cyrilzakka/clinical-trials huggingface dataset:
Overnight and In-house 3D-printed Patient-specific Casts for Non-operative Treatment of Distal Radius Fractures

The aim of this prospective randomized trial is the acquisition and evaluation of data to assess the relevance, feasibility and safety of forearm casts based on 3D-printing technology in the nonoperative treatment of distal radius fractures.

The study design is planned according to similar studies investigating the treatment of distal radius fractures.

Upon the patient's arrival at the emergency unit, the distal radius fracture is examined following the same scheme as before. The wrist is x-rayed in two planes. If there is a distal radius fracture and none of the exclusion criteria apply, the patient is included in the study after giving their consent in writing. The patients are then assigned to the "conventional cast" group (Group A) or the "3D print cast" group (Group B) in randomized trial, either immediately during the emergency consultation or within a week during hand surgery consultation hours. For initial immobilization, a thermoplastic cast splint is used as before. Depending on the randomization, the cast is changed to a Scotchcast cast (Group A) or a 3D printed cast (Group B). Further treatment of both groups occurs based on the same algorithm as before (see below).

The cast for Group B are produced using 3D print technology based on software by a Belgian company, our collaborators: The patient's forearm is scanned with a tablet (duration: approx. 5 min), whereupon the cast is printed overnight according to the scan (duration: approx. 4h) and adjusted to the patient during the next appointment.

The patients are examined after 1, 6, 12, 26 and 52 weeks in the outpatient clinic. Follow up x rays, patient satisfaction and clinical efficacy questionnaires and clinical examinations are conducted.

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature (Appendix Informed Consent Form)
* Undisplaced or minimally displace distal radius fractures

Exclusion Criteria:

1. Age \< 18yrs.
2. Dorsal dislocation (dp angle) \>20°
3. Palmar dislocation
4. Ad latus dislocation
5. Radio-/ulnar angulation in the coronary plane
6. Symptoms of neurologic affection (Median nerve)
7. Bilateral fractures
8. Previous ipsilateral distal radius fracture
9. The patient is unable to give informed consent due to physical or mental impairment
10. The patient is unavailable for follow-up examinations (foreign country, Polytrauma, etc)
11. The patient is under legal custodianship
12. C2- or Drug-abuse or expected incompliance
13. Hypersensitivity/Allergy to one or more components of the used casts
14. Pregnancy/Intention to become pregnant during the course of the study
Urine Proteome of Surgical Patients and Healthy Volunteers

The purpose of this study is to define early urinary biomarkers for diagnosis and prognosis of Renal Cell Carcinoma (RCC) with subsequent development of reliable, cost-effective, screening techniques.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Planned procedure with presumptive diagnosis of RCC, bladder or prostate cancer OR control patient undergoing non-urological surgery OR normal healthy volunteer OR post surgical patient with a diagnosis of RCC and under surveillance for reoccurrence of RCC or treatment of metastatic RCC
* Signed, informed consent

Exclusion Criteria:

* Patients on dialysis
A Phase I Study of Oral BGJ398 in Asian Patients

This study will evaluate safety and tolerability to determine the Maximum tolerated dose (MTD) and/or Recommended dose (RD).

This is a multi-center, open label, dose finding, phase I study of oral single agent BGJ398, administered on a continuous once and/or twice daily schedule.

Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced solid tumors with FGF-R alteration
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Adequate organ function

Exclusion Criteria:

* Patients with untreated and/or symptomatic metastatic Central Nerve System (CNS) disease
* Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply.
Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14 - 21 Weeks LMP): A Randomized-controlled Double-blinded Trial

The primary goal of this study is to determine the clinical advantage of pre-treatment with mifepristone in second trimester misoprostol induction abortion. This will be a randomized controlled double-blinded trial of 260 women comparing misoprostol alone to mifepristone plus misoprostol for second trimester (14-21 weeks' LMP) medical abortion.


Eligibility Criteria:
Inclusion Criteria:

* 14 to 21 weeks gestation, based on menstrual history and clinical exam (with or without ultrasound)
* Meet legal criteria to obtain abortion
* Present with closed cervical os and no vaginal bleeding
* Live fetus at time of presentation for service
* Have no contraindications to study procedures, according to provider
* Be able to consent to procedure, either by reading consent document or by having consent document read to her
* Be willing to follow study procedures

Exclusion Criteria:

* Known previous transmural uterine incision
* Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
* Any contraindications to vaginal delivery, including placenta previa
* Presentation in active labor (defined as moderate to severe contractions every 10 minutes or less)
Exploratory Study of Aerosol Inhalation of FB2001 for Post-exposure Prophylaxis of COVID-19 Close Contacts

This is a single-arm, open-label, dose ramp-up exploratory clinical trial to evaluate the efficacy, safety and tolerance of aerosol inhalation of FB2001 as post-exposure prophylaxis among close contacts of COVID-19 patients.

This study will enroll 20 to 60 close contacts of COVID-19 patients aging 18 to 65 years.

After signing the informed consent form, the qualified subjects will be given FB2001 once or twice daily.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female individuals aged 18-65 years.
2. COVID-19 close contacts determined by epidemiological investigation (living in the same room within 72 hours before screening with individuals having positive nucleic acid amplification test for SARS-CoV-2 ).
3. Having two consecutive negative nucleic acid tests within 72 hours before enrollment.
4. Participants of childbearing age must agree to use a highly effective method of contraception.
5. Sign the informed consent form.

Exclusion Criteria:

1. Pregnant women.
2. Participants who have history of prior drug allergy or are vulnerable to allergy.
3. Participants who infected with SARS-CoV-2 within previous 6 months.
4. Fever (body temperature \> 38 ℃), frequent cough and other symptoms suggestive of COVID-19 upon screening.
5. Participants with a history of asthma or chronic obstructive pulmonary disease.
6. Participants with known history of active liver disease, acute kidney disease or chronic kidney disease.
7. Participants with known history of stroke (except cavity infarction), serious heart disease or myocardial infarction.
8. Participants with known diagnosis of Alzheimer's disease, Parkinson's disease or tumor (except for radical tumor resection).
9. Blood pressure \>180/100mmHg at screening.
10. Participated in other interventional studies within previous 6 months.
11. Uptaking CYP3A4/5 strong inducers or inhibitors (rifampicin, phenytoin, carbamazepine, St. John's wort, clarithromycin, itraconazole, ketoconazole, ritonavir, cobicistat, darunavir, atazanavir, lopinavir, nelmatevir, nefazodone, etc.).
12. Participants who need to use other anti-SARS-CoV-2 therapeutic drugs during the study period.
13. Other conditions are considered unsuitable to participate in the researcher after evaluation by the researcher.
Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC)

This clinical study aims to assess feasibility, safety, tolerability, and compliance of a Nonessential Amino Acid Restriction (NEAAR) medical food in adult patients with locally advanced rectal cancer during standard of care short course radiotherapy followed by standard of care chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of adenocarcinoma of the rectum
* Clinical stage II (cT3-4, N-) or Stage III (cT any, N+) based on MRI
* Eligible for total mesorectal excision
* No evidence of distant metastasis
* No prior pelvic radiation therapy
* No prior chemotherapy
* Age ≥18 years

Exclusion Criteria:

* Patients unable to undergo MRI
* Other anticancer or experimental therapy
* Body mass index (BMI) \<18.5 kg/m2 or \>40 kg/m2
* Serious or refractive cachexia or anorexia
* Insulin-dependent diabetes Taking or needs to take any protein or amino acid containing nutritional supplements (e.g., Ensure®) Patients with a condition where high-fat or fatty food is contraindicated History of confirmed food allergy Active wound or skin graft that would require a significant increase in protein requirements for skin integrity and healing
Plasma Sodium: a Predictor of Perforation in Acute Appendicitis. (The NAP-study)

This clinical prospective diagnostic accuracy study assesses plasma sodium concentration using blood gas analysis at the emergency department in children, age 1-15 years, with suspected acute appendicitis. The overall assumption is that using plasma sodium as a biomarker, a cut-off value of \<136 mmol/L will differentiate perforated from non-perforated acute appendicitis. In addition, traditionally used clinical diagnostic variables as well as radiology used in the diagnosis of acute appendicitis will also be obtained. Histopathology will be used to define if the appendix is perforated or not.

Background: The historical dogma that acute appendicitis always progresses to gangrene and perforation has been rejected. In addition, there is evolving evidence that medical treatment of non-perforated acute appendicitis is safe. On the other hand, perforated acute appendicitis requires appendectomy \[Andersson\]. Therefore, it is important to differentiate perforation from non-perforation in order to enable proper treatment.

In a pilot-study in children with acute appendicitis (n=80), plasma sodium was shown to be an independent predictor differentiating between perforated and non-perforated acute appendicitis \[Lindestam\]. Using plasma sodium at a cut-off value of \<136 mmol/L, the odds ratio of having a perforated acute appendicitis was 31.9 (95% CI, 6.3- 161.9) with an area under the receiver operating curve of 0.93. Sensitivity and specificity were 0.87 (95 % CI 0.60-0.98) and 0.83 (95 % CI 0.72-0.91). Similar results have later been shown by another research group \[Pogorelic\]. Possible mechanism for lower plasma sodium among patients with perforation is higher concentration of arginin-vasopressin, which has previously been shown \[Lindestam\].

Methods: Participants (n=450 in total) whereof 150 in Sweden, 150 in Republic of South Africa, 50 in Germany, 50 in Denmark and 50 in Norway will be included in the study. The patients/parents will be asked for participation in the study and included after decision of surgery has been made by the attendant surgeon. At this timepoint, (i) variables from clinical examination/history (presence of right iliac fossa pain, rebound tenderness, duration of symptoms, vomiting, temperature, gender, age, weight, (ii) blood sampling: blood gas (including plasma sodium), C-reactive protein, neutrophiles, White blood cell count (obtained at the emergency department) and (iii) radiology has been obtained. No intervention is planned. These variables will also be used to calculate the Appendicitis Inflammatory Responce (AIR) score \[Scott\]. Thereafter, plasma sodium concentration will be added and the score will be recalculated.

After surgery, histopathology will be used to determine if the appendix is perforated or not.

Eligibility Criteria:
Inclusion Criteria:

* Children with suspected acute appendicitis

Exclusion Criteria:

* Chronic metabolic disease
* Endocrinological disease
Dance-therapy and Chronic Pain

Pain, when it becomes chronic, can be a threat to patients and it is very common to observe a fear of pain and a fear of movement (kinesiophobia). Avoidance of movement due to fear of pain can lead to a deterioration of body image. Non-medicinal therapies are essential to correct this fear and movement avoidance behavior, to decrease "catastrophic" judgments and thus anxiety. The use of art-therapy in the accompaniment of patients with pain has shown, in particular, decreases in the intensity of pain, the level of anxiety, an improvement in stress, mood and overall psychological state. However, according to the current literature, it appears that 1) this technique is rarely used in children or adolescents, for whom non-medicinal therapies are fundamental, and 2) in the case of chronic pain, the form of art used is very rarely related to the body (most often painting, drawing, music...).

In this project, investigators propose to set up and test the potential benefit of art-therapy sessions related to the body, namely dance-therapy, in adolescents and young adults suffering from chronic pain.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 12 to 20 years, girls or boys, with either complex regional pain syndrome (CRPS) or chronic tension-type headache (CTTH).
* Diagnosis of CRPS or chronic CTTH made in a Pain Management Center
* Patients followed in a Pain Management Center (to ensure that patients entering the protocol have pain that is not relieved by conventional treatments)
* Patients who have given written consent for adults or whose parents have given consent for minors
* Patients who are affiliated with or benefit from a social security system.

Exclusion Criteria:

* Patients with headaches other than CTTH
* Patients with other neurological or psychological disorders
* Patients with psychiatric illnesses
* Patients with chronic pain conditions other than CRPS or CTTH
* Patients with chronic infectious, metabolic, cancerous, autoimmune diseases.
* Patients whose motor limitations are not related to the diagnosis of CRPS or CTTH (e.g. cerebral palsy, spinal cord injury...)
* Non-communicating patients including deaf and hard of hearing patients
* Patients or parents who do not speak or read French
* Pregnant women
* Dance or yoga professionals (dance or yoga teachers or those studying to become teachers)
DTI & Tractography in Pediatric Tumor Surgery

The goal of this project will be to demonstrate that Synaptive Medical's Diffusion Tensor Imaging(DTI) product functionality used in pre-operative planning and intraoperative surgical navigation, improves clinical outcomes corresponding to a reduction in neurological and neuropsychological deficits in pediatric brain tumor surgery.

Brain tumours are the most common form of solid tumours in children which often arise from the cerebellum. Treatment involves a complete resection of the tumour. Although surgical resection may eliminate most of the malignancy, signs of post-neurologic deficit may present as a consequence to the treatment.

One such example is cerebellar mutism syndrome (CMS), a postoperative syndrome typically arising 1 to 2 days after resection of a midline posterior fossa tumor; it consists of diminished speech progressing to mutism, emotional lability, hypotonia, and ataxia. While some of the symptoms recover after a few months, neuropsychological testing shows long term deficits in language (agramatism), executive function and verbal memory.

This study aims to investigate whether the use of Synaptive Medical's BrightMatter™ technology can help neurosurgeons better visualize and plan surgeries by avoiding eloquent fiber tracts in the brain and cerebellum; thus minimizing damage pertaining to neurologic and motor functionality. The use of these products will also be assessed for improved clinical outcomes in pediatric tumor surgery.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric subjects between the ages of 0-18 years with a brain tumor.

Exclusion Criteria:

* Pediatric subjects with contra-indication to MRI (metal, claustrophobia, etc.)
Adding L-carnitine in Clomiphene Resistant Polycystic Ovary Improves the Quality of Ovulation and the Pregnancy Outcome

Adding L-carnitine is more successful than clomiphene as a first line therapy for ovulation induction in women with clomiphene resistant PCOS

Patients younger than 35 years, presenting with primary or secondary infertility following regular intercourse for at least 1 year and diagnosed with PCO according to Rotterdam's criteria who had received five unsuccessful clomiphene citrate-timed intercourse stimulation cycles were included.

Eligibility Criteria:
Inclusion Criteria:

* Patients younger than 35 years, presenting with primary or secondary infertility following regular intercourse for at least 1 year and diagnosed with PCO according to Rotterdam's criteria who had received five unsuccessful clomiphene citrate-timed intercourse stimulation cycles were included. The diagnosis was based on a complete history taking, physical examination and a paper documented complete infertility work-up within the previous 6 months, either conducted within the setting of the hospital or at a licensed infertility management clinic.

Exclusion Criteria:

* age more than 40 years,
* tubal,uterine or male factor infertility
Drug Eluting Balloon for Prevention of Hemodialysis Access Restenosis

The purpose of this study is to evaluate the effectiveness of paclitaxel-coated balloon catheter to prevent restenosis after PTA (percutaneous transluminal angioplasty) of hemodialysis access (HA) in comparison with the uncoated PTA balloon catheter.

In Canada, there are over 20,000 patients with chronic end-stage renal disease (ESRD)on long-term hemodialysis and the number is increasing rapidly.The creation of hemodialysis access (HA) (also called "lifeline" for dialysis patients) has become the most common type of vascular surgery. These HA are frequently complicated by dysfunction after their creation mainly due to neointimal hyperplastic stenosis (\> 60% at one year). PTA is an established cornerstone method of treating stenotic lesions because of its minimally invasive percutaneous nature and widespread availability.Although PTA has a high initial success rate,narrowing will often recur in 2-3 months hence requiring further interventions. There are currently no durable therapies for the prevention or treatment of HA dysfunction restenosis after PTA.

Recently drug eluting balloon (DEB) with paclitaxel have repeatedly demonstrated their effectiveness to prevent restenosis due to intimal proliferation in the coronary and peripheral arterial systems. The investigators believe that the DEB with paclitaxel will significantly decrease the HA restenosis rate at the treated site and therefore will improve the management of HA failures.

Eligibility Criteria:
Inclusion Criteria:

* Clinical or hemodynamic evidence of HA dysfunction according to the clinician's judgment
* Patients with AVF (arteriovenous fistulae)or AVG (arteriovenous graft) located in the forearm or upper arm and is \> 3 months old
* Minimum age of 18 years and written informed consent
* Target lesion stenosis is \<3.0 cm in length and \>50% in luminal diameter reduction
* Maximum of two secondary lesions (stenoses) if the following criteria are satisfied: The secondary lesion is located in the graft or peripheral veins, the secondary lesion is \<3.0 cm in length and located \>1.0 cm away from the target lesion, the secondary lesion is \>50% luminal reduction compared to the reference vessel diameter
* Reference vessel diameter between 4 to 7 mm
* The HA must not be thrombosed and the lesion can be crossed with guide wire before angioplasty
* Lesion site: from 2 cm above the arterial anastomosis to the superior vena cava
* Restenotic lesion (previously treated by PTA or stent) or de novo lesion

Exclusion Criteria:

* Contraindication to angiography or PTA
* Intervention of the HA circuit within the past 30 days
* Systemic infection or a local infection associated with the graft
* The patient is pregnant
* Patient is enrolled in another investigational study.
* Life expectancy \< 12 months
* History of severe allergic reaction to contrast media or to paclitaxel
Evaluation of Swallowing in Patients With Obstructive Sleep Apnea

The purpose of this study is to test the hypothesis that obstructive sleep apnea syndrome is associated with deviant pharyngeal swallowing function, using clinical, endoscopical and manometric evaluation.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of obstructive sleep apnea syndrome

Exclusion Criteria:

* other causes of dysphagia
* pharyngeal surgery
* prior treatment for obstructive sleep apnea
The Effect of Aspirin on Angiogenesis Proteins in Women on Tamoxifen Therapy

Changes in major angiogenic proteins have been seen following initiation of tamoxifen and aromatase inhibitor therapy in women with breast cancer. One source of these proteins is the circulating platelet pool. The investigators hypothesize that in addition to their anti-platelet properties, agents such as aspirin can be used as targeted anti-angiogenesis therapy. The investigators will determine the influence of aspirin on the release of angiogenic proteins from platelets in 35 patients with breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven breast cancer
* Pre or post-menopausal
* Age \>18
* Completed adjuvant non-hormonal therapy \>30 days prior to initiation of study (surgery and/or chemotherapy and/or radiation therapy)
* Platelet count and hemoglobin within normal ranges for local lab within 30 days of initiation of study therapy
* Receiving tamoxifen therapy for at least 90 days prior to initiation of study therapy, and is expected to continue that therapy for the duration of the study (75 days)

Exclusion Criteria:

* Chemotherapy, radiation therapy or surgery within 30 days of study therapy
* Current use of aspirin, anti-platelet or anti-coagulation agents on a continuous basis
* Prior history of gastrointestinal or central nervous system bleeding, or documented or self-reported blood in stools or bright red blood per rectum
Efficacy of Monetary Incentives for Primary Care Physicians on Patients

Patients' recruitment is difficult in clinical trial. Financial incentives are frequently proposed to clinicians in private funded trials. However, the effect of these financial incentives has never been evaluated.

The purpose of this study is to evaluate the effect of financial incentive on the rate of recruitment of patients in a cohort study.

Context: Patients' recruitment is difficult in clinical trials. Financial incentives are frequently proposed to clinicians in private funded trials. However, the effect of these financial incentives has never been evaluated.

Objective: to evaluate the effect of financial incentive on the rate of recruitment of patients in a cohort study.

Design: randomized controlled trial Setting: primary care Participants: physicians (GP and cardiologists) participating in the recruitment of patients in a cohort study (the COFRASA study). The COFRASA cohort study is including aortic stenosis aging patient.

Intervention:75 euros for each patient included Main outcome: percentage of physician including at least one patient at 3 months Secondary outcome: mean number of patients included at 6 months. Sample size 270 physicians

Eligibility Criteria:
Inclusion Criteria:

* Physicians participating in the COFRASA cohort study
* informed consent

Exclusion Criteria:

- None