cyrilzakka/clinical-trials huggingface dataset:
Clinical Study to Investigate the Efficacy and Safety of Wilate During Prophylaxis in Previously Treated Patients With VWD

This is a prospective, non-controlled, international, multi-center phase 3 study investigating the efficacy and safety of Wilate in previously treated adult patients with VWD, to obtain additional data on the safety and efficacy of Wilate in previously treated patients with VWD undergoing regular prophylaxis.


Eligibility Criteria:
Inclusion Criteria:

Patients who meet all of the following criteria are eligible for the study:

* Aged ≥6 years at the time of screening
* VWD type 1 (baseline von Willebrand factor activity \[VWF:Ristocetin Co-factor (RCo)\] \<30 IU/dL, 2A, 2B, 2M, or 3 according to medical history requiring substitution therapy with a VWF-containing product to control bleeding
* Currently receiving on-demand treatment with a VWF-containing product with at least 1, and an average of ≥2, documented spontaneous BEs per month in the last 6 months, with at least 2 of these BEs requiring treatment with a VWF-containing product
* Availability of records to reliably evaluate type, frequency, and treatment of BEs for at least 6 months of on-demand treatment before screening
* Female patients of child-bearing potential must have a negative urine pregnancy test at screening and agree to use adequate birth control measures; in case hormonal contra-ception is used, the medication class should remain unchanged for the duration of the study
* All patients to provide voluntarily given, fully informed written and signed consent obtained before any study-related procedures are conducted

Exclusion Criteria:

Patients who meet any of the following criteria are not eligible for the study:

* Having received on-demand or prophylactic treatment with a VWF-containing product but having no records available to reliably evaluate the type, frequency, and treatment of BEs over a period of at least 6 months of on-demand treatment
* History, or current suspicion, of VWF or FVIII inhibitors
* Medical history of a thromboembolic event within 1 year before enrolment
* Severe liver or kidney diseases (alanine aminotransferase \[ALAT\] and aspartate trans-aminase \[ASAT\] levels \>5 times of upper limit of normal, creatinine \>120 µmol/L)
* Platelet count \<100,000/µL at screening (except for VWD type 2B)
* Body weight \<20 kg at screening
* Patients receiving, or scheduled to receive, immunosuppressant drugs (other than an-tiretroviral chemotherapy), such as prednisone (equivalent to \>10 mg/day), or similar drugs
* Pregnant or breast-feeding at the time of enrolment
* Cervical or uterine conditions causing abnormal uterine bleeding (including infection, dysplasia)
* Treatment with any IMP in another interventional clinical study currently or within 4 weeks before enrolment
* Other coagulation disorders or bleeding disorders due to anatomical reasons
* Known hypersensitivity to any of the components of the study drug
Effects of Whey Protein Consumption by Patients Waiting for Liver Transplantation

Malnutrition is prevalent among chronic liver disease patients. Inadequate ingestion and/or metabolic alterations modify the body composition and biological functions. The purpose of this study is to determine whether whey protein comsumption, due to amino acid profile, digestibility and bioactive compounds may be beneficial for patients waiting for liver transplantation

A randomized, double-blind, intervention study in which patients are randomly assigned to receive packages of 20g of whey protein (WP) or casein (CA) to take twice a day (20g in the morning and 20g at night), as a supplement, during 15 days. They are monitored weekly by calls. Regular usual diet is maintained. Patients underwent muscle functionality assessment by handgrip dynamometry and 6-min. walking test and, the inflammatory response by plasmatic cytokines. All tests are performed at the beginning and the end of intervention.

Eligibility Criteria:
Inclusion Criteria:

* Chronic liver disease, liver transplantation

Exclusion Criteria:

* Children, illiterate, elderly, renal failure
The Effects of Scalp Block on Haemodynamic Response and Postoperative Pain in Posterior Fossa Surgery

This study evaluate the effects of scalp block versus local infiltration on haemodynamic response to head pin replacement and skin incision and postoperative analgesia in posterior fossa surgery

In this study 15 patients will receive scalp block with bupivacaine, 15 patients will receive local infiltration with bupivacaine and 15 patients will receive placebo before surgery. The haemodynamic response to head pin replacement and skin incision will be recorded. Postoperatively all patients will have a patient controlled analgesia (PCA) device containing morphine (1 mg/ml) for analgesia. Visual analogue scale (VAS) for pain evaluation, sedation scores, and also postoperative morphine consumption will be evaluated and recorded.

Eligibility Criteria:
Inclusion Criteria:

* Posterior fossa surgery
* Preoperative GlasGow Coma Score: 15/15

Exclusion Criteria:

* Allergy to bupivacaine
* Uncontrolled hypertension
* Coagulopathy
* Cerebrovascular disease
* Earlier craniotomy
Infrared Laser and Classical Ballerinas' Feet

Overuse injuries and painful symptoms in athletes and dancers (especially classical ballerinas) may lead to reduced functional performance. However, laser application may reduce pain and increase physical conditioning. The aim of the current study was to evaluate the immediate and long-term effects of infrared laser on classical ballerinas' feet. The hypothesis investigators was that the infrared laser would be able to reduce pain perception and enhance functional performance in ballerinas.

High risk of injuries and painful symptoms in athletes and dancers (especially classical ballerinas) may lead to reduced functional performance. The use of photobiomodulation may improve functional performance in ballerinas that are affected by foot pain. An aluminum gallium arsenide (AlGaAs) diode laser device was uded. Infrared laser (808 nm) was applied on ballerina's feet twice a week during three months. Thermography, algometry and unipodal static standing balance test were performed. There were pain relief and improvement of functional performance in ballerinas.

Eligibility Criteria:
Inclusion Criteria:

- Female adults who perform classical ballet training and feel pain in their foot

Exclusion Criteria:

- The occurrence of injuries in the last 6 months
Evaluation of Safety & Tolerability of Multiple Dose Regimens of CHF 5074

To evaluate the safety and tolerability of ascending oral doses of CHF 5074 administered once per day for up to 12 weeks to patients with mild cognitive impairment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of amnestic or non-amnestic Mild Cognitive Impairment.
* Mini-Mental State Examination score higher than 24 at screening.
* MRI scan of the brain at screening with fluid-attenuation inversion recovery (FLAIR) and T2\*-weighted gradient-recalled-echo (GRE) sequences.

Exclusion Criteria:

* Diagnosis of Alzheimer's disease according to the (DSM-IV-TR) or NINCDS-ADRDA criteria.
* Any medical condition that could explain the patients cognitive deficits.
* CT or MRI brain imaging results obtained within 12 months prior to baseline showing evidence of infection, infarction, or focal lesions of clinical significance
* MRI scan at screening showing more than 4 cerebral microhemorrhages (lesions with diameter ≤ 10 mm).
* Geriatric Depression Scale (30-point scale) score \> 9 at screening.
* History of stroke.
* Modified Hachinski ischemic scale score \> 4 at screening.
* Women of childbearing potential.
* Vitamin B12 or folate deficiency.
* Diagnosis of schizophrenia or recurrent mood disorder (including unipolar and bipolar disorders) within 3 years of screening.
* Current diagnosis of peptic ulcer or gastrointestinal bleeding within the last year and/or chronic inflammatory bowel disease.
* Concomitant use of donepezil at doses \> 5 mg/day or other cholinesterase inhibitors (rivastigmine or galantamine) at any dose.
* Concomitant use of memantine at dose \> 20 mg/day.
* Concomitant use of psychoactive drugs (sedatives, hypnotics, etc).
Sahastara Remedy Extract Capsule in Primary Osteoarthritis of Clinical Trial Phase II

To study efficacy and safety of Sahastara 95% ethanolic extract capsules compared to treatment Primary osteoarthritis for primary osteoarthritis, it was compared with diclofenac (Phase II).

Sample size 66 volunteers

The patients were divided randomly into 2 treatment groups. The patients in group 1 received the SHT extract 300 mg/day (1 capsule of 100 mg SHT extract three times daily before meals). The patients in group 2 received diclofenac sodium 75 mg/day (1 capsule of 25 mg diclofenac three times daily after meals). In addition, the patients in both groups received 20 mg of omeprazole, 1 capsule before breakfast for protects of Gastrointestinal adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* No pregnancy
* No Serious Medical Condition evaluated by Physical Examination and Laboratory results in 1 month before study
* No Supplementary food and/or Vitamin during the study Able to follow suggestion during the study

Exclusion Criteria:

* Uncontrolled Hypertension (BP\>140/90 mm.Hg.) BMI \> 30
* Have serious medical condition including Severe peptic ulcer, congestive heart disease, Liver and Renal dysfunction.
* On during use medicine including Rifampicin, Phenytoin, Propranolol, Theophylline
Study of ST266 Versus Saline in Treating Skin Irritation From Radiation

The objective of this study is to evaluate the safety and efficacy of ST266 in treating radiation burns of the skin in patients undergoing treatments for breast cancer and to compare ST266 treated burns with those treated with saline placebo controls.


Eligibility Criteria:
Inclusion Criteria:

* A signed IRB - approved Informed Consent;
* Women 18 - 80 years of age;
* Biopsy-proven diagnosis of breast cancer with the tumor surgically removed.
* Whole breast radiation with or without ipsilateral axilla radiation therapy recommended by her radiation oncologist.
* If a woman is of child-bearing potential, she and her partner must use an effective form of birth control.
* Willing to participate in the clinical study and comply with the requirements of the trial.

Exclusion Criteria:

* Abnormal liver or kidney function studies being greater than 2x the upper limit of normal.
* Patients on hemodialysis
* Psychiatric condition or substance abuse which in the Investigator's opinion may pose a threat to patient compliance;
* History of non-compliance with treatment or clinical visit attendance.
* Participation in an investigational trial within 30 days of study entry.
* Women who are pregnant or lactating
Prevalence and Reversibility of Lung Hyperinflation in Asthma

The aim of this observational study is to evaluate the pulmonary hyperinflation and its immediate reversibility to a short acting beta2 agonist test in uncontrolled persistent asthmatic patients with dyspnea.

The other objectives are :

* the evaluation of the hyperinflation defined by an increase of the residual volume (RV),
* the observation of the relationship between the hyperinflation and the asthma characteristics,
* the study of the improvement of the functional parameters after a reversibility test
* the evaluation of the correlation between hyperinflation parameters evolution, chest tightness and dyspnea

Eligibility Criteria:
Inclusion Criteria:

* Patient with a diagnosis of uncontrolled persistent asthma (ACT \</= 19) or with an MRC score of dyspnea \>/= 1
* Patient requiring a check-up including a pulmonary function test by plethysmography with a reversibility test

Exclusion Criteria:

* Patient participating to an other clinical trial or having participated to a clinical trial with medicine in the last 3 months
Mindfulness to Improve Elders' Immune and Health Status

The purpose of the study is to better understand effects of the Mindfulness-Based Stress-Reduction (MBSR) program on the physical and emotional health and well-being of adults ages 65 and older.

The effects MBSR may have on the immune system is investigated, including how these effects relate to factors such as perceived health, psychological well-being, age, personality, and mood.

This study investigates the effects of Mindfulness-Based Stress Reduction (MBSR) on immune responses to multiple concentrations of keyhole limpet hemocyanin (KLH) in elderly volunteers. The research design thus capitalizes on the antibody response to a novel, benign antigen to which our subjects will be immunologically naïve. The use of a range of antigen concentrations will provide a sensitive indicator for the effects of intervention.

The Aims of the study are the following:

1. To examine the effects of Mindfulness Based Stress Reduction (MBSR) on immunological outcomes, perceived health, and psychological well-being in a sample of seniors 65 years of age and older.
2. To examine whether treatment effects are moderated by age, personality traits, physical health status, or depression.
3. To examine the effects of behavioral, psychological, and physiological mediators of immune outcome.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 or older
* English speaking
* If prescribed antidepressant or anxiolytic medications, must have maintained a stable regimen for eight weeks prior to enrolling

Exclusion Criteria:

* receiving immunosuppressive therapy for cancer or other diseases
* major, uncorrected sensory impairments
* cognitive deficits (MMSE \<25, or deficits deemed significant enough to interfere)
* history of a psychotic disorder, bipolar disorder, organic brain syndrome, or mental retardation
* alcohol or substance abuse within the previous year
* severe cardiovascular disease
* known allergies to shellfish
Dextran-based Priming vs. Crystalloid and Mannitol-based Priming Solution in Adult Cardiac Surgery

This study will compare two priming solutions for extracorporeal circulation, one based on Dextran 40, one based on crystalloid and mannitol. Primary endpoint is oncotic pressure during cardiopulmonary bypass. Secondary endpoints included fluid balance and organ functions.

This is a prospective, single center, double-blinded, randomized controlled clinical trial. Eighty patients are randomized 1:1 to either cardiopulmonary bypass with the dextran-based solution or standard priming with Ringer-Acetate and Mannitol.

Primary endpoint will be oncotic pressure during cardio pulmonary bypass. Secondary endpoints include perioperative fluid balance, coagulation, platelet function, postoperative bleeding volume, transfusion requirements, renal function, liver function, pulmonary function, inflammatory activation and markers for brain and heart injury.

Blood samples for oncotic pressure measurements will be collected from an arterial line before and during surgery. Organ function will be assessed before surgery and 2 hours cardio pulmonary bypass.

Eligibility Criteria:
Inclusion Criteria:

* Age 50 - 75 years
* Elective cardiac surgery procedure with expected CBP time above 90 minutes
* Subject provides a legally effective informed consent.

Exclusion Criteria:

* Known previous cardiac surgery
* Coagulation disorder
* Malignancy
* Kidney failure
* Liver failure
* Ongoing septicaemia
* Ongoing antithrombotic treatment other than acetylsalicylic acid
* Systemic inflammatory disorders treated with corticosteroids
* Not able to understand Swedish
Medico-economic Interest of the Protein S100b in Mild Head Trauma Under Anti-thrombotics

Head trauma is a common injury in emergency department. Investigation to search for complication is guided by the clinical examination and the case history, such as taking anti-thrombotics. Cranial computed tomography (CCT) is the gold standard to investigate, and is mandatory in case of antithrombotic drugs.

Recently, some biomarkers have proven their utility to rule-out mild head trauma without CCT in the general population. Among these biomarkers, S100β protein has been added in guidelines for mild head trauma. Some studies have found similar data in population taking anticoagulant or antiplatelet drugs.

The investigators aim to prove medical utility of S100β protein in population under antithrombotics, by the reduction of CCT use. Then, The investigators hypothesize that the add of S100β protein reduces cost of health care in the management of head injury in that population.


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years old
* Taking antithrombotic medication (antiplatelet drugs, K vitamin antagonist, direct oral anticoagulants, heparins)
* Mild head trauma with Glasgow coma scale ≥ 13
* Trauma occured ≤ 6 hours
* Agreeing the participation in the study

Exclusion Criteria:

* Head injury occured \> 6 hours
* Patient \< 18 years old or under juridic protection
* pregnant women
* polytrauma
* Glasgow coma scale ≤ 12
* ancient or actual cerebral ou cutaneous neoplasia
The Effect on Back Pain and Fatigue Level of Acupressure

This research was conducted with the aim of determining the effect of acupressure on the level of back pain and fatigue after coronary angiography.

To prevent bleeding, hematoma, and embolism after coronary angiography, patients are asked to stay in bed for 6 to 24 hours. During complete bed rest for at least 6 hours, the patient should keep his/her feet flat. The patient should lie in the supine position and avoid rapid movements. Long-term bed rest (at least 6 hours) in post-angiographic patients causes weakening of the lower back muscles and fatigue due to the pressure constantly applied to the same muscles, while muscle fatigue causes muscle spasms and lower back pain. Today, acupressure is also used along with various pharmacological treatments to relieve pain and fatigue.

Acupressure is a massage technique that ensures the proper functioning of energy channels by applying some pressure to certain parts of the body with the thumbs or index fingers, hands, palms, wrists and knees for therapeutic purposes. Acupressure points are the same as acupuncture points. Although there is no needle inserted into the body as in acupuncture.

According to G-power analysis, the total number of samples was calculated as 120.

A total of 120 participants will be randomly assigned to the acupuncture group (n=40), sham acupuncture group (n=40) and control group (n=40).

A Personal Information Form and Visual Analog Scales for Pain and Fatigue will be used to collect data.

Eligibility Criteria:
Inclusion Criteria:

* Planned coronary angiography from the femoral region
* Not diagnosed with low back pain
* No stent or other interventional procedure was performed during the coronary angiography procedure.

Exclusion Criteria:

* Those who have had acupressure before for any purpose
* Problems such as bleeding and dysrhythmia occur after coronary angiography,
* Those with burns, scars, scratches and deformities at the acupressure point
* Having any psychological disorder,
Characteristics of Eye Diseases in Children and Adolescents With Autism Spectrum Disorders and the Effect of Corresponding Treatment on the Quality of Life of Children and Adolescents With Autism and Their Caregivers

This study mainly investigated the incidence of eye diseases in children with autism spectrum disorder(ASD) in Tianjin area, and analyzed related risk factors, so as to raise attention to eye diseases in children with ASD. To evaluate the impact of ophthalmic treatment on the quality of life of children with autism and their primary caregivers.

In recent years, the incidence of autism has increased year by year, which has brought a heavy burden to society and families. For the special group of children with autism spectrum disorder, previous studies focused on the lack of comprehensive and accurate visual function characteristics and defects of this group. In the early stage, it was believed that there was a certain correlation between visual impairment and autism, and some patients with visual impairment were misdiagnosed as autism. Moreover, some studies have shown that the incidence of refractive errors and oblique amblyopia in autistic children is significantly higher than that in normal children. This study mainly includes two parts: On the one hand, investigate the autism children in Tianjin area to understand the incidence of eye diseases. On the other hand, children with eye problems were given relevant interventions, such as optometry, amblyopia training, strabismus surgery, etc., to assess the impact of the corresponding treatment on the quality of life of the children and their primary caregivers.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with ASD but without medical intervention. To cooperate with relevant inspectors.

Exclusion Criteria:

* Brain organic diseases (such as tumors, strokes, epilepsy, etc.) and serious physical diseases (such as heart, liver, kidney and other organ dysfunction, cancer, etc.);Do not cooperate to check.
Oral Antibiotic Prophylaxis in Colorectal Surgery

The investigators perform a case-control study to compare preparation before elective colorectal surgery. The first group is a prospective patient - registry in all patients with mechanical bowel preparation (MBP) and oral antibiotic prophylaxis the day before colorectal surgery. The second group is a historic collective of patients with MBP only and colorectal surgery. The cases were matches in American Society of Anesthesiologists (ASA) physical status classification system, BMI, operative procedure and risk factors.


Eligibility Criteria:
Inclusion Criteria:

* all colorectal resections

Exclusion Criteria:

* allergy
The Role of the GP in the Management of Ambulatory Heart Failure

To describe the causes mentioned by general practitioners, explaining the under-treatment of the three main treatments for heart failure with impaired ejection fraction (ARS blockers of the type ACEinhibitor/ARA2/ARNi, ß- and/or anti-aldosterone).


Eligibility Criteria:
Inclusion Criteria:

* Patients with a previous diagnosis of heart failure with impaired ejection fraction (LVEF \< 40%)
* Under 85 years of age
* Admitted to an Emergency department for cardiac decompensation
* Hospitalized following this decompensation
* Not deceased within one month of hospitalisation
* Whose sum of the doses of ACEI or ARB2 + BB + aldosterone antagonist is less than 50% of the dose required for this patient\* (definition in annex)
* Who did not object within one month of being informed

Exclusion Criteria:- Patient objecting to the use of their data

* Patient who is a minor
* Patient who does not have a general practitioner