cyrilzakka/clinical-trials huggingface dataset:
Study of Bleeding With Extended Administration of an Oral Contraceptive

This is an non-comparative study. There is no statistical hypothesis. The effects of extension of treatment on bleeding will be recorded and described.


Eligibility Criteria:
Inclusion Criteria:

* Healthy women
* Age 25-40
* History of regular cycles

Exclusion Criteria:

* Current or recent (within 2 months) users of hormonal contraceptives
* Contraindications for use of hormonal contraception
* Conditions which affect the absorption or metabolism of steroid hormones
* BMI \> 35
Immediate Versus Optional Delayed Surgical Repair for Treatment of Acute ACL Injuries

Currently, most patients with an anterior cruciate ligament injury undergo surgery. There is a general belief that surgical reconstruction is necessary to safely return to sports and to prevent early knee osteoarthritis or additional meniscus injuries. But there is insufficient scientific evidence to support this belief. Moreover, several studies show that surgical reconstruction of the cruciate ligament does not guarantee successful return to sports or the prevention of osteoarthritis and secondary meniscus injuries. Therefore, immediate surgery after an anterior cruciate ligament injury is questioned. So far, only two RCTs (KANON study and COMPARE study) have assessed this, and they could not show that immediate reconstruction is an added value (in terms of symptoms, knee function, activity level, osteoarthritis or additional meniscal injuries) compared to a conservative approach consisting of rehabilitation and late surgery for persistent knee instability.

Therefore, this additional multicenter RCT, aims to 1) verify these results and 2) to identify predictors that predict which patients in the conservative group will not require late surgery. This has not been investigated to date. It is suspected that factors such as symptoms, strength, findings on the MRI scan and psychological factors may play a role in whether or not a patient will be able to successfully rehabilitate without surgical repair.

This information is invaluable to physicians because it allows them to decide which treatment is best for the patient.


Eligibility Criteria:
Inclusion Criteria:

* Rotational trauma to a knee that had no previous serious injury and for which medical advice was sought within 4 weeks after the injury.
* Medical diagnosis of ACL insufficiency including MRI (both partial and complete ruptures)
* Minimum of 16 years

Exclusion Criteria:

* Participant has a history of a previous ACL injury or knee surgery to the index knee
* Indication for acute surgery because of related injuries to the knee
* Female who is pregnant or plans to become pregnant in the first 4 months of the trial. Since MRI assessment cannot be performed.
Avelumab, Cetuximab, and Palbociclib in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

The purpose of the study is to find out if the study drugs Avelumab, Cetuximab, and Palbociclib will slow or stop your cancer from getting worse, and whether it causes side effects. The second purpose is to measure whether your cancer responds to the study drugs Avelumab, Cetuximab, and Palbociclib. The study drugs Avelumab, Cetuximab, and Palbociclib are types of drugs called a monoclonal antibody. Monoclonal antibodies are made to recognize, target, and bind to specific proteins on cells the building blocks making up your tissues.

This is an open-label phase I trial with a 3+3 dose escalation design. All patients will receive avelumab, cetuximab, and palbociclib. This study will enroll patients with head and neck squamous cell carcinoma not amenable to curative intent therapy.

Treatment will be administered in 28 day cycles with a pre-defined dose escalation schedule.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven squamous cell carcinoma of the head and neck not amenable to curative intent therapy.
* Presence of measurable tumor lesions per RECIST criteria v1.1
* Life expectancy greater than 12 weeks.
* Adequate hematologic, hepatic, and renal function
* Negative serum or urine pregnancy test for women of child bearing potential

Exclusion Criteria:

* Prior therapy with an EGFR inhibitor or PD-1 or PD-L1 inhibitor in the recurrent or metastatic setting
* Uncontrolled central nervous system metastases (stable metastases permitted)
* Chemotherapy 28 days prior to first administration of study treatment and/or monoclonal antibody ≤8 weeks prior to first administration of study treatment.
* History of other malignancies,
* Concurrent systemic immunosuppressant therapy (eg, cyclosporine A, tacrolimus, etc., or chronic administration of \>10 mg/day of prednisone or equivalent)
* Prior organ transplantation
* Known history of human immunodeficiency virus (HIV) or active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV).
BR55 in Characterization of Ovarian Lesions

This is an exploratory phase II, single center, open label, prospective study of BR55 CEUS for characterization of ovarian lesions in subjects with suspected ovarian cancer.

A total of sixty (60) subjects scheduled to undergo salpingo-oophorectomy within 30 days of BR55 CEUS examination will be enrolled to obtain approximately 30 subjects with benign ovarian lesions and 30 with malignant ovarian lesions based on the truth standard (TS).

The first 10 subjects will receive BR55 at a dose of 0.03 mL/kg. Assuming these first 10 subjects will show technically adequate images, subsequent subjects enrolled in the study will continue to receive 0.03 mL/kg dose of BR55; otherwise, subjects will be switched to a 0.05 mL/kg dose of BR55.

The final cancer diagnosis will be obtained for all subjects by histopathology.

Eligibility Criteria:
Inclusion Criteria: Enroll a subject if he/she meets the following inclusion criteria:

* Is at least 18 years of age;
* Has an ovarian lesion that is visible and assessable with trans-vaginal ultrasound;
* Is scheduled to undergo salpingo-oophorectomy for suspected ovarian cancer not earlier than 24 hours and not later than 30 days following BR55 administration;
* Provides written Informed Consent and is willing to comply with protocol requirements.

Exclusion Criteria: Exclude a subject if the subject does not fulfill the inclusion criteria, or if any of the following conditions are observed:

* Is a pregnant or lactating female. Exclude the possibility of pregnancy:

  * by testing on site at the institution (serum βHCG) within 24 hours prior to the start of investigational product administration,
  * by surgical history (e.g., tubal ligation or hysterectomy),
  * by post-menopausal status with a minimum 1 year without menses;
* Has undergone prior systemic therapy for ovarian cancer;
* Has history of concurrent malignancy;
* Has history of any clinically unstable cardiac condition including class III/IV congestive heart failure;
* Has had any severe cardiac rhythm disorders within 7 days prior to enrolment;
* Has severe pulmonary hypertension (pulmonary artery pressure \>90mmHg) or uncontrolled systemic hypertension and/or respiratory distress syndrome;
* Has open and/or non-healing wounds in the chest, abdomen and pelvis;
* Has other systemic vascular abnormalities associated with neovascularization, such as macular degeneration, that in the opinion of the investigator could significantly affect the ability to evaluate the effects of BR55;
* Is participating in a clinical trial or has participated in another trial with an investigational compound within the past 30 days prior to enrolment;
* Has previously been enrolled in and completed this study;
* Has any known allergy to one or more of the ingredients of the Investigational Product or to any other contrast media;
* Is determined by the Investigator that the subject is clinically unsuitable for the study;
* Has had major surgery, including laparoscopic surgery, within 3 months prior to enrolment;
* Has history of surgery to the ovaries or pelvic inflammatory disease.
Radial Artery Patency and Bleeding, Efficacy, Adverse evenT Trial

The objectives of this study are to demonstrate the safety and efficacy of the new 6Fr sheath (Glidesheath slender; Terumo, Tokyo,Japan ; GSS) compared with the contemporary 5Fr sheath (Hydrophilic coating sheath from Terumo; Tokyo, Japan (standard of care ; SOC).


Eligibility Criteria:
Inclusion Criteria:

* Patient is able to verbally acknowledge an understanding of the associated risks, benefits and treatment alternatives and he or his legally authorized representative provides written informed consent prior to the randomization, as approved by the appropriate IRB.
* Patient who is expected to diagnose by coronary artery angiography or followed by PCI.
* Patient must agree to undergo all protocol-required follow-up examinations.
* Patient who can accept radial access.

Exclusion Criteria:

* Patient has other medical illness (e.g., cancer or congestive heart failure) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).
* Hemodialysis patient
* STEMI
Intravenous Immunoglobulin After Relapse in Vasculitis

The aim of this study is to study the efficacy of intravenous immunoglobulins for inducing remission in patients relapsing of systemic vasculitides.

The aim of this study will assess the effects of intravenous immunoglobulin in ANCA+ vasculitides (Microscopic Polyangiitis, Wegener's granulomatosis and Churg-Strauss syndrome) who relapse under corticosteroid and immunosuppressant therapies or after one year post treatment.

Eligibility Criteria:
Inclusion Criteria:

* Wegener's granulomatosis, Microscopic polyangiitis and Churg-Strauss syndrome (satisfying ACR or chapel Hill classification) relapsing either under corticosteroid and immunosuppressant therapies or after one year post treatment
* Age \> 18 years old
* Written informed consent

Exclusion Criteria:

* Systemic vasculitides not previously treated with corticosteroid and immunosuppressant(s)
* Systemic vasculitides treated with corticosteroids and immunosuppressant therapies, but with treatment cessation more than 12 months ago
* Polyarteritis nodosa
* Absence of poor prognosis criteria (according to FFS)
* Nephritis ± renal impairment
* Cancer or malignancy
* Psychiatric disease, lack of compliance
* Age under 18 years old
* Lack of written informed consent
* Other vasculitides (post viral infection and skin localisation)
Unilateral Strength Training and Mirror Therapy for Chronic Stroke Patients

This is a pilot randomised controlled trial investigating a combination of unilateral strength training (cross-education) and mirror therapy for the rehabilitation of lower limb impairment following a stroke. This study has been conducted as part of a PhD qualification at the Institute of Technology Sligo in Ireland with all assessments being conducted at the institute and all therapy sessions taking place at the participant's home. The study was conducted in conjunction with Sligo University Hospital and it attained ethical approval through the relevant University Hospital Ethics Committee.

The study necessitated patients with chronic stroke to perform a strength training programme with their less-affected lower limb. The mirror and strength training group observed the reflection of the training limb in a mirror, the strength training only group exercised without a mirror entirely. Patients were referred through Hospital Health Professionals. Prior to trial commencement all participants were given comprehensive trial information and provided signed written informed consent. A total of 35 participants were recruited. After a warm-up participants performed 4 sets of 5 maximal isometric ankle dorsiflexion contractions with their less-affected lower limb, three days per week, for four weeks. Patients received outcome assessment prior to the beginning of the intervention, directly after it and at three-month follow-up assessment. All assessments were carried out by a blinded Chartered Physiotherapist specialising in stroke rehabilitation. Patients were assessed using established outcome measures for lower limb isometric strength, motor function, muscle tone, and self-perceived participation.

Eligibility Criteria:
Inclusion Criteria:

Chronic stroke diagnosed by a physician at least 6 months prior to study begin Discharged from formal rehabilitation services (not receiving outpatient rehabilitation on more than a monthly basis, but may still be in receipt of occupational or language therapy).

Exclusion Criteria:

Impaired cognition (Mini mental state examination (MMSE) \< 21) Cardiovascular, neurological or musculoskeletal impairments of the lower extremity not related to stroke that would prevent strength training.

Visual impairments that would interfere with the ability to participate safely in isometric training and observe mirror images.
Older Emergency Department Users and Short-term Adverse Events at the Index Visit

This study evaluates the difference between PRISMA-7 and ER2 tool. There are some differences between PRISMA-7 and ER2 tool. The differences consist in evaluation criteria that are used to perform the both surveys. We suppose that evaluation criteria of PRISMA-7 is not accurately enough to calculate the length of hospital stay and to predict the short-term outcomes.

The "Program of Research on Integration of Services for the Maintenance of Autonomy" (PRISMA-7) is the Ministry of Health and Social Services' reference tool for the assessment of older ED users in Quebec (Canada). PRISMA-7 has been initially designed to screen disability in community-dwelling older adults and has never been validated for risk for short-term adverse events in older ED users. "Emergency room evaluation and recommendations" (ER2) is another clinical tool which is currently evaluated in Quebec. Compared to PRISMA-7, ER2 has been especially designed for assessing risk for short-term ED adverse events. No study has compared PRISMA-7 and ER2 risk for short-term adverse events. We hypothesised that ER2 could be a better prognostic tool compared to PRISMA-7 for long length of stay in ED and hospital stay, and hospital admission because it was designed and validated for this specific goal. The study aims to 1) examine and compared PRISMA-7 and ER2 risk for long length of ED and hospital stay and hospital admission, and 2) to establish their performance criteria (i.e., sensitivity, specificity, positive predictive value, negative predictive value, likelihood ratios) for these three short-term adverse events in older ED users.

Eligibility Criteria:
Inclusion Criteria:

* Being 75 years old and over
* Brought at Emergency on medical stretcher

Exclusion Criteria:

* Being less than 75 years old
* Never come at Emergency
An Innovative Approach for Uniblocker Intubation

To measure the distance between the upper edge of the thyroid cartilage to the upper edge of the sternum add the distance from the upper edge of the sternum to the carina was calculated according to the chest CT scans as a guide to the placement of Uniblocker without the aid of FOB.

In previous study, the investigators found Chest computed tomography (CT) image can accurately predicting the optimal insertion depth of Uniblocker,however in some hospital the CT scan performed for the preoperative surgical evaluation without the vocal cords slices. If a more extensive CT scan was needed for obtaining a more reliable image of the vocal cords,the additional exposure dose would be a major disadvantage of the method.So the investigators measure the distance between the upper edge of the thyroid cartilage to the upper edge of the sternum add the distance from the upper edge of the sternum to the carina calculated according to the chest CT scans as a guide to the placement of Uniblocker without the aid of FOB.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients undergoing left side thoracic surgery
2. The thoracic surgery requiring a Uniblocker for one-lung ventilation

Exclusion Criteria:

1. Age\>70 or \<18 years
2. ASA classifications \>III
3. BMI \>35kg/m2
4. Modified Mallampati classification ≥III
5. Thoracic surgery within the last one month
6. Severe cardiopulmonary disease
A Study Comparing Pemetrexed Plus Cisplatin Versus Pemetrexed Alone in NSCLC Patients Who Have Progressed on First Line EGFR-TKI

It has not been established whether platinum-based doublets is better than single agent chemotherapy in EGFR mutant NSCLC patients who failed first-line EGFR TKI.

In this prospective trial, the investigators try to evaluate whether the progression-free survival of pemetrexed/cisplatin (PC) regimen is longer than that of pemetrexed single(P) regimen in NSCLC patients who have progressed after first line treatment of EGFR-TKI.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed nonsquamous NSCLC with activating EGFR mutation (on exon 19 deletion or exon 21 L858R mutation)
* Stage IIIb, IV or recurrent NSCLC (AJCC 7th criteria)
* Age ≥ 20 years
* ECOG performance status of 0 or 1
* At least one measurable lesion by RECIST 1.1
* Progression after first line treatment with EGFR TKIs for advanced NSCLC
* Asymptomatic brain metastasis or symptomatic brain metastasis treated with local treatment such as operation, whole brain radiotherapy, or gamma-knife surgery
* At least 2 weeks later after whole brain radiotherapy or palliative radiotherapy
* Adequate renal function: estimated creatinine clearance ≥ 45 mL/min
* Organ function as evidenced by the following; Absolute neutrophil count \> 1.5 x 109/L; platelets \> 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT \< 3 UNL, in case of known hepatic metastasis, AST/ALT\< 5 UNL
* Written informed consent form
* No other previous systemic chemotherapy

Exclusion Criteria:

* Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia
* Patients with post-obstructive pneumonia or uncontrolled serious infection
* Pregnant or nursing women (Women of reproductive potential have to agree to use an effective contraceptive method)
* Uncontrolled symptomatic brain metastasis
* Presence of third space fluid which cannot be controlled by drainage
* Prior history of malignancy within 5 years from study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer.
Comparing Parenteral Nutrition vs Best Supportive Nutritional Care in Patients With Pancreatic Cancer

A randomised multicentre clinical phase IIIb trial for patients suffering from pancreatic adenocarcinoma receiving defined second or higher line chemotherapy and additionally parenteral nutrition (study arm A) or best supportive nutritional care (study arm B).

Pancreatic cancer is an extremely aggressive malignancy characterized by extensive invasion, early metastasis, and marked cachexia. Subjects are afflicted with a variety of disconcerting symptoms, including profound cachexia and deterioration in performance status, even when their tumour burden is low. Therefore, one of the most important therapeutic targets is the improvement of quality of life. Supplementation with parenteral nutrition improves Quality of Life in subjects with advanced cancer cachexia. The European Society of Parenteral and Enteral Nutrition recommend PN only for malnourished subjects but does not reflect situation in cancer cachexia patients At present, no 2nd-line therapy (or higher) is recommended for pancreatic adenocarcinoma, but often asked for.

Within this clinical trial, we evaluate if parenteral nutrition in combination with chemotherapy in subjects with advanced pancreatic adenocarcinoma have an impact on quality of life?

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Histological confirmed advanced pancreatic adenocarcinoma
* At least one previous chemotherapy (gemcitabine-based)
* ≥ 18 years old
* Body weight ≥ 50 and ≤ 95 kg
* BMI ≥ 19
* Negative pregnancy test (females of childbearing potential)
* Willingness to perform double-barrier contraception during study
* Expected life expectancy \> 3 months

Exclusion Criteria:

* Major surgery \< 4 weeks prior to enrollment
* Weight loss \> 2% within the last seven days or caloric intake ≤ 500 kcal expected within the next five days
* PINI-Index \> 10
* Pregnancy or breastfeeding
* \> 4 weeks of parenteral nutrition within the last 6 months
* Parenteral nutrition \< 4 weeks prior to enrollment
* Vulnerable populations (e.g. subjects incapable of giving consent personally)
* Subject selection conflicts with warnings, precautions and contraindications stated for any investigational product
Effects of a Perioperative Action Observation and Motor Imagery Training in Patients Undergoing Total Knee Arthroplasty

The study is aimed at investigating the effects of action observation and motor imagery training in patients undergoing total knee arthroplasty. Fifty participants will be enrolled during hospital admission and randomized into 2 groups (AO+MI and CTRL groups). AO+MI will undergo 12-minute AO+MI intervention for 3 days (preoperative day, first and second postoperartive days), whereas CTRL group will undergo usual care. At baseline, first and third postoperative days, participants will be assessed for mobility, pain, range of motion, quadriceps acrivation failure and patient's bady-pain representation by a blinded operator.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for total knee arthroplasty
* age greater or equal to 18 years old
* ability to walk independently.

Exclusion Criteria:

* previous total knee arthoplasty on the contralateral side
* revision surgery
* dementia
* musculoskeletal and neurological disorders influencing functional recovery
* visual or auditory deficits.
* postoperative complications
* weight bearing restrictions
* lack of walking independency within the second postoperative day.