cyrilzakka/clinical-trials huggingface dataset:
The GOS-Frail (Geriatric Oncology Supportive Care for Frail Older Adults With Cancer) Study

Background Cancer is more prevalent in older adults, but most cancer treatment trials have mainly involved young and healthy subjects. Among geriatric syndromes, frailty is a significant risk factor for negative outcomes such as treatment delays, discontinuation, and treatment-related side effects, as well as functional decline and poor survival. Research has shown that geriatric assessment with appropriate intervention can improve these outcomes, although the impact may be influenced by the inclusion of patients receiving palliative-intent treatment. Supportive care focuses on symptom assessment and treatment to enhance treatment tolerance and quality of life. To date, there have been no studies examining the combined benefits of geriatric oncology and supportive care clinics. We conducted a pilot study called Geriatric Oncology Supportive Clinic for Elderly (GOSPEL), which demonstrated an improved quality of life for older adults with curable cancer. Based on these results, we developed an enhanced care model.

Aim The study GOS-Frail aims to assess the effect of an integrated Geriatric Oncology Supportive Clinic on the quality of life of older adults with cancer receiving curative-intent chemotherapy and/or radiotherapy at 1 month.

Methods The GOS-Frail study is a multi-centre, open-label, parallel-arm, randomized controlled trial conducted in the specialist outpatient clinics of two university-affiliated tertiary care hospitals. 154 adults aged 65 and above, diagnosed with solid organ cancer and planned for curative-intent chemotherapy and/or radiotherapy, and with a clinical frailty scale score of 4 and above, will be recruited. Subjects will be randomized to either attend a geriatric oncology supportive clinic or receive frailty education material. Quality of life questionnaires will be administered at baseline, 2 weeks, and 1, 3, 6, and 12 months from treatment initiation.

Hypothesis:

The GOS-Frail study investigates on the role of a synergistic geriatric oncology and supportive model of care in improving quality of life in older adults undergoing curative-intent cancer treatment.


Eligibility Criteria:
Inclusion criteria

1. Age ≥ 65
2. Diagnosis of solid organ cancer
3. Plan for curative-intent chemotherapy and/or radiotherapy
4. Clinical Frailty Scale (CFS) score ≥ 4,

Exclusion criteria: Evaluation by Geriatric or Palliative Medicine in the previous 6 months.
The Various Effects of Gaseous Albuterol on Serum Lactate

Empirical data from physician observation indicates an increase in serum lactate in acute asthmatic patients being treated with inhaled albuterol therapy.

It is not clear if this increased serum lactate is in response to a physiological response to the asthmatic process or from the albuterol treatment.

This study is designed to determine if administration of inhaled albuterol increases serum lactate in healthy subjects.

Approximately 30 healthy volunteers will be randomized to Albuterol or placebo. We powered our study to detect a difference of 0.5 mmol/L, but hypothesize that the difference will be greater than 1.0 mmol/L.

All volunteer subjects will sign a written consent, approved by the Institutional Review Board. The intended pool of volunteers will be from residents, attendings, and medical students in the hospital. The consent form will clearly specify that their participation in the study will not impact their academic status or employment.

The subjects randomized to the Albuterol arm will receive a one hour 10 mg continuous Albuterol nebulizer treatment. Those randomized to placebo will receive a one-hour saline nebulizer treatment. The chief pharmacist for the study will randomly assign a number between one and thirty to fifteen Albuterol treatments and fifteen placebo treatments.

Subjects will be monitored with cardiac monitor and serum lactate levels will be drawn every 15 minutes.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older

Exclusion Criteria:

* Pregnant
* Prisoner
* beta agonist allergy
* hypokalemia
* taking furosemide, insulin, thiazide diuretics, metformin or acetazolamide
* coronary artery disease
* hyperthyroidism
* abnormal heart rhythm
* baseline serum lactate level \>2.2 mmol/L
* baseline heart rate \> 120
Study to Evaluate the Safety and Efficacy of Adalimumab in MPS I, II, and VI

Randomized, double-blind, placebo-controlled, parallel-group, single-center study followed by open-label phase, to evaluate the effects of adalimumab compared to placebo on the change from baseline in joint and skeletal disease in children and adults with mucopolysaccharidosis (MPS) I, II or VI.

This study is a randomized, double-blind, placebo-controlled, parallel-group, single-center study followed by open-label phase, to evaluate the effects of adalimumab compared to placebo on the change from baseline in joint and skeletal disease in children and adults with mucopolysaccharidosis (MPS) I, II or VI. Children and adults diagnosed with MPS I, II or VI, with significant joint restrictions and pain will be randomized to adalimumab treatment or placebo treatment for the first 16 weeks. This will be followed by a 32-week open label adalimumab treatment phase.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥5 years of age;
* Diagnosis of MPS I, II or VI;
* Treatment with ERT for ≥1 year or no treatment with ERT for ≥1 year;
* Weight ≥15 kg;
* Significant bodily pain reported by the CHQ-PF50 or SF-36 (\> 1 SD more severe \[below\] than the general population mean);
* ≥ 3 joints with limitations in motion; and Patient or parent/legal guardian is able and willing to provide informed consent. For patients 7 to 17 years of age, assent must also be provided.

Exclusion Criteria:

* History of HCT less than 2 years prior to enrollment;
* Immune suppression therapy less than 1 year prior to enrollment;
* Active graft versus host disease;
* Current diagnosis or history of lymphoma or other malignancy;
* Current active infection;
* History of serious opportunistic infection (e.g., bacterial \[Legionella and Listeria\]; tuberculosis \[TB\]; invasive fungal infections; or viral, parasitic, and other opportunistic infections);
* Positive TB skin test, positive Quantiferon-TB Gold TB test, positive chest X-ray, or a recent exposure to TB
* Congestive heart failure defined by an ejection fracture \<50% measured by ECHO;
* Demyelinating disorders (e.g., central nervous system \[CNS\] disorders including multiple sclerosis and optic neuritis and peripheral nervous system disorders including Guillain-Barre syndrome);
* Hematologic abnormalities (e.g., pancytopenia, aplastic anemia);
* Hepatitis B infection (active or chronic carrier);
* Latex sensitivity;
* Pregnancy or breastfeeding;
* Known or suspected allergy to adalimumab or related products;
* Participation in simultaneous therapeutic study that involves an investigational study drug or agent within 4 weeks of study enrollment;
* Requirement for live vaccine exposure that would be expected to occur during the time frame of the study; or
* Any other social or medical condition that the Investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated or be detrimental to the study.
Efficacy, Safety, and PK of LX9211 in Patients With Diabetic Peripheral Neuropathic Pain

Evaluation of the efficacy of a low and high dose of LX9211 compared to placebo in reducing pain related to diabetic peripheral neuropathy over an 11 week assessment period.


Eligibility Criteria:
Inclusion Criteria:

* Patient has given written informed consent to participate in the study in accordance with local regulations
* Adult male and female patients ≥18 years of age at the time of screening
* Body mass index ≥18.0 to ≤40.0 kg/m2 at Screening
* Diagnosis of DPNP at Screening
* Pain from DPN present for at least 6 months
* A1C ≤11% at screening
* Stable regimen for the treatment of T1DM or T2DM for ≥1 month prior to Screening

Exclusion Criteria:

* Presence of other painful conditions that may confound assessment or self-evaluation of DPNP
* History of major depressive episode, active, significant psychiatric disorders
* History of clinically significant drug or alcohol use disorder
* History of neurolytic or neurosurgical therapy for DPNP
* Use of opioid medications for management of DPNP within the 2 months prior to Screening Visit
* Use of NSAIDs less than 2 weeks prior to the Screening Visit
Gelatines in Pediatric PatientS

The aim of volume replacement is to compensate a reduction in the intravascular volume e.g. during surgery and to counteract hypovolemia in order to maintain hemodynamics and vital functions. So far, there is only few data on the safety and efficacy of the products under investigation in children.

The primary aim of this non-interventional observational study (NIS) is to collect further data of gelatine solutions in a large pediatric population during routine clinical practice.


Eligibility Criteria:
Inclusion:

* Age ≤ 12 years
* American Society of Anesthesiologists (ASA) risk score: ≤ III
* Peri-operative infusion of gelatine solutions
* Informed consent and/or data protection declaration signed by parents/legal guardians (according to local requirements)

Exclusion:

* Inclusion in another investigational study in the field of volume replacement which could interfere with the routine clinical practice regarding the administration of the gelatine solutions
* In addition contraindications as outlined in the valid local Summaries of Product Characteristics (SmPCs) have to be considered.
Effectiveness of Warm Saline Distension Media on Relieving Pain in Office Hysteroscopy

The aim of the study is to compare the effectiveness of warm saline distension media versus room temperature saline distension media on relieving pain in office hysteroscopy .

Research hypothesis :

In women undergoing diagnostic hysteroscopy, warm saline distension media may be effective in decreasing the pain during the procedure .

Research question :

In women undergoing diagnostic hysteroscopy, does warm saline distension media decrease the pain during the procedure ?

Aim of the work :

- This study aim to assess the efficacy of warm saline distension media in decreasing the pain in women undergoing diagnostic hysteroscopy

Eligibility Criteria:
Inclusion Criteria:

1. Age: 20-40 years old (premenopausal women ).
2. Normal cervical morphology during speculum examination.
3. Women complaining of abnormal uterine bleeding
4. Women underging the procedure to evaluate the endocervical canal, uterine cavity and tubal ostia because of infertility.
5. Suspected mullerian anomalies.

Exclusion Criteria:

* a. Pregnancy. b. Suspected acute pelvic inflammatory disease. c. Past history of medical disorders, especially associated with neuropathies, e.g. diabetes, chronic kidney disease, etc.

  d. History of vaginal pruritis, discharge, dysuria, dysmenorrhea, dyspareunia or chronic pelvic pain.

  e. Presence of pain, profuse bleeding or other symptoms at the time of the procedure.

  f. History of uterine surgery that occurred less than 1 month previously. g. History of previous cervical procedures. h. Administration of general, cervical or paracervical anesthesia. i. Administration of sedatives. j. Any use of analgesic agents before the procedure. k. Cervical preparation by misoprostol before procedure orally or vaginally for cervical ripening to improve the likelihood of successful cervical dilation and decrease intraoperative pain .

  l. Need for cervical dilatation during procedure. m. Need for biopsy or any operative intervention during the procedure.
Endoscopic Thyroidectomy Versus Open Thyroidectomy for Papillary Thyroid Carcinoma

Recently, endoscopic thyroidectomy using gasless unilateral transaxillary approach has been proven feasible and safe in several Chinese medical centers. This study is aimed to compare multi-institutional Chinese outcomes of endoscopic thyroidectomy using gasless unilateral transaxillary approach and conventional open surgery.

Most patients with thyroid tumors are effectively treated surgically by practitioners experienced in the techniques of thyroidectomy. Many patients, especially women, undergoing thyroid surgery are concerned about the postoperative cosmetic appearance of the neck. Endoscopic thyroidectomy using gasless unilateral transaxillary approach which can hide the operative scar was associated with a higher degree of patient cosmetic satisfaction. Recently, endoscopic thyroidectomy using gasless unilateral transaxillary approach has been proven feasible and safe in several Chinese medical centers. In this study, we designed a prospective study comparing multi-institutional Chinese outcomes of endoscopic thyroidectomy using gasless unilateral transaxillary approach and conventional open surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* The pathological type is papillary thyroid carcinoma;
* Tumor diameter \<2 cm；
* No extraglandular invasion, or minimal extrathyroidal extension invading only anterior thyroid capsule or sternothyoid muscle；
* cN0 or cN+ without fusion and fixation of metastatic lymph nodes；
* no obvious contraindication for thyroidectomy ;
* Good comply with the research visit plan and other program requirements;
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* patients with severe systemic diseases who can not tolerate general anesthesia or routine surgical posture;
* previous history of neck surgery, radiotherapy or thermal ablation;
* hyperthyroidism and substernal goiter;
* dedifferentiated thyroid carcinoma；
* accompanied with severe thyroiditis.
The Affect of a Ventilated Helmet on Physiological Load

The use of infantry helmets under heavy heat stress conditions, during physical exertion, may hinder the body's ability to effectively dissipate heat from the head area, thereby damaging the soldier's function. Therefore head cooling may potentially enable a longer duration of activity until reaching fatigue. An improvement in function may also be possible.The purpose of this research is to determine the extent of the cognitive and physiological strain caused by wearing a helmet under exertional conditions while exposed to heavy heat stress and to evaluate the effect of a unique ventilation system connected to the helmet on strain reduction.

12 young, healthy civilian volunteers, aged 21-28 will participate in the study. Following a day of examinations and 6 days of acclimatization in a climatic chamber in accordance with a well accepted protocol, the subjects will undergo 3 days of experiment that will include exposure to hot environmental conditions with different helmet-wearing scenarios, while wearing uniform and a combat vest: (a) without a helmet (b) with a helmet (c) with a helmet connected to a ventilation system. All 3 scenarios will include a two hour effort (walking on a treadmill) in heavy heat stress in the climatic chamber at our institute (the Heller institute of medical research).

Eligibility Criteria:
Inclusion Criteria:

* healthy civilian volunteers
* aged 21-28
* without known medical illnesses or medication use

Exclusion Criteria:

* the existence of or suspicion of existing cardiac or respiratory disease
* hypertension
* diabetes
* any hormonal disease or any other chronic illness that may inhibit participation in the experiment
* infectious disease 3 days prior to the experiment.
Severity of RSV Infections in Twins

Respiratory syncytial virus (RSV) infection is the most common cause of severe lower respiratory tract infection (LRTI) in the pediatric population worldwide. Age at the time of infection, prematurity, multiparity, exposure to smoke and the level of passive immunity transmitted at birth are the main risk factors for lower respiratory infection associated with RSV. Other factors, including the innate immune response, respiratory microbiota, and intra-host viral heterogeneity, may also affect outcomes but are not fully considered in RSV infection. Exploring the impact of these factors is difficult due to the heterogeneity of the population which makes statistical adjustment difficult. Thus, twin models are useful in understanding the impact of the host on the environment, as twins often share similar exposure to infection and many risk factors, but not all are ie different prenatal and postnatal conditions, differential transfer of maternal antibodies and the genetic makeup of heterozygotes.


Eligibility Criteria:
Inclusion Criteria:

* Twins born at Hospices Civils de Lyon in the years 2012 to 2020
* At least one twin hospitalized with positive RSV-PCR during the first year of life

Exclusion Criteria:

* Major differential underlying disease between twins
* Death of a twin before the RSV epidemic period of the first year of life
* Nosocomial infection
* Lack of understanding of the study or questionnaire by parents
* Lack of parental consent
Intraocular Pressure (IOP) Patterns in Fast Versus Slow Visual Field (VF) Progression Patients

The purpose of this study is to investigate how the intraocular pressure (IOP) varies in time and if the IOP variations are associated with the worsening of glaucoma. IOP patterns will be recorded continuously over 24 hours with SENSIMED Triggerfish® (TF) a portable investigational device using a contact lens sensor. After completing the Triggerfish lens placement and removal; the patient will complete a formal Polysomnography.


Eligibility Criteria:
Inclusion Criteria:

* Age between 40 and 89 years old
* Diagnosis of treated POAG (including normal tension glaucoma (NTG))
* All IOP measurements during the VF period (to be described further) equal or lower than 18 mmHg and/or on average equal or lower than 16 mmHg in the same period
* Documented glaucomatous VF damage at baseline, characterized by glaucoma hemifield test result outside normal limits on at least 2 consecutive VF tests or the presence of at least 3 contiguous test points within the same hemifield on the pattern deviation plot at p\<0.01, with at least 1 point at p \< 0.005
* At least 8 visual field tests carried out within at least 2 years, all with fixation losses and false positive/negative results equal or less than 33%
* For fast progressing eyes, 1) pointwise progression defined as two or more adjacent VF test locations in the same hemifield that show a threshold sensitivity rate of change more negative than -1.0 dB/year with p\<0.01 or 2) a global rate of VF change based on mean deviation (MD) more negative than -1.0 dB/year
* For slowly or minimally progressing eyes a VF MD rate of change more positive than -0.5 dB/year with no significant pointwise progression as described above
* Not more than 6 diopters spherical equivalent on the study eye
* Have given written informed consent, prior to any investigational procedures

Exclusion Criteria:

* Baseline VF MD more negative than -15 dB. The rationale here is that in severely damaged visual fields, one may not be able to detect and measure rates of progression due to a 'floor effect'
* Corneal or conjunctival abnormality precluding contact lens adaptation
* Severe dry eye syndrome or other ocular disease
* Patients with angle closure glaucoma, traumatic glaucoma or uveitic glaucoma
* Patients with previous intraocular surgery in the enrolled eye, including cataract surgery
* Patients with allergy to corneal anesthetic
* Patients with contraindications for silicone contact lens wear
* Patients not able to understand the character and individual consequences of the investigation
* Participation in unrelated clinical research within the last 4 weeks
Effect of Prevacid on Prostaglandin Levels in Patient With Stress Ulcer

The purpose of this study is to measure the prostaglandin levels in patients with stress ulcer and the effect of Prevacid on prostaglandin levels in patients with stress ulcer.

The prostaglandin system plays an important role in the gastric mucosa to strengthen its resistance against injury. Critically ill patients are at greatest risk of developing stress-related gastric mucosal lesions. Although the levels of prostaglandins in gastric mucosa in patients with stressed animal has been studied, prostaglandin levels in the gastric mucosa in patients with stress ulcer have not been studied and the effect of Prevacid on prostaglandin levels in gastric mucosa from patients with stress ulcer is unknown.

We hypothesize that prostaglandin levels are low in the gastric mucosa in patients with stress ulcer, and Prevacid is an effective agents in increasing prostaglandin levels in the gastric mucosa in stress stress ulcer.

Comparison(s): The prostaglandin levels in patients who treated with Prevacid for stress ulcer, compared to the prostaglandin levels in patients who treated with H2 blocker for stress ulcer.

Eligibility Criteria:
Inclusion Criteria:

* Patients in ICU with documented gastric stress ulcer by endoscopic examination, including patients with H. Pylori infection;
* Patients have no known ulcer within 8 weeks prior to be admitted to ICU;
* Patients not on any PPI for 4 weeks prior to the study;
* Patients or family be consented for the study.

Exclusion Criteria:

* Patients have gastric ulcer within 8 weeks prior to be admitted to ICU;
* Patients have gastric cancer confirmed by pathology;
* Patients on one of the PPIs already;
* Patients on any of the Non-steroidal Antiinflammatory Drugs.
Emergency Administration of EPI-743 to a Single Patient With Leber's Hereditary Optic Neuropathy [LHON]

Expanded access Protocol to treat LHON subjects with EPI743

Emergency use administration of EPI-743 to subjects with LHON. This Protocol was originally developed to treat a single subject but was expanded to treat several at a single institution.

Eligibility Criteria:
Inclusion Criteria:

* Emergency treatment for subjects with LHON who are actively losing site in one eye

Exclusion Criteria:

* Allergy to EPI-743 or sesame oil
* Clinical history of bleeding or abnormal PT/PTT
* Hepatic insufficiency with LFTs greater than 2-times normal
* Renal insufficiency requiring dialysis
* Fat malabsorption syndromes
* Any other concurrent inborn erros of metabolism
* Severe end-organ hypo-perfusion syndrome secondary to cardiac failure resulting in lactic acidosis
* Anemia with a HCT \<25