cyrilzakka/clinical-trials huggingface dataset:
Cancer, Obesity/Overweight and Insomnia Study

This is a randomized pilot study to better understand the relationships among insomnia, weight loss, and breast cancer. This study will assess the effectiveness of a sleep intervention prior to a web- and phone-based weight loss program.

Participants are women with a diagnosis of early stage breast cancer (ESBC), a BMI ≥25, and insomnia. A total of 30 participants will be randomized to either cognitive behavioral therapy for insomnia and behavioral weight loss (CBT-I+BWL) or a sleep education program and behavioral weight loss (EDU+BWL). Measures will be collected at baseline, 8 weeks (after the CBT-I or EDU program) and at 3 and 6 months after starting BWL. The primary outcome will be % total weight loss. Additionally, eating behaviors, physical activity, and sleep parameters will be carefully assessed.

The sleep intervention phase of the study includes 6 sessions over 8 weeks (2 in-person, followed by 4 phone or videoconferencing sessions), and the BWL intervention includes 15 sessions over 6 months (1 in-person, 14 by phone or videoconference). Participants will be given physical activity trackers and will use a dietary app to record their food intake. There are 4 in-person assessment visits (baseline/randomization, 8-week follow up, 3-month follow up, 6-month follow up). These assessment visits are coordinated with in-person sleep and weight loss intervention visits. Some of the measures that will be recorded throughout the study include: height, weight, anthropometric measures (waist/hip measurements), sleep diaries, and self-report measures.

Eligibility Criteria:
Inclusion Criteria:

* Female
* 18 years of age or older
* Histologically-confirmed ductal carcinoma in-situ (DCIS) or stage I-III invasive carcinoma of the breast
* Current BMI ≥ 25 kg/m2 and weight ≤ 400 lbs
* Willing to lose 10% of body weight
* Diagnosed with current breast cancer \>3 and \<60 months from planned baseline visit date
* Completed local therapy (i.e. surgery and radiation therapy) and any planned preoperative or adjuvant chemotherapy within \>3 prior to enrollment
* Diagnosed with insomnia or reports sleep problems
* Has daily access to the internet and/or smartphone

Exclusion Criteria:

* Serious/uncontrolled condition likely to hinder accurate measurement of weight or sleep, such as bipolar I, seizure disorders, autoimmune disease, etc., or a medical condition that makes physical activity unsafe
* Current use of weight loss medications or sleeping aids
* Current enrollment in a sleep or weight loss program
* Sleep disorder other than insomnia
* Plan to become pregnant within next 12 months, or lactating
Causative Diagnosis on Prosthetic Joint Infections: Establishment of a Comprehensive Diagnostic Strategy

On joint orthopaedic hardware infections are one of the most frequently encountered complications in orthopaedic surgery. However 6% of the cultures remain sterile, etiological diagnosis cannot be established despite obvious signs of infection. As part of this research project, we have developed a new strategy diagnosis including directly the use of PCR to reduce the number of negative results. This should have a major therapeutic impact in terms of timeliness and specificity of antibiotic.

Primary:

Evaluate the effectiveness of the new diagnostic strategy on etiological identification of prosthesis infections.

Hypothesis:

Minimum 6 percent increase in the number of patients with an etiological diagnosis of infection on prosthesis.


Eligibility Criteria:
Inclusion Criteria:

* Patient is more than 18 years old.
* Patient with a prescription of a microbiologic diagnostic of Prosthetic joint infection
* Patient who do not declined to have his medical records reviewed for research
* Patient with health insurance

Exclusion Criteria:

* Patient minor (\<18 years).
* Pregnant or lactating woman.
* Major under guardianship Patient.
* Patient deprived of liberty or under court order
Comparing Immunogenicity and Safety of Different Formulations of HBV-MPL Vaccine With Engerix™-B in Adults Aged 18-40 y

This study will evaluate the immunogenicity and safety of different formulations of the candidate HBV-MPL vaccine administered according to a 2-dose schedule and compare it to that of Engerix™-B administered according to a 3-dose schedule in order to determine the optimal dose of each component of the candidate HBV-MPL vaccine when administered at 0 and 6 months

At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Eligibility Criteria:
Inclusion Criteria:

* Age: between 18 and 40 years old.
* Good physical condition as established by clinical examination and history taking at the time of entry.
* Female participants who are at risk to become pregnant will be on a contraceptive programme if necessary during the study period.
* Written informed consent obtained from the subjects

Exclusion Criteria:

* Positive titres at screening for anti-hepatitis antibodies.
* Elevated serum liver enzymes
* History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
* Any acute disease at the moment of entry.
* Chronic alcohol consumption.
* Hepatomegaly, right upper quadrant abdominal pain or tenderness.
* Any chronic drug treatment, including any treatment with immunosuppressive drugs, which in the investigator's opinion, precludes inclusion into the study.
* History of allergic disease likely to be stimulated by any component of the vaccine.
* Simultaneous participation in any other clinical trial.
* Previous vaccination with a hepatitis B vaccine.
* Previous vaccination with an MPL containing vaccine.
* Administration of immunoglobulins in the past 6 months and during the whole study period
* Vaccination one month before and one month after each dose of the study vaccine
Effects of Low Protein Diet in Preventing the Progression of Chronic Kidney Disease(CKD)---a Prospective Study

The purpose of this study is to determine whether low protein diet and very low protein diet supplemented keto-/amino acid is effective in preventing the progression of chronic kidney disease (CKD , stage 2 to 5).

Dietary protein restriction represents a basic therapeutic approach in chronic kidney disease(CKD), by reducing the accumulation of nitrogen catabolic substances, and by delaying the progress of CKD and proteinuria, but the effects of the low protein diet on renal failure progression rate remain to be determined.The aim of this study is to evaluate the efficacy of low protein diet and α-keto acid tablet in retard the progress of CKD. This is a prospective study, 100 patients who meet inclusion and exclusion criteria will be included. The changes of glomerular filtration rate in CKD and time to renal replacement will be evaluated after 1 year treatment.

Eligibility Criteria:
Inclusion Criteria: Patients with chronic kidney disease in stage 2 to 5 (GFR\<60 ml/min/1.73m2) receiving conservative treatment for CKD

Exclusion Criteria: None
The Hemodynamic Response to Prolonged Dobutamine Infusion

A decrease in the response of beta 1 adrenergic receptors to agonists (desensitization) is thought to play a major role in the pathogenesis of diseases such as congestive heart failure. However, currently, there is no in vivo model that will enable us to measure desensitization of the hemodynamic responses to beta 1 adrenergic receptors in vivo.

Our hypothesis is that constant 3 hours intravenous infusion of the selective beta1 adrenergic receptor agonist dobutamine will result in gradual decline in hemodynamic responses to dobutamine over time.


Eligibility Criteria:
Inclusion Criteria:

* healthy subjects

Exclusion Criteria:

* consumption of any medications during the 2 weeks prior to the study
* history of chest pain or tachycardia
Combination of Gonadotropin-releasing Hormone Agonist and Human Chorionic Gonadotropin Triggered by Normal Responder in GnRH-antagonist Cycles

Background

The trigger for the final maturation of the ovum by providing integration of Human Chorionic Gonadotropin (hCG) and Gonadotropin - releasing hormone (GnRH) agonist was first introduced long ago, but clinically not accepted until the advent of GnRH antagonist protocol in IVF treatment.

In a recently published work which compared two types of ovulation induction (standard dose of hcg and in combination of GnRH agonist) in women with normal ovarian response, there was a statistically significant increase in the rates of implantation, clinical pregnancies and live births rates by providing integration of hCG and GnRH agonist.

To conclude, providing GnRH agonist in combination of hCF in standard dose is today an accepted treatment for final maturation of the ovums.

OBJECTIVE

The investigators objective is to investigate whether providing integrated treatment of Gonadotropin - releasing hormone (GnRH) Agonist and human Chorionic Gonadotropin (hCG) to final maturation of the ovum can improve the quality of the embryos, clinical pregnancies and live births rates in women treated with GnRH Antagonist protocol.

The main objective is to compare between two existing treatments.

Background

The trigger for the final maturation of the ovum by providing integration of Human Chorionic Gonadotropin (hCG) and Gonadotropin - releasing hormone (GnRH) agonist was first introduced long ago, but clinically not accepted until the advent of GnRH antagonist protocol in IVF treatment.

In order to prevent Ovarian Hyperstimulation Syndrome in the treatment cycles with GnRH antagonist protocol, it is possible to make the final maturation of the ovums by providing GnRH agonist.

In a recently published work which compared two types of ovulation induction (standard dose of hcg and in combination of GnRH agonist) in women with normal ovarian response, there was a statistically significant increase in the rates of implantation, clinical pregnancies and live births rates by providing integration of hCG and GnRH agonist.

To conclude, providing GnRH agonist in combination of hCF in standard dose is today an accepted treatment for final maturation of the ovums.

OBJECTIVE

The investigators objective is to investigate whether providing integrated treatment of Gonadotropin - releasing hormone (GnRH) Agonist and human Chorionic Gonadotropin (hCG) to final maturation of the ovum can improve the quality of the embryos, clinical pregnancies and live births rates in women treated with GnRH Antagonist protocol.

The main objective is to compare between two existing treatments.

PATIENTS \& METHODS

Women treated through IVF by protocol Gnarl - Antagonist

Eligibility Criteria:
Inclusion Criteria:

* Women who are going through IVF by protocol GnRH - Antagonist

Exclusion Criteria:

* Women with Ovarian Hyperstimulation Syndrome
Clinical Trial of a Therapeutic Vaccine With NY-ESO-1 in Combination With the Adjuvant Monophosphoryl Lipid A (MPLA)

This study is a clinical trial phase I/II. Its goal is to determine the safety, tolerability, immunogenicity and efficacy of a therapeutic vaccine with the tumor antigen NY-ESO-1 combined with the adjuvant MPLA from B. pertussis in cancer patients.

The safety and immunogenicity of the vaccine with the antigen NY-ESO-1 in combination with the MPLA will be evaluated in a phase 1 clinical trial conducted in patients with malignancies that express the antigen (lung, ovarian and melanoma). This study will involve 15 patients, who will receive 250 mcg of NY-ESO-1 and 100 mcg of MPLA.

Eligibility Criteria:
Inclusion Criteria:

* In this study, will be included fifteen patients aged over 18 years, with a confirmed diagnosis of malignant neoplasms, which have proven NY-ESO-1 expression by immunohistochemistry and have undergone the standard treatment.

Exclusion Criteria:

* Will be excluded from the study patients with continuous use of systemic steroids, immunosuppressive agents and antibiotics, and with severe chronic systemic disease.
Bevacizumab in Combination With Temozolomide in Patients With Neuroendocrine Tumors

The purpose of this study is to determine what effects (good and bad) bevacizumab and temozolomide have on patients with neuroendocrine tumors.

Patients will receive temozolomide orally once daily for one week, followed by a one-week rest period. This one-week on/one week off schedule will continue for the duration of treatment unless significant side effects develop.

Bevacizumab will be administered intravenously every other week. After eight weeks (two cycles), a CT scan will be performed to see how treatment affected tumor growth.

Bactrim, an antibiotic, and acyclovir, an antiviral medicine, will be given in order to help prevent infection.

Blood tests will be done every other week to evaluate any side effects.

Once the study has been completed, a physical exam, vital signs, blood tests, and CT scan will be performed.

Patients will remain on the study as long as they continue to receive benefit from the treatment and there are no serious side effects.

Eligibility Criteria:
Inclusion Criteria:

* Histologically documented locally unresectable or metastatic neuroendocrine tumor excluding small cell carcinoma
* Measurable disease \> 1cm by spiral computed tomography (CT) or \> 2cm by other radiographic technique
* ECOG performance status of 0-2
* Life expectancy of \> 12 weeks
* Prior treatment with chemotherapy is allowed
* Total bilirubin \< 2.0mg/dl
* AST \< 5x upper limit of normal (ULN)
* Serum creatinine \< 2.0mg/dl
* Absolute neutrophil count \> 1,000/mm3
* Platelets \> 100,000/mm3
* International Normalized Ratio (INR) \< 1.5

Exclusion Criteria:

* Prior treatment with temozolomide, decarbazine or bevacizumab
* Clinically apparent central nervous system metastases or carcinomatous meningitis
* Clinically significant cardiovascular disease
* Major surgery, open biopsy, or significant traumatic injury within 28 days
* Pregnant or breast-feeding women
* Chronic, daily treatment with aspirin or nonsteroidal anti-inflammatory medication
* Serious, nonhealing wound, ulcer or bone fracture
* Evidence of bleeding diathesis or coagulopathy
* History of other disease or metabolic dysfunction
Electrophysiological Activity of the Anorectum in Children Suspected of Hirschsprung Disease

Children with chronic constipation, suspected of having hirschsprungs disease, who are admitted for rectal biopsy will be included in the study. During the procedure, electrophysiological reading from the site chosen for biopsy will be done. Correlation between electrophysiological data and histopathology will be analyzed.

Hirschsprungs disease is found in 1:5000 newborns, the disease is caused by aganglionosis of the colon, leading to severe constipation and possible bowel obstruction. The diagnosis is based on leveling biopsies taken from the rectum and colon. Treatment is supportive if complications had arisen, and surgical for definitive correction of the pathophysiological condition which is the cause of the disease. Currently, clinicians rely on histopathology, for diagnosing the disease, and planning surgical correction. The main goal of Surgical treatment will be the creation of a continuous patent and innervated bowel, in which effective propulsive peristalsis is taking place. This is achieved by resection of aganglionic colon, and anastomosis of normal colon with normal ganglia, to anus. Today surgeons await histopathology report for the diagnosis of Hirschsprungs disease, and frozen section biopsies taken when in surgery to ascertain the level of ganglionated bowel.

In this study the investigators aim to correlate electrophysiological reading, from colon suspected of Hirschsprungs disease. If correlation is found, or a specific pattern which is diagnostic of the disease may be found, the electrophysiological study may offer a new way of diagnosing the disease, which is not invasive and allows prompt diagnosis in contrast to histopathology which is time consuming. A reliable electrophysiological study for Hirschsprungs disease may be helpful in early and correct diagnosis, with a noninvasive procedure as compared to a biopsy of the colonic wall. Children with chronic constipation, suspected of having hirschsprungs disease, who are admitted for rectal biopsy will be included in the study. During the procedure, electrophysiological reading from the site chosen for biopsy will be done. Correlation between electrophysiological data and histopathology will be analyzed. The actual reading will be carried out by a custom made electrode by GAELTEC DEVICES LTD : DUNVEGAN : ISLE OF SKYE : SCOTLAND.

Eligibility Criteria:
Inclusion Criteria:

* Patient admitted for rectal biopsy, by clinical decision, so that Hirschsprungs disease may be diagnosed or ruled out

Exclusion Criteria:

None

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A Study of CBT-1 and Paclitaxel With Carboplatin in Patients With Advanced Inoperable Non-small Cell Lung Cancer

Multiple Drug Resistance is the phenomena whereby cells become resistant to a variety of drugs with different mechanisms of action. Drug resistance remains a significant impediment to successful cancer chemotherapy inhibitors have been developed and are currently in clinical trials. CBT-1 is a natural product currently in clinical trials as an inhibitor

Lung cancer has the highest incidence and prevalence among cancers in the world and remains the leading cause of cancer-related deaths in Western countries. One-year survival of patients with best supportive care remains low. Non-small-cell lung cancer accounts for almost 85% of all lung cancer cases. Approximately 70% of patients have locally advanced or metastatic disease at presentation and are not candidates for surgery.

Eligibility Criteria:
Inclusion Criteria:

* histological confirmed diagnosis of NSCLC
* advanced inoperable NSCLC
* have adequate renal function, serum creatinine \<2.0 mg/dL or 24 hour creatinine clearance \> 50mL/minute
* have adequate liver function defined as SGOT \<4 times the upper limit of normal (ULN) and bilirubin \<2.0 mg/dL
* have calcium \<11.0 mg/dL and albumin \>2.0g/dL
* have adequate bone marrow reserve defined as granulocyte count \>1,500/mm3, hemoglobin \>10.0 g/dL and platelets \>100,000/mm3
* if female and of child-bearing potential, agree to use one of the following methods of birth control: oral contraceptives, barrier with spermicide, intrauterine progesterone contraceptive system, levonorgestrel implant, medroxyprogesterone acetate contraceptive injection, complete abstinence from sexual intercourse

Exclusion Criteria:

* have previously received taxanes, platinums, vinca alkaloids, anthracyclines, epipodophyllotoxins or CBT-1
* have known or suspected hypersensitivity to platinum containing compounds, taxanes, polyoxyethylated castor oil, or mannitol
* have significant central nervous system disease, including history of seizures within last 3 months or psychiatric history which would impair the ability to give informed consent or prevent compliance with protocol requirements
* be eligible for curative surgery or radiotherapy.
* must not have a diagnosis and/or treatment in the past 5 years of any malignancy other than NSCLC or basal cell carcinoma of the skin
* be pregnant or nursing
* have a history of significant coronary artery disease, cardiac arrhythmias requiring treatment, history of other cardiac disease or other cardiac anomalies determined by ECG which in the judgment of the investigator would compromise the patient's ability to tolerate the therapy
* have ongoing serious infections that require parenteral antibiotics
* have clinically significant bleeding disorders
* have solid organ allograft
* have significant intercurrent disease
* have bleeding peptic ulcer disease
* have participated in any experimental study within 2 months preceding enrollment
* be using a medication that could interact adversely with CBT-1, paclitaxel, or carboplatin. Medications include:aminoglycoside antibiotics, Prilosec, Losec, Zantac
Clinical Research on the Effect of Aspirin on the Disease Free Survival Rate of Esophageal Carcinoma

Esophageal cancers are the seventh most common cancer in the world and one of the most common causes of cancer deaths. In some parts of China, the incidence of SCC is among the highest in the world. Despite surgery and adjuvant radiotherapy, the prognosis for SCC patients was disappointing. There is therefore an urgent need for new prevention and treatment strategies.

Epidemiological investigations have found that about 25% of human tumors are associated with chronic inflammation caused by a variety of causes, and chronic inflammation activates nuclear transcription factors (nuclear Factor,NF), induces gene and epigenetic changes such as DNA methylation, tumor suppressor gene point mutations, and post-translational modification, and participates in the process of tumorigenesis. It has been noted that the long-term regularity of the use of non-steroidal anti-inflammatory drugs aspirin can reduce the incidence and mortality of a variety of tumors, including esophageal cancer.

Aspirin is the earliest, most extensive and common antipyretic analgesics and anti-rheumatism drugs used to play an anti-inflammatory role by inhibiting the synthesis of PGs. COX-2 is a key enzyme in the synthesis of PGs, so it is speculated that the anti-tumor effect of aspirin inhibits the PGs of COX and its inhibition.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients with malignant tumors after radical operation of esophageal squamous cell carcinoma without merging other parts; Pathological results are shown as all staging; Immunohistochemical staining showed positive COX-2 expression; Aspirin or other non-steroidal anti-inflammatory drugs have not been taken in the past; No abnormalities found in coagulation function; Between the ages of 18-70 and five, gender is not limited; Patient KPS≥90, expected survival period of more than 6 months; Patient Signs Informed Consent statement; Pregnant women with fertility must be negative in pregnancy trials.

Exclusion Criteria:

* Severe coagulation dysfunction; Severe liver, kidney and cardiac dysfunction; The lesion failed to completely remove; Active digestive tract Ulcers; Reflux esophageal disease; Allergies to aspirin or other drugs containing salicylic acid; History of asthma caused by salicylic acid salts or salicylate containing substances and non-steroidal anti-inflammatory drugs; COX-2 expression of immune tissue chemical staining weak or not expressed; Wide transfer of the whole body; Ever taken aspirin or other non-steroidal anti-inflammatory drugs; Pregnant and lactating women.
Effects of High-dose Coenzyme Q10 on Biomarkers of Oxidative Damage and Clinical Outcome in Parkinson Disease

The investigators hypothesise that measuring biomarkers of oxidative damage could better inform investigators on the potential merits (and pitfalls) of CoQ10 supplementation in PD subjects.

Subjects with idiopathic PD will be recruited to a 10-week dose escalation study. Each dosage (400mg/day, 800mg/day, 1200/day and 2400mg/day) will be consumed daily for two weeks. Information on safety and fasting blood/urine samples will be collected. Primary endpoint is plasma F2-isoprostanes (adjusted for arachidonate) while secondary endpoint is the change in the total Unified Parkinson Disease Rating Scale (UPDRS) before and after treatment. Serum phospholipase A2 activities, plasma all trans-retinol, plasma total tocopherol (sum of α-, δ- and γ-tocopherol) and serum uric acid will be measured.

Eligibility Criteria:
Inclusion Criteria:

* idiopathic Parkinson disease
* age \>21 years
* able to provide written informed consent

Exclusion Criteria:

* diabetes mellitus, stroke, cardiac and renal diseases and cigarette smoking
* major psychiatric disorder or drug and/or alcohol abuse/dependence
* regular use of antioxidants, dietary supplements, traditional Chinese remedies, non-steroidal anti-inflammatory drugs or immunosuppressive drugs