cyrilzakka/clinical-trials huggingface dataset:
Composite Graft Use in Abdominal Sacrocolpopexy Reduces Erosion Rates

This study is to determine whether the use of a composite biologic/synthetic graft during abdominal sacrocolpopexy leads to a lower rate of erosion while maintaining durability.

This study will examine the erosion rate of a composite graft that is being used during abdominal sacrocolpopexy. The composite graft is composed of a dual layer of biological and syntheric material. Biological grafts have the advantage of significantly reducing erosion rates, but the longevity of biologic graft is uncertain. On the other hand, synthetic grafts have the advantage in that they are durable, but have higher erosion rates through the vagina and require re-operation in a small percentage of patients. This study will look at whether or not the use of a composite greaft carries the advantages of both types of materials and leads to decreased rates of erosion while maintaining longevity. The cost effectiveness of this new type of graft will also be reviewed since the disavantage of utilizing both the synthetic and biologic graft is that it will increase the cost.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent abdominal sacrocolpopexy with Drs. Noblett and Lane from 2001 to present

Exclusion Criteria:

* None
Skeletal Muscle Energy Metabolism in Undernourished Patients With Gastrointestinal Cancer

Undernutrition associated with cancer, or cancer cachexia results from a deterioration of the energy balance that leads to a gradual mobilization of energy reserves in the body and to increasing deterioration of the nutritional status of patients. This will thus significantly reduce quality of life and survival of patients with a lower tolerance to cancer treatments. Despite undeniable progress in knowledge, many pathophysiological mechanisms remain few or not explored, which could explain that there is still no satisfactory therapeutic solution to halt the gradual deterioration of the nutritional status of patients. In this sense, apart from preclinical data obtained in animal models, there is currently no clinical study on the functioning of skeletal muscle energy metabolism in undernourished patients suffering of cancer.


Eligibility Criteria:
Case group selection criteria:

Inclusion Criteria:

* 18 years ≤ Age ≤ 80 years
* Colorectal pancreatic cancer
* Undernutrition related to cancer (weight loss \> 5% weight in one month or 10% in 6 months)
* Indication to systemic chemotherapy
* Indication to the development of an implantable port
* Life expectancy ≥ 3 months
* WHO General Status ≤ 2
* Patients affiliated to social security scheme
* Informed consent signed by the patient

Exclusion Criteria:

* Pregnant or breastfeeding women
* Unbalanced Diabetes
* Systemic corticosteroid treatment
* Any severe uncontrolled medical condition
* Alopecia

Control group selection criteria:

Inclusion Criteria:

* 18 years ≤ Age ≤ 80 years
* Colorectal pancreatic cancer
* Indication adjuvant chemotherapy
* Indication to the development of an implantable port
* Life expectancy ≥ 3 months
* WHO General Status ≤ 2
* Patients affiliated to social security scheme
* Informed consent signed by the patient

Exclusion Criteria:

* Pregnant or breastfeeding women
* Undernutrition related cancer (weight loss \> 5% weight in one month or 10% in 6 months)
* Unbalanced Diabetes
* Systemic corticosteroid treatment
* Any severe uncontrolled medical condition
* Alopecia
Predicting Burnout in Nurses

The purpose of this study is to develop a technology to predict burnout in RNs by measuring workplace, psychological, and physiological factors experienced by nurses.


Eligibility Criteria:
Inclusion Criteria:

* Employed as a registered nurse at Mayo Clinic Rochester or Mayo Clinic Florida.
* Primary work assignment is one of the following: medical-surgical units, operating and recovery rooms, emergency room, intensive/cardiac care units, or other special care units (including neonatal intensive care units and newborn nurseries).
* Proficient in written and spoken English.
* Able to provide written informed consent.

Exclusion Criteria:

- Any exception to above criteria.
National Registry of IRPF in China

The aim of this study is to establish a nation-wide cohort study of idiopathic retroperitoneal fibrosis (IRPF) in China.

Methods: All the patients fulfilling diagnostic criteria of IRPF would be enrolled from multi-centers around China. A online database system has been established.

Endpoints: The primary endpoint is to investigate the clinical manifestations of Chinese IRPF patients; the secondary endpoints including the demographic features,laboratory characteristics, immunological tests, imaging and pathological features, in addition, the treatment and prognosis of the disease.

This is a multicenter registry study of IRPF patients. Newly diagnosed IRPF patients will be recruited from all over the China. Inclusion criteria: patients with newly diagnosed IRPF will be recruited. Exclusion criteria: patients with secondary forms of retroperitoneal fibrosis or malignancy are excluded.

The data will be uploaded through the platform of Chinese Rheumatology Information Platform. Demographic data, initial symptoms, disease duration, history of allergy, and physical examination, organ involvements, laboratory findings, radiological and pathological results, as well as treatment, side effects will be recorded.

This study was approved by the Medical Ethics Committee of PUMCH (Beijing, China). All patients will sign informed consent.

Statistical Analysis: All parameters are described in the standard summary statistics, including mean, standard deviation, minimum, and maximum. All statistical analyses will be performed by SPSS.

Endpoints: The primary endpoint is to investigate the organ involvements of Chinese IRPF patients. The secondary endpoints include the demographic features,laboratory characteristics, immunological tests, imaging and pathological features, in addition, the treatment and prognosis of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Conforming to the diagnostic criteria of IRPF;Definite IRPF must have the following characteristics: (1) The typical finding of Imaging shows retroperitoneal mass, surrounding the abdominal aorta and iliac arteries, with encasement of ureters and/or organ dysfunction; (2) Exclusion of disease progression after standard glucocorticoid treatment; and (3) histopathological findings shows a ﬁbrous tissue with signs of chronic inﬂammation. The inﬂammatory component is comprised of lymphocytes, plasma cells and macrophages. Neutrophils and granulomas are rare ﬁndings. Possible IRPF required (1) and (2), but without histopathological examination.

Exclusion Criteria:

* None of them met the criteria for other autoimmune diseases. None had malignant disease. Secondary forms of RPF related to drugs, infections, malignancies, Erdheim-Chester disease and IgG4-RD, need to be excluded.
Antagonism of Opioid-Induced Respiratory Depression by CX1739 With Preservation of Opioid Analgesia

The study is an investigation to assess the capacity of ascending doses of CX1739 to antagonize the respiratory depressive effect of remifentanil. The study will also investigate whether ascending doses of CX1739 reduce the analgesic effect of remifentanil or alter the BIS measure of sedation and will evaluate the safety of CX1739 when used in conjunction with remifentanil.


Eligibility Criteria:
Inclusion Criteria:

* To be eligible for this trial, subjects must meet all of the following criteria:

  1. Males 18 to 50 years of age, inclusive
  2. Body mass index of 18.0 to 30.0 kg/m2, inclusive, using the formula: weight (kg)/height (m)2
  3. Healthy, as determined by medical history, physical examination including vital signs, and clinical laboratory test results
  4. American Society of Anesthesiologists Physical Status Classification 1
  5. Willing and able to provide voluntary, written informed consent

Exclusion Criteria:

* If a subject meets any of the following criteria, he cannot be enrolled in the study:

  1. History of any chronic illness or evidence of clinically significant organic or psychiatric disease on medical history or physical examination which, in the opinion of the principal investigator (PI), would confound the study results or present a risk to the subject
  2. Acute illness within 2 weeks before dosing
  3. History of any clinically significant pulmonary condition (eg, asthma) within the last 2 years requiring admission to the hospital
  4. Previous diagnosis of obstructive sleep apnea based on polysomnography
  5. Currently using any prescription medication or use within the last 30 days
  6. Laboratory values (clinical chemistry, hematology, urinalysis) outside the laboratory reference range considered clinically significant (NOTE: in the event of any parameter lying outside of the normal range, the sample may be repeated once; this value will be accepted if it lies within the normal range)
  7. Presence of QT interval corrected \> 440 msec on ECG
  8. Resting HR while awake \< 45 or \> 90 beats/minute
  9. History of daily use of tobacco or other nicotine-containing products within 1 year of study entry or positive cotinine test at screening and subsequent study visits
  10. History of allergic hypersensitivity to ampakines (CX717, CX1739), remifentanil, naloxone, or any component of these formulations; history of multiple drug allergies
  11. History or current evidence of abuse of any drug substance, licit or illicit, including alcohol; positive urine drug screen (UDS) for drugs of abuse at screening
  12. Inability to understand the protocol requirements; instructions; study-related restrictions; or nature, scope, and possible consequences of the study
  13. Unlikely to complete the study, eg, because of inability to return for follow-up visits
  14. Participation in another study with any investigational drug in the 3 months preceding this study
  15. Blood or plasma donation of more than 500 mL during the month before randomization and more than 50 mL in the 2 weeks before randomization
Effects of Upper Extremity-Focused Neuromuscular Training in People With Multiple Sclerosis

The effectiveness of upper extremity focused neuromuscular exercise training in early stage people with MS will be investigated. People with MS enrolled in the study will be randomly assigned to three groups: Neuromuscular Exercise Group (NEG), Conventional Exercise Group (CEG), and Control Group (CG). All three groups will be assessed with primary and secondary outcome measures at baseline, week 8, and week 12. NEG, CEG, and CG will be initially assessed for upper extremity function, cognitive function, lower extremity function, grip strength, proximal muscle strength, sensation, coordination, fatigue, postural sway, and core muscle strength and endurance. Then, NEG will receive clinically supervised upper extremity focused neuromuscular exercise training with a minimum of 60 minutes of session time, 2 days a week for 8 weeks. This exercise training includes steps for postural control, weight transfer, proximal and distal muscle strengthening, proprioception, coordination and reaction speed. Similarly, CEG will receive clinically supervised traditional upper extremity exercise training, twice a week for 8 weeks, with a minimum of 60 minutes of session time. This exercise training includes strengthening with the band and manuel dexterity exercises. In both groups, stretching and mobility exercises will be added to the warm-up and cool-down exercises before and after the program. During this process, CG will be on the waiting list. At the end of 8 weeks, all three groups will be re-evaluated. After the exercise training, follow-up will be done and evaluations will be repeated in the 12th week. This study will provide evidence on the effects of upper extremity-focused neuromuscular exercise training on physical and cognitive functions in early-stage people with MS compared to traditional treatment approaches.


Eligibility Criteria:
Inclusion Criteria:

* Definite MS according to McDonald criteria,
* 18-64 years
* RRMS,
* EDSS \< 4,
* Minimal or moderate upper extremity involvement

Exclusion Criteria:

* Having an attack in the last three months,
* Mini Mental Test \<24 or visual deficit,
* Other medical conditions accompanying MS (cardiac, orthopedic or rheumatic, etc.),
* Being pregnant or breastfeeding,
* Doing regular exercise - receiving physiotherapy,
* Having spasticity of 2 or more in the upper extremity
Effectiveness of a Valsartan Based Versus an Amlodipine Based Treatment Strategy in naïve Patients With Stage 1 or Stage 2 Hypertension or in Patients Uncontrolled on Current Monotherapy

The population for this current study will include stage 1 and stage 2 hypertensive patients who are newly diagnosed or didn't have treatment during the last 3 months and patients who are currently treated but uncontrolled on present monotherapy.

The purpose of this study is to evaluate the efficacy of a treatment with valsartan versus a treatment with amlodipine in reaching blood pressure control after 14 weeks of treatment.


Eligibility Criteria:
Inclusion criteria Stage/grade 1 or stage/ grade 2 hypertension, MSSBP ≥ 140 mm Hg, and/ or MSDBP ≥ 90 mm Hg, at Visit 1 and 2 in untreated patients Or Patients who are currently treated on monotherapy and uncontrolled and have a blood pressure ≤ 160/100 mm Hg at Visit 1 and Visit 2

Exclusion criteria Current treatment with a CCB MSSBP ≥ 180 mm Hg or MSDBP ≥ 110 mm Hg at any time between visit 1 and Visit 2 History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures Evidence of a secondary form of hypertension Cerebrovascular accident or myocardial infarction during the last 12 months, prior to Visit 1 Other protocol-defined inclusion/exclusion criteria may apply
Use of High-dose Radiation Therapy Plus Chemotherapy to Improve the Likelihood of Surgical Treatment in Patients With Locally Advanced Pancreatic Cancer

This study is being done to test whether receiving a dose of radiation that is higher than the standard dose, in combination with chemotherapy, improves the chance of becoming a candidate for surgery and improves the chance of extending the patient's life.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytopathologically confirmed adenocarcinoma of the pancreas.
* Locally advanced, unresectable pancreatic cancer defined on post-induction chemotherapy CT as having tumor involvement of \>180° (\> 50%) of the circumference of the superior mesenteric artery (SMA) or celiac axis, unreconstructable superior mesenteric vein (SMV) or PV involvement.
* No evidence of distant metastasis either prior to or after induction chemotherapy.
* Completion of at least 3 months of standard induction chemotherapy for LAPC, which may include FOLFIRINOX or gemcitabine and nab-paclitaxel, within 6 weeks of enrollment.
* For patients currently receiving investigational agents, a washout of at least 2 weeks or 5 half-lives of experimental agent are required prior to the start of RT.
* Age ≥18 years.
* KPS 70-100.
* Patients must have acceptable organ and marrow function as defined below:

  * Leukocytes \>3,000/µL
  * Absolute neutrophil count \>1,500/µL
  * Platelets \>75,000/µL
  * Total bilirubin Within 2 x upper limit of normal
  * AST (SGOT)/ALT (SGPT) \<2.5 x institutional upper limit of normal Creatinine Within 1.5 x upper limit of normal, OR Creatinine clearance \>60 mL/min for patients with creatinine levels above institutional normal
* Any systemic therapy associated toxicity should be Grade 1 or less
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Patients who have borderline resectable disease using NCCN definition.
* Patients who have had prior abdominal radiotherapy.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
* Patients who are not surgical candidates due to medical co-morbidities.
* Patients in whom iodine contrast is contraindicated.
* Pregnant and breastfeeding women are excluded. Women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and for up to 4 weeks after the study are excluded. This applies to any woman who has experienced menarche and who has not undergone successful surgical sterilization or is not postmenopausal (defined as amenorrhea for at least 12 consecutive months, or women on hormone replacement therapy with serum FSH levels greater than 35 mIU/mL. A negative serum pregnancy test must be obtained within 14 days prior to the start of study therapy in all women of child-bearing potential. Male subjects must also agree to use effective contraception for the same period as above.
Prevalence and Genetic Alternation of Autoimmune Polyglandular Syndrome Type II in Taiwan

Autoimmune polyendocrine syndrome (APS) is an autoimmune disease involving at least two endocrine organ. It is classified into type I and type II diseases. Among them, APS type II is more common. It is diagnosed when two of the three following diseases are diagnosed in the same patient, including type 1 diabetes mellitus, autoimmune thyroid disease, and primary adrenal insufficiency. In this study, we will observe the epidemiology, clinical characteristics, and genetic variants of APS II in Taiwan.


Eligibility Criteria:
Inclusion Criteria:

* Patients visited NTUH during 2006-2021, and had at least two of the three diseases: type 1 DM, primary adrenal insufficiency, and autoimmune thyroid disease.

Exclusion Criteria:

* Patients aged less than 20 years old
Position at Birth,Placental Transfusion Volume and Cord Clamping

To compare the evolution of the infant's weight before delayed cord clamping (2 minutes after birth) as an indirect measure of the volume of placental transfusion in a group of healthy and fullterm newborns, placed at the level of the introitus versus another group placed on the abdomen of the mother.

Pilot study. Randomized controlled trial not blind, in one center. Informed consent will be obtained during pregnancy or admittance and previous to birth.

Hypothesis: Placing the infant on the maternal abdomen without cord clamping during the first 2 minutes after birth does not change significantly the transfusion volume as compared to infants whose cord is clamped after 2 minutes but who are placed at the level of the introitus

Term newborns by vaginal delivery and without complications with cord clamping at 2 minutes after birth. Weight differences will be evaluated when positioning the infant at the level of the introitus or on the maternal abdominal-thoracic level (at or over placental level).

Study subjects will be assigned to two groups, both with delayed clamping,according to a sequence of random numbers generated by computer. The assignment will be done through opaque, sealed, easy opening envelopes, opening the envelope at the moment the mother enters the delivery room. Both parents and obstetric group will be then informed about which group the infant will be assigned to.

In both groups: The newborn will be immediately placed on a scale, previously set at the level of the maternal introitus to record his/her weight.

Group 1: Clamping at level of introitus: The infant will be held by the neonatologist at introitus level,immediately after the initial weight Group 2: Clamping on Maternal Abdomen: The newborn will be placed on the abdomen of the mother immediately after the first weight measurement.

In both groups:A plastic clamp will be put at approximately 1cm from the cutaneous insertion of the umbilical cord at 120 seconds after birth and then a new Weight will be obteined after clamping.

Eligibility Criteria:
Inclusion Criteria:

* Term newborns, vigorous born by vaginal delivery, cephalic or vertex presentation.
* Signed informed consent.

Exclusion Criteria:

* History of Placenta previa,
* postpartum hemorrhage background, hemorrhage before 20- week- gestation.
* Multiple gestation. Background of IUGR prenatally diagnosed. Major congenital malformations diagnosed previous to delivery.
* Maternal diseases such as: eclampsia, Rh incompatibility, congestive cardiac failure.
* Extraction of blood sample for bank of umbilical cord stem cells.
* Elimination criteria: Need for immediate assistance of the newborn, Birth weight less than 2500 g, Nuchal cord wrapped too tight,
* Major congenital malformations not diagnosed during prenatal period,
* Delivery surgically finished
* Short umbilical cord which might prevent placing the infant in the assigned place .
Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir

The purpose of this study is to determine whether Peginterferon Lambda-1a (Lambda) combined with Ribavirin (RBV) and Telaprevir (TVR) is effective in the treatment of chronic Hepatitis C (CHC) compared to Peginterferon Alfa-2a (alfa-2a) combined with RBV and Telaprevir.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Chronic hepatitis C genotype 1. GT-1b Capped at 50 % of naïve subjects
* Naives to prior anti-HCV therapy \[Interferon (IFN) and direct antiviral agent (DAA) based\]
* Relapsers (defined as subjects who had undetectable HCV ribonucleic acid (RNA) on prior treatment regimen of alfa-2a/RBV and Hepatitis C Virus (HCV) RNA \> 25IU/mL after discontinuation of treatment). Capped at 20%
* HCV RNA ≥ 100,000 IU/mL
* Subjects with compensated cirrhosis can be enrolled and will be capped at approximately 10%
* Seronegative for human immunodeficiency virus (HIV) and hepatitis B surface antigen (HBsAg)
* Men or women, 18-70 years of age

Exclusion Criteria:

* Chronic liver disease due to causes other than chronic HCV
* Current or past evidence of decompensation
* Conditions that preclude the use of Alfa/RBV/TVR per respective labels
* Diagnosed or suspected hepatocellular carcinoma
Evaluating the Use of a Device Called Impulse Oscillometry in Participants With Vocal Cord Disorders or Asthma

This study will determine if airway resistance to airflow and pressure, measured by Impulse Oscillometry, is impacted in subjects with vocal cord disorders and whether these measurements are different when compared to subjects with asthma.


Eligibility Criteria:
Inclusion Criteria:

* Vaccinated against COVID-19 or testing negative for COVID-19 by viral PCT within 5 days before testing
* Willingness to perform breathing test
* Must be able to speak and understand English
* Documented diagnosis of asthma, documented clinical diagnosis of vocal cord dysfunction, or undergoing evaluation for vocal cord dysfunction

Exclusion Criteria:

* Unable to provide consent or perform oscillometry test