cyrilzakka/clinical-trials huggingface dataset:
Low-dose Cyclophosphamide and Outpatient IV Interleukin-2 in Metastatic Melanoma

The purpose of this study is to determine response rates by administering low dose cyclophosphamide on day 1, followed by 5 days of outpatient IL2.

To determine the response rate, median duration of response and median survival of patients treated with this low-dose cyclophosphamide + moderate dose bolus Interleukin-2 schedule.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have a histologic diagnosis of metastatic melanoma. Patients may have received prior systemic therapy or may be previously untreated.
2. Patients must have measurable disease on physical exam or radiologic studies.
3. ECOG performance status of 0 or 1 and estimated survival of at least 3 months.
4. White blood count of \> 3500/mm3, platelet count \> 100,000/mm3, hemoglobin \> 9.0 gm/dl; bilirubin, ALT, AST \< 3 x upper limit of normal; serum creatinine \< 2.0 mg/dl.
5. Patients must undergo a low-level cardiac stress test as a screen for possible atherosclerotic heart disease. Patients with a positive stress test would be excluded from this trial.
6. Patients with elevated temperatures \> 100.5 F must have sources of occult infection excluded.
7. Patients must be felt to have recovered from effects of prior therapy, such as \> 2 weeks after prior chemotherapy.
8. Women of childbearing potential must have a negative pregnancy test and adequate precautions to prevent pregnancy during treatment must be taken.
9. Patient consent must be obtained prior to entrance onto study.

Exclusion Criteria:

* 1. Medical illness requiring corticosteroids or other immunosuppressive agents (such as cyclosporin or methotrexate.

  2. Autoimmune disease such as inflammatory arthritis which could be exacerbated by immune-based therapy.

  3. Prior history of psychiatric disorder which could be exacerbated by interleukin-2.

  4. Lactation or pregnancy.

  5. Evidence of significant cardiovascular disease including history of recent (\< 6 months prior) myocardial infarction, congestive heart failure, primary cardiac arrhythmias (not due to electrolyte disorder or drug toxicity, for example) beyond occasional PVC's, angina, positive low-level stress test, or cerebrovascular accident.

  6. Current untreated brain metastasis.
Inferior Vena Cava (IVC) Diameters Before & After Interscalene Block

The purpose of this study is to understand how changes to breathing patterns in the chest affect blood flow to the heart from the inferior vena cava in the abdomen. Ultrasound of the upper abdomen will be used to visualize changes in breathing patterns in the chest and blood flow in the abdomen.

In recent practice, point-of-care ultrasound has been used to assess the size and respiratory variation of the inferior vena cava as a marker for volume status and fluid responsiveness. Little investigation has occurred regarding the mechanism of observed respiratory variation. Anesthetic plans for surgery (e.g. shoulder replacement) frequently employ interscalene injections to target and block the brachial plexus, which (on the same side) results in phrenic nerve palsy and paralysis of the diaphragm. The goal of this study is to examine the relationship between diaphragmatic function and variation in IVC diameter. Specifically, the investigators will evaluate and compare the size and variability of the inferior vena cava by point-of-care ultrasound before and after brachial plexus block.

Eligibility Criteria:
Inclusion Criteria:

* Adult (age \> 18 years)
* Scheduled to receive an interscalene block

Exclusion Criteria:

* Any person with known, pre-existing phrenic nerve, diaphragmatic, or inferior vena cava anomaly.
* Patients who cannot be successfully imaged by ultrasound or who cannot participate in spirometry will additionally be excluded.
* Non-English speaking patients will be excluded as well as there is no research funding to translate consent forms. Given that there is no potential benefit to participation in the study, this does not exclude these individuals from any potentially beneficial therapy.
Evaluation of a New Predictive Test of Preterm Birth in Case of Threatened Preterm Labor

Threatened preterm labor (TPL) is defined by cervical changes and regular and painful uterine contractions occurring between 24 and 36 + 6 weeks of gestation that may or may not lead to premature labor and delivery. There is no reliable way to predict preterm delivery.

The study's hypothesis is that the Premaquick® test can improve the prediction of preterm delivery.

The investigators also want to compare this test with the Partosure® (Placental alpha microglobulin-1) test.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged \> 18 years (with no upper age limit)
* Patient affiliated to a social security health regime
* Between 24 and 33 + 6 weeks of gestation (amenorrhea)
* Singleton pregnancy
* Patient with a TPL: Uterine contractions during the last 24 hours felt by the patient, painful or not, and cervix less than or equal to 25 mm on endovaginal ultrasound
* Having signed an informed consent form

Exclusion Criteria:

* Twin pregnancy
* Sexual intercourse less than 24 hours from inclusion
* Cervical cerclage
* Abundant metrorrhagia
* Premature rupture of membranes
* Pre-eclampsia
* Congenital malformation
* Presence of a placenta previa
* Pelvic examination in the previous 24 hours (compared to inclusion)
* Patient under guardianship, curatorship or safeguard of justice
* Persons deprived of their liberty by judicial or administrative decision
* Persons under psychiatric care under duress
Perioperative TPN Improves Surgical Outcomes

Preoperative optimization of patients is a well known concept. Not all patients can tolerate feeds and as such TPN is given. TPN given preoperatively and continued postoperatively in selected group of patients can significantly improve the surgical outcomes and lower the morbidity as well as mortality. So the investigators aim to find the impact of TPN in malnutritional surgical patients.

Any patient who is at risk of malnutrition as well as already malnutritioned were given preoperative TPN for 5 days. After 5 days, elective surgery was done and TPN was continued postoperatively until patient could consume 50% of their daily requirements orally. Patients who underwent emergency surgeries were also enrolled in this study as these patients could receive TPN only postoperatively.

Daily patient charting with Clavien Dindo Classification, length of stay and mortality were mentioned and verified by the operating surgical team.

Data was maintained electronically by the surgical team. Data was also entered in MS-EXCEL at the time of patient discharge. Since data was maintained on everyday basis till patient discharge and does not include follow-ups, there are no missing data.

Upon completion of study, all data will be exported to SPSS and analyzed accordingly using means, SDs, Chi-square and Fisher exact test.

Eligibility Criteria:
Inclusion Criteria:

* 1. All patients who underwent major gastrointestinal surgery and received perioperative TPN or postoperative TPN

Exclusion Criteria:

* Perioperative TPN administration that did not follow the study protocol
* TPN given for reasons other than malnutrition
Non-Comparative Study of Open Abdomen That Require the Use of Negative Pressure Wound Therapy (NPWT) for Temporary Abdominal Closure

A study in which subjects with a Grade 1 or Grade 2 open abdomen that require the use of NPWT for temporary abdominal closure. Subjects will use the NPWT system for up to 14 days, with a 21 day post study initiation follow-up assessment for latent complications and mortality.


Eligibility Criteria:
INCLUSION CRITERIA

1. Eligible subjects must be properly consented before enrollment. If the subject is incapable of providing consent, emergency consent procedures will be followed, or the subject's legal representative must be asked to provide consent on the subject's behalf, per the IRB guidelines.
2. Subjects must be at least eighteen (18) yeaTS of age, or older.
3. Males and non-pregnant females.
4. Grade 1 or Grade 2 open abdomen patients who would benefit from temporary abdominal closure (TAC) with topical Negative Pressure Wound Therapy (NPWT).

EXCLUSION CRITERIA

1. Grade 3 and Grade 4 open abdomens.
2. Malignancy in the reference wound bed or margins of the wound.
3. Patients with non-enteric unexplored fistulas.
4. High risk for imminent death, as determined by the attending surgeon and Principal Investigator (PI).
5. Pre-existing large ventral hernia.
6. Significant loss of abdominal wall fascia as a result of trauma or infection.
7. Patients with a known hist01y of poor compliance with medical treatment.
8. Patients who have participated in this trial previously and who were withdrawn.
Predicting Outcomes From tDCS Intervention in Parkinson' Disease Using Electroencephalographic Biomarkers and Machine Learning Approach: the PREDICT Study Protocol

Parkinson's disease (PD) is a progressive and disabling neurodegenerative disease, clinically characterized by motor and non-motor symptoms. The potential of the "Transcranial direct current stimulation" (tDCS) for symptomatic improvement in these patients has been demonstrated, but the factors associated with the best therapeutic response are not known. The electroencephalogram (EEG) is considered as a diagnostic and prognostic biomarker of PD, and has been used in recent studies associated with machine-learning methods to identify predictors of responses in neurological and psychiatric conditions. Using connectivity-based prediction and machine-learning, the investigators intend to identify and compare characteristics related to baseline resting EEG between PD responders and non-responders to tDCS treatment.

The recruited participants will be randomized to treatment with active tDCS associated with dual-task motor therapy or motor therapy with visual cues. A resting-state electroencephalography (EEG) will be recorded prior to the start of the treatment. The investigators will determine clinical improvement labels used for machine learning classification, in baseline and posttreatment assessments and will use three different methods to categorize the data into two classes (low or high improvement): Support Vector Machine (SVM), Linear Discriminant Analysis (LDA) and Extreme Learning Machine (ELM). The functional label will be based on the Timed Up and Go Test recorded at baseline and posttreament of tDCS treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic Parkinson's disease by a neurologist based on Parkinson's Disease Society Brain Bank (PDSBB) criteria (Hughes et al.,1992)
* Disease staging between 1.5 and 3, according to the modified Hoehn and Yahr scale (Hoehn and Yahr, 1967)
* Regular pharmacological treatment with levodopa (equivalent dose \> 300mg) or taking antiparkinsonian medication such as anticholinergics, selegiline, dopamine agonists (amantadine) and COMT (catechol-O-methyl transferase) inhibitors
* Score of more than 24 points on the Mini-Mental State Examination (Folstein et al., 1975)

Exclusion Criteria:

* Associated neurological, musculoskeletal and/or cardiorespiratory diseases that could compromise gait;
* alcohol or substance abuse disorders;
* Deep brain stimulation implant;
* History of brain trauma or neurological disease that would interfere with study procedures.
Ketamine for MS Fatigue

The purpose of this study is to see whether using ketamine to increase glutamate in the prefrontal cortex can reduce Multiple Sclerosis (MS) related fatigue. The investigator proposes a prospective, crossover, randomized, placebo-controlled study to assess the efficacy and safety of low, single dose Ketamine, to assess its efficacy and safety in patients with MS-related fatigue.

The study treatment is designed in two 28-day cycles: for each cycle, participants will receive study infusion on Day 1 and complete follow-up visits during Days 7 and 28. Participants are randomized 1:1 to receive either ketamine (active treatment) or saline solution (placebo treatment) for their first infusion. They will not be blinded to their study assignment: the study doctor will disclose their assigned treatment group.

After their first infusion cycle, participents will crossover to the other treatment group. Worded differently, if a participant received ketamine during their first infusion, they will receive placebo treatment during their second infusion. Conversely, if a participant received saline treatment during their first infusion, they will receive ketamine during their second infusion.

Eligibility Criteria:
Inclusion Criteria:

1. Female and Male patients with any form of CDMS ages 18-65 inclusive
2. Report fatigue which is interfering with QOL
3. Able and willing to sign informed consent
4. Stable on DMT for at least 3 months prior to baseline visit
5. Not experiencing an MS relapse within 90 days prior to baseline visit.
6. Must agree to practice an acceptable method of contraception
7. Experiencing significant fatigue due to MS (MFIS of ≥10)

Exclusion Criteria:

1. Allergy to Ketamine
2. Taking medications which may interact with ketamine
3. Change in DMT within 3 months prior to baseline visit
4. MS relapse within 90 days of the baseline visit
5. Confirmed diagnosis of untreated Sleep Apnea
6. Confirmed diagnosis of periodic limb movement disorder
7. Serious infection in the 30 days prior to baseline visit.
8. Patients with significant comorbid conditions:

   1. Untreated hypertension (SBP\>160, DBP\>100 at baseline)
   2. Liver disease
   3. Significant renal disease
   4. History of cardiac arrhythmia
   5. Any comorbidities which at the opinion of the investigators post undue risk
9. Current alcohol or drug abuse
10. Participation in another interventional clinical trial in the past 3 months.
11. Pregnant or lactating
12. Any condition which in the opinion of the investigators will cause safety concerns for the patient, or inability to comply with the protocol.
An Appraisal of Minimal Invasive Surgery for Thoracic Neurogenic Tumour

Mediastinal neurogenic tumors are relatively rare in children. Surgical resection is essential. Minimal invasive surgery is more and more used in pediatric population, but his evaluation for resection of thoracic neurogenic tumors is little studied.

Thoracotomy has specific long terms post operative complications. When compared to thoracotomy, thoracoscopy shows less operative blood loss, shorter duration of chest tube ans length of stay.

Recently, the indications of thoracoscopic approach have been assessed according to the presence or absence of image-defined risk factors (IDRF) at diagnosis and after preoperative chemotherapy in a monocentric retrospective study.

The investigators aimed to conduct a multicentric retrospective study to assess the role of thoracoscopy in neurogenic thoracic tumours according to the presence or absence of IDRF at diagnosis, the surgical complications and outcome.

Mediastinal neurogenic tumors are relatively rare in children. Surgical resection is usually essential in there treatment. Minimal invasive surgery with video assisted thoracic surgery is more and more used in pediatric population, but his evaluation for resection of thoracic neurogenic tumors is little studied.

Thoracotomy has specific long terms post operative complications including scoliosis, shoulder elevation, winged scapula and asymmetric nipples. When compared to thoracotomy, thoracoscopy shows less operative blood loss, shorter duration of chest tube and length of stay.

Recently, the indications of thoracoscopic approach have been assessed according to the presence or absence of image-defined risk factors (IDRF) at diagnosis and after preoperative chemotherapy in a monocentric retrospective study. The authors concluded that thoracoscopy could be used for all paravertebral locations without IDRF except the IDRF of T9-T12 location and the presence of an intraspinal component but should be avoided for perivascular locations due to tight adherences of the tumour to the vessels and hence the risk of important bleeding.

The investigators aimed to conduct a multicentric retrospective study to assess the role of thoracoscopy in neurogenic thoracic tumours according to the presence or absence of IDRF at diagnosis, the surgical complications and outcome.

Eligibility Criteria:
Inclusion Criteria:

All children operated for neurogenic thoracic tumors with minimal invasive surgery

Exclusion Criteria:

-
Expanded Access Program of Sofosbuvir With Ribavirin and With or Without Pegylated Interferon in Aggressive Post-transplant Hepatitis C

This is a single arm, open-label study which will be opened at specific clinical sites at the request of an investigator for the treatment of individual subjects for whom there are no other treatment options. Subjects will be treated for 24 weeks with sofosbuvir (400mg QD) with RBV; pegylated interferon may be added at the discretion of the investigator.


Eligibility Criteria:
Inclusion Criteria:

* Age \> or = 18 years
* Previously undergone orthotopic liver transplant (OLT) at least 2 months prior to the planned start of dosing
* Aggressive Hepatitis C infection (including fibrosing cholestatic hepatitis C)
* Life expectancy of \< 12 months if the HCV is left untreated

Exclusion Criteria:

* History of clinically significant drug allergy to nucleoside/nucleotide analogs
* Participation in a clinical study with an investigational drug or biologic within 1 month prior to anticipated dose administration, unless information is available to determine that there is no safety or drug-drug interaction risk to the subject
* Unable or unwilling to follow the contraception requirements
Assessment of the Preoperative Risk Factors for the Development of Post-LASIK Ectasia

: Laser-assisted in situ keratomileusis (LASIK) is one of the most widely performed refractive surgeries, offering effective and long-lasting correction for visual refractive errors. While LASIK has a high success rate and is generally safe, post-LASIK ectasia remains a rare but serious complication that compromises visual outcomes. Several risk factors for post-LASIK ectasia have been identified. The aim of the present study is to determine the preoperative risk factors for the development of post-LASIK ectasia.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of corneal ectasia was made by progressive central or inferior corneal steepening, increased myopia and/or astigmatism, and decreased visual acuity

Exclusion Criteria:

* Subjects who had glaucoma diagnosis, other corneal surgeries (other than LASIK), and central corneal opacity
Artificial Intelligence to Search for Abnormalities in Ambulatory Cancer Patients

During treatment, cancer patients may experience side effects related to their disease but also to the different treatments they receive.

Currently, adverse effects and toxicities are well codified in the oncology community, notably via the NCI CTCAE criteria.

Unlike objective data such as a blood sample or a CTscan, a major bias in patient assessment is the subjective assessment of the physician or its team at a given time, which may not reflect the overall situation (for better or worse). Several studies had already highlighted the discrepancies between medical and patient data collection.

Self-assessment of symptoms is one way to overcome this bias. Moreover, there are now a large number of solutions that allow to perform these self-assessments at home.

Thanks to these tools, there are now two situations, the scheduled evaluation (before a chemotherapy treatment, or after a surgical procedure for instance) and the unscheduled situations, where it is the patient himself who can trigger an evaluation form.

These new evaluation methods also allow to take a quality of life approach. Patient-reported outcomes (PROs) is now a valid evidence-based assay to detect patient's symptoms and therefore provide helpful clinical information to healthcare providers.

The goal of this study is to go one step further than the previous PROs studies and evaluate the ability to train a machine learning algorithm to detect at-risk situations and lay the foundation for a viable solution for future prospective and randomized trials.


Eligibility Criteria:
Inclusion Criteria:

* Follow-up for a solid tumor
* Chemotherapy treatment (oral and/or injectable) scheduled or in progress
* Life expectancy \> 3 months
* Performance Status (PS) \< 3
* Have an internet connection or assistance to answer questions throughout the study (nurse, family members, etc.)
* Patient having understood, signed and dated the consent form
* Patient affiliated to the social security system

Exclusion Criteria:

* Lack of means to answer the online questionnaires
* Patient in another therapeutic trial with an experimental molecule
* Patients and their families who cannot read or speak French
* Persons deprived of liberty or under guardianship (including curatorship)
Head and Neck Phase III Iressa Versus Methotrexate Refractory: Iressa Versus Methotrexate (IMEX)

This study is to compare ZD1839 (250mg and 500mg) versus methotrexate in head and neck cancer in terms of overall survival.


Eligibility Criteria:
Inclusion Criteria:

* Histological confirmation of evidence of squamous cell carcinoma of the head and neck.
* Tumors have progressed after primary treatment with radiation or chemoradiation and have failed to respond to at least one course of standard platinum-based chemotherapy.
* Tumors have progressed after primary treatment with radiation or chemoradiation and are considered unsuitable for platinum-based chemotherapy.

Exclusion Criteria:

* Carcinomas of the post-nasal space, thyroid, sinus or salivary gland tumors.
* Isolated recurrent disease that may be amenable to local therapy; e.g., surgical intervention or radiation therapy.
* Known severe hypersensitivity to ZD1839, Methotrexate or any of the excipients of these products.