cyrilzakka/clinical-trials huggingface dataset:
Growth Curves in Cockayne Syndrome Type 1 and Type 2

Despite the natural progression of Cockayne's syndrome, affected patients also present with variable neurological and gastrointestinal damage (gastroesophageal reflux, recurrent vomiting, swallowing disorders, etc.) with varying repercussions on their growth. Acute intercurrent events such as seizures, constipation, infections can also interact with their metabolism, food intake and influence their growth. The nutritional deficit potentially involved in this growth retardation can be responsible for many manifestations such as anemia, bone fractures, fatigue, coagulation disorders responsible in total for the reduction in quality and life expectancy.

Faced with growth retardation in patients with Cockayne syndrome, medical management is difficult to establish. Is this delay part of the natural course of the pathology?


Eligibility Criteria:
Inclusion criteria:

* Minor patient
* Cockayne syndrome with molecular confirmation, treated between 01/01/1985 and 01/03/2020
* Collection of at least one growth data (height, weight, head circumference) for a given age
* Clinic compatible with type 1 or 2 Cockayne syndrome
* Holder of parental authority not opposing, after information, the reuse of their child's medical data for the purposes of this scientific research.

Exclusion criteria:

* Refusal to participate in the study.
* Lack of molecular confirmation of Cockayne syndrome
* Lack of growth data for a given age.
* Clinic not compatible with type 1 or 2 Cockayne syndrome. Exclusion of type 3 Cockayne syndromes, trichothiodystrophy and xeroderma-pigmentosum.
Evaluation of Sequential Stent Addition vs. Incremental Dilation & Stent Exchange for Management of Anastomotic Biliary Strictures After Liver Transplantation

Prospective, randomized comparison of the incremental dilation and stent exchange vs. sequential stent addition approaches for management of anastomotic biliary strictures will facilitate optimal management of patients who develop anastomotic biliary strictures after liver transplantation.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 and older
2. Clinical concern for anastomotic biliary stricture following liver transplantation (as determined by the referring transplant hepatologist)
3. Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

Exclusion Criteria:

1. Age \<18
2. Potentially vulnerable subjects including, homeless people, pregnant females, employees and students.
3. Complex post-surgical anatomy e.g. Choledochojejunostomy, Billroth type II anatomy, Roux-en-Y-gastrojejunostomy
4. Participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit
5. Other biliary process which accounts for patient's abnormal liver function studies/imaging (i.e. significant non-anastomotic biliary stricture).
A Clinical Study Comparing Standard Anastomosis Closure Technique to Standard Closure Techniques Plus Sylys® Surgical Sealant

The Cohera Sylys® Surgical Sealant study is a prospective, randomized, controlled, multicenter clinical study comparing standard anastomosis closure technique (Control) to standard closure technique plus Sylys® Surgical Sealant (Test) in patients undergoing a colectomy procedure with a stapled anastomosis.


Eligibility Criteria:
Inclusion Criteria:

* Be 22 years of age or older
* Be scheduled for a colectomy procedure with a stapled anastomosis
* At time of surgery, has a completed anastomosis that is able to be visualized and is accessible to allow for circumferential sealant application with minimal bowel manipulation (≥90%)
* Completed anastomosis must be at a location where a WCE can be performed to evaluate for a sub-clinical leak
* Agree to return for all follow-up evaluations and procedures specified in the protocol
* Understand and give informed consent

Exclusion Criteria:

* Albumin \< 3 g/dL
* ASA score (American Society of Anesthesiologists) ≥ 4
* Neutropenia ≤ 800 cells/µl
* Pregnant at time of surgery
* Has AIDS (HIV positive not excluded)
* Has neutropenia (IBD and steroid use not excluded)
* Has a known blood clotting disorder requiring treatment
* Has any condition known to effect wound healing, such as collagen vascular disease
* Has known or suspected allergy or sensitivity to any test materials, reagents, or WCE contrast materials
* Has undergone chemotherapy within 4 weeks of the anastomosis procedure and/or radiation within 3 days of the anastomosis procedure
* Concurrently using fibrin sealants or other anastomosis care devices
* Emergency surgery for abdominal indications
* Has undergone a colectomy procedure in the previous two months
* Has an emergent infection related to a previous colectomy procedure
* Is scheduled to undergo a Hartmann's procedure
* Is scheduled to undergo trans-anal endoscopic microsurgery (TEM)
* Is scheduled to undergo procedure using omental wrapping
* Is participating in another medical device trial involving colectomy with anastomosis

First 20 subjects ONLY:

• Is diagnosed with high risk cancer as determined by preoperative clinical evidence or diagnostic imaging (if patient's cancer stage has been downstaged through treatment prior to baseline screening, subject is allowed to be included):

* Lymph Node Cancer Stage: N2
* Cancer Tumor Size: T4
* Circumferential resection margin: CRM+ (Positive)
Phase II, Randomized, Placebo-controlled Trial in Patients With Charcot-marie-tooth Disease Type 1A

The present trial is a randomized, placebo-controlled study evaluating 3 different doses of PXT3003 in patients with CMT1A disease.

In addition to the safety and tolerability of the treatment, clinical, electrophysiological and biological endpoints (PMP22 mRNA, skin biopsy histology and plasma biomarkers) will be assessed. Standard laboratory tests and drug plasma concentrations will also be measured. Because of the slow progression of the disease and the nature of the observed symptoms, a minimum duration of 12 months of treatment is required in order to observe a potential improvement in any of the efficacy parameters.

Eligibility Criteria:
Inclusion Criteria:

* DNA proven CMT1A
* Muscle weakness in at least foot dorsiflexion (clinical assessment)
* Age between 18 and 65 years
* Male or non pregnant, non breastfeeding female
* CMT neuropathy score at screening ≤ 20
* Agrees to perform electrorophysiological studies and two cutaneous biopsies for determination of PMP22 expression and histology
* Providing signed written informed consent to participate in the study and willing and able to comply with all study procedures and scheduled visits

Exclusion Criteria:

* Patients with another neurological disease
* Patients using unauthorized concomitant treatments, ascorbic acid, opioids, levothyroxine and potentially neurotoxic drugs. Patients who can/agree to stop these medications 4 weeks before randomization can be included
* Patients who have participated in another trial of investigational drug within the past 30 days
* Concomitant major systemic disease
* Clinically significant history of unstable medical illness over the last 30 days (unstable angina...)
* History of significant hematologic, kidney, liver disease, or insulin-dependent diabetes
* Clinically significant abnormalities on the prestudy laboratory evaluation, physical evaluation, electrocardiogram (ECG)
* ASAT/ALAT levels above the upper limit of normal (ULN). However, patients with an isolated elevation of either ASAT or ALAT (\<1.5 ULN) can be included at investigators" discretion if the remaining liver function tests are normal and if ASAT or ALAT value is stable at 2 distinct evaluations in the month prior to inclusion
* Serum creatinine levels above the upper limit of normal
* Limited mental capacity or psychiatric disease rendering the subject unable to provide written informed consent or comply with evaluation procedures
* History of recent alcohol or drug abuse or non-adherence with treatment or other experimental protocols
* Female of childbearing potential (apart of patient using adequate contraceptive measures), pregnant or breast feeding
* Suspected inability to complete the study follow-up (foreign workers, transient visitors, tourists or any others for whom follow-up evaluation is not assured)
* Limb surgery in the six months before randomization or planned before completion of the trial
* Known hypersensitivity to any of the individual components of PXT3003
* Porphyria
Pre-surgical Antisepsis Using an Alcoholic Solution of Chlorhexidine Digluconate and Potassium Sorbate ( Sorbectol )

The present study evaluates the effects of bactericidal load reduction after surgical hand antisepsis using the reference antiseptic product propanol- 1 60% as control versus a surgical hand antisepsis with addition of a solution of alcohol, chlorhexidine digluconate and potassium sorbate in order to test if pass the standard european norm 12791.

The investigators conducted a crossover clinical trial to evaluate the antiseptic effectiveness of surgical hand antisepsis using propan-ol-1 60% by using the reference antiseptic product propan-ol-1 60% as control versus a surgical hand antisepsis with addition of a solution of alcohol, chlorhexidine digluconate and potassium sorbate in order to test if pass the standard european norm 12791. Samples will be taken from the hands of each volunteer after a surgical hands antiseptic.

Eligibility Criteria:
Inclusion Criteria:

* Participants with healthy skin in both hands and short fingernails.
* No use of antibacterial agents for at least three days before the intervention.
* Not received antibiotic treatment for at least ten days before the intervention.

Exclusion Criteria:

* Known systemic pathologies
* Wearing hand jewelry on the hands
* Allergy to any ingredient of which the solutions used in the clinical trial are composed
* Cognitive and / or motor limitation that makes it impossible to carry out instructions for hand washing
Study to Assess the Efficacy and Safety of Sitagliptin in Recently Diagnosed, Naive Type 2 Diabetics With Inadequate Glycemic Control on Diet and Exercise (0431-158)

After 24 weeks of treatment evaluate the efficacy and security.


Eligibility Criteria:
Inclusion Criteria:

* Patients Being Treated With Metformin
* Patients With Hba1c Between 6.5 % And 12.0%.
* Type 2 DM
Psychological Strengths and Burden Among Osteoarthritis Patient

Osteoarthritis (OA) is a common and debilitating disease, For the majority of patients, pain in OA is episodic in nature.

The experience of pain is generated or modified by nociception, neuropathic symptoms, psychological and personality factors, genetic influences, past painful experiences, comorbid conditions, and expectations related to future pain Previous studies have shown psychological well-being has been significantly associated with disability in patients with OA, and anxiety has been found to be associated with knee pain in women.

Previous studies also found that there are large interindividual differences among persons with knee osteoarthritis (OA) with respect to psychological function.

Psychological strengths and weaknesses are evaluated among new patient with osteoarthritis presented to joint replacement clinic, to facilitate our understanding of those patients need, and correlating with their radiological and clinical findings. Psychological strengths and weaknesses, positive and negative affects are evaluated in form of questionaires.

Reference:

Adaptation to disability: Applying selective optimization with compensation to the behaviors of older adults with osteoarthritis.

MAM Gignac, C Cott, EM Badley - Psychology and aging, 2002

Analgesic effects of multisensory illusions in osteoarthritis C Preston, R Newport - Rheumatology, 2011

Psychological factors and their relation to osteoarthritis pain BL Wise, J Niu, Y Zhang, N Wang, JM Jordan... - Osteoarthritis Cartilage. , 2010 - Elsevier

Introduction:

Osteoarthritis (OA) is a prevalent painful condition that may cause disability among older adults (Cruz-Almeida et al., 2013). Psychological traits and emotional states of patients were found to be correlated with symptoms of OA and daily functioning of patients (Cruz-Almeida et al., 2013; Dezutter et al., 2015).

The experience of pain is generated or modified by nociception, neuropathic symptoms, psychological and personality factors, genetic influences, past painful experiences, comorbid conditions, and expectations related to future pain. Previous studies have shown psychological well-being has been significantly associated with disability in patients with OA, and anxiety has been found to be associated with knee pain in women.

Previous studies also found that there are large interindividual differences among persons with knee osteoarthritis (OA) with respect to psychological function.

Aim of project:

This research is trying to find out what psychological strengths or factors could attenuate the chronic pain of knee OA patients. The purpose of the study is to find psychological evidences that may be used in the future to help chronic pain patients for improving their daily functioning and well-being.

Eligibility Criteria:
Inclusion Criteria:

* all new patient present to AHNH clinic referred for osteoarthritis for considering joint replacement
* Present with knee pain (unilateral or bilateral) contributed by osteoarthritis

Exclusion Criteria:

* mentally unsound
* dialectic speaker that difficult to communicate
Acute Effects of Sitting and Physical Activity on Brain Health

The specific aim of this study is to understand how a working day composed of prolonged sitting, sitting regularly interrupted by light aerobic exercise or resistance exercise affects an important mechanism underpinning healthy brain functions, namely cerebral blood flow. It is primarily focused on investigating these effects in ecologically valid conditions, i.e. activity patterns that closely resemble a typical day at the office.

The study will be a controlled crossover experimental trial with three conditions involving 13 adult participants aged between 40 and 60 years. Each participant will complete each of the three experimental conditions, separated by a washout period of minimum four days. As well, physical activity behaviours and sleep the day/night before the test day will be measured. The first visit will be a familiarization session. On the second, third, and fourth visits, participants will undergo three different standardized 3-hour interventions in a randomized order. Before and immediately after the three-hour interventions, blood pressure, augmentation index, and cerebral hemodynamic response of the prefrontal cortex during standardized cognitive tasks (1,2, and 3-back tests) will be measured. Additionally, saliva samples will be collected the morning of the test day and before and after the interventions, blood glucose will be assessed continuously during the trial, and fitness will be measured at the familiarization visit.

Eligibility Criteria:
Inclusion Criteria:

- Has a BMI under 35kg/m2

Exclusion Criteria:

* Has diabetes, epilepsy, or circulatory conditions
* Has experienced heart failure, stroke, or myocardial infarction
* Takes treatment for high blood pressure, sleep disorders, depression, or psychosis
Optimal Dose of Extracorporeal Shock Wave Therapy After Botulinum Toxin Type A Injection for Post-stroke Spasticity

Recently, It is known that the efficacy of botulinum toxin type A (BTX-A) with extracorporeal shock wave therapy (ESWT) is greater than that of BTX-A with electrical stimulation in the management of post-stroke spasticity of the upper limb. However, it was not determined which dose of ESWT is optimal as a adjuvant therapy after BTX-A injection on the upper limb in patients with stroke. Therefore, the aim of this study is to evaluate the optimal dose of ESWT after botulinum toxin type A injection for post-stroke spasticity


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age ≥20 years
* inpatients
* Elbow flexor spasticity in patients, confirmed to be mainly due to biceps brachii
* Modified Ashworth scale (MAS) ≥2,
* At least a 3-month period from stroke,
* Written informed consent has been obtained

Exclusion Criteria:

* Fixed contractures and/or deformities at the elbow,
* Previous fractures of the paretic upper limb,
* Peripheral nervous system disorders/myopathies,
* Previous BTX-A treatment and/or ESWT,
* Structural alterations in the soft tissue (e.g., fibrosis),
* Known allergy or sensitivity to the study medication or its components
* Presence of an unstable medical condition or uncontrolled systemic disease
* Any medical condition that may put the patient at increased risk with exposure to botulinum toxin therapy. (ex. Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interface with neuromuscular function.
* Bleeding tendency and/or anticoagulation therapy
* Presence of infection or skin disorder at injection sites
* Females were are pregnant, nursing, or are planning a pregnancy during the study
* Females of child-bearing potential (including pre-menstrual woman), not using a reliable means of contraception
* Participant who should be withdrawn from the study in the opinion of the investigator for any reason
Local Recurrence Due to Rectal Cancer in Sweden

The aim of this retrospective national registry study is to validate the reporting of local recurrence in the registry. Another aim is to identify preoperative risk factors for local recurrence. This can in turn indicate the need for a more intense follow-up. The treatment of local recurrence, including the impact of the multidisciplinary team conference (MDT) and the surgical procedure and the referral pathways of local recurrences will also be determined.

We aim to evaluate treatment outcome after local recurrence for patients operated or treated between 2007-2018.


Eligibility Criteria:
Inclusion Criteria:

* Rectal cancer with a curative intent

Exclusion Criteria:

* Rectal cancer without curative intent
The Clinical Value of an Artificial Intelligence System Using Abbreviated Protocol of Breast MRI Facilitates Classification of Breast Lessions

This study aims to use a combination of abbreviated protocol and artificial intelligence to automatically identify lesions and make diagnosis without decreasing the diagnostic accuracy of breast cancer, thus enhancing the comfort of patient examination, accelerating the flow of examination and reducing the load of clinical work.

Full sequence of MRI scan is:

MR scan protocol:

1. Magnetic fields and coils: Use MR scanners with high fields of 1.5 T and above with dedicated breast coils.
2. Scanning position: prone position with bilateral breasts naturally draped over the center of the breast coil. The position should ensure that all breast tissue is located in the coil, the skin and breast are not folded, the bilateral breast is symmetrical, the nipple is perpendicular to the ground, and the midline of the sternum is located in the middle line of the coil.
3. Scanning sequence and parameters: T1WI non-fat suppressed sequence, T2WI fat suppressed sequence, dynamic five-phase enhanced T1WI fat suppressed sequence, and diffusion weighted imaging (DWI); delayed sagittal T1W1 fat suppressed sequence.

Imaging parameters: the thickness of the scanned layer should be ≤3 mm, the resolution within the layer should be \<1.5 mm, and the single scan time should be \<2 min.

Enhancement scan: Gadobutrol used as the contrast agent, and the injection dose was 0.1 ml/kg, which was injected through the elbow vein at a rate of 2-3 mL/s using a pressure syringe, and 10-20 mL of saline was injected into the tube at the same rate after the contrast agent injection. The T1WI sequences before and after enhancement were preferably fat-suppressed and bilateral mammary glands were imaged simultaneously, and subtraction treatment was recommended. The recommended duration of delayed enhancement scan is 7 min, not less than 5 min.

Abbreviated sequences : T1WI + dynamic enhanced T1 phase I + maximum density projection images generated by automatic reconstruction in three directions. No extra sequences are required.

By adding artificial inteeligence, a diagnostic performance comparable with full sequences is expected.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with breast lesions detected by ultrasound and mammography that cannot be characterized
2. Patients who were consecutively included in our hospital for breast MRI without treatment
3. Underwent preoperative full-protocol breast MRI
4. Pathological results are available, of which benign lesions can be determined by follow-up

Exclusion Criteria:

1. Poor MRI image quality
2. Patients who have been received the biopsy
Observational Study of Neurofilament Light Chain (NfL) as a Biomarker in Asymptomatic Carriers of the Transthyretin (TTR) Variants and Patients With Hereditary Transthyretin-mediated (hATTR) Amyloidosis With Polyneuropathy

This is a single-center observational study evaluating the potential value of NfL as a biomarker for diagnosis, detection of disease onset, monitoring of disease progression, and treatment response in asymptomatic carriers of TTR variants and symptomatic hATTR amyloidosis patients with polyneuropathy.

In this study, participants' data will be extracted from their medical records or collected based on clinical and laboratory assessments during routine visits, per the site's standard of care. Blood samples collected from the participants during routine visits will also be used for analysis. The study will be conducted in two parts: Cross-Sectional part during which a single measurement of NfL levels will be performed using blood samples collected from asymptomatic carriers, and symptomatic hATTR amyloidosis patients; Longitudinal part during which measurements of NfL levels will be performed over time using blood samples (already collected from the participants during routine visits) from asymptomatic carriers and patients with symptomatic hATTR amyloidosis.

Eligibility Criteria:
Inclusion Criteria:

- Carrier of a documented pathogenic TTR variant confirmed with genotyping with predicted disease onset within 5 years and not diagnosed with hATTR amyloidosis with polyneuropathy

OR

Confirmed diagnosis of hATTR amyloidosis with polyneuropathy with a documented TTR variant confirmed with genotyping

- Participant is able to understand the study and does not oppose participating in the study after reviewing the content of the PIS provided.

Exclusion Criteria:

* A known condition (other than hATTR amyloidosis) that can cause nerve damage and affect NfL levels
* Estimated glomerular filtration rate (eGFR) \<45 milliliters per minute per 1.73 meters squared (mL/min/1.73 m\^2)
* Currently enrolled in a clinical study for any investigational agent.
The Efficacy Evaluation of Buckwheat Husk Extract on Cardiovascular Disease Risk Factors

To assess the efficacy evaluation of buckwheat husk extract on cardiovascular disease risk factors

This is a double-blind and randomized study. Subjects are informed to consume the samples every day for 2 months. The clinical diagnosis item of cardiovascular disease is evaluated by the doctor.

Eligibility Criteria:
Inclusion Criteria:

1. 20 to 65-year-old males or non-pregnant females who are willing to sign the subject's consent.
2. The systolic blood pressure is 121-139 mmHg and the diastolic blood pressure is between 81-89 mmHg.
3. Those who are not pregnant and are willing to cooperate with contraception during the trial period.
4. No history of organ transplantation, epilepsy or convulsions, liver or kidney disease, malignant tumor, endocrine disease, mental disease, alcohol or drug abuse, or other major organic diseases (according to medical history).

Exclusion Criteria:

1. Pregnant women.
2. People with a history of organ transplantation, epilepsy or convulsions, liver and kidney disease, malignant tumors, endocrine diseases, mental illness, alcohol or drug abuse, and other major organic diseases (according to medical history).
3. No person has undergone major surgery.