cyrilzakka/clinical-trials huggingface dataset:
Dynamic Cervical Change: Prediction of Preterm Labor in Symptomatic Patients

Transvaginal ultrasound of the cervix has become a common tool to evaluate patients who are at risk for preterm delivery. A shortened cervical length has been associated with an increased risk of preterm delivery. Dynamic cervical change is visible shortening(\>6mm) of the cervix seen during the ultrasound examination. Prior studies have shown that the presence of dynamic change in patients with a shortened cervical length(\<3cm) is not independently predictive of preterm delivery. However, a subset of patients with normal initial cervical length(\>3cm) and dynamic change did demonstrate an increased rate of preterm delivery. Because this was a small sub-group, the present study was designed to obtain a larger sample size for further evaluation. The second focus of this study involves patients with a dilated cervix and whether cervical length adds predictive value to gestational age at delivery.

Patients presenting to with symptomatic preterm labor(vaginal pressure or uterine contractions), who consent to the study, will undergo the standard evaluation for preterm labor(described in detail below.) The only additional evaluation is a prolonged transvaginal ultrasound of approximately 10 minutes to evaluate for the presence of dynamic change during a contraction.

Null hypothesis:

Symptomatic preterm labor patients, with normal initial cervical length(\>3cm), who exhibit dynamic cervical change deliver at a gestational age equal to those without dynamic change.

Alternative hypothesis:

Symptomatic preterm labor patients, with normal initial cervical length(\>3cm), who exhibit dynamic cervical change deliver at an earlier gestational age than those without dynamic change.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women between the ages of 18 and 45 years.
* Intrauterine pregnancy with gestational age between 22 0/7 and 34 6/7 weeks gestation.
* Presenting with symptomatic preterm labor (e.g. Regular uterine contractions, uterine cramping, or pelvic pressure).

Exclusion Criteria:

* Cervical cerclage
* Ruptured membranes noted on initial speculum examination
* Cervical os dilation \>4 cm noted on initial digital examination
* Known HIV-positive or active HSV(to minimize the risk of perinatal exposure)
* Presence of multiple genital warts
* Patients under extreme duress from their uterine contractions
Effects of Different Coffee Amounts on Energy Intake, Appetite, Glucose Metabolism and Inflammatory Markers

The purpose of the study is to investigate whether different doses of caffeinated coffee consumption has acute effects on subjective appetite feelings, energy intake and biochemical markers related to appetite, inflammation and glucose metabolism compared to water consumption in normal weight and overweight/obese participants.


Eligibility Criteria:
Inclusion Criteria:

* apparently healthy
* habitual coffee drinkers (\>= 1cup of coffee/day)

Exclusion Criteria:

* smokers
* restrained eaters (as this was evaluated using the Dutch Eating Behaviour Questionnaire)
* those who reported slimming or any other dietary regime
* athletes
* participants with a known diagnosis of either hypertension, diabetes, impaired glucose tolerance or a fasting blood glucose concentration above 125 mg/dl
* subjects on medication for hypertension or on medication known to alter glucose metabolism
* subjects who were on medication that may have an impact on appetite and sensory functioning or who reported a metabolic or
* endocrine disease,
* gastrointestinal disorders,
* a history of medical or surgical events that may have affected the study outcomes
RLS In Adults: Comparing Immediate Release Formulation With Extended Release Formulation Of Ropinirole

Restless Legs Syndrome (RLS) study in adults comparing immediate release ropinirole with extended release ropinirole over 12 weeks


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary RLS according to RLS Diagnostic Clinical Interview and International Restless Legs Syndrome Study Group Diagnostic Criteria.
* Disturbed sleep, with both evening (between 5:00 pm and 8:00 pm) and night time (between 8:00 pm and 8:00 am) symptoms requiring treatment.

Exclusion criteria:

* Signs of secondary RLS.
* Primary sleep disorder or movement disorder other than RLS.
* Unstable medical conditions.
* Inability to tolerate dopamine agonists or dopamine antagonists.
* Unwilling to discontinue any medications currently being taken to treat RLS symptoms.
DV 100 as a Framework for the Hospital Incident Command System

There is limited scientific research on the organizational structure of the Hospital Incident Command System. The Hospital Alarm and Emergency Planning manual by the German Federal Office of Civil Protection and Disaster Assistance (BBK) recommends a continental staff system-based organization, as outlined in the Service Regulation DV 100, similar to military, fire, and police structures. This approach is frequently discussed at professional conferences, but evidence on its functionality in hospitals is lacking. This study aims to generate new insights into the use of a continental staff system-based Hospital Incident Command System and qualitatively analyze transition and communication processes within the command structure.


Eligibility Criteria:
Inclusion Criteria:

* Participation in at least one hospital incident command system (ICS) training and, if applicable, in a ICS exercise.

Written informed consent from the employee for participation in the second part of the study (semi-structured interview)

Exclusion Criteria:

* Decline of study participation
Strength Training in Nonagenarians

The Health Enhancing Strength Training in Nonagenarians (STRONG) is a randomised control trial to assess the effectiveness of an aerobic and strength training program for improving functional capacity and quality of life in nonagenarians. Sixty (51 women) nonagenarians (age range: 90-102 years) who live in a geriatric nursing home will be randomly assigned to either a usual care (control) group (n=30) or an intervention (training) group (n=30). Participants allocated in the usual care group will receive general physical activity guidelines and participants allocated in the intervention group will also enroll in three weekly non-consecutive individualized training sessions (\~45-50 min each) during 8 weeks. The exercise program will consist of muscular strength \[with a special focus on leg press at 30% (start of the program) to 70% 1 repetition maximum (end)\] and aerobic exercises (cycle-ergometry during 3-5 to 15 minutes at 12-14 points in the rate of perceived exertion scale). Results from STRONG will help to better understand the potential of regular physical activity for improving the well-being of the oldest population groups.


Eligibility Criteria:
Inclusion Criteria:

* Age: 90 years or over.
* Planning to stay in the same nursing home during the study.
* Able to ambulate, with or without assistance.
* Able to communicate.
* Informed consent: Must be capable and willing to provide consent.

Exclusion Criteria:

* Acute or terminal illness.
* Myocardial infarction in the past 3 months.
* Not capable to ambulate.
* Unstable cardiovascular disease or other medical condition.
* Upper or lower extremity fracture in the past 3 months.
* Severe dementia.
* Unwillingness to either complete the study requirements or to be randomised into control or training group.
* Presence of neuromuscular disease or drugs affecting neuromuscular function.
Superior Vena Cava Isolation Plus Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation

Pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (PAF) has limited success. The superior vena cava (SVC) has been identified as one of the most common non-pulmonary vein triggers for PAF. It is estimated that SVC isolation (SVCI) could improve the clinical results of patients with PAF. However, results from previous studies about SVCI remain controversial. Safety concerns for SVCI may outweigh its benefits and lead to inadequate ablation. To address this issue, the introduction of a quantitative ablation index (AI) for SVCI may provide a solution. Therefore, the investigators sought to initiate a retrospective, multi-center study, to explore the efficacy and safety of quantitative SVCI in addition to PVI in PAF.

Catheter ablation has emerged as an effective treatment for drug-refractory PAF and is recommended as first-line therapy by current guidelines. PVI is considered the cornerstone of catheter ablation for atrial fibrillation (AF). However, despite persistent PVI, a subgroup of patients may experience recurrent AF due to focal ectopic discharges originating outside the pulmonary veins. Among the non-pulmonary vein triggers, the SVC stands out as a common culprit, making it a promising ablation target for maintaining sinus rhythm. Nevertheless, results from previous studies that evaluated the efficacy of SVCI showed conflicting results. One possible explanation is that SVC is adjacent to critical anatomical structures (such as the sinus node and the phrenic nerve), which raises safety concerns and often leads to inadequate ablation.

Therefore, it is necessary to establish a standardized ablation procedure for SVCI, ensuring both safety and efficacy. To address this issue, the investigators proposed the concept of "quantitative ablation for SVCI." By introducing AI as a quantitative measure, it is possible to achieve precise catheter ablation while minimizing the risk of procedure-related complications.

This study aimed to investigate the safety and feasibility of quantitative AI-guided SVCI in addition to PVI. Participants with PAF who required catheter ablation will be consecutively enrolled in three hospitals in China.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic paroxysmal AF that are unresponsive to antiarrhythmic drugs (one or more than one).
* Willing to undergo catheter ablation for AF.

Exclusion Criteria:

* History of any type of catheter ablation for cardiac arrhythmias.
* Sinus node dysfunction that requires permanent pacemaker implantation.
Novel Lenses for Myopia Progression Trial

This is a multi-center , prospective, randomised, longitudinal study to evaluate rate of myopia progression with novel lenses compared to Single-Vision spectacles. A total of 342 children will be recruited where 57 participants each are randomised to wear one of 5 test spectacle lens designs or a single vision lens (control) for 12 months. At the end of 12 months, those randomised to single vision lenses will be transferred to one of the test lenses and all the groups continued for another 12 months. Myopia progression during the second year with test lenses will be compared to historical or published controls.


Eligibility Criteria:
Inclusion Criteria:

be accompanied by a parent or guardian who is able to read and comprehend Chinese/English and sign a record of informed consent/assent; at baseline, be within the age range of 7 to 13 years old inclusive; be diagnosed as myopic having cycloplegic spherical equivalent between -0.75 dioptre (D) and -5.00 dioptre (D); astigmatism ≤1.50D; anisometropia of not more than 1.50D; be willing to comply with the wearing of clinical trial spectacles and clinical trial visit schedule as directed by the investigator; have ocular findings deemed to be normal; vision correctable to at least 0.8 or better in each eye with spectacles.

Exclusion Criteria:

Any pre-existing systemic or ocular condition, including infection or disease that is likely to affect visual acuity and refractive error; Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants.

Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant's ocular health / physiology in an adverse or beneficial manner at enrolment and/or during the clinical trial.

History of eye trauma Amblyopia Strabismus History of use of myopia control interventions such as Orthokeratology, atropine or eye surgery 6 months prior to commencement of this trial.

Known allergy or intolerance to ingredients to cycloplegic eye-drops. Currently enrolled in another clinical trial.
Youth and Sport Study

The Youth and Sport Study (YSS) is a 20-22-year follow-up study of Danish teenagers born between 1964 and 1969. Baseline data originate from two different studies carried out in 1983 and 1985, and the follow-up study was carried out in 2005.

The first baseline study was conducted in 1983 and included 1260 students in high school or trade school. The questionnaire was designed with focus on various aspects of sports and physical activity beside more general questions on family, socioeconomic status, height, weight, alcohol intake, smoking, etc. Furthermore, the participants were subjected to a set of physical tests and measurements.

The second baseline study was conducted in 1985 and included a representative sample of 2498 teenagers drawn from the Danish Civil Registration (CPR) and invited to participate in the study with the aim of validating the results from the first baseline sample. The study consisted of a questionnaire with virtually the same questions as the questionnaire from 1983. A short 28-item food frequency questionnaire (FFQ) was added to the questionnaire, as well as a few questions about dietary habits.

The follow-up study was carried out in 2005, when the subjects had reached an age of around 40 years. A total of 1904 subjects were traced and asked to complete a general questionnaire, a food frequency questionnaire, and deliver a DNA sample, all distributed and returned through mail correspondence. The general questionnaire included questions on education, occupation, height, previous and present weight, weight loss history, physical activity, smoking, civil status, children, other family, stress, diseases, hospital admissions, and medicine use, among other things. The questions about physical activity were adopted from the baseline questionnaire. Other questions were adopted from other validated questionnaires. Moreover, a semi-quantitative, 195-item Food Frequency Questionnaire (FFQ), which previously has been used and validated in the Danish "Diet, Cancer and Health" study was included. The study was approved by the local ethics committee for Copenhagen and Frederiksberg (J.nr. KF 01-260/04).

Eligibility Criteria:
Danish teenagers born between 1964 and 1969.
A Study of LCAR-AIO in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus

This is a prospective, single-arm, open-label, dose-exploration and expansion clinical study of LCAR-AIO in adult subjects with relapsed/refractory systemic lupus erythematosus.

This is a prospective, single-arm, open-label exploratory clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy profiles of LCAR-AIO, a chimeric antigen receptor (CAR) -T cell therapy in subjects with relapsed/refractory systemic lupus erythematosus. Patients who meet the eligibility criteria will receive LCAR-AIO infusion. The study will include the following sequential stages: screening, apheresis, pre-treatment (cell product preparation: lymphodepleting chemotherapy), treatment (LCAR AIO infusion) and follow-up.

Eligibility Criteria:
1. Subjects voluntarily participate in clinical research.
2. Age 18-65 years.
3. Have been diagnosed of SLE at least 6 months before screening.
4. At screening, antinuclear antibody, and/or anti-dsDNA antibody, and/or anti-Sm antibody should be positive.
5. Fulfill relapsed/refractory SLE conditions.
6. Adequate organ function at screening.
7. Clinical laboratory values meet criteria at screening.

Exclusion Criteria:

1. Active infections such as hepatitis and tuberculosis.
2. Other autoimmune diseases.
3. Serious underlying diseases such as tumor, uncontrolled diabetes.
4. Female subjects who were pregnant, breastfeeding, or planning to become pregnant while participating in this study or within 1 year of receiving LCAR-AIO treatment.
5. Participated in other clinical trials within
A Study to Compare Quality of Life and Compliance in Patients Receiving High-dose Interferon Versus Pegylated Interferon in Patients With Surgically Resected Melanoma

To evaluate the compliance with and perceptions of treatment, as well as health-related quality of life (HRQOL) in surgically resected melanoma patients undergoing HDI or PEG IFN therapy.

The primary objective of this study is:

• To evaluate compliance with the administration of standard HDI versus PEG IFN for patients with melanoma in need of adjuvant therapy

The secondary objectives of this study are:

* To compare the convenience and satisfaction with chemotherapy for patients on standard HDI versus PEG IFN using a chemotherapy convenience and satisfaction questionnaire (CCSQ) and to evaluate the treatment-related side effects that may impact the patient's HRQOL using the Functional Assessment of Cancer Therapy of Biologic Response Modifier (FACT BRM)
* To assess the frequency of Grade 3 and 4 toxicities, according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) for patients on standard HDI versus PEG IFN
* To examine reasons for patients' choice of treatment with HDI versus PEG IFN, for those cases in which patients are presented with a choice of either treatment option
* To assess Health Resource Utilization on both arms of the study

Eligibility Criteria:
Inclusion Criteria:

* Patient is male or female at least 18 years of age
* Patient has had surgically resected melanoma and plans to receive adjuvant therapy with HDI or PEG IFN
* Patient is willing and able to give written informed consent
* Patient is willing to comply with all study requirements

Exclusion Criteria:

* Patient is unable or unwilling to complete QoL questionaire or compliance diary
* Patient has a history of anaphylaxis due to any interferon alpha product
* Patient has autoimmune hepatitis
* Patient has decompensated liver disease (Child-Pugh score\>6 ( Class B and C)
* Patient has a history of neuropsychiatric disorder (including depression) that, in the judgment of the investigator, may impair the patient's ability to successfully complete treatment or protocol-related requirements
A Client-Based Outcome System for Individuals With Lower Limb Amputation

Standardized outcome measures can be used to document patient health outcomes and improve treatment of those requiring prosthetic and orthotic (O\&P) services. Though numerous instruments have been developed, existing measures of O\&P outcomes have serious shortcomings including limited evidence that the scores are responsive to clinical changes.

The investigators are developing the Prosthetic Limb Users Survey-Mobility (PLUS-M) using modern measurement methods to be a brief, precise and flexible measure of mobility for persons with lower limb amputation (LLA). The investigators propose the following objectives to achieve this goal.

Key objective 1: develop a measure (item bank) for measuring mobility in persons with lower limb loss

Key objective 2: study health profiles of lower limb prosthetic users

Key objective 3: validate the measure in a longitudinal study of people receiving replacement prosthetic limbs

Key objective 4: study longitudinal health patterns of persons with lower limb amputation


Eligibility Criteria:
Inclusion Criteria:

(1) be 18 years of age or older; (2) have a unilateral or bilateral amputation of the lower limb between the hip and knee or between the knee and ankle; (3) own and use a lower limb prostheses; (4) and be able to read, write, and understand spoken English.

Exclusion Criteria:

(1) do not currently use or do not intend to be fitted for a lower limb prosthesis; or (2) appear to have moderate to severe cognitive impairment, as evidenced by inconsistent responding to the study instruments.
Phase IV Clinical Trial of Nimotuzumab in the Treatment of Nasopharyngeal Carcinoma

This clinical study is designed as an open, single group, multi-center, phase 4 clinical study to assess the safety of Nimotuzumab in the treatment of nasopharyngeal carcinoma and to provide a more reasonable basis for clinical drug programs.

This clinical study is designed as an open, single group, multi-center, phase 4 clinical study to assess the safety of Nimotuzumab in the treatment of nasopharyngeal carcinoma and to provide a more reasonable basis for clinical drug programs.

Subjects who meet the inclusion/exclusion criteria are administered of Nimotuzumab based on medication instructions or adjusted by clinicians according to the treatment. In case of the progression of disease, unacceptable toxicity, withdrawal of the consent, or judgment by investigator that the treatment needs to be stopped, the treatment of Nimotuzumab is stopped.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically or cytologically confirmed nasopharyngeal carcinoma
2. Sex and age without limiting
3. Treatment without limiting
4. Subjects with reproductive potential (males and females) willing to use reliable means of contraception
5. Able and willing to give written informed consent and comply with the requirements of the study protocol

Exclusion Criteria:

1. Patients with severe allergies or idiosyncratic constitution
2. Women who are pregnant (determined by urine pregnancy test)or breast feeding
3. Any other severe complications or functional disorder of organ systems, which will affect the evaluation of safety of patients or will interfere with the test drug according to the researcher's point of view