cyrilzakka/clinical-trials huggingface dataset:
[18]F-FAZA PET Imaging Study in Patients With Cancer of the Head & Neck, Lung, Renal Cell, Brain, Lymphoma and Neuroendocrine Tumours

Positron Emission Tomography (PET) is a Nuclear Medicine procedure that uses positron emitting radiolabeled tracer molecules to visualize biological activity. The presence of hypoxia (low oxygen) is associated with poor prognosis in a variety of tumour types and treatment strategies targeting hypoxic cells have been developed. The PET tracer \[18\]F-FAZA can identify hypoxic areas, and changes in uptake during treatment may predict tumour response.

The proposed clinical trial will be a Phase I/II imaging, open label, single site study. In Phase I, one 18F-FAZA PET scan will be conducted in patients with known squamous cell carcinoma of the Head \& Neck, SCLC, NSCLC, lymphoma, GGM, neuroendocrine tumours or renal cell carcinoma. In Phase II, three 18F-FAZA PET scans will be done on patients with the above tumours as follows: one pre-treatment, one mid course and one post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Male or female greater than or equal to 16 years of age.
* If female of child-bearing potential and outside of the window of 10 days since the first day of the last menstrual period, a negative pregnancy test is required.
* Patients with known primary or suspected metastatic squamous cell carcinoma of the head and neck, non-small cell or small cell carcinoma of the lung, lymphoma, GBM (greater than or equal to 3 glioma), neuroendocrine tumours, or renal cell carcinoma with at least one lesion \>1 cm in diameter.
Effects of Foot Medial Arch Electrical Stimulation on Foot Functions and Balance

The aim of this study is to investigate the immediate effects of sole session of foot medial arch' NMES on foot strength, arch stability, static plantar pressure distribution and dynamic postural balance.

The study design is a randomised controlled trial in population with pronated feet. The aim of this study is to investigate the immediate effects of sole session of foot medial arch' NMES on foot strength, arch stability, static plantar pressure distribution and dynamic postural balance. This is the 2nd study to investigate the effect one session as previous study showed immediate effect on plantar pressure distribution on the midfoot and durable effect at 2 months follow-up. However, no studies investigated the effects on others parameters than plantar pressure.The general objective of our study is to question electrical stimulation as a modality for foot strengthening to enhance dynamic postural balance and foot functions.

Eligibility Criteria:
Inclusion Criteria:

* Foot Posture Index (FPI) between +6 à +12 (slight pronation / increased pronation)

Exclusion Criteria:

* History of ankle or foot sprain or pain within the last 3 months
* Fracture in the leg or in the foot that occurred during the last year
* Severe foot deformity
* Self-reported disability due to neuromuscular impairment in the lower extremity
* Neurological or vestibular impairment that affected balance (diabetes mellitus, lumbosacral radiculopathy, a soft tissue disorder such as Marfan or Ehlers-Danlos syndrome)
* Any absolute contraindication to NMES (pacemaker, seizure disorders, pregnancy)
* Experience of NMES at the foot region or foot core strengthening
The BEACH Interview Study- Pregnant and Breastfeeding Mothers

Interview pregnant and breastfeeding mothers in the Gainesville, FL area to optimize; clinical study recruitment and retention, patient-centered outcomes, and stool collection procedures.

This is an interview study that will enroll mothers during 28 weeks or greater of pregnancy and assess recruitment, patient-centered outcomes, and stool collection procedures via individualized interviews and data collection. Participants will be recruited from the greater Gainesville, FL area. Data collection will include questionnaires/surveys as well as minimal risk non-invasive biological samples such as stool, human milk, saliva, vaginal swab, and urine collection. Participants will be seen at a location convenient for them.

Eligibility Criteria:
Inclusion Criteria:

* Females 18\>45, between 28-38 weeks pregnant, lives in Gainesville, Florida, and committed to exclusively breastfeeding through 6 months.
* Females 18\>45, actively breastfeeding for \<12 months and lives in Gainesville, Florida

Exclusion Criteria:

* Mothers who do not plan to exclusively breastfeed their infant for at least the first 6 months or actively breastfeeding.
* Mothers who do not live in Gainesville, FL
* Mothers who are not between the ages of 18-45
* Mothers who are not between 28-38 weeks of gestation or a breastfeeding mother.
* Mothers who have only one breast which is capable of producing milk and/or have a history of inadequate milk production.
* Mothers who have consumed alcohol during this pregnancy.
* Mothers who have abused drugs during this pregnancy.
* Mothers who have smoked during this pregnancy.
* Mothers who have been diagnosed with pre-eclampsia during this pregnancy.
* Mothers who have had a previous pre-term delivery (baby born 2 months before the due date or \<35 weeks).
Avastin for PDR (Proliferative Diabetic Retinopathy)

The purpose of this study is to determine the effect of anti-VEGF drug (Avastin) adminstration in eyes prior to surgical treatment for Traction retinal detachment (TRD) in patients with Proliferative Diabetic Retinopathy (PDR).

Traction retinal detachment (TRD) due to proliferative diabetic retinopathy is a blinding disease caused by contraction of fibrovascular proliferation, treatment of which is limited to surgery. Fibrosis and neovascularization are both associated with high levels of connective tissue growth factor (CTGF) and vascular endothelial growth factor (VEGF) in the eye. Small, nonrandomized studies have suggested that pre-operative adjunctive anti-VEGF administration may reduce intra- and post-operative complications and provide visual benefit in patients with this condition.

Eligibility Criteria:
Inclusion Criteria:

* Active fibrovascular proliferation due to PDR with TRD given pre-operative clearance for pars plana vitrectomy (PPV) and TRD repair.

Exclusion Criteria:

* Dense vitreous hemorrhage
* Inability to follow-up for surgery within 3-7 days after intravitreal injection
* History of stroke, thromboembolic event, or heart attack within the last 6 months
* Less than 18 years of age
* Pregnancy
Evaluation of IL-33 in Patients With the Acute Ischemic Stroke

Aim of the study is to evaluate the usefulness of interleukin 33 in the blood plasma in patients with the acute ischemic stroke of the brain in relation to mode of treatment (thrombolysis, thrombectomy, no treatment), risk factors in correlation with other inflammatory state markers (hsCRP, morphology with smear ). Blood is collected on the first and seventh days of stroke.

The purpose is to clarify utility of IL 33 as a biomarker of acute stroke.

Stroke is the third most frequent cause of death in highly developed countries (after heart disease and cancer), the main cause of disability in adults and the second most frequent cause of dementia syndromes. The annual incidence of stroke in the general population is approximately 0.2%. The risk of stroke increases with age.

Globally 15 million people are affected each year and 5.5 million die every year for this reason (20% in 30 days and up to 40% in a year from getting ill). In Poland, the incidence of stroke is around 175/100,000 in men and 125/100 in women.It is assumed that the cause of sudden cerebral insufficiency is mainly the embolism coming from the newly formed wall clot forming at the site of the atherosclerotic plaque rupture.

In recent years, the role of inflammatory factors is associated with the occurrence of severe atherosclerotic complications such as stroke or heart attack. Cytokines are glycoproteins that are released by activated cells of various tissues. They have a significant impact on the inflammation processes, they control all phases of the immune response. Interleukin is one of the cytokine groups. This study aims to find a relationship between level of IL 33 concentration and the size of the stroke and neurological deficit.

Blood will be collected on the first and seventh days of stroke for examination of Il 33, blood morphology and hsCRP

Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* Consent on participation
* Diagnosed Ischemic Stroke

Exclusion Criteria:

* Active cancer disease
* Kidney failure
* Liver failure
* Pregnancy
* Breastfeeding
Fursultiamine in Esophageal Squamous Cell Carcinoma Patients Who Receive Concurrent Chemoradiotherapy

Esophageal cancer is a common and fatal malignancy. It is the eighth most common incident cancer and the sixth leading cause of cancer death in the world. In Taiwan, esophageal cancer was newly diagnosed in 2199 patients and was the cause of 1507 deaths in 2011. Squamous cell carcinoma is the predominant histological tumor type, accounting for about 90% of the cases. Esophageal squamous cell carcinoma (ESCC) is an aggressive disease, characterized with extensive local growth and frequent metastases. Concurrent chemoradiotherapy (CCRT) with or without surgery is the treatment option for locally advanced ESCC. Further, target therapy is used in conjunction with CCRT and surgery in ESCC since several years ago. However, the therapeutic outcomes are not satisfactory due to the emergence of chemo-radioresistance. It is imperative to investigate new biomarkers and to find novel treatment targets in ESCC.

A small population of tumor-initiating cells or cancer stem cells (CSCs) possess some biological functions like normal stem cells, including self-renewal, asymmetric cell division, slowly proliferation rate and drug-resistance. CSCs from many primary tumors and cell lines express specific stem cell markers, including Oct4, Sox2, Nanog, CD133 (promimin-1), Nestin, CD44 ,CD24, ALDH (Aldehyde dehydrogenase) and c-Kit. There are many evidences that CSCs are responsible for tumor initiation, progression and metastasis. CSCs are also believed to have important roles in cancer recurrence due to their resistance to anti-cancer drugs and radiation. CSCs express high levels of ATP-binding cassette (ABC) transporters. ABC transporter can pump cytotoxic drugs out of cells and is one important mechanism of multidrug resistance in CSCs. In addition, CSCs have high reactive oxygen species (ROS) scavenger expression to remove ROS produced from irradiation therapy.

Fursultiamine (also known as thiamine tetrahydrofurfuryl disulfide, TTFD) is a derivative of vitamin B and currently used for nutrition supplement. The investigators have identified that Fursultiamine suppressed OCT-4, SOX-2, NANOG expression and decreased ABCB1 and ABCG2 in tumor sphere of ESCC cell lines. In this project, the investigators will conduct a prospective phase II study to investigate the effect of Fursultiamine combined with CCRT in ESCC patients. Stem cell markers in clinical specimens collected before and after CCRT will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed stage II and III esophageal squamous cell carcinoma

Exclusion Criteria:

* ECOG≧2;
* impaired function of lung, liver, kidney or bone marrow
Strengthening Exercises Versus Proprioception and Balance Exercises in the Treatment of Knee Osteoarthritis

The aim of the study is to investigate and compare the effect of balance and proprioception exercises with strengthening exercises on muscle strength, pain, proprioception, function and quality of life in knee osteoarthritis patients.

Damage or loss of mechanoreceptors in osteoarthritis patients affects balance and proprioception. There are studies showing that proprioceptive deficit is associated with the onset and progression of knee osteoarthritis leading to pain and disability. Because the proprioception provides a sense of power generation and allows the power output to be better regulated. When the literature is examined, studies investigating the effects of proprioception and balance exercises on muscle strength, function and pain are limited.

In our study patients will be randomly divided into two groups: Group I (Proprioception and Balance) and Group II (muscle strengthening exercises). While Group I will be applied Proprioception and Balance training exercises, Group II will be applied closed and open kinetic strengthening exercises. Two group will perform exercise 3 times a week during 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have a diagnosis of knee Osteoarthritis according to the American Society of Rheumatology (ACR) criteria,
* Between 45 to 75 years of age
* Can read and write in Turkish language

Exclusion Criteria:

* Active synovitis
* Taking any physical therapy section in the last 6 months
* Have a neurological problems that affect walking
* Have an arthritis problem in the ankle and hip joint
* Have a history of lower extremity surgery
* Intraarticular steroid injection in the last 6 months
* Use psychoactive drug
* Have a severe defect of vision and hearing, speech disorders
* Vestibular dysfunction
Sequential Conditioning in Haploidentical Transplantation for Hematopoietic Stem Cells in Patients With Relapsed or Refractory Lymphoid Hematological Disorders

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is the only treatment option with a significant chance of healing in lymphoid hematological refractory or multiple relapses after chemotherapy. However, all patients with an indication of allo-HSC can not benefit because of two limitations: the toxicity of the treatment and graft shortage available.

For patients refractory or in relapses with an indication of allo-HSC, used the combinaison of an SET followed by the reduced-intensity allo-HSC (RIC) has shown some interesting results.

A post-transplant immune modulation with prophylactic injections of donor lymphocytes (PDLI) showed its effectiveness to decrease the risk of relapse while having a lower toxicity than chemotherapy


Eligibility Criteria:
Inclusion Criteria:

* Patients with an indication of allo-HSC for a lymphoid hematological malignancy like Hodgkin's lymphoma, non hodgkin's lymphoma b cell (mantle follicular, diffuse large cells, marginal zone,MALT) or T (peripheral T whithout specificity, anaplasic, angio-immunoblastic, natural killer cells, gamma / delta T cells, Sezary's syndrome, primitive cutaneous T), prolymphocytic leukemia, chronic lymphocytic leukemia, waldenström's disease and for which a therapeutic strategie combining a sequential chemotherapy followed by the reduced-intensity conditioning(SET RIC + PDLI) is decided
* Patients at least in partial response (standard criteria) after a rescue treatment the day of evaluation at 1 month before the conditioning
* Advanced age ≥ 18 to \<60 years
* Cardiac ejection fraction of the left ventricle ≥ 45%
* Lung function - free diffusion capacity for carbon monoxide ≥ 50% of predicted value
* Creatinine clearance ≥ 50 ml / min depending on the CKD-EPI formula
* Availability of an HLA haploidentical donor in the family
* Collection of non-opposition

Exclusion Criteria:

* Invasion of uncontrolled CNS
* Availability of an HLA identical family donor who agreed to donate hematopoietic stem cells OR non-related donor HLA-compatible 10/10 on HLA-A alleles, B, C, and DRB1 DQB1 available and ready to give in 4 weeks to make a decision allograft
* Presence in the patient HLA-specific antibodies directed against an antigen HLA haploidentical donor family
* Karnofsky score \<70%
* Patient HIV positive
* Hepatitis B or C or chronic active
* Uncontrolled infection at the time of start packing
* Contraindication to the use of treatments provided by the protocol
* Previous history of allo-HSC
* No beneficiary of a social security scheme.
* life expentancy estimated less than 1 month by investigator
The Effect of Placental Cord Drainage on Postpartum Blood Loss

To determine if placental cord drainage decreases the blood loss after spontaneous vaginal delivery

Postpartum hemorrhage complicates 3% of pregnancies in the United States and is a leading cause of maternal morbidity and mortality. ACOG defines PPH as cumulative blood loss greater than 1000cc; however a blood loss \>500cc should be considered abnormal. Primary PPH occurs in the first 24 hours and is largely secondary to uterine agony. ACOG as well as the WHO recommend active management of the third stage of labor to prevent PPH. This includes oxytocin administration, uterine massage, and gentle cord traction. Placental cord drainage (PCD) is the unclamping of the umbilical cord to allow for drainage of the blood from the placenta. It is another technique used to shorten the third stage of labor; however, it has not been well studied

Eligibility Criteria:
Inclusion Criteria:

* Singleton Gestation
* Ages 18-45
* English Speaking
* Third Trimester Gestation

Exclusion Criteria:

* Operative Vaginal Delivery
* Multiple Gestation
* Cesarean Delivery
* Episiotomy
* 3rd or 4th degree laceration
* Less than the Third Trimester of Pregnancy
* Chorioamnionitis
* History of Postpartum Hemorrhage
* Macrosomic Infant
Outcome of Low Energy Ankle Fractures

Ankle fractures are among the most common osseous injuries to the lower extremity, and remain a significant source of morbidity for both the young and the elderly. Recent cross-national studies have shown a significant increase in the incidence and severity of ankle fractures among the elderly population.


Eligibility Criteria:
Inclusion Criteria:

- all types of trumatic ankle fractures due to low energy amenable to surgical open reduction and internal fixation .

Exclusion Criteria:

* previous surgery.
* Disorders of bone metabolism other than osteoprosis (ie, Paget disease , renal osteodystrophy , osteomalacia )
* Patient with moderate or severe congnitive impairment or patients with Parkinson disease or dementia
Mind-body Therapy (Remotely Delivered) for Knee Osteoarthritis

This proposal aims to provide crucial knowledge about the neurobiological mechanisms underlying Tai Chi mind-body therapy for knee osteoarthritis (OA). The central mechanism of knee OA pain will be investigated using brain imaging technology to evaluate how brain function and structure change in response to mind-body exercise over time.

Sixty eligible individuals who meet the American College of Rheumatology criteria for knee OA will be randomized into Tai Chi or wellness education interventions for 12 weeks. The investigators will compare changes in resting state functional connectivity of the cognitive control network, and functional magnetic resonance imaging responses to pressure pain and brain morphometry, as well as their association with clinical outcomes. The findings will lead to the establishment of a new treatment paradigm in OA and have broad application to the management of chronic musculoskeletal pain.

The study will investigate the central mechanism of knee OA pain using brain imaging technology to evaluate how brain function and structure change in response to mind-body exercise over time. Tai Chi mind body therapy may work by modulating the interaction among cognitive control network, default mode network, descending pain modulation system, limbic system, salient network, and sensory motor system through complex mind-body interactions. By combining multiple brain imaging modalities measurements, investigators will examine the neural substrates of Tai Chi compared with wellness education in adults with knee OA. The investigators will compare changes in resting state functional connectivity of the cognitive control network, brain morphometry and functional magnetic resonance imaging responses to pressure pain, as well as their association with clinical outcomes. Results of this innovative mechanistic study will have important therapeutic implications and provide critical insight into the clinical, behavioral, and neurobiological mechanisms of the potential disease-modifying role of mind-body therapies for knee OA.

Eligibility Criteria:
Inclusion Criteria:

* Age 50 years or older
* Unilateral or bilateral Knee OA
* Fulfills the American College of Rheumatology Criteria for symptomatic knee OA
* Willing to undergo MRI at baseline and follow-up
* WOMAC pain subscale score ≥2 on weight-bearing questions

Exclusion Criteria:

* Serious medical conditions limiting ability of patient to participate in the study such as, symptomatic cardiovascular, symptomatic pulmonary disease requiring supplemental oxygen, uncontrolled metabolic diseases, severe renal and liver disease
* Presence of any contraindications to fMRI scanning. Including but not limited to: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy, weight \>300 lbs
Impact of Manual Therapy on Laryngeal Function Following Total Thyroidectomy

In this clinical trial, the investigators are seeking to learn if a course of voice therapy, including neck massage, stretches and pain science education in addition to voice exercise and scar massage will effectively treatment patient complaints of swallowing or voice changes after total thyroidectomy as compared to voice exercise and scar massage alone.

The main questions it aims to answer are:

Will neck massage, stretches and pain science education reduce patient complaints of swallowing changes after total thyroidectomy?

Will neck massage, stretches and pain science education reduce patient complaints of voice changes after total thyroidectomy?

Will neck massage, stretches and pain science education reduce patient complaints of scar tethering and quality changes after total thyroidectomy?

Will neck massage, stretches and pain science education improve quality of life after total thyroidectomy?

Participants will:

Participate in 4 visits with the participant's endocrine/laryngology surgeon. One prior and 3 after surgery for endoscopic evaluation and tests.

Participate in 5 Speech-Language Pathology Sessions for intervention exercises and tests. One prior and 4 after surgery.

Complete a journal of the participant's Home Exercise Practice


Eligibility Criteria:
Inclusion Criteria:

* The study population consists of individuals with malignant or benign thyroid disease scheduled to undergo total thyroidectomy
* native speakers of English
* All patients will be greater than or equal to 18 years of age

Exclusion Criteria:

* Participants will be excluded if they have completed voice therapy prior
* are current smokers
* have organic vocal fold pathology or clear mucosal changes to the vocal folds that can affect vibration (e.g., vocal fold scar, polyp, or nodules),
* pre-existing unilateral or bilateral vocal fold paralysis
* have had prior surgical neck or chest history including central or lateral neck dissection
* pre- or post-operative abscess or inflammation
* have a history of radiation, chronic cervical pain or cervicalgia, abnormal baseline swallowing
* have underlying and, or plan to change supplemental hormones
* greater than 10% otherwise unexplained weight loss
* had a recent aspiration pneumonia
* history of esophageal interventions or surgeries