cyrilzakka/clinical-trials huggingface dataset:
41.8 Degree Centigrade Whole Body Hyperthermia for the Treatment of Rheumatoid Diseases

Recently a non-toxic system for whole body hyperthermia (WBH) used at the University of Wisconsin has been shown to induce soluble tumor necrosis factor-receptor (sTNF-R) I and II when patients are heated systemically to 41.8C for 60 minutes. This observation might provide a biological basis for the therapeutic application of WBH to rheumatoid diseases, for which there is a positive anecdotal clinical experience. Inherent in the hypothesis which is the basis for this protocol is the concept that the induction of TNF receptors by WBH may induce a remission in patients with active rheumatoid arthritis. Beyond clinical response the biological endpoint for this investigation includes cytokine levels, TNF levels, sTNF-R levels and changes in cellular TNF receptors.


Eligibility Criteria:
Inclusion Criteria:

* Patients are required to meet the criteria of the American College of Rheumatology (ACR)for rheumatoid arthritis.
* Patients should be in functional class II, or III according to the criteria of the ACR.
* All candidates must be unsuccessfully treated (lack of efficacy) with at least two of the following disease-modifying antirheumatic drugs: hydroxychloroquinine, oral or injectable gold, methotrexate, azathioprine, penicillamine, and sulfasalazine.
* Patients receiving nonsteroidal antiinflammatory drugs (NSAIDs), corticosteroids (\<= 10 mg per day), or both are eligible if the dosage has been stable for at least four weeks before treatment and remained so throughout the study and follow-up period (the use of narcotics for pain flares is allowed).
* The necessary degree of disease activity at enrollment should be confirmed by a finding of 10 or more swollen joints, 12 or more tender joints, and one of the following two criteria: a Westergren erythrocyte sedimentation rate of at least 28 mm per hour or a serum C-reactive protein level of more than 2.0 mg per deciliter; or morning stiffness for at least 60 minutes.
* Patients must have adequate bone marrow function, adequate liver function, adequate renal function, calcium and electrolytes.
* Patients must have a dobutamine stress ECHO, or exercise cardiac MUGA, or exercise ECHO scan prior to entry and must fulfill certain criteria to be eligible. The spirit of the criteria are to rule out organic heart disease.
* Respiratory status: Patients who have FEV1 of \>= 60% of predicted, as well as a maximum voluntary volume (MVV) of \>= 60% of predicted, and blood gases with a PO2 of \>= 60 or oxygen saturation of \>= 90% are eligible.
Effect of Yogurts Supplemented With Mobilee on Joint Function in Healthy Individuals With Joint Discomfort

The purpose of this study is to determine whether the daily eating of a yogurt supplemented with Mobile is effective in improving joint function and quality of life of individuals with low intensity gonalgia.

The prevalence of low intensity gonalgia is relatively high in western population. The purpose of the present intervention study is to determine whether the daily consumption of a yogurt supplemented with Mobile is effective in improving joint function and quality of life of individuals with low intensity gonalgia. Previous research using in vitro and animal models have demonstrated the efficacy of Mobilee in reducing inflammation and promoting anabolic responses in joint tissues. In addition, in two previous human intervention trials, the effects of Mobilee in joint function had been assessed using isokinetic tests. The present trial aims to confirm those previous results.

Eligibility Criteria:
Inclusion Criteria:

* Adult (between 20 and 70 years of age)
* Subject with low intensity knee gonalgia (VAS pain intensity between 3 and 5cm during at least the last 6 months)
* Healthy individual according to its medical records, physical and laboratorial parameters
* Positive informed consent

Exclusion Criteria:

* Individuals requiring acetaminophen or any other drug to control pain
* Active rheumatoid arthritis or any other inflammatory joint disease
* Oral treatment with corticosteroids 4 weeks before selection
* Intra-articular treatment with corticosteroids 3 months before selection
* Significant injury of the study joint 12 months before selection
* Individuals receiving any drug or supplement for osteoarthritis
* Individuals requiring any type of medical prescription to control pain
Predictive Model for Pain After TACE

The main aim of this study was to analyze the risk factors that helped to predict the pain after transarterial chemoembolization (TACE).This was a prospective observational study enrolled all hepatocellular carcinoma (HCC) patients undergoing TACE in our hospital. Pain score at rest was assessed after TACE by the patients themselves using a Visual Analogue Scale (VAS). Independent variables such as age, gender, tumor location, tumor size and number, drug delivery method and presence of portal vein tumor thrombosis (PVTT) were recorded and analyzed.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of HCC was confirmed either histologically or based on consistent findings obtained from at least two imaging techniques.

Exclusion Criteria:

* patients aged \< 18 year
* significant heart or lung dysfunction
* use of additional analgesics to relieve pain during TACE
* cognitive impairment
* use of psychiatric medications
* drug or alcohol abuse
Tacrolimus Plus Glucocorticoid for Severe Thrombocytopenia in SS

This 12-week randomized, open-label study evaluates the efficacy and safety of Tacrolimus combined with Glucocorticoid for Sjogren's syndrome patients with severe thrombocytopenia.

This study evaluates the efficacy and safety of Tacrolimus combined with Glucocorticoid for the treatment of severe thrombocytopenia in Sjogren's syndrome patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Sjogren's syndrome according to the 2002 revised American-European Consensus Group (AECG) criteria.
* Baseline platelet counts less than 30×109/L.

Exclusion Criteria:

* Concomitant other systemic autoimmune diseases.
* Other severe complications of Sjogren's syndrome.
* Abnormal laboratory tests such as: white blood cell count \<2.5x10\^9/L, hemoglobin \<80 g/L, AST/ALT \>1.5 ULN, serum creatine \> 1.5 mg/dL.
* Received glucocorticoids, immunosuppressants, or biological agents within 3 months.
* Active acute or chronic infections.
* History of malignancy.
* Pregnancy or breastfeeding.
Bupropion for the Prevention of Postpartum Smoking Relapse

This two-arm, double-blind, placebo-controlled randomized clinical trial will enroll pregnant women who quit smoking after learning they were pregnant and are motivated to stay abstinent postpartum. Participants will be randomized to receive extended-release bupropion (active 300mg or placebo once daily beginning 4 to 10 days postpartum to 12 weeks post-randomization). All participants will complete the same data collection procedures (e.g., biological sample collection for hormone and cotinine analysis and completion of validated questionnaires) at baseline (gestational week 36), weekly from 4 to 10 days postpartum through 12 weeks post-randomization and at weeks 12, 24, 36 and 52 post-randomization.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent
* Age 18 to 45 years old
* Stable health
* 7-day point prevalence abstinence demonstrated at randomization
* Lifetime history of at least 100 cigarettes smoked
* Quit smoking during the current pregnancy
* Self-report of intention to remain abstinent after delivery ≥ 7 on a 10 point Likert-type scale
* Uncomplicated delivery
* Denies plans to become pregnant again during the trial.
* Full-term delivery ≥ 37 weeks gestation
* Home within 10 days of delivery

Exclusion Criteria:

* Current use of other forms of tobacco or nicotine (e-cigs, chew, snuff, etc.)
* Current use of cessation aids (e.g., varenicline, NRT)
* Current use of illicit drugs or alcohol dependence
* Current use of antidepressant medication
* Bipolar disorder, eating disorder, or psychotic disorder based on the Structured Clinical Interview
* Medications \& conditions that may increase the risk of taking bupropion (e.g., current or history of pulmonary embolus, stroke, heart disease, kidney disease, glaucoma, diabetes, seizure disorder, traumatic head injury, use of medications metabolized by CYP2D6)
* Family history of seizures or seizure disorder
* Maternal use of medications that lower seizure threshold
* Newborn with an elevated risk of seizure
Homeopathic Treatment of Children Suffering From PFAPA

Periodic fever, aphthous stomatitis, pharyngitis, cervical adenitis (PFAPA) syndrome is frequently diagnosed in young children. Fevers recurring at a nearly predictable rate every three to eight weeks are the signature symptom of PFAPA syndrome. PFAPA is an acquired autoinflammatory disorder, which recurs in association with at least one sign of aphthous stomatitis, pharyngitis, and cervical lymph node enlargement. The aim of this retrospective case report is to gain an impression of the course of disease during individualized homeopathic treatment in children suffering from PFAPA.

In this retrospective study, the investigators collected the history and symptoms of 13 consecutive PFAPA patients. The investigators also described the individually chosen homeopathic medicinal products (HMPs) used, as well as the course of the disease. Clinical outcome of case reports was assessed using the "Modified Naranjo Criteria for Homeopathy-Causal Attribution Inventory". Eight points are taken as the threshold for the possible correlation between homeopathic therapy and improvement of symptoms or cure in chronic cases

Eligibility Criteria:
Inclusion Criteria:

Children suffering from fever with at least one of the symptooms of PFAPA besides fever

Exclusion Criteria:

Parents not willing to sign informed consent.
Assessment Study of the Effect of NMBA on Bowel Peristalsis

Phase III prospective randomised study : curare vs placebo, comparing bowel peristalsis (abdominal echography) in the first minutes of after general anesthesia induction.

Primary End Point: proportion of patients with a score of motion = 0

Primary End Point Proportion of patients with a score of motion = 0

Secondary End Point Time at which thumb adductor twitch measurement disappears (3rd consecutive measure with a twitch at 0) Mean minimal twitch measurement for those patients in who twitch measurement does not disappear Concordance study between twitch measurement and bowel peristalsis XML File Identifier: 1vUwHz2uUXeSc7soLu1cQwRAfcM= Page 15/24 ultrasound score.

Eligibility Criteria:
Inclusion Criteria:

* elective surgery
* scheduled oro tracheal intubation

Exclusion Criteria:

Counter indication to NMBA:

* predicted difficult airway
* surgical counter indication: facial or laryngeal nerve function monitoring
* allergy to muscle relaxants neuro muscular disease Possible alteration of sensitivity to muscle relaxants due to ongoing medication: ex Valproate or aminoglycoside antibiotics. Predictable alteration of bowel movements or difficult abdominal ultrasound:
* scheduled abdominal surgery
* abdominal surgery in last month
* obesity: body mass index over 30 Full stomach or pregnancy requiring suxamethonium for intubation
Effects of Early and Late Time-restricted Eating on Overweight Adults With Metabolic Syndrome

Investigators aim to compare the effects of early and late time-restricted feeding on overweight adults with metabolic syndrome


Eligibility Criteria:
Inclusion Criteria:

1. Age from 18 to 65 years
2. Body mass index (BMI): 24.0-40.0 kg/m2
3. Diagnosed with metabolic syndrome (i.e., more than 3 abnormal findings out of 5):

   1. Waist circumference ≥ 90 cm (men) or ≥ 80 cm (women).
   2. Elevated triglyceride (TG) (use of medications for elevated TG is an alternate indicator) ≥ 150 mg/dL (1.7 mmol/L).
   3. Reduced high-density lipoprotein cholesterol (HDL-c) (use of medications for reduced HDL-c is an alternate indicator) \< 40 mg/dL (1.0 mmol/L) in males \< 50 mg/dL (1.3 mmol/L) in females.
   4. Elevated blood pressure (use of hypoglycemic medications is an alternate indicator). Systolic blood pressure (SBP) ≥ 130 and/or diastolic blood pressure (DBP) ≥ 85 mmHg.
   5. Elevated fasting blood glucose (FBG) (used of hypoglycemic medications is an alternate indicator) ≥ 100 mg/dL (5.6 mmol/L).

Exclusion Criteria:

1. Unstable weight (change \> 10% current body weight) for 3 months prior to the study
2. Pregnant or breast-feeding
3. Night shift workers
4. History of major diseases or related diseases, such as cancer, inflammatory disease, chronic obstructive pulmonary disease and major adverse cardiovascular event
5. Active viral hepatitis, acquired immune deficiency syndrome, syphilis and other sexually transmitted diseases, tuberculosis and other infectious diseases
6. Being treated with antibiotics or corticosteroids
7. Current participate in other weight-management program, current on a prescribed diet for special disease or current on any drugs that effect appetite
8. The researcher deemed it inappropriate to participate in the experimenter.
Radiofrequency-assisted Transection of the Pancreas vs Stapler

Main objective: The main end-point of this study is to compare in a randomized clinical trial that radiofrequency-assisted pancreas transection (RF) reduces the incidence of postoperative pancreatic fistula (POPF) compared to the classical method of transection (stapler). As secondary end-points, other clinical and demographic variables of the patients will be evaluated (sex, age, ASA classification, consistency of the pancreas, as well as the type of procedure, open or laparoscopic surgery, estimated intraoperative bleeding, pancreatic duct size, duration of intervention, type of tumor and quality of lymphatic resection). Methodology: Phase III prospective multicenter study in patients undergoing distal pancreatectomy for any origin. All consecutive patients who undergo a distal pancreatectomy for any cause in a multicenter setting will be included. A simple randomization of the participants to the RFA group or to the control group (stapler) will be carried out. The incidence of pancreatic fistula will be assessed as main variable; predictive multivariable models with multiple regression for quantitative variables, logistic regression for categorical variables and Cox regression for survival analyzes. In addition to histological study, molecular analysis of resection specimen and clinical and radiological follow-up with volumetry of necrosis in the area of post-pancreatectomy transection will be performed.


Eligibility Criteria:
Inclusion Criteria:

* Solid or cystic, benign or malign pancreas neoplasms.
* Patients undergoing a distal pancreatectomy, i.e pancreas transection beyond \> 2 cm from the SMV (assessed by computer tomography or RM) with or without splenectomy
* Both open and laparoscopic approaches are valid.

Exclusion Criteria:

* Patients who required a pancreatectomy with transection at the level of the neck.
* Non-intervention group: only stapler transection will be accepted, other pancreatic transection methods will be excluded.
* Patients ASA≥IV
* Absence of informed consent
* Underage (\<18 years)
Discovering Cancer Risks From Environmental Contaminants and Maternal/Child Health

The DREAM Cohort is a longitudinal observational study developed to enhance our understanding of how multiple exposures to environmental chemicals and pollutants across a diverse population of pregnant women and their offspring are linked to cancer risks. Because pregnancy induces multiple maternal hormonal and physiological changes that can increase cancer susceptibility to environmental chemical exposures, this study will focus on pregnancy as a period of particular vulnerability to toxic agents.

The environmental exposures will focus on two major components: Consumer product related chemicals (including per- and polyfluoroalkyl substances (PFAS), phthalates and plasticizers, phenolic compounds, pesticides, and aromatic amines) measured via biomonitoring and prioritized based on widespread public exposure; and environmental pollutants in air and water, evaluated via geographic information system analyses of participants' residential histories.

The study team will collect questionnaire data and biospecimen samples starting at the second trimester of pregnancy up until the child reaches four years of age. A Cohort Ambassador Program will also be established to invite participants across our three sites to provide continuous feedback which will be integrated into the research priorities.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women, over the age of 18 years.
* English or Spanish-speaking.
* Children born of participants enrolled during pregnancy will be enrolled in the DREAM cohort.
* Inclusion criterion for the DREAM Cohort Ambassador Program is limited to research participants in the DREAM Cohort.

Exclusion Criteria:

* Women under the age of 18.
* Women expecting the birth of multiples (twins, triplets, etc.).
Oxaliplatin - Induced Peripheral Neuropathy in Patients With Gastrointestinal Tract Cancer

This study will examine DNA from Gastrointestinal Tract of cancer patients treated with oxaliplatin to look for a variation (mutation) of the ABCG2 gene that may lead to drug-induced peripheral neuropathy in certain patients.

The DNA will be extracted from patients' blood samples and are analyzed for the ABCG2 single nucleotide polymorphism (G34A - rs2231137 and A/A -rs3114018 genotypes) and correlated with peripheral neuropathy grades.

Pharmacogenetic analysis/genotyping :

Genotyping is conducted via High Resolution Melting (HRM) TECHNIQUE, To confirm the genotyping results, the Polymerase chain reaction (PCR) product of the samples will be examine via direct sequencing using 3500 Genetic analyzer from ThermoFisher (applied biosystem) at two ABCG2 loci using the following PCR primers:

1-ABCG2 G34A - rs2231137

Forward :

5'-TGC AAT CTC ATT TAT CTG GAC TA-'3

Reverse :

5'-AAT GCC TTC AGG TCA TTG GA-'3

-Annealing temp :57 -Product size : 163

2- ABCG2 A/A - rs3114018

Forward :

5'- TGATGTTCCTTCAGCCACTG-'3

Reverse :

5'-TTGTGGAAACCTCACAAAAGTG-'3

- Annealing temp : 59 - Product size : 124

Eligibility Criteria:
Inclusion Criteria:

* Gastrointestinal Tract Cancer patients treated with Oxaliplatin-containing chemotherapy
* Measurable disease
* Age of 18 years to 80 years

Exclusion Criteria:

* Pregnant women
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Oxaliplatin.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Neurologic disease or patients with disease impairing the neurologic function affecting
Pharmacokinetics of RLX030 in Subjects With Mild, Moderate and Severe Hepatic Impairment Compared to Healthy Subjects

This study will assess the pharmacokinetics of RLX030 during and after administration in subjects with mild to severe hepatic impairment and matched healthy control subjects.

20 to 24 patients and 20 to 24 healthy subjects will be enrolled.


Eligibility Criteria:
Inclusion criteria:

* All subjects:

  • Female subjects must be of non-child bearing potential OR use an effective method of contraception and sexually active males must use a condom during intercourse while taking the drug and for 5 half-lives after stopping treatment
* Subjects with hepatic impairment:

  * Subjects must have either mild, moderate or severe hepatic impairment

Exclusion criteria:

* All subjects

  * Hepatic impairment due to non-liver disease
  * Use of other investigational drugs at time of enrollment
  * History of malignancy of any organ system
  * Donation or loss of 400 mL or more of blood or plasma within 8 weeks prior to initial dosing
  * Hemoglobin levels below 10.0 g/dL at screening or baseline
* Subjects with hepatic impairment:

  * Presence of any non-controlled and clinically significant disease that could affect the study outcome or that would place the patient at undue risk
  * Treatment with any cytostatic drug, vasodilator, autonomic alpha blocker or B2 agonist
  * Any surgical or medical condition other than hepatic impairment which might significantly alter the distribution or excretion of drugs

Other protocol-defined inclusion/exclusion criteria may apply.
Regional Anesthesia in Colon Rectal Surgery

This study will compare recurrence rates in patients with colorectal cancer who will be randomly assigned to epidural anesthesia/analgesia combined with general anesthesia or to general anesthesia followed by opioid analgesia.

The study population will consist of patients who are scheduled for open laparoscopic or laparoscopic assisted surgery for colon cancer. Patients will randomized into one of two groups. The intervention group will receive combined regional and general anesthesia during surgery. Postoperative pain treatment will be based on regional anesthesia techniques. The Control group will receive general anesthesia during surgery. Postoperative pain treatment will be based primarily on opioids. After surgery, patients will be followed daily during their hospital stay. Patients will be contacted by telephone every 6 months for five years. Quality of life questionnaires will be administered at these follow ups.

Eligibility Criteria:
Inclusion Criteria:

* Primary colon cancer without known extension beyond colon (T3, N0, M0)
* Scheduled for open, laparoscopic assisted and laparoscopic resection of the colon.
* Written informed consent, including willingness to be randomized to epidural anesthesia/analgesia or to sevoflurane general anesthesia and postoperative opioid analgesia.

Exclusion Criteria:

* Previous surgery for colon cancer;
* Any contraindication to epidural anesthesia or analgesia (including coagulopathy, abnormal anatomy);
* Any contraindication to midazolam, propofol, sevoflurane, fentanyl, or morphine;
* Age \<18 or \>85 years old;
* ASA Physical Status ≥4;
* Other cancer not believed by the attending surgeon to be in long-term remission;
* Systemic disease believed by the attending surgeon or anesthesiologist to present ≥25% two-year mortality.