cyrilzakka/clinical-trials huggingface dataset:
Humoral Immunodeficiency With Rituximab and Therapy With Subcutaneous Ig

To study the use of subcutaneous (injected under the skin) immunoglobulin replacement therapy (replacement of antibodies, which are infection-fighting proteins) in patients with a type of blood cancer called lymphoma, who have been treated with rituximab (a type of chemotherapy) and have an abnormal immune system putting them at increased risk of infection.

The investigators propose evaluating patients with B cell non-Hodgkin's lymphoma treated with rituximab within the past 2 years with baseline immunoglobulin levels and vaccine responses to polysaccharide (pneumococcus, meningococcus) and peptide (tetanus, diphtheria) antigens. Patients with impaired vaccine responses may benefit most from immunoglobulin prophylaxis and will be proactively started on 20% subcutaneous replacement therapy. This study is novel in that it will stratify patients according to their humoral response to polysaccharide and peptide vaccines, and will proactively initiate therapy with the new 20% subcutaneous immunoglobulin in those with impaired humoral response rather than starting it after infections occur. This will potentially lead to decreased infections and improved quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of B cell non-Hodgkin's lymphoma
2. Medically stable
3. Able to understand and willingness to sign a written informed consent
4. Able to comply with study procedures

Exclusion Criteria:

1. Previously diagnosed primary immunodeficiency
2. Additional immunosuppressive states
3. Ongoing therapy with Ig replacement
Ocular Imaging With Spectral Domain Optical Coherence Tomography

The purpose of this study is to analyze macular retinal thickness and macular volume using the spectral domain - optical coherence tomography (SD-OCT) in normal eyes and in eyes with various ocular diseases.

Assessment of macular thickness is important for the treatment and follow-up of a variety of ocular diseases. The introduction of optical coherence tomography (OCT) has enabled clinicians to reliably detect small changes in macular thickness and to quantitatively evaluate the efficacy of different therapeutic modalities. In this study using the spectral domain-OCT, we examined the variations of macular retinal thickness and macular volume in normal eyes and in eyes with various ocular diseases.

Eligibility Criteria:
Inclusion Criteria:

* normal eyes
* myopic eyes
* hypermetropic eyes

Exclusion Criteria:

* systemic illness
* cataract
* previous ocular trauma or surgery(other than cataract surgery or refractive surgeries)
Manual Therapy Effectivity and Exercises in Musicians

Orofacial pain is one of the most common dysfunctions among wind musicians, a population with a high incidence of temporomandibular disorder (TMD). Regarding the treatment of TMD, the efficacy of manual therapy and therapeutic exercise has been studied, but there is a lack of high quality research supporting its implementation. There is, however, an agreement on the need of combining the treatment of the temporomandibular joint and the cervical spine, due to their close biomechanical relation.

Aims of the study: To analyse the efficacy of an evidence-based manual therapy protocol alone or in combination with an exercise program on the treatment of orofacial pain during musical practice on wind musicians. Furthermore, this study aims at observing whether if said treatment is more effective in the short, medium, or long term, and which variables are the most influenced.

Methods: A sample of 40 wind musicians with orofacial pain during practice with the instrument will be recruited in the different conservatories of the Community of Madrid. The sample will be divided into two different groups: a control group who will receive the manual therapy protocol, and an experimental group who will, in addition, receive an exercise program. Treatment will consist of ten session distributed along 5 weeks, of an approximated duration of 30 minutes per session. Assessments will be carried out pre- and post-intervention, and for a two- and four-months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Metal or wood wind musicians
* Orofacial pain during the practice in the last 30 days.
* More than 20 hours by week in the practice.
* Between 18-65 years old.

Exclusion Criteria:

* Neurological diseases.
* Analgesics previous treatments.
* Any trauma or bone fractures in skull or cervical spine.
* Any surgical intervention in cervical spine, orofacial region or temporo-mandibular joint.
Clinical Evaluation of DCB-WH1 in Healing of Chronic Diabetic Foot Ulcers

The primary objective of this Phase 2 study is to evaluate the efficacy of DCB-WH1 ointment in wound closure as compared to vehicle control when applied topically to chronic diabetic foot ulcers for 12 weeks. The secondary objective of this study is to collect safety information of DCB-WH1 ointment.

This is a randomized, double-blind, parallel group, vehicle-controlled, multi-center study of DCB-WH1 ointment applied topically to grade 1 foot ulcers (according to Wagner grading system) in 50 subjects with diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

1. Ages 20 or older with diabetes mellitus (Type 1 or 2) who has a cutaneous ulcer on the foot and present for at least 2 weeks
2. The target ulcer is classified as a grade 1 ulcer according to a modified Wagner system, which includes wounds involving the epidermis, the dermis, the hypodermis or the subcutaneous fat but not the tendon or joint capsule. The thickness of aforesaid layers wounds be approximately between 0.2 mm and 8 mm and is ranging in size between 3 and 15 cm2 post debridement.
3. An ankle brachial index ≥0.80.
4. The study ulcer should show "infection control" as judged by the investigator
5. The subject should be free of any necrotic or infected soft and bony tissue.
6. Signed informed consent form.

Exclusion Criteria:

1. Ulcers caused by venous or arterial insufficiency, osteomyelitis.
2. Poor nutritional status (albumin \< 3g/dl), poor diabetic control (HbA1c \> 10%), anemia (hemoglobin\<10 g/dL), a leukocyte counts \< 1,000/cumm.
3. Requiring prostaglandin treatment.
4. Requiring treatment with corticosteroids, immunosuppressive or chemotherapeutic agents, radiotherapy.
5. Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement.
6. Presence of connective tissue disease, renal failure (\*eGFR≦30 ml/min/1.73m2), abnormal liver function (Aspartate Aminotransferase(AST), Alanine Aminotransferase(ALT)\>2.5x upper limit of normal range), malignancy.
7. vascularization surgery performed \<8 weeks before entry in the study.
8. A history of cerebrovascular events, coronary intervention (stent or coronary artery bypass graft (CABG)) or myocardial infarction, within 6 months prior to study.
9. Female patient who has a positive pregnancy test or who is breastfeeding or unwilling to use appropriate contraceptive methods during study.
Evaluation the Growth Factors(IGF-1,IGFBP-3and HGH)in Patients With Chronic Liver Disease

BACKGROUND The insulin-like growth factor system (IGFs) plays an important role in cell growth and differentiation. Nevertheless, the roles played by insulin-like growth factor-1 (IGF-1), insulin-like growth factor binding protein-3 (IGFBP-3) and human growth hormone (HGH) in the progression of chronic liver disease remain to be elucidated and investigated.

METHODS The subjects in the present study included 60 healthy controls, 30 hepatitis patients, 60 liver cirrhosis patients and 60 untreated hepatocellular carcinoma patients. Blood was drawn by venipuncture into Venoject tubes. To find the possible correlations between liver damage and IGFs, serum IGF-1, GH, IGFBP-3 concentration and related biochemical parameters were measured. We used immunoradiometric assay to determine the levels of IGF-1, HGH and IGFBP-3 in serum.

healthy controls:one blood sample (7.5 cc) hepatitis: three blood samples, at admission, at 3rd and 7-10th day of admission liver cirrhosis: two blood samples, at 1-2 years interval (7.5 cc/each session) hepatocellular carcinoma: three blood samples, before, 1 day after and at the 7th day of transcatheter arterial chembolizatiom

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Hepatocellular carcinoma
* Must be primary Hepatocellular carcinoma and untreament

Exclusion Criteria:

* treatment Hepatocellular carcinoma
Effects of Dronabinol (Oral THC) on Cannabis Use

Study participants received dronabinol (0, 120mg/day and 240mg/day) for 12 consecutive days in a randomized order. During each dronabinol maintenance period they were able to self-administer active or placebo cannabis using either a progressive ratio schedule or choice between cannabis and monetary alternative.


Eligibility Criteria:
Inclusion Criteria:

* Current use of marijuana
* Able to give informed consent

Exclusion Criteria:

* Daily use of psychoactive medication
* Current Axis I psychiatric disorder other than dependence on cannabis or nicotine, or abuse of drugs or alcohol
* Women who are pregnant, breast feeding, or planning to become pregnant within the next 3 months
* Those seeking treatment for cannabis-related problems or using cannabis under the guidance of a physician for a medical disorder
* Uncontrolled or unstable cardiovascular disease
* Allergy to sesame oil
Obstructive Sleep Apnea in Pulmonary Embolism

Obstructive sleep apnea (OSA) is a clinical syndrome characterized by repetitive closure of the airway and frequent awakenings during sleep. Repeated episodes of hypoxia, decrease in intrathoracic pressure, increased venous return and venous stasis, damage to vascular wall may ensue. An increased tendency for coagulation has also been reported in OSA. Venous stasis, vascular endothelial activation and hypercoagulability are also known risk factors for thromboembolism. All of these pathophysiologic changes in OSA may predispose patients for the development of pulmonary embolism (PE) however there is limited data about role of thromboembolic events in OSA.


Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients diagnosed with pulmonary embolism

Exclusion Criteria:

* less than 18 years of age
* any restrictive or obstructive lung disease
Tumor Markers in Lung Cancer

The aim of this study is to determine if DCAMLK1 can be measured in the endobronchial biopsy specimens and bronchial washings from patients with lung cancer.

DCAMLK1 is a Ca2+ - ca/modulin (CaM) - dependent protein kinase that is a marker of stem cells in colonic crypts. Mutations within the stem cell population are thought to be responsible for the development of most colorectal carcinomas and studies have shown that DCAMLK1 is highly expressed in these tumors. Since the lung is an embryological development of the foregut, we speculate that DCAMLK1 will also be upregulated in lung cancers. The aim of this pilot study is to determine if DCAMLK1 can be measured in the endobronchial biopsy specimens and bronchial washings from patients with lung cancer.

This is a prospective study in 10 patients with lung masses suspected to be malignant who are scheduled for diagnostic bronchoscopy.

Patients with lung masses scheduled for diagnostic bronchoscopy will be included if they can give informed consent to participate and the diagnostic portion of the bronchoscopy has been uncomplicated. Patients considered to be at high risk during bronchoscopy because of either abnormal blood gases (Pco2 \> 50 mmHg or PaO2 \< 70 mmHg on oxygen) or coagulopathy (platelets \<100,000 or INR \> 1.5) will be excluded.

If the preliminary results indicate this is feasible, we will then propose a larger study to examine DCAMLK1 distribution in normal and cancerous tissue as well as the predictive value of this biomarker.

Eligibility Criteria:
Inclusion Criteria:

* abnormality on chest x-ray that requires diagnosis and physically capable of undergoing bronchoscopy

Exclusion Criteria:

* \<45 years
* Patients with severe abnormalities in blood gases and/or a coagulopathy will be excluded.
Optimized and Personalized Trans-cranial Brain Stimulation in Partial Refractory Epilepsies

Epilepsy is one of the most common neurological diseases, affecting between 0.5% and 1% of the general population. Therefore, new diagnostic and treatment methods are having a big impact on society. Epilepsy is also one of the most commonly diagnosed pediatric neurological disorders, with long-term implications for the quality of life of those affected and their relatives. In only two-thirds of cases, seizures can be adequately controlled with anticonvulsant drug therapy. For other patients with a drug-resistant focal epilepsy (up to around 2 million in Europe) epilepsy surgery is currently the most effective treatment. However, only 15-20% of these drug-resistant patients are eligible for epilepsy surgery. This is either because the cortical epileptogenic zone cannot be localized with sufficient precision with standard diagnostic means, or because the epileptogenic zone overlaps meaningful cortical areas, so that it cannot be surgically removed without considerable neurological deficit.


Eligibility Criteria:
Inclusion Criteria:

* Any patient, male or female aged 1 to 18, with refractory partial epilepsy considered potentially surgical according to the definition of ILAE. Drug-resistant epilepsy can be defined as the failure of adequate therapeutic trials of two antiepileptics (either monotherapy or in combination) so that the patient is free from seizures on a lasting basis.
* Any epileptic patient with interictal epileptic spikes on his standard or High Resolution EEG and or on the Magnetoencephalography examination
* Any epileptic patient undergoing a structural MRI
* Any patient who has agreed to participate in the PerEpi 1 study allowing the optimization of the location of epileptic sources and the modelling of the optimization of the parameters of transcranial electrical stimulation
* Patients who have at least 4 seizures per month

Exclusion Criteria:

* Patient not meeting the age criteria
* And/or presenting generalized epilepsy
* And/or presenting diffuse interictal peaks and/or presenting a serious alteration of the general condition and vital functions
* And/or in the event of refusal by one of the parents or the child
* Pregnant, parturient or breastfeeding woman.
* Contraindication to the use of mc-tDCS stimulation without seizure
Does the Management of Anastomotic Leakage After Low Rectal Resection Affect Survival

The aim of this retrospective cohort-study is to assess the effects of AL and its severity divided according the ISREC-classification on the long-term oncological outcome.

Rectal cancer is one of the most common malignancies in the world. Its costs and cancer-related mortality are increasing worldwide. The surgical treatment was revolutionized in recent years by the total mesorectal excision (TME) technique as well as the laparoscopic, robotic, and transanal approach. But anastomotic leakage (AL) remains one of the most feared complications after low rectal resection regarding postoperative morbidity and mortality as well as functional outcome. Several risk factors causing AL like low level of anastomosis, large tumor mass, male gender, smoking, perioperative bleeding, and preoperative radio-chemotherapy are known. Protective ileo- or colostomy formation and transanal tube placement may decrease the risk of AL and reduces the rate of reoperation due to AL. Diverting results of the association between AL and the long-term oncological outcome (local recurrence, systemic recurrence, survival) are described in the current literature.

The International Study Group of Rectal Cancer (ISREC) provides a classification of AL according to its clinical management:

* Grade A results in no change in patient's management
* Grade B requires active therapeutic intervention without re-laparotomy
* Grade C requires re-laparotomy

This classification allows a good stratification regarding postoperative morbidity and mortality. However, the association between the ISREC-classification of AL and the long-term oncological outcome is not yet clear.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving elective low anterior resection (LAR) between February 1991 and December 2020 at the Cantonal Hospital of St. Gallen

Exclusion Criteria:

* Other diagnosis than rectal cancer
* Discontinuity resection (no anastomosis)
* Emergency situation
* R1-resection
* Incomplete staging
* Metastatic cancer
* 30-day mortality
* Decline of a retrospective data analysis
* Secondary malignancy
* Age under 18 years
An 18 Week Efficacy and Safety Study of Saxagliptin and Metformin XR Combination in Subjects With Type 2 Diabetes

The purpose of this study is to compare reduction in A1C for subjects taking Saxagliptin and Metformin XR vs. uptitrated Metformin XR.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetics taking metformin IR or XR greater than or equal to 850mg and less than or equal to 1500mg only for at least 8 weeks prior to screening
* A1c: 7.5-11% (at screening)
* BMI less than or equal to 45 kg/m2

Exclusion Criteria:

* Significant cardiovascular history
* Active liver disease, renal impairment
The Vertos MILD™ Preliminary Patient Evaluation Study

This is a single-center, open label, prospective clinical study to assess the clinical application and functional outcomes of symptomatic patients undergoing the Minimally Invasive Lumbar Decompression (MILD™) treatment for lumbar spinal stenosis. In this study, patient-reported outcomes over a 3 month period following treatment will be collected by the investigator. Periodic surveys for each study subject's pain, functional status, quality of life and physical examination will track outcomes following MILD™ treatment.

The Vertos MILD™ devices are used for image-guided Minimally Invasive Lumbar Decompression, referred to as the MILD™ procedure. This percutaneous procedure is performed under fluoroscopic image guidance through a dorsal approach to the spine. Lumbar decompression is performed through the removal of tissue and bone, where indicated. All procedures are conducted in accordance with the product labeling and indications for use. A minimum of ten up to a maximum of twenty-five adult patients will be enrolled and followed for a period of up to 6 months. Patients with symptomatic lumbar spinal stenosis who meet the study enrollment criteria will be offered the MILD™ procedure as an alternative to surgery or continued standard non-surgical medical management.

Eligibility Criteria:
Inclusion Criteria:

1. Symptomatic lumbar spinal stenosis (LSS) primarily caused by dorsal element hypertrophy.
2. Prior failure of conservative therapy.
3. Radiologic evidence of LSS (L3-L5), Ligamentum flavum \> 2.5 mm, confirmed by pre op MRI and/or CT.
4. Central canal cross sectional area \< 100mm2.
5. Anterior listhesis \< 2 - 3mm.
6. Able to walk at least 10 feet unaided before being limited by pain.
7. Available to complete 12 weeks of follow-up.
8. A signed Informed Consent Form is obtained from the patient.
9. Adults ≥ 18 years of age.

Exclusion Criteria:

1. Prior surgery at intended treatment level.
2. History of recent spinal fractures with concurrent pain symptoms.
3. Disabling back or leg pain from causes other than LSS (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.).
4. Significant disk protrusion or osteophyte formation.
5. Excessive facet hypertrophy.
6. Bleeding disorders and/or current use of anti coagulants.
7. Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 5 days of treatment.
8. Epidural steroids within prior three weeks.
9. Inability of the patient to lie prone for any reason with anesthesia support (e.g. chronic obstructive pulmonary disease (COPD), obesity, etc.).
10. Any potential wound healing pathologies that may compromise outcomes, including: diabetes, excessive smoking history, cancer, connective tissue diseases, recent spine radiation and severe COPD.
11. Dementia and/or inability to give informed consent.
12. Pregnancy.
To Compare the Pharmacokinetics of a Single Oral Dose of TC-5214 in Subjects With Renal Impairment and With Subjects With Normal Renal Function

The purpose of this study is to compare the absorption and distribution of a single oral dose of TC-5214 in subjects with renal impairment and with subjects with normal renal function.


Eligibility Criteria:
Inclusion Criteria:

* Males and non-pregnant, non-lactating females 18 to 80 years old inclusive with suitable veins for cannulation or repeated venipuncture with a weight of at least 50 kg.
* Regarding renal function, subjects will be classified as either normal or as suffering from mild, moderate or severe renal impairment. Classification of renal impairment will be based using an abbreviated 4 variable Modified Diet in Renal Disease (MDRD) equations. To ensure the assessment of consistent estimated glomerular filtration rate (eGFR) using the MDRD, a single equation will be used (see Section 6.2)
* Negative screen for Human Immunodeficiency Virus and negative results for serum hepatitis B surface antigen
* Regarding renal function, subjects will be classified as either normal or as suffering from mild, moderate or severe renal impairment. Classification of renal impairment will be based using an abbreviated 4 variable MDRD equation. To ensure the assessment of consistent estimated glomerular filtration rate (eGFR) using the MDRD, a single equation will be used.

Exclusion Criteria:

* History of any clinically significant medical, neurologic or psychiatric disease or disorder (other than those previously defined as acceptable for these population) which, in the opinion of the Investigator and sponsor, may either put the subject at risk because of participation in the study, or influence the results of the subject's ability to participate in the study: This includes seizure activity and repeated episodes of major depression.
* Subjects with a history of suicide attempts in the past year and/or seen by the Investigator as having a significant history of risk of suicide or homicide, or considered at risk for suicide or homicide during the study
* Subjects with an active renal transplant (subjects who have previously received a renal transplant and are currently undergoing dialysis due to transplant failure may be enrolled)
* Any clinically significant acute illness or medical/surgical procedure within 4 weeks of the first administration of investigational product (IP) (other than those previously defined as acceptable for these population) as judged by the Investigator.
* Positive test in drugs of abuse screens (except for prescription medications, which are verified by the Investigator), or alcohol on admission to the clinic prior to the administration of the IP
Effect of Tonsillar Pillar Closure on Postoperative Pain and Bleeding Risk After Tonsillectomy

The purpose of this study is to determine if closing the tonsil fossa after tonsillectomy leads to less pain and bleeding risk than leaving it open to heal by secondary intention.

After induction of appropriate general anesthesia, a tonsillectomy was performed and control of bleeding was achieved as is routine for the individual Otolaryngologist performing the procedure. Next the surgeon used 3-0 chromic (absorbable) sutures on tapered needles to close one tonsillar fossa but leave the tonsillar fossa on the other side open. The side chosen was determined by a computer generated schedule. Routine postoperative care was given.

Eligibility Criteria:
Inclusion Criteria:

* Any patient for whom tonsillectomy is recommended for recurrent pharyngitis, obstructive sleep disorder, snoring, halitosis, feeding difficulty associated with adenotonsillar hypertrophy, and who in the investigator's opinion, is capable of providing reliable responses to post-operative follow-up questions as defined in this protocol.

Exclusion Criteria:

* Any patient for whom tonsillectomy is recommended for suspected malignancy or active peritonsillar abscess