cyrilzakka/clinical-trials huggingface dataset:
Health-Related Quality of Life in Crohn's Disease Participants With Complex Perianal Fistula Before and After Treatment

The purpose of this study is to assess the impact of treatment (medical and/or surgical) on Health-related Quality of Life (HRQoL) in participants with Crohn's Disease (CD) and Complex Perianal Fistula (CPF), by the Quality of Life in patients with Anal Fistula Questionnaire (QoLAF-Q), at 12 months after treatment initiation in routine clinical practice.

This is a prospective follow-up post-authorization observational study of participants with CD and CPF. The study will provide real-world data on how CPF treatments in CD participants affect their HRQoL.

The study will enroll approximately 300 participants. All participants will be enrolled in one observational cohort.

This multi-center trial will be conducted in Spain. The study will collect data from a routine medical practice visits for CD participants with CPF and an application that will be designed ad hoc and will passively record participant's data. The overall duration of this study will be approximately 31 months. Participants will be followed up at Months 6 and 12 post-treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with CD and CPF (defined as a fistula meeting any of the following criteria: high location \[high intersphincteric, high transsphincteric, extrasphincteric, or suprasphincteric\], multiple external openings, perianal abscess, anal stenosis, or proctitis).
2. Has tried and failed at least one prior treatment for CPF.
3. Starting a new pharmacological or surgical treatment for CPF.

Exclusion Criteria:

1. Diagnosed with indeterminate/unspecified type of inflammatory bowel disease (IBD).
2. Diagnosed with ulcerative colitis.
3. Diagnosed with fistula other than CPF (example rectovaginal).
4. Treated with darvadstrocel or other stem cells-based therapies within the eligibility period.
5. Previous fecal incontinence.
6. Lost to site follow-up for reasons other than death.
7. Participates or plans to participate in any interventional clinical trial.
8. Non fluent in Spanish.
INvestigating SIGnificant Health TrendS in the Management of Superficial Vein Thrombosis

Superficial vein thrombosis (SVT) and venous thromboembolism (VTE) are related entities. Only in the last years a series of observational studies mainly conducted in France could show that ´isolated SVT´ (without concomitant deep vein thrombosis and/or pulmonary embolism) is in fact not a benign and spontaneously healing disease but bears a potential for severe thromboembolic complications once not treated adequately. INSIGHTS-SVT study aims at collecting representative data on the current management and outcomes of SVT in Germany under real-life conditions. It will document the implementation of the recently issued national SVT guidelines issued by the Society for Angiology (DGA) and the Society for Phlebology (DGP).


Eligibility Criteria:
Inclusion Criteria:

* Confirmed, acute, isolated SVT of the lower extremities
* written informed consent

Exclusion Criteria:

* SVT located at ≤ 3 cm of the saphenofemoral crossing (as such patients need to be treated for DVT)
* Subjects unlikely to comply with the requirements of the protocol (due to cognitive and/or language limitations)
* Patient(likely) not available for 1-year documentation
Budesonide With Intratracheal Surfactants in Extremely Preterm Infants

This is a phase I/II trial in preterm infants aimed at identifying the optimal dose of budesonide with bovine lipid extract surfactant as vehicle for intratracheal administration.

Premature infants of gestational age less than 29 weeks with respiratory distress syndrome and clinical indication for surfactant administration will be recruited for this Phase I/II open-label study.

A total of 30 subjects will be recruited from 2 neonatal intensive care units:

1. Children's Hospital-Health Sciences Centre (HSC), Winnipeg
2. St. Boniface General Hospital, Winnipeg, MB

3 groups of 10 infants each will receive single dose of intratracheal budesonide (0.0625 mg/kg, 0.125 mg/kg, and 0.25 mg/kg) with BLES surfactant (5 ml/kg). PK/PD analysis will be done using clinical parameters, serum biomarkers, tracheal aspirate biomarkers and plasma budesonide levels obtained at fixed intervals.

The duration of subject participation will involve 12-17 weeks for the clinical intervention, depending on gestational age at birth and discharge date. Participants will be followed until 40 weeks or discharge, whichever comes first.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female infant born between 23 and 28+6 weeks of GA
2. Infant diagnosed with RDS according to clinical protocol criteria
3. Able to adhere to surfactant administration protocol
4. The patient is born in the study centre.
5. Subject's parent(s)/legal guardian(s) has provided signed and dated informed consent and authorization to use protected health information, as required by national and local regulations.
6. In the investigator's opinion, the subject's parent(s)/legal guardian(s) understand(s) and can comply with protocol requirements, instructions, and protocol-stated restrictions, and is likely to complete the study as planned.

Exclusion Criteria:

1. Older than five days at inclusion.
2. Presence of known clinically significant congenital heart disease or other major congenital malformation
3. Subjects with clinically significant laboratory abnormalities which are deemed by the investigator to represent a safety risk to participation in this study. Other laboratory parameters outside the reference range for the subject's age may be included if the investigator considers the abnormalities unlikely to introduce additional risk factors and will not interfere with data interpretation.
Wheelchair Indoors Curling With SCI patients_RCT

This study investigates if, patients with diagnosed chronic spinal cord injury will benefit from an Indoor Curling Exercise program on their control capabilities of trunk movements and on their intrinsic motivation for physical activity. Half of participants will receive 8 training-sessions during 4 weeks, while the other will receive usual care.

Spinal cord injury (SCI) is a catastrophic event that can be devastating and costly in human and social terms. These patients require multidisciplinary and interdisciplinary treatment. Physiotherapy is important factor in SCI rehabilitation.

The objectives of physiotherapists are manifold and include the development of the force of healthy muscles, the teaching of transfer techniques, the maintenance of joint motion and of the body map, and the reestablishment of sitting balance in order for the patients to regain their autonomy.

Maintaining postural stability when seated is a challenge for people with a SCI as their sensory and motor systems in their trunk, lower and upper extremities have been damaged to different degrees. To train this postural stability, physiotherapists include many interventions. Physical activities in sport therapy are some of them. In addition to usual physical activities (basketball, tennis, wheelchair running,...) the investigators propose to practice wheelchair Indoors Curling Exercise with wooden Curling Stones.

Eligibility Criteria:
Inclusion Criteria:

* Traumatic, non-traumatic or ischemic Spinal Cord Injury with complete or incomplete para- or tetraplegia
* Complete spinal cord status (ASIA Score)
* Sitting capabilities ≥ 4 hours
* Capability to bench 20° forward in trunk flexion
* Signed informed consent after being informed

Exclusion Criteria:

* Progressives pathologies
* Problem in vestibular system
* Severely impaired vision
* Tetraplegia without hand function
* Acute pain
* Contraindications on ethical grounds
* Previously reduced capabilities of cooperation
* Know or suspected non-compliance
Macrolane Prospective Survey

The study objective is to evaluate the long term safety when Macrolane Volume Restoration Factor is used in female breasts in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Females recently treated with Macrolane Volume Restoration Factor in the breasts.
* Signed informed consent

Exclusion Criteria:

* There are no exclusion criteria
A 20-Week Study Assessing the Efficacy of Apremilast in Patients with EB Simplex Generalized

The goal of this clinical trial is to Assessing the Efficacy and Safety of Apremilast in Patients \> 6 years of age with EB simplex generalized . The main question it aims to answer are: describe efficacity of this treatment.

Participants will take treatments and have to use bullets during the study period.

The patient will have 7 visits. After Confirmation of inclusion criteria and no exclusion criteria, the study will be explain to the patient after signing the inform consent and be included in the study Treatment Period (Period 1); challenge period This period will be the first treatment period that will occur from 8 weeks. During this period the patient will see the doctor at the hospital, he will perform the study procedures The second period : dechallenge (period 2): All patients stop their treatment for 4 weeks.

The second treatment period - rechallenge (period 3) the patient will take the treatment for a second 8 weeks period At week 20 - End of study

At each visit:

The investigator at each visit compliance to the treatment and adverse events, Measure vital signs and perform clinical examination.

The patient will assess the different questionnaires, for the study

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients 6 years or older
* Laboratory confirmed diagnosis of EBS-sev due to KRT5 or 14 mutation (autosomal)
* Mean daily number of new blisters \>3.
* Subject/caregiver agrees not to use any topical therapies other than the investigator approved

Exclusion Criteria:

* - EBS lesions requiring oral therapy to treat an infection
* Use of any diacerein containing product within 6 months prior to Visit 1
* Use of systemic immunotherapy or cytotoxic chemotherapy within 60 days prior to Visit 1
* Use of systemic steroidal therapy within 30 days prior to Visit 1
* Use of any systemic product that, in the opinion of the investigator, might put the subject at undue risk by study participation or interferes with the study assessments within 30 days prior to Visit 1
POETRY: Study of Estrogen Replacement Therapy in Postmenopausal Women With Parkinson's Disease

The primary objectives of the POETRY study are to assess the safety and tolerability of estrogen replacement therapy (ERT) in postmenopausal women with Parkinson's disease (PD) and to assess recruitment for a study of ERT in postmenopausal women with PD.

POETRY is an 8-week study of 30 post-menopausal women with Parkinson's disease (PD) who will be enrolled at six clinical sites in the United States. The study is designed to measure the safety and tolerability of estrogen replacement therapy (ERT). The study will also measure how ERT affects thinking and behavior, movement and activities of daily living, as well as motor fluctuations and dyskinesias. Although we know there are gender differences in PD, no studies have assessed their impact on symptom management. Women with PD usually require less levodopa, are more likely to experience drug-related dyskinesia, and commonly report changes of their symptoms with menstruation, menopause and use of hormones, implying that hormonal changes may impact PD symptoms. All perimenopausal women face the decision whether or not to use estrogen replacement therapy (ERT) and for women with PD, information about estrogen's effects in PD may facilitate decision-making.

Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women with Parkinson's disease who experience levodopa-related motor fluctuations averaging at least 2 hours daily in the "off" state confirmed by home diaries
* Must be on a stable dose of carbidopa/levodopa, immediate or controlled release therapy, antidepressants, or anxiolytics (for the last 30 days)

Exclusion Criteria:

* Insulin dependent diabetes
* Thyroid disease
Post-Marketing Study to Assess the Safety and Effectiveness of Oral Atogepant in Korean Adult Participants for the Prevention of Chronic or Episodic Migraine

Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. The study will assess the safety and effectiveness of atogepant for the preventive treatment of migraine in Korean adult patients with chronic migraine or episodic migraine under routine clinical practice.

Atogepant is an approved drug for preventive treatment of migraine in adults. Approximately 3000 adult participants who are prescribed atogepant by their doctors will be enrolled in this study in Korea.

Participants will receive atogepant oral tablets as prescribed by their physician. Participants will be followed for up to week 12.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Participants with migraine suitable for the treatment with atogepant according to the latest approved local label.
* Participants prescribed atogepant in accordance with the approved local label.

Exclusion Criteria:

* Participants with any contraindication to atogepant as listed on the latest approved local label.
* Participants currently participating in another clinical research except observational study.
Use of Blood Ketone Meters to Improve Ambulance Hyperglycaemia Care

In this KARMA2 feasibility study the investigators are testing whether ambulance staff can reliably and safely identify patients at high risk of diabetic ketoacidosis using blood ketone meters and start fluid (saline) therapy before arriving at hospital. The investigators aim to include 800 patients in this stepped wedge control study and the results will help decide if a larger study is warranted.

Diabetic ketoacidosis (DKA) is a potentially life-threatening condition which requires immediate treatment. National Health Service (NHS) hospital guidelines recommend immediate fluid (saline) therapy. Delays in diagnosis and treatment are known to be associated with health complications and death.

There is an opportunity to involve ambulance crews to improve DKA identification and treatment times; however, currently ambulance staff do not have access to ketone testing, and fluids are recommended only when it is thought a patient is critically unwell.

In this KARMA2 feasibility study the investigators are testing whether ambulance staff can reliably and safely identify patients at high risk of DKA using blood ketone meters and start fluid (saline) therapy before arriving at hospital.

During an 8-month period (4-month control followed by 4-month intervention), 120 ambulance clinicians from the East of England Ambulance Service NHS Trust will receive training to consent 400 patients with hyperglycaemia and unwell patients with diabetes to the control group receiving usual care, followed by determining the presence of ketones using capillary blood testing from a further 400 consenting patients with hyperglycaemia and unwell patients with diabetes. Subsequent patient care will depend on the ketone value obtained: high-risk DKA patients will receive fluid therapy.

Twenty ambulance and hospital clinicians will be invited to an online interview to share views of DKA care and the impact of ambulance blood ketone meters. The results will help the investigators decide if a larger study would be a good idea.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or more
* Attended by study clinician
* Informed or Proxy consent to participate
* Blood glucose level greater than 11mmol/L or unwell with history of diabetes
* If required will be transported to partner hospital

Exclusion Criteria:

* Failure to meet inclusion criteria
* Previously recruited to study
GlideScope® Versus Macintosh Laryngoscope for Post-thyroidectomy Assessment of Vocal Cord Mobility

Vocal cord dysfunction is a serious post-thyroidectomy complication. This can lead to various postoperative clinical consequences as hoarseness of voice, aspiration or stridor . It is also one of the common reasons for post-thyroidectomy malpractice claims.

This study will compare GlideScope® with Macintosh laryngoscope regarding accuracy of assessment of post-thyroidectomy vocal cord mobility.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I and II,
* Elective thyroid surgery with
* Normal thyroid profile

Exclusion Criteria:

* History of previous thyroid surgery,
* Preoperative vocal cord dysfunction
* Predicted difficult airway
Prospective Study to Evaluate the Performance and Safety of Personalized Implants in Cranio-Maxillofacial (CMF) Surgery Indicated for Orthognathic Surgery

With the digital age, guided surgery and cases of fully computer-assisted surgeries via 3D printing guides and preformed plates are booming.

Our project aims to study the performance and safety of personalized implants (personalized guides and plates) in orthognathic surgery in order to obtain specific clinical data on SLS France devices.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient, adult or minor having reached bone maturity according to the judgment of the investigator,
* Patient having first orthognathic surgery with SLS France personalized guides and plates,
* Patient who received orthodontic treatment prior to orthognathic surgery,
* Patient able to read, understand and answer the study quality of life questionnaire,
* Patient (and legal representative if a minor) who is not opposed to his participation in the study or to the processing of his data.
* Patient affiliated to a social insurance

Exclusion Criteria:

* Patient allergic to one of the compounds of the plates and / or guides,
* Patient with physical or mental disability making it impossible to follow up in the study,
* Patient with significant expansion
* Patient with a congenital craniofacial malformation
* Patient with acute or chronic local or systemic infection,
* Person placed under legal protection,
* Pregnant or breastfeeding women.
A Non Interventional Study With Doce Onkovis (Docetaxel) Utilized for the Treatment of Cancer

The main purpose of this observational study with Docetaxel is to determine the number of treatment cycles and the quantity of Doce onkovis needed therefore under the special circumstance of ambulant chemotherapy.

onkovis aims an economical utilization of the chemotherapeutics.The provision with adapted packaging sizes as to decrease the excess quantity to be discarded follows also this objective.

Secondary objectives are the evaluation of the safety and tolerability of Doce onkovis. To this purpose data regarding co medications and adverse events are also collected.


Eligibility Criteria:
Inclusion Criteria:

* Indication for Docetaxel according to the SmPC and treating physician

Exclusion Criteria:

* according to the Docetaxel SmPC
Clinical Trial of Clarithromycin, Lenalidomide and Dexamethasone in the Treatment of the First Relapsed Multiple Myeloma

BiRd regimen consisting of clarithromycin and Rd is safe and effective in NDMM. It can significantly increase ORR (up to 90.3%) , relief depth (≥VGPR), and prolong PFS to 43 months. In our previous study, thirty RRMM patients treated with BiRd regimen in 6 centers in China benefited.It suggested that BiRd regimen may not only improve overall efficacy of RRMM , especially long-term benefits, but also reverse Rd resistance in patients who fail to achieve any remission after multiline therapy.The study is a Prospective, Multicenter, Single Arm, Phase II Clinical Trial, which intend to recruit first relapse MM patients over 18 years old. Once included, patients will receive the treatment of Clarithromycin Lenalidomide Dexamethasone (BiRd) Regimen. (Clarithromycin 500mg，po，bid，d1-21; Lenalidomide 25mg，po，daily，d1-21 (dose according to creatinine clearance rate); Dexamethasone 20mg，po，daily，d1-2, 8-9,15-16, 22-23) And we will evaluate efficacy and adverse events of the BiRd regimen at a point of time predetermined.


Eligibility Criteria:
Inclusion Criteria:

1. diagnosed as symptomatic multiple myeloma.
2. the first relapse/progression with thalidomide, bortezomib or lenalidomide based current first-line treatment or resistance to the first-line treatment (previous treatment line number =1).
3. there must be measurable lesions to determine disease progression (PD): according to the IMWG 2016 efficacy evaluation criteria.
4. the expected survival time is longer than 3 months.
5. ECOG score less than 2 points.
6. the serum AST/ALT level \<3 times higher than the normal value; the serum total bilirubin level\<2 times of the normal value; creatinine clearance rate was ≥30ml/mi.
7. neutrophil count \>1000/mm3 ; platelet count \>75000/mm3 (if bone marrow plasma cell \<50%) or \>30000/mm3 (if the plasma cells in the bone marrow is not less than 50%).
8. women of childbearing age were negative for pregnancy before admission, and agreed to carry out pregnancy screening during the study (once a month until 4 weeks after the last dose), and agreed to use contraceptive measures within 3 months after the study and the last dose.
9. all patients were required to sign informed consent.

Exclusion Criteria:

1. under the age of 18
2. ECOG score \>2
3. non secretory myeloma, defined as serum protein M \< 1g/dL, urinary M protein \< 200mg/24h and sFLCR ≤100mg/L
4. there is growing demand, pregnant or lactating women within one year
5. HIV infection
6. activity of HBV or HCV infection
7. 4 weeks before entering the group of thromboembolic events
8. not signed informed consent
Flipped Classroom vs. Flip-Jigsaw in Theoretical Physiotherapy Education

Study Summary:

This quasi-experimental pre-test-post-test study aims to compare the effects of Flipped Classroom (FC) and Flip-Jigsaw instructional models on theoretical knowledge acquisition, academic motivation, and class engagement among 86 third-year physiotherapy undergraduates enrolled in a theory-based public health course.

Primary Questions:

How does the hybrid Flip-Jigsaw model impact learning and motivation outcomes compared to FC alone?

Do FC and Flip-Jigsaw differ in enhancing theoretical knowledge, motivation, and participation?

Comparison: Researchers will compare the FC group (pre-class videos + in-class discussions) with the Flip-Jigsaw group (video-based pre-learning + structured peer teaching) to evaluate differences in outcomes.

Participant Tasks:

Attend lectures and complete pre-/post-knowledge tests.

Engage in practical sessions (FC: group discussions; Flip-Jigsaw: peer-led jigsaw activities).

Complete motivation surveys and participation assessments.

Significance: Addresses the gap in understanding Flip-Jigsaw's efficacy in physiotherapy education, despite prior reports on FC and Jigsaw's individual benefits.


Eligibility Criteria:
Inclusion Criteria:

* To be between the ages of 18-25
* Volunteering to participate in the study
* Taking the course for the first time
* Having access to the Internet
* Compulsory course attendance

Exclusion Criteria:

* Being a minor student
* Not being the first undergraduate education
* To have previously attended courses, seminars, webinars, etc. related to public health
* Participation in other pedagogical studies during the same academic term.
* Failure to complete ≥1 assessment (pre-test, post-test, or surveys).