cyrilzakka/clinical-trials huggingface dataset:
Reducing Pain and Increasing Comfort During a Retinopathy of Prematurity Examination

The aim of this study is to investigate the effect of baby massage applied to babies with retinopathy of prematurity on the pain and comfort of the newborn.

This was randomised-controlled study in the NICU at the Health Sciences University Bursa High Specialization Training and Research Hospital, Bursa, Turkey. The population of the study will consist of preterms hospitalized in the neonatal intensive care unit during the time period of the study. In the calculation of the sample size, the power level was 80% and the significance level was 5%. When the effect size was determined as 0.8 in the examination of the difference between the experimental and control groups in terms of the premature infant pain profile (PIPP) variable, it was determined by the statistical expert that the number of babies to be included in each group was 26 and 52 babies in total should be included in the study. Based on this, the study sample was determined as 60 preterm infants in 30 experimental and 30 control groups. Block randomization method will be applied in the randomization of the groups.

Case report form, PIPP=Premature Infant Pain Scale and Premature Infant Comfort Scale (PBIQ) will be used to collect the study data. Patients included in the study will be examined by the same ophthalmologist.

The infant massage to be applied before the examination will be applied by a single nurse=researcher. Video recordings will be taken before and during the ROP examination and evaluations will be made by two neonatal nurses other than the researcher.

Infants will be massaged by the researcher in accordance with IAIM guidelines and massage techniques. Total massage time will be equal for each infant.

The researcher has an IAIM infant massage certificate. Before starting the infant massage, jewelry will be removed and hands will be washed. In the study, leg and face massage will be applied among the massage techniques in the IAIM guidelines.


Eligibility Criteria:
Inclusion Criteria:

* \<32 gestational age
* Birth weight of \<1500g
* Who were clinical stable
* Baby's first eye examination
* The baby's family has permission

Exclusion Criteria:

* Infants with previous ROP examination
* Lack of mechanical ventilator support
* Major congenital anomaly
* Intraventriculer bleeding
* Receiving analgesic medication
Dual Anti-HER2 Therapy (Lapatinib and Trastuzumab) Plus Chemotherapy in HER2-positive MBC

To explore the real world situation of trastuzumab and lapatinib combined chemotherapy in China, and to explore the relationship between progression free survival and treatment.


Eligibility Criteria:
Inclusion Criteria:

* 1. woman, age \> 18 years old 2. Diagnosed with HER2 +Metastatic Breast Cancer 3. Dual anti-HER2 therapy (lapatinib and trastuzumab) plus chemotherapy for at least one cycle, starting from 2013.09.01-2019.07.31 4. Available medical history

Exclusion Criteria:

* 1. Incomplete medical history
Comparison Between Low and Medium Dose Radial Extracorporeal Shock Wave Therapy on Patients with Cervicogenic Headache: a Randomized Controlled Trial

A randomized double blinded controlled trial will be conducted to determine and compare the effects of low and medium dose radial extracorporeal shock wave therapy on upper trapezius trigger points in patients with cervicogenic headache. Data will be collected at base line and at the end of the treatment program. Participants will be assigned randomly into three groups Group (A) will receive 2000 shock waves at frequency 10 MHz and 0.02mj/mm2 flux density plus strengthening and stretching exercise for upper trapezius muscle.

Group (B) will receive 2000 shock waves at frequency 10 MHz and 0.178 mj/mm2 energy flux density plus strengthening and stretching exercise for upper trapezius muscle.

Group (C) will receive sham shock wave therapy plus strengthening and stretching exercise for upper trapezius muscle.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms of mechanical neck pain lasting for more than three months
* Skeletal muscle with a palpable taut band
* Hypersensitive point inside the taut band with the ability to reproduce referred pain when the sensitive spot is palpated,
* Joint soreness in at least one of the upper cervical spine's joints (c1-c3)
* Unilateral discomfort that originates in the neck and radiates to the frontotemporal area
* Pain that is made worse by moving the neck
* Headaches that occur at least once a week for a duration longer than three months.

Exclusion Criteria:

* Other primary headaches (i.e., migraine, tension-type headache)
* Bilateral headaches,
* Other defined cervical problem such as fracture, dislocation, skin disease, illness that is inflammatory, neural illness, vertebrobasilar insufficiency, a birth defect, tumor, or infection.
Study to Assess the Feasibility in Bile cfDNA of Resectable Biliary Tract Carcinomas

This study intends to use Onconscreen plus 520 Panel (Burning Rock, China) to conduct NGS testing in matched tissue, blood , and bile samples of patients with Resectable Biliary Tract Carcinomas（BTC）. In order to explore thefeasibility in bile cfDNA of BTC，we will collect relevant clinical information and follow-up treatment information. This study aims to reveal the effectiveness, accuracy, and feasibility in bile, as compared to tissues and blood samples.

In this study, we will investigate the potential of bile for genomic alterations using matched tissue, plasma and bile from 20 Resectable BTC Patients。The patient samples will be submitted for next-generation sequencing (NGS)，The results will include but will not be limited to genomic profling, tumor mutation burden (TMB), microsatellite instability (MSI) status, homologous recombination repair deficiency (HRD)。Patients will be followed-up for treatment responses until radiological confirmation of disease recurrence ,The molecular assay results will then be analyzed with clinical data including objective responses disease-free survival outcomes, among others, to reveal the effectiveness, accuracy, and feasibility in bile, as compared to tissues and blood samples.

Baseline tissues, plasma and sputum samples from 20 Resectable BTC Patients with 520 Panel sequencing (tissue 1000X, ,plasma cfDNA 10000X，bile 10000X), in different methods will be compared.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are diagnosed with diagnosed with BTC (including IHCC、EHCC、GBC)by histology or cytology
2. Patients who signed informed consent form;
3. Patients who agree and have the ability to follow the planned research visits, provide surgical tissue, blood, and bile samples, provide clinical information, and cooperate with other research steps.

Exclusion Criteria:

a.Patients who be deemed unsuitable for enrollment by the researchers.
Proof of Biological Activity of SAR100842 in Systemic Sclerosis

Primary Objective:

- To evaluate safety and tolerability of 8-week oral administration of SAR100842 in patients with diffuse cutaneous systemic sclerosis.

Secondary Objectives:

* To evaluate the pharmacodynamic effect of SAR100842 in patients with systemic sclerosis as measured by disease related biomarkers and Lysophosphatidic acid (LPA) receptor signaling markers in blood and skin;
* To explore the effect of SAR100842 on skin thickness in patients with systemic sclerosis as measured by the modified Rodnan Skin Score (mRSS);
* To explore the effect of SAR100842 on quality of life as measured by the Scleroderma Modified Health Assessment Questionnaire (SHAQ);
* To document long term safety of SAR100842 during the extension part.

Core part: randomized, double-blind, placebo-controlled study - 8-week treatment Extension part for participants completing the core part: Open label non-controlled study - 16-week treatment

Each patient's participation in the study will be approximately 13 or 33 weeks depending on their participation in the extension part: up to 2 weeks of screening, 8 weeks of treatment in the core part, 1 to 30 days wash-out between core part and extension part , 16 weeks of treatment in the extension part and 3 weeks of follow up.

Eligibility Criteria:
Inclusion criteria :

- Patients who meet the American College of Rheumatology (ACR) criteria for systemic sclerosis with diffuse cutaneous involvement and \<36 months since the onset of the first systemic sclerosis manifestation other than Raynaud's phenomenon and have a Modified Rodnan Skin Score (mRSS) ≥ 15 and an area of definite involvement of the dorsal forearm that is considered amenable to repeated 4mm skin biopsies.

Exclusion criteria:

1. Patients with high dose or unstable low dose immunosuppressive drugs, cytotoxic, anti-fibrotic or glucocorticoids drugs at least 4 weeks prior to screening
2. Serum creatinine \> 2.0 mg/dL
3. Gastrointestinal involvement preventing oral administration of study drug
4. Severe cardiac and/or pulmonary disease

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Narrow QRS Ischemic Patients Treated With Cardiac Resynchronization Therapy (NARROW CRT)

Current recommendations require a QRS duration of ≥120ms as a condition for prescribing cardiac resynchronization therapy (CRT). This study was designed to test the hypothesis that patients with heart failure of ischemic origin, current indications for defibrillator implantation and QRS \<120ms may benefit from CRT in the presence of marked mechanical dyssynchrony.


Eligibility Criteria:
Inclusion Criteria:

* NHYA class II-III heart failure
* ischemic cardiomyopathy
* ejection fraction of 35% or less
* QRS interval of 120ms or less
* evidence of mechanical dyssynchrony as measured on echocardiography

Exclusion Criteria:

* conventional indication for cardiac pacing
* persistent atrial fibrillation
* life expectancy lower than 1 year
Epidural PCA on Pain Relief After L-spine Surgery

This study aimed to evaluate the effect of epidural patient-controlled analgesia (PCA) on postoperative pain relief after lumbar spine surgeries. The eligible patients received two types of postoperative pain management: PCA and standard pain treatment. Comparisons between the two groups were made in terms of postoperative pain level.

This study included patients who underwent lumbar spine surgeries for degenerative spinal disease. The eligible patients were divided into two groups, the PCA group and the control group, for two types of postoperative pain management. The patients in the PCA group received 72-hour epidural PCA. The PCA catheter was inserted by the surgeon prior to wound closure in the lumbar spine surgery. The PCA catheter was maintained until 72 hours after the surgery and was removed at the postoperative day 4. The control group received postoperative standard pain treatment, including oral acetaminophen and muscle relaxants. No non-steroidal anti-inflammatory drugs were given in this study. All patients were provided the option to request intramuscular morphine injection (0.5 mg of morphine) for additional pain control, with a minimum interval of 6 hours between doses. Pain assessment was conducted using a visual analogue scale on the first four postoperative days and on the day of discharge. At the postoperative day 4, pain assessment was performed before the PCA removal. The level of pain and the number of morphine injections were compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

1. Age greater than 60 years
2. Having lumbar spine surgeries for degenerative spinal stenosis, spondylolisthesis, herniated intervertebral disc, or osteoporotic spinal fracture with spinal stenosis

Exclusion Criteria:

1. Spinal infection (e.g., tuberculosis, epidural abscess, and vertebral body osteomyelitis
2. Iatrogenic cerebrospinal fluid leakage or dura tear during surgery
3. Spinal tumor or spinal metastasis
4. Having minimally invasive procedures with the bilateral paramedian approach
Fenfluramine and Cognition

In this study, the investigators will investigate the cognitive effects of fenfluramine, a drug that directly stimulates the release of serotonin in the brain and positively modulates σ1 function. The investigators will use fenfluramine to assess the cognitive effects of modulating serotonin and σ1 function in healthy volunteers using a battery of cognitive tasks that measure learning and memory, executive functioning, reward processing, and emotional processing. The study design is double-blind, and participants will be randomised to either seven days of fenfluramine or placebo administration. All participants will attend two screening visits to assess eligibility. There are two main study visits; during the first, participants will undertake cognitive tasks and questionnaires before taking the initial study dose. One the second study visit, participants will once again complete these tasks and questionnaires after a week of fenfluramine/placebo administration.


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the research
* Not currently taking any medications (except the contraceptive pill)
* Aged 18-22 years
* Male or female
* Sufficiently fluent English to understand and complete the task
* Body Mass Index above 18-30
* Weight of 40-75kg

Exclusion Criteria:

* Current pregnancy (as determined by urine pregnancy test taken during Screening and First Dose Visit) or breast feeding
* Any past or current Axis 1 DSM-V psychiatric disorder
* Clinically significant abnormal values for liver function tests, clinical chemistry, urine drug screen, blood pressure measurement and ECG. A participant with a clinical abnormality or parameters outside the reference range for the population being studied may be included only if the Investigator considers that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures
* History of, or current medical conditions which, in the opinion of the investigator, may interfere with the safety of the participant or the scientific integrity of the study, including epilepsy/seizures, brain injury, hepatic or renal disease, severe gastro-intestinal problems, Central Nervous System (CNS) tumours, neurological conditions
* Current or past history of drug or alcohol dependency
* Current or past use of 3,4-Methylenedioxymethamphetamine (MDMA)
* Use of recreational drugs (e.g. cannabis, cocaine, amphetamines) within past 3 months
* Participation in a study which uses the same computer tasks as those in the present study (determined by asking participants about previous studies participated in during screening)
* Participation in a study that involves the use of a medication within the last three months
* Smoking \> 5 cigarettes per day
* Typically drinks \> 6 caffeinated drinks per day (e.g. tea, coffee, coca cola, Red Bull)
* Participant is unlikely to comply with the clinical study protocol or is unsuitable for any other reason, in the opinion of the Investigator
Families Left Behind

The United States is facing unprecedented rates of drug overdose deaths, profoundly impacting millions of families who are left to navigate their grief. Those bereaved by overdose experience a unique form of grief characterized by feelings of guilt, shame, and blame, which can worsen their suffering and deter them from seeking help. Individuals coping with overdose loss often endure more severe health consequences compared to those grieving non-drug related deaths, including prolonged grief disorder, substance use disorders, PTSD, depression, and suicidal thoughts. Moreover, bereaved individuals, particularly those with a history of substance use, may engage in risky behaviors as a means of coping, further exacerbating the risk of overdose and mortality within this vulnerable population. Peer grief support interventions have emerged as a promising approach to assist those experiencing such losses. To combat these outcomes, we are collaborating with Peer Community Support Partners (PSCP) in a novel practice-research partnership to implement the RIVER peer grief support model. Though RIVER has shown success in community settings, it has yet to be rigorously evaluated. In a three-aim approach, this study aims to assess the effectiveness of the RIVER model while also enhancing and engaging grievers with support resources via medical examiner offices (MEOs), which routinely contact families during death investigations. This research represents a pivotal advancement in addressing the needs of the overlooked bereaved community, aligning with the NIH's Helping to End Addiction Long-term (HEAL) initiative to develop effective strategies against the opioid crisis. Together, community engagement and rigorous research efforts aim to enhance support for those affected by the tragedy of drug overdose.


Eligibility Criteria:
Inclusion Criteria:

* people who lost a loved one to an unintentional drug overdose death within the past year
* age 18 and older
* fluently understand English or Spanish
* have the capacity to give consent (e.g., excluding those with severe cognitive impairment, those in active psychosis, and those with developmental disabilities).

Exclusion Criteria:

* people who need hospitalization for psychiatric symptoms or substance use disorders. (Note, people who use drugs but who do not require hospitalization will be included.)
* people have active suicidal ideation
* people who lost someone to a drug overdose death more than one year ago
* people who lost someone to a drug overdose death that was suicidal in nature or of undetermined intent
Prospective Screening and Differentiating Common Cancers Using Peripheral Blood Cell-Free DNA Sequencing

The goal of this observational study is to screen and differentiate common cancers in participants with or without suspicious lesions. The main question the investigators aim to answer is: Can the developed model, using peripheral blood cell-free DNA sequencing, work well in screening and classifying common cancers especially in the early stages? Participants will undergo the collection of 15\~20ml of blood and 1\~2 telephone follow-up calls.


Eligibility Criteria:
Inclusion Criteria:

1. \>20 and \< 80 years old.
2. Cancer group: Newly diagnosed cancer patients with a confirmed pathological diagnosis within 90 days before blood collection or within 30 days after blood collection, including lung cancer, esophageal cancer, breast cancer, stomach cancer, colorectal cancer, liver cancer, and pancreatic cancer.

Non-cancer group: Individuals who have not been diagnosed with cancer during routine physical examinations and one-year follow-up.

Exclusion Criteria:

1. Uncontrolled or active systemic diseases, such as autoimmune diseases, tuberculosis, AIDS, etc.
2. New onset, recurrence, or exacerbation of various inflammations within 2 weeks before blood collection, or the presence of fever, use of corticosteroids.
3. New onset or exacerbation of thromboembolic diseases, hemorrhagic diseases, or those who have received allogeneic blood transfusion within 1 month before blood collection.
4. Any cancer treatment performed within the past 3 years.
5. Individuals who have undergone organ or bone marrow transplantation.
6. Participants during pregnancy or lactation.
7. Individuals with malnutrition, severe mental illness, or genetic diseases.
8. Other diseases or conditions deemed by the physician as unsuitable for participation in this study.
9. Individuals who are unable to sign an informed consent form.
Study to Evaluate the Effect of a Known and Marketed Product, Itraconazole (Mycosis Treatment) on Lu AF11167 Entering the Body and Subsequently Elimination. The Study is a Drug-drug Interaction Study in Healthy Volunteers.

The purpose of this study is to evaluate the increase in exposure of Lu AF11167 following a single oral dose of Lu AF11167 with and without administration of multiple oral doses of itraconazole (a strong CYP3A4/5 inhibitor) in healthy subjects with inferred metabolic status as CYP2C19 extensive metabolisers


Eligibility Criteria:
Inclusion Criteria:

* Subjects be 18 years of age and 55 years of age and with a BMI \>18.5 kg/m2 and \<30.0 kg/m2 at the Screening Visit. Women must not be pregnant or lactating.

Other pre-defined inclusion and exclusion criteria may apply.
Ovulation and Follicular Development Associated With Mid Follicular Phase Initiation of Combined Hormonal Contraception

Quick starting combined oral contraception containing estradiol hemihydrate/nomegestrol acetate is effective to inhibit ovulation in healthy reproductive age women and non-inferiority to combined oral contraception containing ethinyl estradiol/gestodene.

This study is a randomized control, non-inferiority trial which compare the proportion of ovulation between two oral combined pills when delay starting the first tablet at mid-follicular phase of menstrual cycle in 18 - 40 year old, healthy women with prior normal and regular periods. Participations will be undergone trans-vaginal or trans-rectal ultrasonography between day 1 - 3 of menstrual period for evaluation of ovarian follicle/cyst (if present). Only women who have normal looking of ovaries without dominant ovarian follicle will be included in study-protocol. Immediately after trans-vaginal/trans-rectal ultrasound between day 7 - 9 of menstrual period, all participants will be randomly assigned to receive one pack of investigated pills (1.5 mg estradiol hemihydrate/2.5 mg nomegestrol acetate or 20 mcg ethinyl estradiol/75 mcg gestodene) and to take the first tablet under direct observation by research-nurse. Participants will take one consecutive tablet at about the same time each day until complete pack. The next appointments will be every 2 - 3 days to monitor ovarian function by using Hoogland score until ovulation or follicular quiescence will be presented. The last visit will be about 1 week after complete pack to monitor adverse effect and safety through out the protocol.

Eligibility Criteria:
Inclusion Criteria:

* healthy women, age 18 - 40 years
* prior normal and regular interval of menstruation

Exclusion Criteria:

* current breast feeding women
* within 1 month period of child-delivery or miscarriage
* body mass index 30 kg/m2 or more
* contraindicated to use combined hormonal contraception
* current using other hormonal drugs that affect ovulation function