

* Males and postmenopausal (defined as no menses for 12 months and confirmed by follicle-stimulating hormone \[FSH\] levels determined at screening to be in the postmenopausal range) or surgically sterile females
* Must be in good health and have normal vital signs as determined by the Investigator, based on medical history and screening evaluations.
* Must agree to abstain from alcohol ingestion for the duration of the study.
* Must agree to abstain from consumption of grapefruit or grapefruit-containing products for the duration of the study, starting at least 24 hours prior to admission to the inpatient facility.
* Must agree to abstain from taking St. John's Wort (herbal preparation) for the duration of the study
* Must agree to abstain from any vigorous exercise (as determined by the Investigator) for the duration of the study.
* Must have a body mass index of 18 to 30 kg/m2, inclusive.

Key Exclusion Criteria:

* History of or positive test result at screening for human immunodeficiency virus, hepatitis C virus antibody, or hepatitis B virus (defined as positive for hepatitis B surface antigen \[HBsAg\] or hepatitis B core antibody \[HBcAb\]).
* Presence of a metal device (e.g., any type of electronic, mechanical, or magnetic implant; cardiac pacemaker; aneurysm clips; implanted cardiac defibrillator) or potential ferromagnetic foreign body (metal slivers, metal shavings, other metal objects) that are contraindications for MRI.
* History of asthma, wheezing, allergies involving the lungs, or airway obstruction.
* History of bronchodilator or inhaler use.
* Clinically significant abnormal hematology or blood chemistry values, as determined by the Investigator.
* Inability or unwillingness to comply with study requirements.
* Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, make the subject unsuitable for enrollment.

Note: Other protocol defined inclusion/ exclusion criteria may apply.
Dynamic Guided Implant Surgery VS Static Guided Surgery.

This study aims to evaluate if dynamic-guided surgery is an accurate system for placing dental implants.

Researchers will assess the dental implant accuracy of the dynamic guided system compared to the static pilot guide.

Participants will:

* Receive implant treatment that will be placed by a dynamic or static pilot drill guided system.
* Receive post-operative radiological exam for comparative (on the same appointment).


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older,
* ASA type 1 or 2,
* Full mouth plaque scores up to 25% (O'LEARY TJ. The plaque control record 1972;43:38), -Partially edentulous with at least one missing tooth
* Having a bone crest of at least 10mm in length and 6mm in width.

Exclusion Criteria:

* medical conditions contraindicating surgery,
* untreated periodontal disease or caries
* the need for bone augmentation
* acute local infections
* history of head/neck radiation.
Prevalence of Internet Addiction and it's Effects on Psychological Well-being of Adults in Hong Kong

The goal of this quantitative study is to learn about the the prevalence of internet addiction and its effects on psychological well-being of adults in Hong Kong. The main question it aims to answer is:

• What is the prevalence of internet addiction and its effects on psychological well-being of adults in Hong Kong

Participants will be invited to complete a set of questionnaire that includes assessment on their level of Internet use, depression, anxiety, sleep quality, QOL together with basic demographic data in the current situation of COVID with popularity of Metaverse..

Internet addiction (IA) appeared to become serious issues since the emergence of Internet over the decades. The definition of Internet Penetration Rate (IPR) is the percentage of the entire population who has Internet usage. As of July 2022, Denmark, the UAE, and Ireland had the highest IPR, all recording 99% of their population accessing the internet. While in Hong Kong, it has reached 93.6%, not far from the first in Asia - South Korea (98%). The widespread use has shown the popularity of Internet is skyrocketing through the years.

Despite there are several studies conducted on IA from the West, the results might not be not applicable in adults in Hong Kong due to various reasons such as policies against COVID and cultural difference as lifestyle, living and social environment, family relationship style. Those might have potential influence on the engagement in physical and social activities and involvement in Internet. In addition to the emergence of Metaverse, situations, policies and people's attitude towards COVID might have changed drastically and affect the prevalence of IA in Hong Kong adult. To conclude, the effect of COVID and Metaverse on the prevalence of IA in adults in Hong Kong and the mechanisms/reasons behind is unclear.

In the present study, the investigators aim to investigate the prevalence and effects of IA on the psychosocial well-being among adults in Hong Kong by measuring the level of Internet use, depression, anxiety, sleep quality, QOL together with basic demographic data in the current situation of COVID with popularity of Metaverse.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-40
* Resided in Hong Kong
* Can speak Cantonese and write Chinese

Exclusion Criteria:

* Self-reported to have identified cognitive problems and communication problems
Pharmacokinetic Study to Investigate the Bioavailability and Tolerability of 3 Oral Formulations of Sodium Thiosulfate

Chronic treatment and prophylaxis of vessel and soft tissue calcification as well as of renal calculi could be a future indication for sodium thiosulfate (STS). Using an oral formulation might increase the compliance and treatment success compared to parenteral administration.

Three gastro-resistant formulations of STS for oral administration were developed with different release characteristics: fast-release, medium-release and slow-release tablets. Aim of the enteric coating was to increase the oral bioavailability of STS. The bioavailability and tolerability of these formulations for oral administration in healthy volunteers will be compared in this clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Male or female healthy subjects ≥ 18 years
* Negative pregnancy test in female subjects of childbearing age
* Able to understand character and individual consequences of the clinical trial and to provide written informed consent to participate in the study

Exclusion Criteria:

* Pregnant or lactating subjects.
* Renal impairment (creatinine clearance \<60ml/min)
* Concomitant medication
* Gastrointestinal diseases
* History of alcohol abuse, illicit drug use, significant mental illness, physical dependance to opioid, other drug abuse or addiction (last 12 months)
Study of the Intermediate Metabolism in Children With Acute Lymphoblastic Leukemia (ALL)

Study of the intermediate metabolism in children diagnosed with ALL compared to healthy matched controls.

The primary cause of this study is to investigate the changes that ALL may cause to the metabolome of pediatric patients, in order to better understand its mechanism of action and target metabolic pathways for potential therapies.

Eligibility Criteria:
* Sex: all
* Minimum age: 1 year
* Maximum age: 16 years
* The study accepts healthy volunteers as matched controls for the patinets.
* Inclusion criteria: 1)Children diagnosed with ALL 2) Diagnosis confirmed with bone marrow biopsy 3) Sampling before the initiation of therapy 4) Informed consent signed
* Exclusion Criteria: 1) Children with a known chronic illness before ALL diagnosis 2) ALL remission 3) Not signed informed consent
* Population description: Patients are recruited from the Pediatric Hematology/Oncology Department of Aristotle University of Thessaloniki (AHEPA hospital) and from the Pediatric Hematology/ Oncology Department of Ippokration Hospital, that host all children diagnosed with ALL in nothern Greece. Matched controls are recruited from outpatient clinic of the 2nd and 4th Pediatric Department of Aristotle University of Thessaloniki.
* Sampling method: Non-probability sample
Anti-infection of Low-does IL-2 in SLE

The objective of this clinical study is to evaluate the potential effect of anti-infection of low-does IL-2 in patients with SLE.

Systemic lupus erythematosus (SLE) is a chronic autoimmune syndrome affecting various organs.Many feel that glucocorticoid and immunosuppressor are the standard therapy for patients with SLE. While it can improve the risk of infection among SLE patients. A novel therapy to treat SLE with low-does IL-2 has been identified recently. IL-2 also used to against some virus infect. So we hypothesized that low-dose IL-2 could reduce risk of infection in SLE patients.

Methods: A total of SLE patients (n=30) were divided into two groups randomly. One received standard therapy, while another one administrate with low-does IL-2 plus standard therapy.Each patient will be treated with low-dose IL-2. The end points are clinical and immunologic response.

Expected Results: This trail wlii provide both clinical and basic profe that low-dose IL-2 plus standard therapy have lower infection risk in SLE patients.

Eligibility Criteria:
Inclusion Criteria:

* Meet the American College of Rheumatology criteria for the diagnosis of SLE.
* Under standard treatment (≥ 2 months) at the time of inclusion
* Background treatment failed to control flares or to permit prednisone tapering
* With at least one of the following manifestations: thrombocytopenia, disease-associated rash, mouth ulcer, non-infectious type of fever, active vasculitis, renal disorder(proteinuria\>0.5g/day), neuropsychiatric SLE.
* Positive for at least one of the following laboratory tests: ANA\>1:160, anti-dsDNA, immunoglobulin\>20g/L, decreased C3 or C4, leukopenia\<3×10\^9/L, thrombocytopenia\<100×10\^9/L;
* SLE disease activity index(SLEDAI) ≥ 8.
* Negative HIV test.
* Negative for hepatitis B and C virus.
* Written informed consent form.

Exclusion Criteria:

* Sever chronic liver, kidney, lung or heart dysfunction; (heart failure (≥ grade III NYHA), hepatic insufficiency (transaminases\> 3N) )
* Serious infection such as bacteremia, sepsis;
* Cancer or history of cancer cured for less than five years (except in situ carcinoma of the cervix or Basocellular carcinoma);
* High-dose steroid pulse therapy (\>1.5mg/kg) or IV bolus of corticosteroids in the last 2 months.
* History of administration of rituximab or other biologics;
* Purified protein derivative (tuberculin) \>10mm
* Mental disorder or any other chronic illness or drug-abuse that could interfere with the ability to comply with the protocol or to give information;
* Inability to comply with IL-2 treatment regimen.
The Value of Lymph Node Dissection of Indocyanine Green-guided Near-infrared Fluorescent Imaging in Esophagectomy

Indocyanine green (ICG) has been recently introduced in clinical practice as a fuorescent tracer. Lymphadenectomy is particularly challenging in esophageal cancer surgery, owing to the complex anatomical drainage.Therefore, the purpose of this study was to explore whether the NIR-ICG imaging system could accurately assess the lymph node markers during radical resection of esophageal cancer.

This study will be accepted in esophageal cancer patients with Radical Esophag-ectomy as the research object.We will divide them into two groups: experimental group for injection of indocyanine green group and control group for injectable in-docyanine green group.We will compare with the accuracy,false positive rate and false negative rate,sensitivity, specificity and related indicators of intraoperative lymph node cleaning,in order to explore the common position of esophageal cancer sentinel lymph node,guidance of esophageal cancer lymph node cleaning thoroughly.

Eligibility Criteria:
Inclusion Criteria:

1. Age and gender: 18-75 years old, male and female unlimited;
2. Preoperative biopsy was pathologically diagnosed as esophageal squamous cell carcinoma;
3. Preoperative combination with neoadjuvant chemoradiotherapy;
4. Surgical resection of esophageal carcinoma under endoscopic selection and intraoperative anastomosis;
5. Heart, lung, liver and kidney functions can tolerate operation;
6. Patients and their family members can understand and are willing to participate in this clinical study and sign the informed consent.

Exclusion Criteria:

1. Allergic to ICG or iodine;
2. Patients with a history of chest surgery or thoracic lymph node dissection;
3. Patients needing emergency surgery;
4. Patients whose tumors involve neighboring organs and need to be removed by combining organs;
5. Patients with tumor recurrence or distant metastasis;
6. Patients who had participated in or were participating in other clinical trials within the previous 4 weeks were included;
7. A history of serious mental illness;
8. Pregnant or lactating women;
9. Patients with other conditions considered by the researcher should not participate in the study.
Single Lipiflow Treatment to Reduce Pharmacologic Burden in DED

Purpose: To evaluate the efficacy of vectored thermal pulsation treatment in subjects with a history of dry eye disease currently using a topical immunomodulator medication.

Prospective, non-randomized, interventional study. Subjects with bilateral use of a topical immunomodulator drop and a history of dry eye disease were recruited to participate. All subjects underwent a vectored thermal pulsation treatment (LipiFlow). Patients were seen at baseline in a visit immediately prior to treatment and at months 1 and 3 following treatment. Data collected included tear osmolarity, tear break up time (TBUT), tear meniscus height (TMH), meibomian gland function and patient-reported symptoms using the ocular surface disease index (OSDI) questionnaire. Following the 3-month visit, patients were given the option to resume topical immunomodulator therapy.

Eligibility Criteria:
Inclusion Criteria:

* No prior history of meibomian gland treatment procedures LipiFlow, TearCare, or I-Lux
* lifitegrast or cyclosporine eye drops daily for a period of at least one year but not exceeding five years
* Meibograpy documneted retention of at least 50% of meibomian glands.

Exclusion Criteria:

* evidence of meibomian gland dropout exceeding 50%
* ocular rosacea,
* ocular surgery within the preceding three months
* prior in-office thermal meibomian gland treatment
* ocular trauma within preceding three months
* ocular herpetic infection
* chronic or recurrent inflammation
* eyelid abnormalities affecting lid function ocular surface abnormalities compromising corneal integrity (eg, epithelial basement membrane dystrophy, corneal burn)
* pregnant
Transcranial Laser Therapy in the Rehabilitation of Hemiplegic Patients From Ischemic Stroke

The aim of this study is to determine the efficacy of transcranial laser therapy applied in automatic noncontact scanning mode for improving functional disability in patients with hemiplegia from ischemic stroke undergoing a rehabilitation program.

Transcranial laser therapy is applied with an InGa(Al)As diode laser.The laser in automatic scanning is applied over both cerebral hemisphere during 15 sessions. Patients simultaneously performed a program of therapeutic exercises 3 days a week. Outcome measures were the Fugl-Meyer Upper Extremity scale, which assessed upper limb motor function, and the Barthel index, which assessed general functional disability.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with hemiplegia secondary to cerebral stroke ischemic.
2. Requirement of shaving the scalp area.
3. Initiation of the TLT procedure begins between 70 and 100 days after stroke onset.
4. Informed written consent before enrolling in the study.

Exclusion Criteria:

1. Hemiplegia secondary to hemorrhagic stroke.
2. Metallic brain implants.
3. Neurodegenerative disorders.
4. Bilateral motor problems.
PMCF Study on the Safety of Linovera® for the Treatment of Category-I Pressure Ulcers/Injuries

To assess the safety and performance of Linovera® in the treatment of Category- I pressure ulcers/injuries.

The aim of this clinical study is to generate further clinical evidence for the use and benefit of Linovera® in the treatment of Category-I PUs. The results of this study will generate further clinical evidence for the use and the benefit of Linovera® in this indication.

Furthermore, the proactive collection of clinical data for Linovera® will support the maintenance of this skin oil on the market, so that in the future other patients can receive the product for the treatment of Category-I PUs.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient (≥ 18 years)
* Patients with at least one Category-I PU/I (remark: follow-up will be done for one ulcer per patient).
* Provision of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the EC prior to all evaluations.
* Patient naïve to Linovera® 2 weeks before visit 1 (only applicable to the area of the skin that will be assessed).
* Patients which can be potentially followed until their Category-1 pressure ulcer/injury is healed throughout the duration of the study, according to the clinicians opinion.

Exclusion Criteria:

* Age \<18 years
* Known allergies and/or hypersensitivity to any component of Linovera®.
* Any medical or psychological disorder that, in the investigator's opinion, may interfere with the patient's ability to give informed consent and comply with the study procedures.
* Any planned intervention that, in the investigator opinion, may affect skin condition of the patient (e.g. chemotherapy or radiotherapy).
* Simultaneous participation in an interventional clinical trial (drugs or medical devices studies).
* Any other additional topical treatments applied in the area of the skin that will be assessed.
Cervix Image Sharing Protocol (CISP)

The Clinical Epidemiology Unit in the Clinical Genetics Branch of the Division of Cancer Epidemiology, NCI has a strong interest in fostering cervical cancer prevention solutions for all kinds of settings, including lowresource ones that rely on development of robust, low-cost screening and triage tools. Therefore, to support development of algorithms for cervical image recognition software, NCI seeks to share digital cervical images and accompanying clinical data from our large epidemiological studies on HPV and cervical cancer screening with interested and qualified image analysis researchers. To accommodate the many researchers that are interested, we have created this standard protocol to describe a unified process for sharing deidentified cervical images and accompanying de-identified clinical data from the following NCI studies: Costa Rican Natural History Study of HPV and Cervical Neoplasia , ASCUS LSIL Triage Study-- ALTS , SUCCEED and Costa Rica Vaccine Trial .

The Clinical Epidemiology Unit in the Clinical Genetics Branch of the Division of Cancer Epidemiology, NCI has a strong interest in fostering cervical cancer prevention solutions for all kinds of settings, including lowresource ones that rely on development of robust, low-cost screening and triage tools. Therefore, to support development of algorithms for cervical image recognition software, NCI seeks to share digital cervical images and accompanying clinical data from our large epidemiological studies on HPV and cervical cancer

screening with interested and qualified image analysis researchers. To accommodate the many researchers that are interested, we have created this standard protocol to describe a unified process for sharing deidentified cervical images and accompanying de-identified clinical data from the following NCI studies: Costa Rican Natural History Study of HPV and Cervical Neoplasia , ASCUS LSIL Triage Study-- ALTS , SUCCEED and Costa Rica Vaccine Trial .

Eligibility Criteria:
* This protocol will include de-identified images and clinical data from NCI studies.