cyrilzakka/clinical-trials huggingface dataset:
The Safety and Tolerability of Alpha-1 Modified Process (MP) In Subjects With Alpha-1-antitrypsin (AAT) Deficiency

The purpose of this clinical study is to assess the safety and tolerability of Alpha-1 MP in adult Alpha1-antitrypsin deficient patients.

The objective of this clinical trial (STAMP: Safety and Tolerability of Alpha-1 Modified Process) is to study the safety and tolerability of Alpha-1 MP in adult Alpha 1-antitrypsin deficient subjects as reported over 20 weeks of therapy. The primary objective is to describe the nature and frequency of treatment-emergent adverse events with "treatment-emergent" defined as any adverse event occurring after the start of the first study drug infusion.

Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of congenital Alpha1-antitrypsin deficiency
* Documented forced expiratory volume in 1 second (FEV1 ) between 20% - 80% of predicted value within last 6 months.
* Signed written informed consent prior to initiation of any study related procedures.

Exclusion Criteria:

* Females who are pregnant, breast feeding, or if of child-bearing potential, unwilling to practice adequate contraception throughout the study
* Use of systemic steroids within the 2 weeks prior to receiving study treatment (this does not include the use of inhaled steroids used on a routine or as needed basis).
* Subjects who have had exacerbations of their disease within one month of trial entry
Consequences of Intensified Handwash and Hand Disinfection Among Children During the COVID19 Pandemic

During the COVID-19 pandemic after reopening of the country, school, kindergarten and daycare, children have been obligated to do frequent handwash. The study group wished to investigate whether this has had implications on symptoms of dry, red, itchy or sore hands and hand eczema. The investigation was performed within the first and second week after reopening by questionnaires distributed to parents electronically via schools, kindergartens and daycare facilities electronic platforms.

During the COVID-19 pandemic Denmark closed down, including schools, kindergartens and daycare. After reopening of the country 5 weeks later obligatory frequent handwash was a requirement from the government and routines has been implemented at all reopened schools, kindergartens and daycare. The study group wished to investigate whether this has had implications on symptoms of dry, red, itchy or sore hands and hand eczema. Also the study group wished to investigate if frequency or use of hand disinfection mattered. The investigation was performed within the first and second week after reopening by questionnaires distributed to parents electronically via schools, kindergartens and daycare electronic platforms. The questionnaire included 20 questions on demographics, frequency of hand wash and use of disinfectants, current and previous symptoms of eczema, atopic dermatitis and dispositions.

Eligibility Criteria:
Inclusion Criteria:

* All children returned to daycare, kindergarten or school after covid19 close down of the country

Exclusion Criteria:

* None
TTT Versus TTT and Triamcinolone to Decrease Exudation in Choroidal Melanoma After Proton Beam Therapy

Proton beam therapy is a safe irradiation modality for choroidal melanoma. But often after irradiation the exudation increases resulting in an exudative retinal detachment requiring vitreoretinal surgery. It is known that intravitreally injected triamcinolone and TTT is capable to decrease the exudation. If there is any advantage in a combined treatment this study will investigate.

Proton beam therapy is an eye preserving irradiation modality for uveal melanoma. After proton beam therapy tumor related lipid exudation and exudative retinal detachment often increase. Therefore vitreoretinal surgery is sometimes required to reattach the retina to protect visual acuity. It is known that intravitreally injected triamcinolone and TTT is capable to decrease exudation. If there is any advantage in a combined treatment and if it is that effective to possibly avoid vitreoretinal surgery this study will investigate.

Eligibility Criteria:
Inclusion Criteria:

•exudation (tumor associated exudation/exudative retinal detachment) after proton beam therapy in choroidal melanoma and/or ciliary body melanoma

Exclusion criteria:

* Tumor recurrence
* Endoresection and / or previous vitrectomy
* Treatment with anti-angiogenic drugs or intravitreal corticosteroids or any other investigational drug within 3 months prior to randomisation
* Prior laser photocoagulation treatment within 3 months (focal / grid laser) or 6 months (panretinal) prior to study entry
* Known hypersensitivity against local anaesthetics
Diclofenac Patch for Treatment of Mild to Moderate Tendonitis or Bursitis

The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium patch to the skin near or over the painful area. In this study, the location being studied will be one of the following: the affected shoulder, elbow, or wrist.

The secondary purpose of this study is to assess the safety and tolerability of the diclofenac patch on the subject's skin, in the location being studied.

Cerimon Pharmaceuticals is investigating a topical patch formulation of diclofenac sodium containing 15 mg of diclofenac sodium for the local treatment of acute musculoskeletal pain.

Eligibility Criteria:
Inclusion Criteria:

* 18 years to 75 years of age
* Onset of painful upper extremity tendonitis or bursitis, no more than 21 days prior to study entry
* Eligible diagnoses are rotator cuff tendonitis, bicipital tendonitis or subdeltoid/subacromial bursitis of the shoulder, medial or lateral epicondylitis of the elbow, and DeQuervain's tenosynovitis of the wrist
* Spontaneous pain with motion or resisted motion and tenderness to palpation over the involved tendon(s), bursa, or epicondyle
* Presence of pain of at least 5, with a maximum of 9, on an 11-point Numerical Rating Scale (NRS)

Exclusion Criteria:

* Aspirin, or short half-life NSAID use within 12 hours, or longer half-life NSAID use within 24 hours prior to study entry (see Appendix B: for table of NSAIDs)
* Opioid use within 3 days prior to study entry
* Topical treatment, other than local ice or heat, applied to the painful region within 3 days prior to study entry
* History of peptic ulcer disease within 1 year prior to study entry, any history of gastrointestinal bleeding, or coagulation disorder
* A history of, or evidence for underlying articular disease such as osteoarthritis, rheumatoid arthritis, gout, or pseudogout (calcium pyrophosphate deposition disease)
* Clinically significant and poorly controlled pulmonary, gastrointestinal, hepatic, renal, endocrine, or cardiovascular disease
* A history of hypersensitivity to diclofenac or diclofenac-containing products
* A history of intolerance to acetaminophen (rescue medication in this trial)
* A history of skin sensitivity to adhesives (e.g. adhesive tape)
* Pregnant or breastfeeding women and women of child-bearing potential not using effective means of contraception
Global Management of Facial Rejuvenation With a New Range of Hyaluronic Acid Dermal Fillers

The aim of this study is to assess performance and tolerance as well as investigator and subject satisfaction linked to the global management of facial rejuvenation with a new range of hyaluronic acid dermal fillers.

The range of fillers tested in this study includes 5 different hyaluronic acid dermal fillers: Emervel Touch, Emervel Classic, Emervel Deep, Emervel Volume and Emervel Lips.

The study will last 6 month.

Injections will be performed at baseline. If necessary, the investigator will perform touch-up injections at the following visit (3 weeks later).

Investigator and subject satisfaction will be collected through questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Seeking tissue augmentation treatment on the face,
* Presenting a score of 3 (Moderately deep wrinkle)or 4 (Deep wrinkle) on the Lemperle Rating Scale (LRS) of both nasolabial folds.

Exclusion Criteria:

* At risk in term of precautions, warnings and contra-indication referred in the package insert of the study devices,
* Who underwent previous injection of permanent filler in the injected area.
Effect of MET With and Without MCTE in Mechanical Neck Pain

Work had to be done previously on METs and MCTE techniques, but no study has compared both techniques together to make it more comprehensible. The rationale of this will be to find out the combined effect of motor control therapeutic exercises and muscle energy technique for the treatment of pain, range of motion and disability associated with mechanical neck pain. This study will be effective for the clinicians to treat patients of mechanical neck pain.

Therapeutic exercises and manual therapy were shown to be useful in managing pain and lowering disability in patients with non-specific chronic neck pain (NCNP). However, little studies investigated the benefits of muscle energy technique and motor control therapeutics exercise on mechanical neck pain (MNP). The current research fulfill this gap by comparing the short and long term benefits of muscle energy technique with and without motor control therapeutic exercises (MCTE) with the grail of determining best approach for lowering pain and disability in mechanical neck pain patients.

Eligibility Criteria:
Inclusion Criteria:

* • Subjects were between 20 and 50 years old.

  * Pain in cervical or neck region with no radiating pain in one or both upper limbs.
  * Pain minimum of 3 months.
  * Neck disability index (NDI) score of should be at least 10%.
  * Forward head posture.

Exclusion Criteria:

* • Neck pain associated with vertigo.

  * Irradiated neck pain.
  * Vertebral fracture.
  * Osteoporosis.
  * Previous neck injury.
  * Red flags (night pain, severe muscle loss, loss of involuntary control.
  * Subjects with difficulty in communication or understanding.
Renal Ex Vivo Warm Advanced Resuscitation Through Machine Perfusion

The REWARM study is an open label, randomized controlled clinical efficacy study, with primary outcome renal function 6 months after transplantation of kidneys recovered from deceased donors aged 50 years or older. Prior to transplantation, kidney grafts in the intervention group will receive 4-6 hours of NMP, following standard HMP and kidneys in the control group will only receive standard treatment, being HMP. It is a multi-center trial. Given the total annual 50+ deceased donor kidney transplantation volume of the three participating transplant centers combined, inclusions in the study are expected to last 2.5-3 years, aiming for a total of 140 patients in each of the two arms (280 patients total).


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving their first or second kidney transplant;
* Patients receiving a graft from a ≥ 50-year-old donor;
* Patients receiving a graft from a DCD or DBD donor;
* Patients receiving a kidney transplant in the UMCG, the Erasmus MC, or the LUMC;
* Patients receiving a graft stored on HMP;
* Patients ≥ 18 years of age;
* Patients having provided written informed consent.

Exclusion Criteria:

* Patients receiving their third or subsequent kidney transplant;
* Patients receiving a graft from a donor \< 50 years;
* Patients receiving a graft not stored on HMP;
* Patients receiving a graft from a donor that underwent normothermic regional perfusion (NRP);
* Patients receiving a kidney transplant in another center than the UMCG, Erasmus MC, or LUMC;
* Patients receiving a multi-organ transplantation;
* Patients receiving a kidney with complex arterial anatomy (3 or more arteries);
* Recipients \< 18 years of age.
The Study of Atherosclerosis With Ramipril and Rosiglitazone

The purpose of this study is to determine if ramipril and/or rosiglitazone retard the progression of atherosclerosis as evaluated by serial carotid intermedial thickness measurements.

STARR is a multi-centre, international, randomized controlled clinical trial with a 2x2 factorial design, that will evaluate the effects of ramipril and of rosiglitazone on atherosclerosis progression, as determined by B-mode carotid ultrasound (US). It is designed as a substudy of DREAM (Diabetes Reduction Assessment with ramipril and rosiglitazone Medications) Trial. The study is designed to enroll 1,200 study participants and follow is proposed for an average of 3.75 years.

SIGNIFICANCE OF THE PROPOSED RESEARCH: With regards to ramipril this study will provide important mechanistic data regarding potential benefits of ACE inhibitor therapy on atherosclerosis and by inference in reducing CV risk in a lower risk younger population than studied in previous trials. In this population a clinical outcome trial focusing primarily on CV events would be difficult to conduct due to the expected fairly low event rate. If the study on atherosclerosis is positive, this may provide a rational for therapy in this subset of patients without overt CVD or diabetes, but with impaired glucose tolerance or impaired fasting glucose.

Eligibility Criteria:
Inclusion Criteria:

* impaired glucose tolerance (FPG \< 7 mmol/L or 126 mg/dL \& 2hr PG between 7.8-11.0 mmol/l \[140-199 mg/dl\] after a 75 g OGTT
* impaired glucose tolerance (FPG≥ 6.1 mmol/l \[110 mg/dl\]) and no diabetes (i.e. a FPG \< 7.0 mmol/l \[126 mg/dl\])
* a technically adequate baseline carotid ultrasound examination

Exclusion Criteria:

* current use of an ACE-inhibitor (ACE-I) or thiazolidinedione (TZD)
* known hypersensitivity to ACE-I
* prior use of anti-diabetic medications 9with the exception of during pregnancy)
* use of systemic glucocorticoids or niacin
* congestive heart failure or EF \< 40%
* existing cardiovascular disease (previous MI, stroke, angina, uncontrolled hypertension)
* diabetes
* renal or hepatic disease
* major illness
* use of another experimental drug
* pregnant or unwilling to use reliable contraception
* major psychiatric disorder
* diseases that affect glucose tolerance
* unwillingness to be randomized or sign informed consent
* known uncontrolled substance abuse
* inability to communicate with research staff
Clinical Outcomes After Arthroscopic Tenotomy or Tenodesis of the Long Head of the Biceps

Degenerative changes of the long head of the biceps brachii (LHB) are frequent and often associated with cuff tendinopathy. The function of the LHB in the shoulder is still controversial and uncertain, whereas its function in the elbow is certain. The biceps brachii is a flexor of the elbow and supinator of the forearm. Suppression of the pathologic long head of the biceps permits pain relief and is very reliable in the literature. Two options are available for the remaining tendon : simple tenotomy or tenodesis which consists to reattach the tendon to the humerus. Our hypothesis is that there is no difference in strength or endurance of the biceps brachii after tenotomy or tenodesis of the LHB. The aim of this study was to compare the strength and the endurance of the biceps brachii during supination and flexion after tenotomy or tenodesis of the LHB.

the investigators proposed a prospective and randomized study. All the patients treated in our department for an arthroscopic rotator cuff repair were included in this study after signed consent. Participants will complete isokinetic strength and endurance testing for elbow flexion and supination on the operative and nonoperative sides a minimum of 1 year after biceps tenotomy or tenodesis. The clinical evaluation included the range of motion measurement, Constant Score, Quick-DASH and SSV at 6 weeks, 3 months, 6 months and one year.


Eligibility Criteria:
Inclusion Criteria:

* surgery tenotomy or tenodesis type of the long head of the biceps (broken tendinopathy or not rotator cuff escaping a well conducted medical treatment and under a repair or cap pathology of the long head of the biceps during the arthroscopy)
* Patients treated in the orthopedic service of the Reims University Hospital
* Patients agreeing to participate in the research and who signed the informed consent
* Major patients.

Exclusion Criteria:

* prior Shoulder Surgery
* surgery scheduled contralateral shoulder
* patient protected by law
REFLECTION: A Clinical Practice Learning Program for Galleri®

REFLECTION is a multi-center, prospective, non-interventional, cohort study that will enroll approximately 17,000 individuals who have opted to be screened with Galleri®, a blood-based, multi-cancer early detection (MCED) test in routine clinical settings. The purpose of the study is to understand the real-world experience of Galleri® in clinical settings.


Eligibility Criteria:
Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria apply:

* Participant has the ability to understand and the willingness to sign a written informed consent form (ICF);
* Participant is at least 22 years old at the time of consent;
* A provider or their designee has ordered the Galleri® test; and
* Participant has the ability to comprehend the participant questionnaires.

Exclusion Criteria:

* There are no exclusions
Optimizing the Delineation of the Tumour Bed in Breast Irradiation

The aim of the present study is:

1. to verify whether the delineation of the tumour bed, based on the combination of the visible postoperative changes and the position of the surgical clips on a CT scan in treatment position acquired 1 week before the start of the radiotherapy (RT), provides an accurate localisation of the boost volume compared to the localisation of the tumour on a pre-operative CT-scan.
2. to document the changes that occur in the tumour bed as seen on a CT scan as a function of the delay between surgery and radiotherapy.
3. to determine the ideal number and the positioning of the clips needed to reproduce the best treatment volume for the boost.
4. to propose new guidelines for tumour bed definition and delineation based on the study findings.

Start of the study: february 2012

Eligibility Criteria:
Inclusion Criteria:

* Breast Cancer patients, without metastases, who will undergo breast conserving surgery and probably will receive adjuvant chemotherapy and thereafter radiotherapy.

Exclusion Criteria:

* Metastases at time of diagnosis
Cord Blood Transplantation for Patients With Cancer

The primary objective of this study is to assess the rate of engraftment with combined haploidentical-cord blood transplantation in patients with pre-existing donor specific antibodies and in those with active disease.

Primary Objective

- To assess the rate of engraftment with combined haploidentical-cord blood transplantation in patients with pre-existing donor specific anti-HLA antibodies and in those with active disease

Secondary Objectives

* To determine the long term fate of the haplo transplant and the cord blood transplant in this setting.
* To describe the incidence and severity of acute and chronic GVHD.

Eligibility Criteria:
Inclusion Criteria:

* Relapsed or refractory acute leukemia (myeloid or lymphoid)
* Acute leukemia in first remission at high-risk for recurrence
* Chronic myelogenous leukemia in accelerated phase or blast-crisis
* Chronic myelogenous leukemia in chronic phase
* Recurrent or refractory malignant lymphoma or Hodgkin lymphoma
* Chronic lymphocytic leukemia, relapsed or with poor prognostic features
* Multiple myeloma
* Myelodysplastic syndrome
* Chronic myeloproliferative disease
* Hemoglobinopathies
* Aplastic anemia

Exclusion Criteria:

* Zubrod performance status \> 2
* Life expectancy is severely limited by concomitant illness
* Patients with severely decreased LVEF or impaired pulmonary function tests
* Estimated Creatinine Clearance \<50 ml/min
* Serum bilirubin\> 2.0 mg/dl or SGPT \>3 x upper limit of normal
* Evidence of chronic active hepatitis or cirrhosis
* HIV-positive
* Patient is pregnant
* Patient or guardian not able to sign informed consent
Comparison of Antegrade and Retrograde Fixation With Intramedullary Screws in Metacarpal Fractures

Purpose: Intramedullary fixation has proven to be an efficacious intervention for metacarpal fractures. Advantages involve stable fixation facilitating early surgical rehabilitation and higher fracture union rates, without increased morbidity. We aimed to compare the results of fixation of metacarpal fractures with headless cannulated screws towards antegrade or retrograde on pain, function and quality of life in patients with metacarpal fractures.

Methods: Patients admitted to Pamukkale University Orthopedics and Traumatology Department, due to metacarpal fracture were prospectively included in the study and randomly grouped. A total of 22 patients and 26 metacarpal fractures were assessed. Group I patients were operated with antegrade(proximal entry) , and group II with retrograde (distal entry) , using intramedullary headless cannulated screws. Appropriate screw selection was made by measuring the metacarpal isthmus diameter of the patient's x-ray results (AP and oblique direction). We used headless cannulated screws with diameters between 3.5mm and 5mm in the fractures.

This was a prospective randomised comparative single-blinded study comparing the effects of intramedullary fixation direction and entry site in patients with metacarpal fractures.

The participants were first evaluated at post-operative 6th week and the last evaluation was performed at post-operative 12th week The evaluations included radiographic union, grip strength measurement (with Jamar hydraulic hand dynamometer), range of motion measurement (compared to the opposite hand), and Michigan Hand Outcome Questionnaire (MHQ) questionnaire. All assessments were performed by the same investigator. The researcher who performed the evaluations did not know which group the participants were in.

In the antegrade headless cannulated screw fixation technique, a small incision was made on the extensor aspect of the fractured metacarpal at the level of the carpometacarpal (CMC) joint and the extensor tendon was excised. After fracture reduction, k-wire was inserted intramedullarly. After appropriate drilling, 1 headless cannulated screw was applied distally.(figure 1) In the fixation technique with retrograde headless cannulated screw, a small incision was made on the extensor side of the fractured metacarpal at the level of the MCP joint, and the extensor tendon split was passed. After fracture reduction, k-wire was inserted intramedullarly. After appropriate drilling, headless cannulated screw was applied proximally.

Eligibility Criteria:
Inclusion Criteria:

* Operated for metacarpal fracture,
* Speak and understand Turkish,
* Understand the verbal and written information given.
* Regular follow-up visits

Exclusion Criteria:

* Open epiphysis
* Pathological fractures
* Fractures requiring bone grafting