cyrilzakka/clinical-trials huggingface dataset:
Cetuximab and Stereotactic Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer That Cannot Be Removed By Surgery

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving cetuximab together with stereotactic radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how giving cetuximab together with stereotactic radiation therapy works in treating patients with recurrent squamous cell carcinoma of the head and neck cancer that cannot be removed by surgery.

OBJECTIVES:

Primary

* Evaluate local control at 12 months in patients with recurrent squamous cell carcinoma of the head and neck treated with cetuximab and stereotactic radiotherapy.

Secondary

* Determine the incidence of cutaneous toxicity.
* Assess the care and development of skin reactions.
* Determine the quality of life of patients treated with this drug.
* Determine tumor response at 2 months.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV once weekly for 5 weeks. Patients undergo stereotactic radiotherapy 3 times weekly during weeks 2 and 3.

After completion of study therapy, patients are followed at 2 months and then every 3 months for 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed squamous cell carcinoma of the head and neck

  * Unresectable disease
  * Recurrent disease
* No metastatic disease
* Disease in previously irradiated area must be proven by biopsy or imaging

  * At least 3 months between prior radiotherapy and diagnosis of recurrent disease
* Surgery or brachytherapy must be possible
* Measurable or evaluable disease by RECIST criteria
* No available curative therapy

PATIENT CHARACTERISTICS:

* Karnofsky performance status 60-100%
* Not pregnant or nursing
* No psychological, familial, social, or geographical reasons that would make monitoring the patient impossible
* No other malignant disease

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No concurrent participation in another clinical study of an experimental drug
The Combination of Immunotherapy and Neoadjuvant Chemoradiotherapy in MSS Locally Advanced Rectal Cancer

The study evaluates the addition of immunotherapy of PD-1 antibody in neoadjuvant chemoradiotherapy in microsatellite stable (MSS) locally advanced rectal cancer (LARC). A total of 50 MSS LARC patients will receive 2 cycles of PD-1 antibody, followed by capecitabine plus irinotecan radiosensitized neoadjuvant chemoradiotherapy, and another 3 cycles of PD-1 antibody, finally received the total mesorectal excision (TME) and 6 cycles of adjuvant chemotherapy of XELOX. The tumor response grade, adverse effects and long-term prognosis will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

1. pathological confirmed adenocarcinoma
2. clinical stage T3-4 and/or N+
3. the distance from anal verge less than 12 cm
4. without distance metastases
5. age 18-70 years old, female and male
6. KPS \>=70
7. UGT1A1\*28 6/6 or 6/7
8. the MSI status is MSS or p-MMR
9. without previous anti-cancer therapy or immunotherapy
10. with good compliance
11. signed the inform consent

Exclusion Criteria:

1. pregnancy or breast-feeding women
2. history of other malignancies within 5 years
3. serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc.
4. immunodeficiency disease or long-term using of immunosuppressive agents
5. baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10\^9/L, Hb≥90g/L, PLT≥100×10\^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
6. DPD deficiency
7. UGT1A1\*28 7/7
8. the MSI status is MSI-H or d-MMR
9. allergic to any component of the therapy
Evaluation of Coblation Channeling in Treating Chronic Tonsillitis

The investigators wish to evaluate coblation channeling in the treatment of chronic tonsillitis.

The tonsillar crypts play an important role in chronic tonsillitis. They are covered by stratified epithelium and may be initiated via the epithelium to mount immune responses to various presenting antigens. Go M. et al, investigated the expression and function of tight junctions in the epithelium of human palatine tonsils from patients with tonsillar hypertrophy or recurrent tonsillitis. These studies suggested unique expression of tight junctions in human palatine tonsillar epithelium, and it was suggested that the crypt epithelium may possess an epithelial barrier different from that of the surface epithelium.

Bacteria within biofilms are resistant to host defenses and antibiotics. The presence of bacterial biofilms within the tissue and crypts of inflamed tonsils may explain the chronicity and recurrent characteristics of some forms of tonsillitis. There is strong anatomical evidence for the presence of bacterial biofilms in chronically diseased tonsils.

Our hypothesis was that treatment of the crypts and tonsillar tissue may decrease the possible antigen-immune system interaction and inflammation.

The combination of the radio frequency energy and the fluid creates a "plasma" field containing highly ionized particles. The ionized particles have sufficient energy to break organic molecular bonds that can remove tissue selectively without excessive heat production and damage the surrounding tissue. Employing this new technique, the investigators will try to eliminate the cause for chronic tonsillitis.

The combination of the radio frequency energy and the fluid creates a "plasma" field containing highly ionized particles. The ionized particles have sufficient energy to break organic molecular bonds that can remove tissue selectively without excessive heat production and damage the surrounding tissue. Employing this new technique, the investigators will try to eliminate the cause for chronic tonsillitis.

Our hypothesis was that treatment of the crypts and tonsillar tissue may decrease the possible antigen-immune system interaction and inflammation.

Eligibility Criteria:
Inclusion Criteria:

* suffering from at least 4 episodes of tonsillitis in past year.
* suffering from recurrent or chronic sore throat.
* suffering from irregular tonsils with crypts, slight redness or enlargement.

Exclusion Criteria:

* suffering from mouth ulcers or other oral מחלת ריריות
* allergic to the type of medication included in the study.
* suffering from gastrointestinal (GI) reflux or chronic הפרשה הוסטנזלית
* contraindication to medical or surgical treatment.
* suffering from peritonsillar abscess.
VTX958 Versus Placebo for the Treatment of Active Psoriatic Arthritis (Tranquility-PsA)

The objective of this study is to evaluate if VTX958 is safe and effective in adult participants with active Psoriatic Arthritis. Approximately 195 eligible participants will take VTX958 Dose A, VTX958 Dose B, or matching placebo (no active drug) for 16 weeks and then move on to a 36 week Long Term Extension (LTE). The study will include 16 weeks of treatment, 36 weeks of LTE, and a 30-day follow-up period.

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two doses of VTX958 tablets, Dose A and Dose B, in adults with active Psoriatic Arthritis. Approximately 195 participants will be assigned in a 1:1:1 ratio to one of three groups, VTX958 Dose A, VTX958 Dose B, or placebo, for 16 weeks and then move on to a 36 week Long Term Extension (LTE). The study consists of a 30-day screening period, a 16 week double-blind treatment period, 36 weeks of LTE, and a 30 day follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Psoriatic Arthritis for 6 months or more prior to Screening
* Documented history or active signs of at least 1 confirmed lesion of plaque psoriasis and/or nail changes attributed to psoriasis
* Active PsA as defined by 3 or more swollen joints and 3 or more tender joints at Screening and Day 1
* Women must not be of childbearing potential or must agree to use a highly effective contraception during the study and for 30 days after the last dose of the study product
* Men with a partner who is of childbearing potential must agree to use condoms during the study and for 90 days after the last dose of study product

Exclusion Criteria:

* Has non-plaque psoriasis at Screening or Day 1
* Has inflammatory bowel disease or active uveitis
* Has a history of chronic or recurrent infectious disease
* Has a known immune deficiency or is immunocompromised
* Has hepatitis B or hepatitis C infection, human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), or active tuberculosis (TB) at screening
Pharmacokinetics of High-dose Tigecycline in Critically Ill Patients

The objective of this study is to describe the pharmacokinetics of tigecycline in critically ill patients receiving continuous venovenous haemodialysis (CVVHD) and to evaluate the frequency of pharmacokinetic/pharmacodynamic target attainment with high dosing strategy (200 mg loading dose and 100 mg/12h).

This is a prospective observational study performed on critically ill patients. Inclusion criteria are: severe sepsis on admission requiring broad-spectrum antibiotics. Both medical and surgical patients will be included. Any type of infections will be included (pulmonary, abdominal, urinary tract, etc.) Antibiotics regimen includes: tigecycline (200 mg every 12 hours intravenously), meropenem (2 grams every 8 hours intravenously).

Blood samples (3 mL) will be collected 2, 4, 8 and 12 hours after each dose of tigecycline for 3 consecutive days. The standard arterial canula will be used to obtain samples.

In each case CVVHD will be started and continued for at least 3 days' period. 30 minutes after a collection each sample will be centrifuged for 10 minutes at 3,000 rpms. Subsequently, supernatant will be collected and frozen.

Serum tigecycline concentration will be measured with high performance liquid chromatography.

Each patient's hemodynamics parameters will be recorded with the use of transpulmonary thermodilution technique (PICCO). Other therapies i.e.: ventilatory support, sedation, an antifungal agent will be given as required.

Eligibility Criteria:
Inclusion Criteria:

* Patients who require ICU treatment due to severe sepsis
* age 18-80 years
* CVVHD treatment
* an eligible consent obtained from the patient or his/her attendant

Exclusion Criteria:

* allergy to tigecycline or meropenem
* contraindication to CVVHD
* lack of consent to participate in the study
* age of patients below 18 or above 80 years
Intravenous CTLA4-lg Treatment in Recent Onset Type 1 Diabetes Mellitus

The purpose of this study is to determine whether treatment with CTLA4-Ig (Abatacept) in individuals with new onset T1DM will improve insulin secretion (C-peptide production) compared to placebo.

Type 1 diabetes mellitus (T1DM) is a T-cell mediated autoimmune disease in which insulin-producing beta cells are completely or near completely destroyed resulting in life-long dependence on exogenous insulin.

CTLA4-Ig (Abatacept) inhibits a crucial stimulatory pathway in the activation of T cells. By this mechanism, the drug is thought to arrest or slow the T cell mediated autoimmune destruction of beta-cells and preserve their function. At the time of clinical onset of T1DM, a significant amount of insulin producing beta cells are destroyed, but as many as 10-20% are still capable of insulin production. By using CTLA4-Ig close to the onset of T1DM, we hope to arrest or slow down the autoimmune destruction of these beta-cells and extend the endogenous insulin production. CTLA4-Ig regulates T cell function but does not deplete T cells. Therefore, its safety profile appears to be better than other immunosuppressive agents.

Eligible participants will be randomized to the experimental or control groups. The experimental group will receive intravenous infusions of CTLA-4 Ig. The first infusion will occur at the time of randomization, followed by another infusion 2 and 4 weeks later. Subsequent infusions will be given monthly for two years during the treatment phase of the study. There is a total of 27 infusions during the treatment phase of the study.

Participants in the control group will receive intravenous infusions of placebo according to the same schedule outlined above.

Both groups will receive standard intensive diabetes treatment with insulin and dietary management.

All participants randomized into the study will be seen at study site monthly for 24 months and then every 6 months for up to an additional 2 years. Participants will undergo assessments of their insulin production, immunologic status, overall health and well being and diabetes care.

Eligibility Criteria:
Inclusion Criteria:

1. Age 6-45
2. Within 3 months (100 days) of diagnosis of T1DM based on ADA criteria
3. At least one diabetes-related autoantibody
4. Stimulated C-peptide level \>0.2 pmol/ml by MMTT conducted 21 days after diagnosis of T1DM and within 37 days of randomization
5. At least three months from last live immunization received and willing to forgo live vaccinations for three months following last dose of study treatment

Exclusion Criteria:

1. Immunodeficiency, chronic lymphopenia, active infection, positive PPD result or a history of malignancy
2. Serologic evidence of current or past HIV, Hepatitis B or C
3. Pregnancy, lactation, or intention of pregnancy while on study
4. Current use of immunosuppressive agents, or medications known to influence glucose tolerance or glycemic control
5. Current participation in another T1DM treatment study
Impact of Peer Education Program on Headache Disorders

Worldwide, headache disorders are among the most common medical conditions. Many people with headache need not experience further pain if the diagnosis and treatment are correct. Most patients do not have correct diagnosis and treatment. This study tested a model for treatment of people with headache disorders at primary health-care level in rural areas of Haryana, India.


Eligibility Criteria:
Inclusion Criteria:

* All residents of the Region Kaithal (haryana) may apply for recruitment
* Primary headache disorders including tension type headache, migraine

Exclusion Criteria:

* Planning to move the area
* Refused to consent
Effects of Preoperative Anxiety and Pain Sensitivity in Cases of Endoscopic Ultrasonography Received Sedoanalgesia

The objective of this study was to detect whether preoperative anxiety and pain sensitivity had effects on the consumption of anesthetics, time to achieve desired level of sedation, patient and endoscopist satisfaction, and postoperative recovery time and pain in deep sedation.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1-2 category
* between the ages of 20 and 65
* patients who has an education level and mental state to complete the scale and questionnaire provided for assessment

Exclusion Criteria:

* patients who has a psychiatric and neurological disease and use psychiatric drugs and chronic alcohol intake
Identification of a Biomarker Associated With Cis-duplication of the SMN1 Gene

Spinal Muscular Atrophy (SMA) is a neuromuscular disorder characterized by loss of motor neurons in the anterior horn of the spinal cord and leading to muscle atrophy. SMA has an autosomal recessive inheritance and affects 1 in 6000 infants with a carrier frequency of 1 in 40. In most cases, it is caused by homozygous gene deletion or gene conversion of the SMN1 gene (0+0 genotype) on 5q11-q13. This genomic region has been duplicated and inverted during evolution. Thus the SMN1 gene has a very homologous copy, called SMN2. Genetic counseling aim at detecting carriers with only one copy of the SMN1 gene (0+1 genotype). SMA carrier testing relies on total copy number quantification of the SMN1 copies by quantitative PCR methods. Nevertheless, cis-duplication of the SMN1 gene on one allele and deletion on the second allele (2+0 genotype) can lead to a misinterpretation as molecular methods show 2 copies of the SMN1 gene and cannot detect the carrier status.

The aim of the study is the characterization of a biomarker specific of the cis-duplication of the SMN1 gene in order to allow the detection of this 2+0 genotype which constitutes a trap for genetic counseling. We will use molecular combing to identify a genomic morse code (GMC) composed of a combination of probes specific of a structural motif on the cis-duplication chromosome. The characterization of this GMC is based on the comparison of two sample groups:

* The test group, with a maximum of 137 individuals carrying 3 copies of the SMN1 gene (suggesting a cis-duplication on one allele)
* The control-1 group, with a maximum of 137 individuals carrying 2 copies of the SMN1 gene

A pilot study performed on 24 samples in the two groups is needed to define the exact sample number necessary for statistical analysis of the study. When the GMC will be characterized, its specificity will be evaluated by testing two sample groups:

* The test group, with 37 individuals carrying 3 copies of the SMN1 gene
* The control-2 group, with 37 individuals carrying 3 copies of the SMN2 gene Molecular combing needs long DNA fibers and usual methods for DNA extraction are not appropriate. This project requires new blood samples for specific DNA extraction.

If this project is successful, during a second project, this GMC will be converted into a simple and cheap PCR-based method. We will then evaluate the sensitivity of this method on our sample collection, notably on individuals with the 2+0 genotype defined by familial genotyping.


Eligibility Criteria:
Inclusion Criteria:

* Adult individual
* Individual with either 2 copies of the SMN1 gene (control-1 group), 3 copies of the SMN1 gene (test group), or 3 copies of the SMN2 gene (control-2 group).
* Individual with a social insurance
* Signed consent form

Exclusion Criteria:

* Pregnant women, nursing women
* Individual without freedom by administrative decision or judicial decision or individual under administrative supervision or legal guardianship
The Clinical and Laboratory Characteristics of Recurrent Drug- Related Hyponatremia

The aim of this study is to identify factors associated with hyponatremia among patients hospitalized in the internal medicine ward. Consequtive patients hospitalized because of hyponatremia will be recruited. Follow up will include clinical factors such as background diseases, complete drug history, blood tests including Biochemistry tests (Sodium, renal function), endocrinological evaluation, thyroid function tests, cortisol,urinary sodium on addmition. One month following discharge follow up Sodium level will be taken.


Eligibility Criteria:
Inclusion Criteria:

* patients hospitalized to the internal medicine ward due to hyponatremia

Exclusion Criteria:

* None
Prandial Metabolic Phenotype in Adults

Previous studies suggest that changes in metabolism due to the effects of aging might serve as a potential for therapeutic agents. The investigating lab developed a pulse method combining multiple stable isotopes to study multiple metabolic pathways in the same individual simultaneously. By measuring whole-body metabolism in a large group of older adults, the investigators may be able to unravel age-related deterioration in protein turnover (synthesis and breakdown) that contributes to impaired functional capacity. Metabolic profiles could explain differences in pathways in the aging process with special interest in metabolism of amino acids as they have been associated with aging-related disorders.

The study involves 1 screening visits of approximately 3 hours and 6 study days of approximately 8 hours.

Subjects will be asked to arrive in the fasted state on all study days. Fasting prior to screening is not required. On the screening day, body weight, height, and body composition by Dual-energy X-ray absorptiometry (DXA) will be measured. In addition, The Six-Minute Walk Test (6MWT) and skeletal muscle function tests will be assessed at the end of each screening visit.

Each study visit will begin with vital signs. Before administration of the feeding or the tracer solution, baseline blood will be collected for measurement of the natural enrichment of metabolites. After the baseline sample is collected, feeding will begin and will be followed by tracers of several compounds that may be administered by IV pulse.

Next, the subjects will be fed one of six liquid nutritional supplement every 20 minutes for 6 hours. The liquid nutrition supplement will target the amino acid formulation in the following meals (1) total amino acid, (2) Essential Amino Acids (EAA), (3) EAA + -hydroxy -methylbutyric acid (HMB), (4) EAA + leucine (LEU), (5) EAA high, and (6) Placebo.

Eligibility Criteria:
Inclusion Criteria:

* Age: 60-80, inclusive
* Stable body-weight (± 5%) for the past 3 months
* Subject is judged to be in satisfactory health based on medical history, physical examination, and laboratory screening evaluations.
* Ability to walk, sit down and stand up independently or with walking mobility aids
* Ability to lie in supine or elevated position for up to 7 hours
* Willingness and ability to comply with the protocol

Exclusion Criteria:

* Established diagnosis of current malignancy
* History of untreated metabolic diseases including hepatic or renal disorder
* Presence of acute illness or metabolically unstable chronic illness
* Presence of fever within the last 3 days
* Use of short course of oral corticosteroids within 4 weeks preceding study day
* (Possible) pregnancy
* Failure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
* Already enrolled in another clinical trial and that clinical trial interferes with participating in this study
* Any other condition according to the PI or nurse that was found during the screening visit, that would interfere with the study or safety of the patient