cyrilzakka/clinical-trials huggingface dataset:
Cutaneous Lupus Medication Experience Study

Cutaneous lupus is a chronic, relapsing, auto-immune skin disease that can have many presentations. Its effect on physical appearance greatly affects patients' quality of life. In addition, 10% of patients with cutaneous lupus will develop systemic lupus. Topical therapies are the mainstay of cutaneous lupus treatment; however patients often find these treatments to be messy, inconvenient, or ineffective. In addition, for more severe disease patients are often placed on concurrent systemic therapies. The primary hypothesis of our study is that poor adherence contributes to poor treatment outcomes in patients with cutaneous lupus.

Cutaneous lupus is a chronic, relapsing auto-immune disease that negatively impacts patients' quality of life. As there are many safe topical therapies that require daily use to be effective, and adherence to medication remains a common problem in dermatology, it is worthwhile to reliably measure adherence to medication in patients with cutaneous lupus. By elucidating barriers to effective control of cutaneous lupus with topical medications, we can improve patient care and guide interventions that will avoid the use of systemic therapy which often has more side effects.

The primary aim is to determine adherence to topical and systemic lupus treatment. Subjects will receive standard of care therapy (low potency and high potency topical corticosteroids) and systemic therapy when clinically appropriate. Adherence to medications will be monitored electronically in all subjects. The following hypothesis is to be tested: Non-adherence to topical and systemic medication contributes to treatment failure in patients with cutaneous lupus.

Eligibility Criteria:
Inclusion Criteria:

* Any male or female 12 years or older of age with a diagnosis of cutaneous lupus by a dermatologist
* Capable of understanding and willing to provide a signed and dated written voluntary informed consent before any protocol specific procedures are performed
* Able to complete the study and comply with study instructions, including attending all study visits

Exclusion Criteria:

* Individuals younger than 12 years of age
* Known allergy or sensitivity to study medication
* Inability to complete all study-related visits
* Introduction of any other prescription medication, topical or systemic, for cutaneous lupus while participating in the study
Prevention of Pain Caused by the Oro-gastric Tube Laying in Neonatology

Subject of research : Evaluation of a technique of care to reduce the pain caused by the laying of the gastric tube in the newborn

After inclusion, the nurse performs randomization by opening the envelope. The newborn then receives the care with the introduction of the gastric tube after randomization (experimental arm with holed baby bottle nipple and control arm: with pacifier). The treatment is filmed and recorded by a previously installed camera. The films are viewed by two independent experts from the pain of the study, to assess pain by scale score (DAN acute pain of the newborn

Eligibility Criteria:
Inclusion Criteria:

* Newborn term, or premature (from 32 weeks) from 48 hours to 14 days of life.
* Presence of sucking reflex
* Patient whose authors of parental authority have given their written consent for their participation
* Patient affiliated to or benefiting from a social security scheme

Exclusion Criteria:

* Newborn intubated or NIV and / or sedated
* Newborn with malformation (especially cleft palate)
* Contra-indication to sugar administration
* Newborn previously included in the study
* Administration of analgesics in the previous 8 hours
* Atresia of the unoperated esophagus
* Non-operated oeso-tracheal fistula
* Major swallowing disorders
* Necrotizing ulcerative colitis
The Antibiotic Guardian Study- Clinical Evaluation of a Novel, Rapid Diagnostic for Gonorrhoea and Mycoplasma Infections.

Primary research question:

Are novel molecular tests for rapid detection of Mycoplasma and Gonorrhoea infections and antimicrobial resistance sensitive and specific in symptomatic patients attending a sexual health clinic?

Secondary research question:

Are novel molecular tests for detection of antimicrobial resistance in Mycoplasma and Gonorrhoea infections more accurate than standard laboratory culture techniques?

This clinical study aims to clinically evaluate a novel, rapid molecular diagnostic for Mycoplasma and Gonorrhoea infections. This diagnostic detects both infection and also detects any antimicrobial resistance. These tests detect these organisms and provide information about antimicrobial resistance in a laboratory, but are not widely used in sexual health clinics in the UK and have not been clinically evaluated in symptomatic patients in detail.

Our primary objective is to determine if the novel molecular test for rapid detection of Mycoplasma and Gonorrhoea infections and antimicrobial resistance is sensitive and specific in symptomatic patients attending a sexual health clinic.

Our secondary research objective is to determine whether the novel molecular test for detection of antimicrobial resistance in Mycoplasma and Gonorrhoea infections more accurate than standard laboratory culture techniques.

Eligible participants will be aged between 16 and 99 years and attend a sexual health clinic at Cwm Taf Morgannwg Sexual Health department. They will be symptomatic.

Participants will have routine swabs performed as per routine sexual health care, following gaining participant consent in writing. Waste urine and discharge from vaginal swabs will be utilised in the study. Samples will be given a unique study number and sent to the normal NHS laboratory for analysis as per routine care. Left-over samples of urine and swabs will be pseudo-anonymised and then transported to the academic laboratory for analysis with the novel diagnostic with the unique study ID.

Results from routine tests for Mycoplasma and Gonorrhoea detection and for antimicrobial resistance will be compared to results of the novel diagnostic.

This study has had a substantial amendment reviewed and passed by an ethics committee, due to COVID disruptions in healthcare. It has changed from an interventional study to an observational study.

Eligibility Criteria:
Inclusion Criteria:

* Patients that are sexually active.
* Patients that are symptomatic with:
* Dysuria
* Urethral discharge
* Vaginal discharge
* Rectal discharge
* Dysparenia (pain during sex)
* Pelvic pain
* Testicular pain
* Post-coital bleeding (bleeding after sex)
* Vulval/Glans/Perianal pain.

Exclusion Criteria:

* Pregnancy.
* Aged under 16 years.
* Sexual assault case.
* Patients with very severe symptoms that need admission to a ward or referral for urgent gynaecology or urology interventions.
* Patients lacking capacity to consent.
The Impact of Exercise Approaches on Sleep in Children With Acute Lymphoblastic Leukemia

Sleep is one of the basic and indispensable daily life activities that affect the quality of life and health of individuals and is a concept with physiological, psychological and social dimensions. In the literature, sleep difficulties and problems have begun to be investigated in children with acute lymphoblastic leukemia and have not been found in national publications. In these children, sleep quality, strengths and disorders and a study evaluating this variation on a scale have not been found. For this reason, our study will be done in order to determine the factors affecting sleep and sleep in children with cancer and to show the effect of exercise on these factors.

Primeraly that progresses in the disease process, secondary problems seen with the effects of symptoms make it difficult to cope with disease and treatment process in children with acute lymphoblastic leukemia (ALL) . Sleep difficulty is not affected by the direct effects of the disease but it is affected and becomes more difficult with the fatigue and difficulty of treatment as a secondary. Parents with ALL children stated that they experienced 12.4% of sleeping difficulty. It turns out that about a quarter of the children are sleeping problems. It is stated that 27% of these children have drowsiness, and more than 25% of them have frequent awakenings at night. It is also stated that parents use the option of rest-sleep as an option to benefit from treatment in coping with the disease, but children with sleeping difficulties also make it difficult to treat them. Being a healthcare professional as a biopsychosocial approach model and planning the treatment interventions for the deficiencies and disorders that will be done in order to get rid of the symptoms of the disease as soon as possible will make it easier to cope with the disease with both child and parent and multidisciplinary approach. In this way, we will investigate the effects of children's exercise habits on their sleep and sleep related complaints by using video-based game consoles which are currently used in our workout approaches. The games to be selected from the aerobic exercise programs that are used to increase the functional capacity on the basis of exercise will also be targeted to the exercises with maximum motivation and participation of the children. In the exercises where goodness and continuity are also taken into consideration, in-game guidance will be provided with verbal commands under the supervision of a physiotherapist.

Eligibility Criteria:
Inclusion Criteria:

* Having ALL a diagnosis
* Being between 2-18 years of age
* Therapy (surgery, chemotherapy, radiotherapy) to be finished

Exclusion Criteria:

* Continue active treatment (surgery, chemotherapy, radiotherapy)
* Recurrence of the disease
* Any mental / physical problem that will have a cooperative problem
Study of EC0489 for the Treatment of Refractory or Metastatic Tumors

This is a Phase 1 clinical trial evaluating the safety and tolerability of escalating doses of EC0489 in patients with refractory or metastatic tumors who have exhausted standard therapeutic options.

This is a Phase 1, dose escalation study of EC0489 administered by intravenous bolus (IV) during weeks 1 and 3 of a 4-week cycle in PART A and weekly on a 4-week cycle in PART B.

Both Parts are open to patients with refractory or metastatic cancer who have exhausted standard therapeutic options. EC0489 is a drug that is specifically designed to enter cells via a folate vitamin receptor. Experimental evidence shows that the target receptor is over-expressed in many human cancers. There are no previous human studies of EC0489; however, lab research (research in test tubes or animals) using EC0489 has shown activity against tumors in animals. This activity in animal models suggests that EC0489 may be useful as chemotherapy against human cancers. The primary objective of this study is to determine the safety and maximum tolerated dose of EC0489 given by intravenous bolus. The efficacy of treatment will also be measured.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Histological or cytological diagnosis of neoplasm
* No effective standard therapeutic options
* ECOG performance status of 0-2
* ≥ 4 weeks post therapeutic radiation or recovered (or returned to baseline) from any acute toxicity associated with prior cytotoxic therapy. Patients previously treated with non-cytotoxic therapy (e.g., EGFR, VGEF, etc.) and who have recovered from or have controlled drug-associated toxicity are allowed to enter the trial after a period consisting of 4 half-lives of the agent.
* Negative serum pregnancy test for women of child-bearing potential within one week prior to treatment with investigational agents (99mTc-EC20 and EC0489)and willingness to practice contraceptive methods
* Adequate bone marrow reserve, renal and hepatic function

Exclusion Criteria:

* Concurrent malignancies
* Women who are pregnant or breast-feeding
* Evidence of symptomatic brain metastases
* Receiving concomitant anticancer therapy (excluding supportive care)
* Requires palliative radiotherapy at time of study entry
* Requires antifolate therapy for comorbid conditions
* Heart failure characterized as greater than NYHA Class I
* History of myocardial infarct
* Any of the following baseline echocardiogram findings: valvular lesions (stenosis or insufficiency) characterized as greater than moderate, systolic ventricular impairment characterized as greater than mild, left ventricular ejection fraction \< 55%, any feature of the echocardiogram that would confound interpretation of the serial echocardiograms required by the protocol
Post-operative Analgesia in Elective, Soft-tissue Hand Surgery

The purpose of this research study is to find out which combination of pain medications following surgery work the best and result in the fewest side effects.

This is a prospective, randomized, double-blind study comparing the efficacy of acetaminophen/hydrocodone (AH) to acetaminophen/ibuprofen (AIBU) in providing adequate post-operative pain relief in elective, soft tissue hand surgery patients.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18
* Male or Female (non-pregnant)
* Elective, soft tissue hand surgery indicated based on diagnosis made by either clinical exam or diagnostic studies (ie nerve conduction study, EMG) or a combination of the two (carpal tunnel release, trigger finger release, first dorsal compartment release, ganglion cyst excision, second extensor compartment release)
* Subjects are capable of giving informed consent

Exclusion Criteria:

* Allergy to study medication
* Any pre-existing pain condition requiring analgesia
* Fibromyalgia
* Recent upper gastrointestinal bleeding
* Coagulopathy (primary or medication-related)
* Renal impairment
* Liver disease
* Pregnancy
* Patients who consent to the study but require unexpected admission, including those requiring admission resulting from operative complications, will be excluded before randomization
Nordic Walking on Knee Osteoarthritis

The goal of this randomized clinical trial is to improve osteoarthritis symptoms and quality of life in older people with knee osteoarthritis from a primary care center. The main question it aims to answer is:

* To participate in a Nordic walking reduces pain measured on WOMAC pain dimension?
* To participate in a Nordic walking improves mobility measured on WOMAC physical activitiy dimension? Researchers will compare pain and physical activity outcomes between intervention and control arm (randomly allocated).

Osteoarthritis is one of the clinical circumstances that produces the most disability in terms of disability-adjusted life years (DALYs), its main localization is in the knees and hips, the most disabling joints. Ten percent of the adult Spanish population has knee osteoarthritis , which is accompanied by symptoms of pain, mechanical alterations, stiffness, and decreased functionality, constituting one of the most common causes of disability in older people.. Decreased muscle mass and strength of knee extensor-flexor muscles are associated with symptomatic progression of oseoarthritis and lower general health status.

Eligibility Criteria:
Inclusion Criteria:

* Aged of 60 years or older
* Knee osteoarthritis
* Body mass index less than 35 kg/m2

Exclusion Criteria:

* People who had a knee prostheses
* To have any contraindication for physical activity
* To have an acute exacerbation of any chronic condition at enrollment
Clinical Evaluation of Systane® ULTRA Compared to OPTIVE® in Ocular Surface Staining

The purpose of this study is to compare Systane® ULTRA lubricant eye drops to OPTIVE® lubricating eye drops for ocular surface staining within dry eye subjects and to evaluate the safety of Systane® ULTRA after 3 months of use.

Following a 2-week washout phase with saline eye drops, subjects were randomized to receive either Systane® ULTRA or OPTIVE® for the remainder of the study.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to attend all study visits.
* Diagnosis of dry eye, as specified in protocol.
* Uses artificial tears, as specified in protocol.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Poor visual acuity, as specified in protocol.
* Women of childbearing potential who are pregnant, lactating, or not using adequate birth control, as specified in protocol.
* Any hypersensitivity or allergy to the investigational products or ingredients.
* Any eye disorder, ocular surgery, medication, medical condition, or systemic disease, as specified in protocol.
* Contact lens use within 2 weeks of Screening Visit.
* Other protocol-defined exclusion criteria may apply.
Primary Biliary Cirrhosis: Investigating A New Treatment Option Using NI-0801, an Anti-CXCL10 Monoclonal Antibody

The purpose of the study is to assess safety and efficacy of multiple doses of NI-0801 in primary biliary cirrhosis patients with an inadequate response to ursodeoxycholic acid.


Eligibility Criteria:
Inclusion Criteria:

* Proven primary biliary cirrhosis (PBC), as demonstrated by the presence of at least 2 of the following 3 diagnostic factor (History of increased alkaline phosphatase levels for at least 6 months; positive serum AMA titer; Liver biopsy consistent with PBC)
* Elevated liver enzyme levels at screening
* Have given written informed consent

Exclusion Criteria:

* Screening bilirubin \> 2.9 mg/dL (50 μmol/L)
* Screening creatinine clearance \< 80 ml/min
* History or presence of hepatic decompensation (e.g., esophageal variceal bleeding, hepatic encephalopathy, or ascites)
* Positive serology result for Human Immunodeficiency Virus (HIV), Hepatitis B or C
* Known or previous diagnosis of malignancy
* Presence of any active infection
* Previous history of active TB within 12 months of screening
Impact of Healthy Diet on Metabolic Health in Men and Women

The overall aim of the present research program is to determine how a healthy whole-diet approach impacts on cardiometabolic health in adults. With its interdisciplinary approach, the study depicts mechanisms behind disease progression and the impact of healthy dietary patterns on changes in markers of low-grade systemic inflammation together with the exploration of knowledge and attitudes about healthy diets. The study has a preventive character as it targets older adults (65+) without manifest disease.

This two arm randomized-controlled study includes the following groups: Controls and Healthy Diet group.

The study will particularly address the following aspects:

* determine food literacy, perceived attitudes and barriers for the adoption of new dietary habits incorporating increased fruit and vegetable intake in adults.
* explore the effects of a randomized controlled intervention promoting healthy dietary patterns (increased intakes of fruit and vegetable, whole-grain, nuts and low fat dairy products and replacing saturated with unsaturated fats and decreased red meat and salt consumption) for a period of 4 months on components of the metabolic syndrome, a large panel of pro- and anti-inflammatory biomarkers and metabolomic profile in adults.
* assess the long-term adherence to healthy dietary patterns in adults.
* provide support for behavioural change and evaluate participants' perception of this support.

Eligibility Criteria:
Inclusion Criteria:

* 65-70 years
* not meeting 5 servings of fruit and vegetable per day
* Waist circumference \>80 cm (female) and \>88 (male)

Exclusion Criteria:

* Movement disability
* Diabetes, cardiovascular disease, lung disease, overt disease
CONDOR Temporomandibular Muscle and Joint Disorders (TMJD) Survey

The purpose of study was to characterize using an online questionnaire the feasibility of recruiting dentists in primary care dental practices in the practice-based research network and documenting their current initial care for their TMJD pain patients.

The overall goal of this project was to collect data to be used in preparing an application for a Clinical Trial Planning Grant and then in designing a subsequent Phase III clinical trial. The ultimate goal of this series of research projects is to determine the most practical approach to conduct a randomized clinical trial (RCT) to evaluate initial intervention for patients with painful temporomandibular muscle and joint disorders (TMJD) using NIDCR's Collaboration of Networked Dental and Oral Health Research (CONDOR) group consisting of three dental Practice-Based Research Networks: The Dental Practice-Based Research Network (DPBNR), Northwest Practice-Based Research Collaborative in Evidence-based Dentistry (PRECEDENT), and Practitioners Engaged in Applied Research and Learning (PEARL).

Eligibility Criteria:
Inclusion Criteria:

* DPBRN dentist practitioner-investigator (general dentists or specialists) who had completed a DPBRN Enrollment Questionnaire
* 22 years of age or older
Effect of Hatha Yoga on Pulmonary Function

The goal of this clinical trial is to to investigate the acute and chronic effects of a four-week hatha yoga (HY) exercise program with different durations (60 min and 30 min) on pulmonary function in sedentary young individuals.. The main questions it aims to answer are:

• Does a four-week hatha yoga (HY) more effective than 30 min of a four-week hatha yoga (HY) and the control group in improving the pulmonary function? Researchers will compare a four-week OF 60 min duration hatha yoga (HY) , 30 min duration of HY and control to see the differences in the pulmonary function among high school sedentary students

Participants will:

Participants will be randomly assigned to one of three groups:

1. 60-minute Hatha Yoga group (60mHY, n=21)
2. 30-minute Hatha Yoga group (30mHY, n=21)
3. Control group (CG, n=21)

Objective: To investigate the acute and chronic effects of a four-week hatha yoga (HY) exercise program with different durations (60 minutes and 30 minutes) on pulmonary function in sedentary young individuals aged 15-16 years.

Study Design: Randomized Controlled Trial (RCT)

Participants:

• Sample Size: 52 sedentary individuals

Inclusion Criteria:

* High school adolescence
* Showed Sedentary lifestyle (defined as not participating in regular physical activity for at least 6 months.

Exclusion Criteria:

* Any known history of pulmonary, cardiovascular, or musculoskeletal conditions that would contraindicate exercise,
* participation in any other exercise program during the study period
* obesity (BMI \> 25.00)
* Participants who are in medication that stimulate the heart of medication such as antibiotic use were excluded from the study

Randomization:

Participants will be randomly assigned to one of three groups:

4. 60-minute Hatha Yoga group (60mHY, n=21) 5. 30-minute Hatha Yoga group (30mHY, n=21) 6. Control group (CG, n=21)

Intervention:

* 60mHY Group: Participants will undergo a 60-minute hatha yoga session twice a week for four weeks.
* 30mHY Group: Participants will undergo a 30-minute hatha yoga session twice a week for four weeks.
* Control Group: Participants will receive information about physical activity guidelines but will not engage in any structured yoga exercise during the study period.

Outcome Measures:

• Primary Outcome: Pulmonary function measured by spirometry.

Eligibility Criteria:
Inclusion Criteria:

* High school adolescence
* Sedentary lifestyle (defined as not participating in regular physical activity for at least 6 months.

Exclusion Criteria:

* Any known history of pulmonary, cardiovascular, or musculoskeletal conditions that would contraindicate exercise,
* participation in any other exercise program during the study period
* obesity (BMI \> 25)
* Participants who are on medication that stimulates the heart of medication such as antibiotic use were excluded from the study