cyrilzakka/clinical-trials huggingface dataset:
Three-dimensional Kinematic Motion Analysis of Finger and Wrist During Daily Activities

Development of reliable and objective evaluation methods is required for natural upper-extremity tasks. Three-dimensional imaging measurement techniques are a powerful tool for quantitative assessment of multijoint movements.


Eligibility Criteria:
Inclusion Criteria:

* Volunteers of 20 healthy, right dominant hands
* 10 patients with tendon pathologies
* 10 patients with Dupuytren disease
* 10 patients with osteoarthritis of the wrist
* Patients older than 18 years
* Patient willing and able to give written informed consent to participate in the study

Exclusion Criteria:

* Inflammatory disease (e.g. rheumatoid arthritis)
* Pregnant women
* German language barrier to complete the questionnaires
* Any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder)
* Legal incompetence
* Participation in any other medical device or medicinal product study within the previous months that could influence the results of the present study
Application of an Exercise Program Versus Exercise Plus Manual Therapy in the Treatment of Adhesive Capsulitis.

The main objective is to evaluate whether a treatment program combining manual therapy (joint mobilization) and exercise is more effective in the treatment of adhesive capsulitis than an exercise program applied in isolation.

The researchers will compare both groups (experimental group and control group) using the different techniques.

During the sessions, mobility will be evaluated with a goniometer and data will be recorded to monitor progress, maintaining a confidential record of the data.


Eligibility Criteria:
Inclusion Criteria:

* men and women from 40 to 60 years old, whether or not they carry out physical activity
* intervention through therapeutic exercise and/or joint mobility.

Exclusion Criteria:

* children
* older people
* people with previous shoulder pathology
* people with cognitive impairment who cannot complete questionnaires
* treatment that does not include exercise or joint mobility
* treatment with machines.
An Evaluation of Post Discharge Utilization Among Patients With an Acute Exacerbation of COPD

Patients who are hospitalized at select Carolinas Healthcare System (CHS) sites with Chronic Obstructive Pulmonary Disorder (COPD) acute exacerbation symptoms will be treated per the CHS COPD Clinical Pathway. Patient outcomes will be followed, including but not limited to readmission. Patients on the pathway will also have access to navigator services.

Patients hospitalized at participating CHS sites with COPD acute exacerbation symptoms, will be treated per the CHS COPD clinical pathway. The COPD clinical pathway will include four components: (i) discrete, evidence-based care steps (ii) patient navigation, (iii) daily data driven care gap identification, (iv) monthly leadership huddles. These components are all part of usual care for patients in this population, but each component is not applied to patients consistently across the System. For this reason, the pathway will be applied consistently and completely in patients meeting COPD acute exacerbation criteria at participating sites. Patients will be followed for 60 days in total after discharge from their COPD acute exacerbation symptoms to determine the potential effectiveness of complete implementation of all 4 components in the care of COPD patients. Patients on the pathway will also have access to navigator services.

Eligibility Criteria:
Inclusion Criteria:

* Identified as having an acute exacerbation of COPD within 24 hours of admission

Exclusion Criteria:

* Death during the index encounter
* No initial discharge as of the end of the study period
PD-L1 PET Imaging During Neoadjuvant (Chemo)Radiotherapy in Esophageal and Rectal Cancer

The overall aim of this pilot study is to prospectively monitor programmed death-ligand 1 (PD-L1) expression dynamics in vivo, during neoadjuvant chemoradiotherapy (CRT) or short-course preoperative radiotherapy (SCPRT) in rectal and esophageal cancer by a positron emission tomography (PET) imaging approach.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* All sexes
* Histologically confirmed carcinoma of the rectum or oesophagus (squamous cell carcinoma and adenocarcinoma, including oesophago-gastric junction cancers)
* Medical need for a neoadjuvant CRT/SCPRT
* Suitable to withstand the course of neoadjuvant CRT/SCPRT
* Written informed consent form (ICF) for participation in the study

Exclusion Criteria:

* Metastatic disease, which is considered incurable by local therapies (expect for oligometastatic disease with a curative intend)
* Previous surgery of the tumor other than biopsy
* Pregnancy, breastfeeding or expectancy to conceive
* Prior therapy with anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2 or any other agent directed against co-inhibitory T cell receptors or has previously participated in clinical studies with immunotherapy
* Disagreement of participants with reproductive potential to use contraception throughout the study period and for up to 180 days after the last dose of study therapy
* Hepatitis B or C
* Human immunodeficiency virus (HIV)
* Immunodeficiency
* Allogeneic tissue or solid organ transplantation
* Autoimmune disease that has required systemic therapy in the past 2 years with modifying agents, steroids or immunosuppressive drugs
* Active non-infectious pneumonitis
* Active infection requiring systemic therapy
* Systemic steroids or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
* Diagnosed and/or treated additional malignancy within 5 years of randomization, with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin and/or curatively-resected in situ cervical and/or breast cancers
* Treatment with botanical preparations (i.e. herbal supplements or traditional Chinese medicines) intended for general health support or to treat the disease under study within 2 weeks prior to randomization/treatment
* Participants with serious or uncontrolled medical disorders
* Uncontrolled or significant cardiovascular disease (myocardial infarction, uncontrolled angina, any history of clinically significant arrhythmias, QTc prolongation in males \> 450 ms and \> 470 ms in females, participants with history of myocarditis)
* Allergies and adverse drug reaction (history of allergy or hypersensitivity to study drug components, contraindications to any of the study drugs of the chemotherapy regimen)
* Other exclusion criteria: Prisoners or participants who are involuntarily incarcerated, participants who are compulsorily detained for treatment of either a psychiatric or physical (i.e. infectious disease) illness
MED3000 Topical Gel for On-Demand Treatment of Post-Radical Prostatectomy Erectile Dysfunction

The investigators are doing this research to evaluate the efficacy and safety of topical MED3000 therapy in men with persistent erectile dysfunction 1.5 to 4 years following radical prostatectomy surgery.

MED3000 is a topical gel that has been developed to treat patients with erectile dysfunction. The investigators postulate that on demand treatment with MED3000 can improve on-demand erectile function among men status-post radical prostatectomy, allowing for some endogenous cavernosal nerve function recovery for 1.5 to 4 years post-surgery among men with normal baseline pre-surgical erectile function.

Eligibility Criteria:
Inclusion Criteria:

* Men who underwent robotic bilateral nerve-sparing radical prostatectomy between 18 and 36 months prior to study commencement
* Subjects are 18-48 months status-post radical prostatectomy
* Subjects have any degree of erectile dysfunction based on IIEF questionnaire
* Age 40 - 70 at study commencement
* Diagnosed with low/intermediate-risk prostate cancer:

  * PSA \< 20 ng/ml
  * Gleason score =\< 8
  * Prostate Cancer stage =\< T3a
* Normal pre-radical prostatectomy erectile function (IIEF \>=26) or equivalent response on EPIC
* Baseline erectile dysfunction at time of screening (despite use of erectogenic aids of any kind) and enrolment following washout (IIEF-ED domain \<=25)
* Sexually active, in a stable heterosexual relationship for at least 6 months prior to screening
* Able to understand and complete patient questionnaires
* Serum prostate specific antigen (PSA) undetectable (no evidence of disease recurrence)
* Able to consent to participate
* Documented written informed consent from both patient and his female partner

Exclusion Criteria:

* Anatomical abnormalities in the genitalia or pelvic region such as severe phimosis
* Post-Radical Prostatectomy complications that could impact safety or effectiveness of medical therapy for erectile function (treatment for pelvic hematoma, urinary or intestinal fistula, unresolved anastomotic leak)
* Tumor upstaging beyond T3a
* Incomplete / sub-total nerve sparing on either side
* Previous or scheduled treatment with pelvic salvage radiotherapy and/or androgen deprivation therapy
* Prior receipt of androgen deprivation therapy
* Any other condition that would prevent the patient from completing the study, as judged by the Principal Investigator
Study Evaluating The Efficacy And Safety Of SBI-087 In Seropositive Subjects With Active Rheumatoid Arthritis

This study is designed to evaluate the safety and efficacy of a dose and dosage regimen of SBI-087 in seropositive patients with active Rheumatoid Arthritis, who are on a stable dose of methotrexate.


Eligibility Criteria:
Inclusion Criteria:

* Meets the American College of Rheumatology (ACR) 1987 revised criteria for classification of Rheumatoid Arthritis (RA) for at least 6 months prior to screening
* Active RA as defined by \>= 5 swollen and \>= 5 tender joints (28-joint count) and at least 1 of the following: C-reactive protein \>= 10 mg/L or Erythrocyte Sedimentation Rate \>= 28 mm/h
* Must be seropositive as defined by a documented history of rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti-CCP) positivity
* Must be receiving a stable route and dose of methotrexate (up to 25 mg weekly)

Exclusion Criteria:

* Any significant health problem other than rheumatoid arthritis
* Any clinically significant laboratory abnormalities
* Any prior use of B cell-depleting therapy
Bacterial Colonization With and Without Iodophor-impregnated Adhesive Drapes in Hip Surgery: a Prospective, Randomized Trial

This is a prospective, randomized control trial evaluating the efficacy of iodophor-impregnated adhesive drapes for reducing bacterial count in hip surgery.


Eligibility Criteria:
Inclusion Criteria:

* Primary femoroacetabular osteoplasty (FAO) patients
* Primary Periacetabular Osteotomy (PAO) patients

Exclusion Criteria:

* Total hip arthroplasty (THA) patients
* Revision FAO surgery
* Septic or septic arthritis patients
* Patients with systemic or topical allergy to iodine
The Effect of Telerehabilitation in Patients With Chronic Neck Pain

Telerehabilitation offers more efficient follow-up of patients during their home exercise period as a cost-effective and effective treatment model. This study was planned to examine the effectiveness of telerehabilitation in patients with chronic neck pain. The aim of the study is to compare the video-based and telerehabilitation based home-exercise program in patients with chronic neck pain. It is aimed to evaluate the patients in terms of pain, functionality, quality of life, and exercise adherence.

With telerehabilitation, patients can easily adapt to home exercise programs and be monitored remotely. In this way, it will be ensured that individuals can apply their exercises at an optimum level in non-clinical settings and to prevent exercise application errors that occur due to the learning effect frequently observed in conventional methods. Exercise is considered a central element in physical therapy and rehabilitation management in patients with chronic neck pain. However, studies have found that improvements after physical therapy and rehabilitation are not preserved in the long term, and recurrence of chronic low back pain is common. With a more cost-effective treatment model, "telerehabilitation", it is aimed that patients can be followed more efficiently during their home exercise period. The aim of the study is to compare the video-based and telerehabilitation based home-exercise program in patients with chronic neck pain. It is aimed to evaluate the patients in terms of pain, functionality, quality of life, and exercise adherence.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18 - 65
* Patients who have suffered from neck pain for at least 3 months
* Signing the consent form

Exclusion Criteria:

* Situations that prevent the evaluation or communication with the individual
* Illiterate individuals
* Individuals who have undergone an operation due to neck pain problem, diagnosed with a tumor, infection, ankylosing spondylitis, rheumatoid arthritis or inflammatory diseases, fracture, cauda equina syndrome
* Conditions in which specific pathological condition is proven such as malignant condition, fracture, systemic rheumatoid disease
* Orthopedic and neurological problems that prevent evaluation and/or treatment
* Complaints of pain and numbness spreading to the upper extremities
* Individuals with a diagnosed psychiatric disease
* Individuals who have received physiotherapy in the last 6 months
* Individuals using another treatment method during the study
* Individuals with musculoskeletal pain in any other part of the body during work
* Pregnant participants
Photodynamic Therapy for Oral Leukoplakia and Erythroleukoplakia

Photodynamic therapy for oral leukoplakia and erythroleukoplakia

Photodynamic therapy for oral leukoplakia and erythroleukoplakia

Eligibility Criteria:
Inclusion Criteria:

* patients with leukoplakia or erythroleukoplakia

Exclusion Criteria:

* oral cancers
A Comparison of the Effect of Two Types of Whole Body Vibration on Fibromyalgia. A Randomized Controlled Trial.

The objective of this study is to compare the effectiveness of two types of body vibration platform, one vertical and one rotational, through a 12-week training in patients with fibromyalgia.

This is a single blind randomized controlled trial. Sixty patients of FM will be assigned randomly to 3 study groups: 20 patients will be part of the vertical whole body vibration experimental group in the EG1, that will perform a neuromuscular treatment using the vertical whole body vibration platform, another 20 will constitute the rotational whole body vibration experimental group in the EG2, that will perform a neuromuscular treatment using the rotational whole body vibration platform, and another 20 will constitute the control group (CG). All these subjects will sign the corresponding informed consent for their participation in the study, according to the ethical criteria established in the Helsinki Declaration. The study will take place between January and December 2016. Three groups of variables were analyzed in the present study three times: before, after and follow-up after three months of the intervention.

Eligibility Criteria:
Inclusion Criteria:

-Diagnosis of fibromyalgia according with the 1990 classification criteria of the American College of Rheumatology for fibromyalgia

Exclusion Criteria:

* History of severe trauma.
* Severe disease that prevents supporting the program physical load.
* Pregnancy.
* Participation in a psychological or physical therapy program.
Feasibility and Safety of Intranasally Administered Breast Milk in HIE

This is a prospective intervention single center study to evaluate the feasibility and safety of intranasal breast milk in hypoxic-ischaemic encephalopathic neonates receiving therapeutic hypothermia.

Perinatal asphyxia and the resulting hypoxic-ischemic encephalopathy (HIE) are the leading cause of neonatal mortality and long-term neurodevelopmental disabilities. Based on our current knowledge, therapeutic hypothermia is the only therapy that has been proven to reduce central nervous system damage in HIE neonates. Improving neurodevelopmental outcomes of newborns with HIE has been an intense area of research over the past decade.

Breast milk is a complex biological substance that contains a variety of bioactive components including neurotrophic growth factors, cytokines, immunoglobulins, and multipotent stem cells. Studies have shown that exclusive breastfeeding in the early stages of development has a positive impact on cognitive outcomes. Animal studies support that mesenchymal stem cells and neurotrophic substances found in breast milk, when administered intranasally enter the central nervous system and reduce the extent of neurological damage. In preterm infants, it has been shown that intranasally administered breast milk is safe and well-tolerated.

In this prospective study we aim is to assess the feasibility and safety of intranasally delivered breast milk to HIE infants treated with hypothermia. Our objective is to administer fresh, own-mother's breast milk intranasally to neonates with HIE starting from the first day of life and continuing for 1 month.

Feasibility will be based on the ability to initiate treatment within 48 hours of birth using own mother's fresh milk expressed within 4 hours and continuing treatment after discharge until day 28. Safety will be assessed through monitoring vital signs and documenting any adverse events. Time to reach full enteral feeding and lengths of exclusive breast feeding will be recorded and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Moderate or severe hypoxic- ischaemic encephalopathy, receiving therapeutic hypothermia
* ≥ 35. gestational week
* \< 48 hours of life
* Hypothermia treatment for 72 hours
* Parental consent form

Exclusion Criteria:

* Congenital malformation
* Concurrent cerebral lesions
* ECMO therapy
* Contraindication of lactation
* Mother unable or unwilling to provide fresh breast milk
* Postpartum asphyxia
Prospective Case Collection Study for New Mammography Technologies

To evaluate the safety and efficacy of the proposed investigational device and assess its clinical utility in breast cancer screening and diagnosis to support continuing technology development of the investigational technology.


Eligibility Criteria:
Inclusion Criteria:

* Subject is female of any race and ethnicity
* Subject is at least 35 years old
* Subject is indicated for a screening or diagnostic mammogram or breast biopsy

Exclusion Criteria:

* Subject is pregnant or thinks she may be pregnant
* Subject has breast implants, cardiac pacemakers, nipple piercings, or IV ports in the mammography field of view
* Subject previously participated in the study
Treat Clozapine ( CLZ )-Resistant Schizophrenia Comparing CLZ + Haloperidol vs. CLZ + Electroconvulsive Therapy (ECT)

Clozapine treatment resistant schizophrenia is still prevalent.The effectiveness of augmenting clozapine : one augmenting with haloperidol and the other with electroconvulsive therapy should be determined.This study is a randomized control trial.


Eligibility Criteria:
Inclusion Criteria:

1. schizophrenic patients diagnosed with schedules for clinical assessment in neuropsychiatry ( SCAN )in accordance with DSM-IV-TR or ICD-10
2. Resistant to at least 6 weeks of clozapine treatment in therapeutic dosage
3. Voluntary to participate the research protocol expressed by signing informed consent form

Exclusion Criteria:

1. Patient does not volunteer himself or herself
2. Patient is having epilepsy, DM, cardiac disease, autistic disorder and illiterate
3. Patient is deaf, blind , dumb to obstruct good communication
Efficacy of Tramadol With Levobupivacaine for Modified Pectoral Nerve Block

The aim of this study is to evaluate the addition of tramadol combined with levobupivacaine in the reduction of postoperative pain, postoperative opioid consumption after modified radical mastectomy surgery.

Breast surgeries are usually associated with sever postoperative pain ,good perioperative analgesic technique after breast surgery is always questionable Thoracic epidural and paravertebral blocks became the gold standard techniques for pain relief, however they may be associated with complications such as spinal cord injury, total spinal anesthesia ,inadvertent intravascular injection and pneumothorax.

Pecs block is less invasive procedure involving ultrasound guided inter-fascial injections which has been suggested as potential alternative analgesic technique.

The block produces excellent analgesia and can be used as a rescue block in cases where the analgesia provided by the paravertebral or epidural was patchy or ineffective .

Different drugs, including opioids, non-steroidal anti-inflammatory drugs, ketamine, clonidine, and neostigmine, have been added to local anesthetics to improve the duration and quality of analgesia.Tramadol has also been used for pain management of patients.

The power of this clinical trial was prospectively calculated using the G Power analysis program. Using a priory power analysis with accuracy mode calculations with visual analogue score (VAS) as the primary variant and assuming type I error protection of 0.05 and an effect size convention of 0.9, a total sample size of 54 patients (27 patients in each group) produced a power of 0.90. To protect against drop out cases we added 6 cases to the total number (total of 60 cases)

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status I or II.
* Patients scheduled for radical mastectomy surgery.

Exclusion Criteria:

* Severe or uncompensated cardiovascular diseases
* renal diseases
* Hepatic diseases
* Endocrinal diseases.
* Pregnancy
* Postpartum
* Lactating females
* Allergy to study medications.
* Local skin infection
* Bleeding disorder
* Coagulation abnormality
* Spine deformity
* chest deformity
* Psychiatric disease
Evaluation of the Effect of Adding Corticosteroid to Viscosupplementation

The purpose of this study is to evaluate if the investigators can achieve better early outcomes adding triamcinolone to the viscosupplementation procedure.

So far there is no convincing evidence that any treatment can be really effective in slowing or preventing the development of OA. The viscosupplementation by intraarticular injection of hyaluronate-derived products has gained popularity as a treatment modality of gonarthrosis. Today there are various papers on the treatment of gonarthrosis by intraarticular injection. Several methods have shown good results. There isn't, however, a consensus on the best method. The investigators know that in the treatment of osteoarthritis, with the viscosupplementation Hylan is superior in the long term, than the infiltration with cortisone. The good short term results achieved by infiltration of cortisone make us think about the combination of these drugs. The investigators will be assessing 104 patients with osteoarthritis of the knee, divided into two groups. Patients in group 1 will be subjected to infiltration procedure 6ml of Hylan. Patients in Group 2 will undergo the procedure of infiltration with 6ml of Hylan and 1ml (20mg) of hexacetonide Triamcinolone. The researcher will apply the informed consent term, the pain visual analog scale (VAS), WOMAC and Lequesne questionnaires. The questionnaires will be answered before infiltration (week zero), one week after the puncture (week 1), four weeks after (week 4) and 12 weeks after (week 12) and 24 weeks after (week 24).

Eligibility Criteria:
Inclusion Criteria:

* age between 45 and 80 years
* Osteoarthritis Diagnosis with radiographic evidence
* absence of previous intraarticular knee fracture
* absence of allergy to Synvisc or Triancil

Exclusion Criteria:

* Development of Pioarthritis
* Failure to attend to the consultations