cyrilzakka/clinical-trials huggingface dataset:
A Study of Chemo +/- Low-dose Radiation as Induction Therapy in SCCHN

The primary hypothesis of this study is that hyper-radiosensitivity (HRS) seen at extremely low doses of radiation can be exploited to enhance the effect of chemotherapy, and that this effect differs from the cellular effect of higher, standard fractions of radiation used in traditional radiation treatment paradigms.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed locally advanced head and neck cancer of squamous type stage III, IVA and IV B and select Stage II tumors of the BOT who are appropriate for potentially curative therapy with chemoradiotherapy.
* Measurable disease.
* ECOG performance status of 0, 1 or 2
* No prior chemotherapy for the current locally advanced SCCHN.
* Age ≥18 years.
* Life expectancy of greater than 3 months
* Normal organ and marrow function measured within 14 days of registration as defined below:

  * absolute neutrophil count ≥ 1,000/mcL
  * platelets ≥ 100,000/mcL
  * total bilirubin \< institutional upper limit of normal
  * AST(SGOT ≤ 2.5 × institutional upper limit of normal
  * Alkaline phosphatase ≤ 2.5 × institutional upper limit of normal
  * creatinine within normal institutional limits
* OR

  o Creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, throughout the duration of active treatment and for 4 months after completion of chemotherapy and radiation. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of active study treatment, and for 4 months after completion of chemotherapy and radiation (both induction and definitive) administration.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Prior chemotherapy for SCCHN
* Patients who are receiving any other investigational agents.
* Patients with known brain metastases
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Carboplatin or Docetaxel.
* 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.
* Pregnant women
* HIV-positive patients on combination antiretroviral therapy
* Other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated previous Stage I or II cancer from which the patient is currently in complete remission or other cancer from which the patient has been disease-free for 3 years.
* Patients with nasopharynx or salivary gland primary site
* Patients with distant metastatic disease (M1c)
* Patients with grade II or greater peripheral neuropathy
Comparison of Laryngeal Mask Airway (LMA®) and Tracheal Tube in Modified Radical Mastectomy on Breast Cancer

Airway management in anesthesia is critical to guarantee appropriate treatment of possible respiratory complications and successful operative practice. LMA® is an alternative to tracheal tube in some surgeries like as mastectomy on breast cancer. Given no need using muscular relaxants in mastectomy, the investigators hypothesized that LMA® would be a superior manner in airway management in radical modified mastectomy on breast cancer than the tracheal tube, and the LMA® might produce less influence on patients' circulatory homeostasis, and easier to be placed before operation.


Eligibility Criteria:
Inclusion Criteria:

* Chinese
* Diagnosed breast cancer
* Undergoing modified radical mastectomy
* Agreed to participate the study with informed contract.

Exclusion Criteria:

* Organic dysfunction
* Long-lasting post-anesthetic care unit(PACU) staying.
A Study to Assess the Safety, Tolerability, and Efficacy of IONIS-GHR-LRx Administered in Patients With Acromegaly

The purpose of this study was to determine the safety, tolerability, and efficacy of IONIS-GHR-LRx subcutaneous (SC) injection as monotherapy in patients with acromegaly.

This was a multi-center, open-label, randomized, Phase 2 study of IONIS-GHR-LRx in up to 40 participants with acromegaly. Participants were randomized to 1 of 2 treatment groups to receive IONIS GHR-LRx monthly for 73 weeks. At the end of 73 weeks, participants entered a 14-week post-treatment (PT) evaluation period.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females with a documented diagnosis of Acromegaly\* who are 18 to 75 years old (inclusive) at the time of informed consent.
2. Have had pituitary surgery (e.g. transsphenoidal) unless there was a contraindication to surgery and are either acromegaly medical treatment naïve, or who had not taken any other acromegaly medications prior to the screening visit as outlined below

   * bromocriptine: 2 weeks
   * cabergoline: 4 weeks
   * quinagolide: 4 weeks
   * octreotide daily injection (SC) or oral formulation: 4 weeks
   * pegvisomant: 4 weeks
   * octreotide LAR: 3 months
   * pasireotide LAR: 4 months
   * lanreotide (all formulations): 3 months
3. At Screening, serum IGF-1 (performed at the central lab) between 1.3 to 5 × ULN, inclusive, adjusted for age and sex.
4. Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, abstinent, or using 1 highly effective method of birth control

Exclusion Criteria:

1. Participants who received surgery for pituitary adenoma within the last 3 months before the trial, and/or planning to receive surgery during the trial
2. Participants who received radiotherapy for pituitary adenoma within the last 2 years before the trial, and/or planning to receive radiotherapy during the trial
3. Participants with a pituitary tumor that, per Investigator judgment, is worsening (e.g., either growing or at risk of compressing or abutting the optic chiasm or other vital structures) as assessed by pituitary/sellar MRI protocol at Screening or within 3 months of Screening. CT scan is allowed if MRI is contraindicated
4. Evidence of decompensated cardiac function per medical judgement and/or New York Heart Association (NYHA) Class 3 or 4
5. Clinical evidence of symptomatic hyperprolactinemia that would necessitate treatment
6. Symptomatic cholelithiasis, and/or choledocholithiasis
Intravenous Ferric Carboxymaltose vs. Oral Iron Substitution in Patients With Metastatic Colorectal Cancer (CRC) and Iron Deficiency Anemia: a Randomized Multicenter Treatment Optimization Study.

Iron deficiency has a high prevalence in colorectal cancer patients ranging at ca. 60%. About 70% of these patients suffer from iron deficiency anemia (IDA) which adds both physical and cognitive impediments to an already straining chemotherapy. Moreover, a chronic disease like cancer often results in a reduced availability of iron for the body. In clinical practice iron substitution is usually administered orally. Due to low resorption rates, frequent gastric side effects and thus poor patient compliance a parenteral substitution seems to be a better option in terms of efficacy. In the framework of a randomized multicenter clinical trial ('FerInject') a comparison of efficacy parameters of parenteral vs. oral iron substitution will now be conducted in order to identify the best treatment form for clinical practice in oncology. Furthermore detailed quality of life-data (QoL) will be collected in both treatment arms for effect comparison.


Eligibility Criteria:
Inclusion Criteria:

1. Metastatic or inoperable colorectal carcinoma. No curative therapy available.
2. Current palliative chemotherapy. Patients under conversion therapy must not be enrolled to this study.
3. Iron deficiency anemia: hemoglobin ≤ 10.5 g/dl and transferrin saturation \< 20 % and/or serum ferritin \< 20 ng/ml
4. Male and female patients aged ≥ 18 years; maturity
5. ECOG ≤ 2
6. Written informed consent
7. Life expectancy \> 6 months
8. Body weight ≥ 40 kg

Exclusion Criteria:

1. Oral or intravenous iron substitution within the last 4 weeks
2. Age \< 18 years or body weight \< 40 kg
3. Absorption dysfunction due to short bowel syndrome or after gastric resection
4. Therapy with recombinant erythropoietin within the last 4 weeks
5. Chronic diarrhea
6. Chronic inflammatory bowel disease
7. Ferritin \> 800 mg/dl at baseline
8. Hypersensitivity or contraindication to ferric carboxymaltose or iron (II) glycine sulphate complex
9. Known vitamin B12 or folic acid anemia
10. Necessary total parenteral nutrition
11. Participation in another interventional study
12. Pregnancy or lactation
Translating 3-Step Workout for Life in a Local Senior Living Community

The study evaluates the feasibility of a staff-lead workout program, 3-Step Workout for Life, in a local senior living community. Eligible participants will complete assessments before and after the workout program.

The 3-Step Workout for Life program is designed to help older adults improve muscle strength and apply the improved muscle strength to perform activities of daily living. The 10-week workout consists of single-joint resistance exercise, multiple-joint resistance exercise, and activities of daily living exercise. Participants will exercise in small groups in a community room as well as one-on-one with the fitness staff in their home. The community fitness staff will learn the 3-Step Workout for Life program from the University partner and deliver the program.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 60 years old and above
2. Residents of the local study community
3. Communicable in English
4. Took more than 16 seconds to complete five chair stands with arms crossed at the chest.
5. Self-reported difficulty in performing one or more activities of daily living, which must include difficulty in feeding/eating, dressing, grooming/personal hygiene, bathing/showering, using the toilet, or functional mobility/transfer.

Exclusion Criteria:

1. Aged above 90 years old.
2. Unwilling to commit to the study program 3 sessions per week for 10 weeks.
3. Plan to move away from the current community in 6 months.
4. Having three or more errors on a six-item cognitive impairment screener.
5. Having any terminal illness, cardiovascular, neurological, psychiatric, orthopedic, or cognitive impairments that are contraindications to participating in an exercise program.
6. The difficulty of performing activities of daily living is due to neurological disorders (e.g., stroke, Parkinson's), orthopedic conditions (e.g, amputees), or sensory deficits (diabetic palsy, low vision).
7. Physician's recommendation of no moderate physical exercise.
8. Receiving home health rehabilitation therapy or exercise at moderate intensity for more than twice a week (last more than 20 minutes each time).
Variable Rate Phenylephrine Infusion for Prevention of Spinal-induced Hypotension for Cesarean Delivery

Rapid administration of crystalloid immediately after induction of spinal anesthesia (coload) to be more effective in terms of managing hypotension as compared to administering crystalloid before spinal anesthesia (preload).

Phenylehrine infusion is a safe and effective way to reduce incidence and frequency of hypotension during SA for cesarean delivery. Hypotension was virtually eliminated by use of high-dose prophylactic phenylephrine infusion at a rate of 100 µg/min and rapid crystalloid coload up to two liters (administration at the time of SA). However, incidence of reactive hypertension was frequent up to 47% with decrease in maternal heart rate (HR). This may raise concern in patients in whom increase of blood pressure may be detrimental, like chronic hypertension and in the presence of a compromised uteroplacental blood flow. A recent study found that infusing phenylephrine at a fixed rate of 75 and 100 ug/min is associated with more episodes of hypertension than placebo or the lower infusion rates of 25 and 50 ug/min respectively. However, there was no reduction in the number of physician interventions (phenylephrine boluses and stopping the infusion) needed to maintain maternal systolic blood pressure within 20% of baseline among all groups. Prophylactic fixed rate infusions may have limited application in clinical practice, and a variable rate (i.e. modifying the rate according to hemodynamics) has been advocated. The bolus administration of phenylephrine to treat hypotension is still commonly used, but requests multiple interventions from the anesthesiologists and is time consuming.

Eighty patients scheduled for cesarean delivery under spinal anesthesia will be assigned to one of two groups. Immediately after spinal injection, rapid crystalloid colaod of lactated Ringer of 15 mL/kg over a period of 10-15 min will be initiated. Patients in Group I will receive infusion of normal saline (placebo) and patients in group II variable infusion rate of phenylephrine started at 0.75 ug/kg (close to the dose of 50 ug/min recommended for fixed infusion rate). The number of interventions needed to maintain maternal systolic blood pressure within 20% of baseline, hemodynamic performance, intraoperative nausea and vomiting, and umbilical cord blood gases will be compared between the two groups.

We will define a reliable and safe method to ensure maternal hemodynamic stability during spinal anesthesia for cesarean delivery with the least physician interference.


Eligibility Criteria:
Inclusion Criteria:

* Parturients beyond 37 weeks gestation
* ASA І or ІІ

Exclusion Criteria:

* pregnancy-induced hypertension
* chronic hypertension
* multiple pregnancy
* fetal compromise
* diabetes mellitus
* polyhydramnios
* body weight \>100 kg
* major systemic disease
* anemia (hemoglobin concentration\<10 g/dl)
* clotting diathesis
Electrical Stimulation for the Treatment of Post-Amputation Pain Using the SPRINT System

The purpose of this study is to determine if electrical stimulation (small levels of electricity) can safely and effectively reduce post-amputation pain. This study involves a device called the SPRINT System. The SPRINT System delivers mild electrical stimulation to nerves in the residual limb. The SPRINT System includes a small wire (called a "lead") that is placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Stimulator).


Eligibility Criteria:
Key Inclusion Criteria:

* At least 18 years old
* Traumatic lower extremity amputation(s)
* Healed amputation and healthy residual limb based upon the investigator's evaluation

Key Exclusion Criteria:

* Change of prescribed medications affecting pain within the past 4 weeks
* Compromised immune system based on medical history
* Implanted electronic device
* Bleeding disorder
* History of valvular heart disease
* Confounding central nervous system injuries and disorders
* History of recurrent skin infections
Mindfully Optimizing Delivery of End-of-Life Care

The study evaluates the feasibility, acceptability, and preliminary efficacy of a mindfulness meditation-based intervention designed to provide a synergistic solution to the avoidant coping that often inhibits advance care planning discussions that are crucial to quality end-of-life care.


Eligibility Criteria:
Inclusion Criteria:

Oncologists:

* Be a physician specializing in medical oncology
* Care for oncology patients at the affiliated cancer center
* Have a patient panel that will allow for ≥6 eligible patients to be enrolled in the study
* Be willing to attend the 5-session MODEL Care program for providers at the specified location, date, and time

Patients:

* Adults ≥ 18 years of age
* Receiving care from a medical oncologist enrolled in the study
* Diagnosed with an incurable and advanced-stage solid malignancy (late stage III \[B or C\] or stage IV)
* Have an attending medical oncologist who would not be surprised if the patient died in the next 12 months
* Willing and able to travel to the class location for 6 weekly 2-hour sessions
* Have a family member or friend eligible and interested in participating in the MODEL Care study
* Able and willing to provide informed consent
* Not have completed a Physician Orders for Scope of Treatment (POST) form

Family Caregivers:

* Adults ≥18 years of age
* Chosen by a family member or friend with cancer to join them in participating in the MODEL Care study
* Willing and able to travel to the class location for 6 weekly 2-hour sessions
* Able and willing to consent.

Exclusion Criteria:

Oncologists:

* Planning to leave current practice setting for other employment in the next 3 months.

Patients:

* Eastern Cooperative Oncology Group (ECOG) performance status of \>2 or Karnofsky performance status \<60 (suggesting patient is capable of only limited self-care, confined to bed or chair more than 50% of waking hours, or requires considerable assistance and frequent medical care) as rated by the attending oncologist
* Currently receiving hospice care.
The Effect of Intravenous Tranexamic Acid and Interscalene Block Applied on Shoulder Arthroscopy

Nerve blocks are used for pain and surgery after many operations today. It has been demonstrated by studies that the amount of postoperative bleeding decreases. On the other hand, surgical teams can use additional medications, such as Tranexamic acid, which have been proven by different studies that have reduced bleeding during and after arthroscopic surgery.

The investigators aimed to investigate the effect of interscalene block application and tranexamic acid on bleeding in shoulder arthroscopy operation.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were in the American Society of Anesthesiologists (ASA) I-III class
* underwent elective shoulder arthroscopy
* Patients with consent to participate in the study

Exclusion Criteria:

* history of arterial or venous thromboembolic disease
* Bleeding diathesis disorder
* Allergy to local anesthetics
* cardiac stent placement
Intra-operative Feed Back on Traction Force During Vacuum Extraction: Safe Vacuum Extraction Alliance

The objective of the clinical investigation is to test whether intra-operative traction force feed back during vacuum extraction leads to a significant decrease in incidence of brain damage in neonates.

By randomization, half of the vacuum extraction patients will be assigned to delivery using a new intelligent handle for vacuum extractions, and half will be assigned to conventional method without traction force measurement.

The most common indications for vacuum extraction are dystocia and/or fetal asphyxia. The safety of assisted vaginal delivery with vacuum extraction has been discussed since its introduction almost fifty years ago. Serious complications such as asphyxia, intracranial hemorrhage and seizures are overrepresented at vacuum extraction compared to spontaneous vaginal delivery.

Little has been done to improve the procedure since the introduction. Safety measures recommended include restricting total time and number of pulls, a full 34 week gestation, and station of the head at the spines or below. A general advice is also to avoid excessive traction force. There is no general agreement to what a safe traction force might be. With exceeding force there seems to be an increased risk for rupture of the sagittal sinus and tearing of the falx at its attachment to the tentorium. Furthermore, when the fetal head is becoming exceedingly elongated and flattened, and as the cup pops off it might cause damage to the brain and blood vessels.

During the procedure the obstetrician is under significant stress and the subjective element of the evaluation of traction force is a concern. The difficult decision of whether to continue a heavy extraction or abort the operation is made under stressful conditions and based mostly on subjective impressions.

To provide the obstetrician with more objective information, the investigators developed a new device consisting of an intelligent handle hooked to the chain of a regular metal cup.

Eligibility Criteria:
Inclusion Criteria:

* Medical or social reasons for vacuum extraction with a metal cup, gestational age ≥37+0 weeks, singleton, cephalic

Exclusion Criteria:

* Multiple pregnancy, breech presentation, gestational age \<37+0
Pharmacokinetics in Adolescents

The purpose of this study is to study pharmacokinetics in adolescents.

An open, single centre, phase I study in male adolescents with asthma, aged 12 to 17 years, to assess pharmacokinetics of orally administered AZD1981 tablets 100 mg twice daily for 61/2 days.

Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures
* A minimum of 6 months documented history of asthma
* Be a non-smoker or ex-smoker who has stopped smoking for \>6 months prior to Visit 1 (pre-entry)

Exclusion Criteria:

* Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the result of the study, or the patient's ability to participate
* Any clinically relevant abnormal findings in phys.examination, clinical chemistry, haematology, urinalysis, vital signs, or ECG at baseline which, in the opinion of the investigator, may put the patient at risk because of his participation in the study
The Clinical Utility of QuantiFERON in the Diagnosis of Active Tuberculosis

The investigators will evaluate the usefulness of QuantiFERON-TB Gold in-tube (QFT) in the diagnosis of active tuberculosis in young adults group, highly clinically suspected tuberculosis.

Investigators will enroll prospectively all clinically and radiologically suspected tuberculosis patients from 20 to 29 years old who visited the Armed Forces Capital Hospital. Investigators will perform QFT and tuberculin skin test. Diagnosis of tuberculosis will be made by World Health Organization guideline and the physician will not know the QuantiFERON-TB Gold in-tube results before the diagnosis and anti-tuberculosis medication. Investigators will evaluate the sensitivity and specificity of QuantiFERON-TB Gold in-tube in the diagnosis of active tuberculosis among young adults.

Eligibility Criteria:
Inclusion Criteria:

* All clinically and radiologically suspected TB patients from 20 to 29 years old who visited the Armed Forces Capital Hospital

Exclusion Criteria:

* Soldiers who do not agree with study protocol
Chairside Mouthrinse Test and Cost Effectiveness

The aim is to study whether participants at risk could be identified using an aMMP-8 chairside mouth rinse test and to study if oral health and health behaviour is linked to the test result in Finnish adolescents.

Adolescents (14-15-year-olds) are randomly divided to control group and test group. Chairside mouth rinse test for aMMP-8 is performed for the test group. Two groups are compared with each other.

Participants are asked to fill a questionnaire which consists of questions concerning oral hygiene habits, tobacco products, alcohol, drug and snuff use.

Eligibility Criteria:
Inclusion Criteria:

* All 8 class (aged 14-15 years) pupils in Jukola, Hämeenlinna, Finland
* Written informed consent from the participants and their parents (one of them)

Exclusion Criteria:

* No written consent to the study