cyrilzakka/clinical-trials huggingface dataset:
Allogeneic Umbilical Cord Blood Therapy in Children With CP

This open-label study aims to analyze cytokines related to clinical outcomes of allogeneic umbilical cord blood therapy for children with cerebral palsy.

Cerebral palsy (CP) is a group of neurodevelopmental conditions with abnormal movement and posture resulted from a non-progressive cerebral disturbance. It is the most common cause of motor disability in childhood. Most therapies are palliative rather than restorative. Umbilical cord blood (UCB) may be used as restorative approach for children with CP.

Many experimental animal studies have revealed that UCB is beneficial to improve and repair neurological injuries.

Based on animal studies and some clinical trials, UCB is suggested as a potential therapy for children with CP. This study was designed to find cytokines relevant to UCB therapy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cerebral palsy
* Age of ≤15 years
* Mismatch in HLA-A, B, and DR ≤2, and total nucleated cell count ≥3x10\^7/kg. If the cell count is less than given values, more than 1 unit could be used.
* Decision of participation in the study by and acquisition of informed consent from the subject's representative
* Willingness and ability to be hospitalized according to the schedule specified in the protocol and continue the study for 12 months after study entry

Exclusion Criteria:

* Current aspiration pneumonia
* Known genetic disease
* History of hypersensitivity reaction to any study drugs pertinent to the study
* Patient with severe seizure disease who has clinical convulsion despite combination therapy with 3 or more agents
* Uncontrolled hypertension defined as systolic blood pressure \>115 mmHg and/or diastolic blood pressure \>70 mmHg
* Hepatic impairment defined as asparate aminotransferase (AST) \>55 IU/L and/or alanine aminotransferase (ALT) \>45 IU/L
* Renal impairment defined as creatinine (Cr) ≥1.2 mg/dL
* Presence of diagnosed or suspected malignant tumor and/or hematologic malignancy
* Non-compliance with study visits specified in the protocol or unwillingness of care-giver due to lack of understanding of the patient
SP-303T Applied to the Skin of Patients With Herpes Simplex Virus (HSV) Infection and AIDS Who Have Not Had Success With Acyclovir

To evaluate the safety and tolerance of topically applied SP-303T in AIDS patients. To observe the effect of this drug on herpes simplex virus lesions in patients who have failed to heal in response to oral or intravenous acyclovir therapy.

The lack of alternative treatments for herpes simplex virus infection in patients with AIDS and the development of resistance to acyclovir for patients requiring repeated treatment presents a therapeutic dilemma for physicians. SP-303T has good in vitro activity against resistant strains and offers a convenient and inexpensive means of drug administration in comparison to the use of intravenous medication.

The lack of alternative treatments for herpes simplex virus infection in patients with AIDS and the development of resistance to acyclovir for patients requiring repeated treatment presents a therapeutic dilemma for physicians. SP-303T has good in vitro activity against resistant strains and offers a convenient and inexpensive means of drug administration in comparison to the use of intravenous medication.

Patients receive 14 days (and up to 42 days) of treatment with topically applied SP-303T. SP-303T is applied directly onto herpes simplex virus lesions three times daily in a quantity sufficient to thinly cover the entire lesion, which may then be covered with an appropriate dressing, if needed. At the end of the treatment period, patients enter a follow-up period of 2 weeks.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV-1 infection.
* AIDS.
* Chronic mucocutaneous herpes simplex virus (HSV) infection, with one or more lesions unresponsive to oral acyclovir therapy.
* No uncontrolled infections other than HSV.
* Sufficient mental status to understand the purpose of the study and to comply with study requirements.
* Sufficient general health to be an outpatient and to come to the clinic for required follow-up visits.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Known hypersensitivity or allergy to citrus fruits, black currant berries, and rose hips.
* Any disease condition that, in the opinion of the investigator, would interfere with evaluation of the study drug, affect patient compliance, or place the patient at increased risk.

Concurrent Medication:

Excluded:

* Other unapproved investigational new drugs.
* Concurrent other therapy for herpes simplex virus (HSV) infection or medications with known activity against HSV.

Required:

* A minimum of 10 days of prior oral acyclovir (at least 1 g daily) or 10 days of prior intravenous acyclovir (15 mg/kg daily).
Comparing Magnesium 2g Versus 4g Versus Placebo in the Incidence of Treating AFF RVR

The purpose of this prospective, randomized, double-blinded study is to further evaluate the safety and efficacy of varying doses of intravenous magnesium in the treatment of AFF RVR.

Intravenous magnesium has become a commonly utilized agent in the treatment of cardiac arrhythmias as an adjunct therapy to rate and rhythm control medications, such as its use in atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR). Though its benefit in the treatment of AFF RVR has been well documented, a consensus on the optimal dosing of magnesium has yet to be achieved. Only one randomized, controlled, double-blinded study has investigated the optimal dosing of magnesium.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years or older
* Able to provide informed consent
* Primary diagnosis AFF RVR greater than or equal to 120 bpm
* Diltiazem as rate control agent
* English speaking

Exclusion Criteria:

* Hemodynamically unstable patients (SBP \<90, MAP \<65)
* Impaired consciousness
* End stage renal disease on hemodialysis or peritoneal dialysis
* Acute heart failure exacerbation based on clinical diagnosis, physician exam, bedside echo, and/or additional imaging
* Patient in AFF RVR that is highly suspected to be a compensatory mechanism for an alternative clinical diagnosis
* Rhythms other than AF, such as sick sinus syndrome or wide-complex ventricular response
* Acute myocardial infarction
* Pregnancy defined as a positive urine HCG (human chorionic gonadotropin)
* Contraindications to magnesium sulfate (including myasthenia gravis)
* Allergy or sensitivity to any study drugs
* Previously enrolled in this trial during a different patient encounter
* Withdrew from study
An Italian Multicentric Retrospective Observational Study to Assess Effectiveness and Safety of the Combination of Tafasitamab and Lenalidomide in Diffuse Large B-cell Lymphoma Patients Treated Under Named Patient Program

The study is pilot, observational, retrospective, Italian multicenter study.

The study will involve the collection of patient data from medical records of patients with R/R DLBCL treated with at least one dose of tafasitamab in association with lenalidomide as part of standard of care under the NPP (D.M. 7 Sep 2017), between April 2022 and December 2022, in several selected Italian centres. The observational, non-interventional nature of the study is based on the retrospective observation of current clinical practice without the application of any kind of ad hoc 'intervention' for the study itself. In fact, patients participating in the study will not be subjected to any procedures outside the normal clinical practice; likewise, the clinical variables that will be collected for the study are those that are already commonly collected by the physicians in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed diagnosis of R/R DLBCL.
2. Patientswho received at least one dose of tafasitamab in association with lenalidomide under the NPP (D.M. 7 Sep 2017), between April 2022 and December 2022.
3. Age ≥ 18 years at enrollment.
4. Signature of written informed consent (if applicable).

Exclusion Criteria:

1) R/R DLBCL patients who received tafasitamab in association with lenalidomide in a clinical trial context.
Evaluation of Changes in Weight, Sleep, and Other Psycho-behavioural Parameters During Covid-19 Confinement in Subjects Monitored by the RNPC Network

During confinement, food intake can become compulsive, physical activity is significantly reduced, sleep is altered with exacerbated anxiety and stress levels and increased family violence. In some at-risk patients, mental health may even deteriorate. The temptation is great for all to take refuge in food or in front of screens. The main elements that can impact weight changes during this period of confinement are stress and anxiety, lack of physical activity, changes in eating habits, sleep disturbance and alcohol consumption.

The investigators wish to study the impact of confinement on pre-post confinement weight loss kinetics in adults included in weight reduction programs (RNPC).


Eligibility Criteria:
Inclusion Criteria:

* BMI \> 25 kg/m² and/or waist circumference \> 80 cm in women and 94 cm in men
* Persons registered in the RNPC program
* Be legally able to give consent after adequate information and submission of the information note
* Person affiliated to social security

Exclusion Criteria:

* Being unable to understand, follow objectives and methods due to cognition or language problems Subjects listed in articles L1121-5 à L1121-8: Pregnant women, feeding and parturient; subject under administrative or judicial control, persons who are protected under the act.
S-3304 in Treating Patients With Advanced Solid Tumors

RATIONALE: S-3304 may stop or slow the growth of solid tumors by stopping blood flow to the tumor.

PURPOSE: Phase I trial to study the effectiveness of S-3304 in treating patients who have solid tumors.

OBJECTIVES:

* Determine the maximum tolerated dose and safety profile of S-3304 in patients with advanced solid tumors.
* Determine the pharmacokinetic profile of this drug in these patients.
* Estimate the starting dose of this drug for subsequent phase II efficacy studies.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive oral S-3304 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 6-8 patients receive escalating doses of S-3304 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 3 of 8 patients experience dose-limiting toxicity.

Patients are followed at 30 days.

PROJECTED ACCRUAL: A total of 6-28 patients will be accrued for this study within 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed solid tumor that failed to respond or relapsed after prior therapy or for which no standard therapy exists
* Biopsy-accessible lesion
* No brain metastasis unless clinically stable and off therapy

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2

Life expectancy:

* More than 6 weeks

Hematopoietic:

* Absolute neutrophil count greater than 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9.0 g/dL

Hepatic:

* Bilirubin no greater than 2 times upper limit of normal (ULN)
* Transaminases less than 2.5 times ULN

Renal:

* Creatinine less than 2.0 mg/dL

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 30 days after study
* Able to tolerate oral medication
* HIV negative
* No AIDS
* No serious underlying gastrointestinal disorders (e.g., recurrent vomiting or inflammatory bowel disease)
* No other serious concurrent illness

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 4 weeks since prior immunotherapy
* Concurrent stable doses of epoetin alfa are allowed during the second and subsequent courses
* No other concurrent immunotherapy

Chemotherapy:

* At least 4 weeks since prior chemotherapy
* No concurrent chemotherapy

Endocrine therapy:

* At least 4 weeks since prior hormonal therapy
* Concurrent stable doses of steroids for prostate cancer are allowed during the second and subsequent courses
* No concurrent hormonal therapy

Radiotherapy:

* At least 4 weeks since prior radiotherapy
* No concurrent radiotherapy

Surgery:

* No prior significant gastric resection

Other:

* Recovered from prior therapy
* At least 4 weeks since other prior investigational antitumor drugs
* No other concurrent investigational antitumor drugs
* Concurrent stable doses of bisphosphonates, cyclo-oxygenase-2 inhibitors, and non-steroidal anti-inflammatory drugs are allowed during the second and subsequent study courses
Examination of the Anti-inflammatory and Insulin Sensitizing Properties of Doxycycline in Humans

Obesity is a heightened state of inflammation in which production of cytokines and matrix metalloproteinases (MMPs) result in loss of function of insulin receptors and insulin resistance. Doxycycline (DOX) is a potent MMP inhibitor. We hypothesize that DOX will enhance insulin sensitivity and decreases inflammation in obese participants with type 2 diabetes (DM2).

Design and Setting: 84 day (D84), double-blind, randomized, placebo (PL)-controlled clinical trial conducted in an academic tertiary care center.

Patients: Non-DM2 Controls (n=15); participants with DM2 receiving PL (n=13) or DOX (n=11).

Interventions: All participants were evaluated at day 1 (D1); those with DM2 were also evaluated at D84 after DOX 100mg twice daily or PL.

Eligibility Criteria:
Inclusion Criteria:

* Ambulatory, medically stable, able to give informed consent, and comply with the protocol.
* Obesity with BMI \>30 kg/m2.
* DM2 for less than 10 years.
* 7.5% \< HA1C \< 10%
* Taking insulin and/or oral medications (biguanide, sulfonlylurea, etc.)

Exclusion Criteria:

* Mental states that would preclude complete understanding of the protocol and compliance.
* Chronic illness such as renal failure (with creatinine clearance \<80 ml/min for Specific Aim 2).
* Women of child-bearing age because of the potential hazard to the fetus (doxycycline may cause permanent discoloration of the teeth and deposition in bone inhibiting growth) and because doxycycline may render oral contraceptives less effective.
* Nursing mothers.
* Allergy to tetracyclines.
* Subjects taking the following drugs: penicillin or it's derivatives, anticoagulant therapy, antacids containing aluminum, calcium, or magnesium, iron-containing preparations, bismuth subsalicylate, barbiturates, carbamazepine, phenytoin or methoxyflurane, thiazolidinediones (TZD)
Evaluation of Improved Onboard Patient Imaging

The primary objective of radiation therapy is to deliver a therapeutic dose of radiation precisely to the target while minimizing exposure to healthy surrounding tissues. Image-guided radiation therapy (IGRT) involves acquiring cone beam computed tomography (CBCT) scans just before or during treatment sessions. By comparing the CBCT images with the reference images from the treatment planning process, clinicians can make necessary adjustments to ensure precise targeting and account for any changes that may have occurred since the initial planning. Conventional CBCT technology is, however, limited by several factors including long acquisition times that result in motion artifacts in the image, smaller fields of view that limit the volume of anatomy that can be imaged, poor image quality that limits soft tissue visibility, and artifacts created by dense metal implants. This study will evaluate a novel CBCT imaging solution ("HyperSight") that has the potential to address the challenges of conventional CBCT.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is willing and able to provide written consent.
2. Patient is at least 18 years of age at the time of consent.
3. Patient has biopsy confirmed malignancy and recommendation for definitive or palliative radiation to the head and neck, breast, lungs, upper GI structures, or pelvis.
4. Patient has ECOG performance status 0-2.
5. Patient will be receiving radiation therapy at University of Maryland Medical Center, Department of Radiation Oncology.

Exclusion Criteria:

1. Patient is pregnant or attempting pregnancy.
2. Patient has implanted cardiac devices or nerve stimulation devices.
3. Patient has known genetic pre-disposition for sensitivity to radiation (e.g., Li Fraumeni).
4. Patient receives palliative radiation for 5 or fewer fractions.
5. Patient is part of a vulnerable population (per ISO 14155:2020, "individuals who are unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response"). This includes prisoners.
CanScan; Community-based Registry to Assess, Address and advaNce SCreening for cANcer Prevention and Management

Early diagnosis of cancer allows for better treatment outcomes, higher survival rates, and lower costs of care. It is shown that cancer monitoring for cancer in at-risk populations is a key component in early diagnosis. The HMH Hennessey Institute for Cancer prevention and Applied Molecular Science (HICAP) is a newly founded institute, providing clinical services for cancer screening and risk assessment to the community, as well as research in cancer risk and prevention. The CanScan registry will prospectively collect data from participants in the form of questionnaires. The registry will also capture data that is collected as per non-research assessments, for participants who consent to participate. The registry will facilitate better understanding of cancer risk, screening, and diagnostics.


Eligibility Criteria:
* Adults ( 18 and older)
* Ability to provide own consent
* Must meet at least one of the below criteria, Indicating an increased risk for cancer, any of the following:

  * Family or personal history suggests a familial/hereditary disorder known or suspected of predisposition to cancer.
  * Personal factors associated with an increased risk for cancer include benign breast disease, polyps, tobacco use, etc.as defined by the investigator.
  * Family members of participating individuals.
* Any participant in the HICAP program regardless of cancer risk
Transcricoid Injection vs. Spray as You go Method for Local Anaesthesia During Bronchoscopy

Flexible bronchoscopy is one of the most widely performed procedures for diagnosis of various bronchopulmonary diseases. Most patients tolerate the procedure well although cough is often reported as a distressing symptom. It is likely that the acceptance of bronchoscopy would be significantly improved with control of cough. Use of sedation during bronchoscopy has been reported to improve procedure tolerance. However, awake(no sedation) bronchoscopy is routinely performed at many centres including ours.

Topical lignocaine is administered during bronchoscopy for local anaesthesia. There is limited literature on the efficacy of transtracheal/transcricoid injection versus spray as you go method for lignocaine delivery to the airways during bronchoscopy. This study would help to determine the procedure comfort for the patient while using the transtracheal/transcricoid method vs the spray as you go method.

For all patients meeting the inclusion criteria, the demographic profile including age, sex, weight, smoking history and the type of procedures performed during bronchoscopy shall be recorded. A written informed consent will be obtained from all participants. The patients who undergo flexible bronchoscopy would be randomised in a one is to one ratio either to transcricoid or spray as you go group. Prior to the bronchoscopy blood pressure, pulse rate, respiratory rate and pulse oximetry saturation will be recorded at the baseline Patients in both the groups shall be prepared in a similar fashion except for the initial route of lignocaine delivery.

During the procedure, 1.5 ml aliquots of 2% lignocaine solution will be delivered through the bronchoscope when using spray-as-you go technique. Patients in the transcricoid group shall initially receive 5 ml of 2% lignocaine solution instilled transtracheally along with two baseline 1.5 cc bronchial spray aliquots of lignocaine, and additional aliquots of 2% lignocaine using the spray as you go method. The total lignocaine dose during the procedure will be recorded. The patients would be monitored for any adverse effects throughout the procedure. The bronchoscopist doing the procedure will be provided 2 VAS charts to mark the severity of cough and overall procedure satisfaction. Cough count shall be noted.

Eligibility Criteria:
Inclusion Criteria:

* Indication for diagnostic or therapeutic flexible bronchoscopy
* Age \> 18 years
* Hemodynamic stability (defined as systolic BP \>100 mm Hg and, \<180 mm Hg).

Exclusion Criteria:

* Refusal of consent
* Known documented hypersensitivity to lignocaine
* Procedure performed under general anaesthesia
* Pregnancy
* Hypoxemia (oxygen saturation \[by pulse oximetry\] \< 92% with Fio2 of ≥ 0.3
* Bronchoscopy done through endotracheal or tracheostomy tube
* Midline neck mass or thyroid enlargement making the identification of cricothyroid membrane difficult'
* Patients with central airway obstruction
* Patients with active ongoing hemoptysis
A Study of Cognitive-Behavioral Therapy for Rumination Disorder

The primary aim of this study is to pilot cognitive behavioral therapy (CBT-RD) for 10 individuals ages 10 and older who have rumination disorder

Rumination disorder (RD; also known as "rumination syndrome") is a disordered eating behavior characterized by the repeated regurgitation of food during or soon after eating. The frequency of repeated regurgitation of food typically occurs at least a few times per week, frequently daily with subsequent re-chewing, re-swallowing, or spitting out of the regurgitated material. The widely used technique for treatment of RD has typically been diaphragmatic breathing, which works by serving as a competing response to abdominal wall contractions, which is hypothesized to trigger regurgitation. However, the efficacy of diaphragmatic breathing remains unknown and has mainly been delivered through a one-session instruction with an occasional follow-up.

In the absence of evidence-based treatments for RD, the investigators, alongside a collaboration with Dr. Jennifer Thomas at the Eating Disorders Clinical and Research Program (EDCRP) at Massachusetts General Hospital, have created a manualized treatment, Cognitive-Behavioral Therapy for Rumination Disorder (CBT-RD) informed by published case reports and currently in use at EDCRP at Massachusetts General Hospital and the Psychological Services Center at Drexel University. CBT-RD targets the habitual contraction of the abdominal wall and preceding events through the use of habit reversal, using primarily diaphragmatic breathing as a competing response.

This study involves a phone screen to determine eligibility, followed by 5-8 sessions of CBT-RD (approximately 50 minutes each). A battery of questionnaires will be administered at pre-treatment, post-treatment, and 3-month follow-up intervals.

Eligibility Criteria:
Inclusion Criteria:

* Age 10 or above
* Experience repeated regurgitation of food during or soon after eating, consistent with rumination disorder
* If applicable, have stable psychiatric medication for the past three months

Exclusion Criteria:

* Currently engage (in past three months) in any regular compensatory behaviors (e.g., self-induced vomiting, laxative/diuretic use)
* Current diagnosis of anorexia nervosa
* Acute suicide risk
* Are currently receiving psychological treatment for rumination disorder
* Co-morbid clinically significant psychological disorder that would require attention beyond the study treatment (e.g., psychotic disorder, substance dependence)
* Current pregnancy