cyrilzakka/clinical-trials huggingface dataset:
Enhancing Health and Quality of Life for Individuals With Dementia Through Transitional-State Snacks

Malnutrition significantly contributes to the disability and mortality associated with Alzheimer's disease and Alzheimer's disease-related dementias. Thus, nutritional status is one important, modifiable clinical factor for maintaining physical and cognitive health among persons with dementia (PWD). This project will pilot an innovative approach to enhancing nutrition through the use of transitional-state snack supplements, or foods that start as one texture and change to another.

Specifically, this study aims to demonstrate the feasibility, acceptability, and safety of a transitional-state therapeutic nutrition supplement among adults with dementia. The central hypothesis is that access to ready-made, savory, nutrient- dense snack supplements that resemble "typical" preferred foods and eating habits will result in improved nutritional intake and status among PWD.


Eligibility Criteria:
Inclusion Criteria:

* Medically stable
* Community dwelling
* Has a medical diagnosis of dementia or possible dementia

Exclusion Criteria:

* Does not live at home
* Cannot participate in the protocol independently and do not have a consistent caregiver who can provide assistance
* Does not have smartphone access
* Requires 100% feeding assistance
* Is NPO (nil per os)
* Has multiple food allergies
* Requires a strict renal, low-fat, and/or no-salt diet
* Is deemed unsafe for the transitional-state foods by a speech-language pathologist
Effect of Mechanical Insufflation-exsufflation on Respiratory Parameters in Two Neuromuscular Populations.

A single session of Mechanical Insufflation-Exsufflation (with Cough AssistÒ) may improve airway flow and gas exchange in neuromuscular atrophy patients. The goal of this study is to confirm the beneficial effects of this treatment in a larger neuromuscular population, to study its mechanisms of action and to assess whether the effects observed persist over time. A better knowledge of this treatment should help to define its position in the respiratory management of neuromuscular patients.

30 SMA and DMD adult patients will be recruited in the home ventilation unit of the intensive care department of Raymond Poincaré Hospital (Assistance Publique-Hôpitaux de Paris,Garches, France).

Respiratory parameters and comfort will be evaluated before and after (5min,

1h, 3h) a MI-E session. Vital capacity, maximal inspiratory and expiratory pressures (PImax and PEmax), peak cough flow and peak expiratory flows will be measured. Breathing pattern will be recorded allowing the measurements of respiratory frequency, tidal volume, Inspiratory time (Ti),total breath (Ttot) during tidal breathing and the calculation of tension-time index (TT0.1).

Gas exchange will be evaluated by measuring end tidal CO2, transcutaneous CO2 and pulse oxymetry.

Respiratory comfort will be assessed with a visual analog scale. Optoelectronic plethysmography will be use to perform regional ventilation evaluation. Using chest wall motion analysis we will compute respiratory participation of upper, lower thorax and abdomen, right and left side.

Results should allow to analyse the effects of MI-E on regional ventilation. The mechanisms of action of MI-E on respiration and chest-wall motion will be analysed and the persistence of the beneficial effect of MI-E will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged more than 18 years
* Written consents
* Neuromuscular disorders
* Hemodynamic stability

Exclusion Criteria:

* Pulmonary disorder
* Acute respiratory failure
* Cognitive deficit
In Vitro Correction of Thrombin Generation by Concizumab (Anti-TFPI) for Severe Hemophilia Patients

Studies have shown, in haemophilia patients, the effectiveness of Anti TFPI antibody (aTFPIAb) to prevent joint and muscular bleeding (tissues poor in Tissue Factor (TF)). However, cases of cerebral thrombosis (tissues rich in TF) have been observed in some patients treated with this antibody. Because an inter-individual variation in thrombin generation correction by aTFPIAb, an aTFPIAb concentration effective at low TF concentration could be at the same time thrombogenic at high TF concentration.

The aim of this study is to determine, for each patient, the minimum concentration of aTFPIAb necessary to restore thrombin generation in the presence of low (1pM) TF concentration and to evaluate at this concentration of aTFPIAb a potential thrombogenic effect in the presence of a high (10pM) TF concentration.

Eligibility Criteria:
Inclusion Criteria:

* Severe or moderate haemophilia A or B patient with FVIII or FIX \<5% with or without prophylaxis
* Affiliated or beneficiary of a social security regimen
* Signature of consent

Exclusion Criteria:

* Haemophilia patients aged 12 years or less with a weight less than 30 kg (taking into account the volume of blood collection).
* Patients who received factor VIII concentrates less than 48 hours or factor IX concentrates less than 96 hours prior to the routine blood draw at the Hemophilia Clinic. 96 hours prior to the routine blood draw at the Hemophilia Centre
Monitored Breathing Awareness Therapy for Insomnia Disorder in Older Adults-2

Insomnia can be a chronic problem that leads to significant daytime fatigue, stress and numerous negative health consequences including depression. Advanced Medical Electronics, in partnership with researchers are the University of Pennsylvania, propose developing an innovative, non-drug, low-risk, intervention that can be implemented on mobile devices for the treatment of insomnia


Eligibility Criteria:
Inclusion Criteria: 1) Sleep onset latency \> 30 min for at least 3 nights per week

Exclusion Criteria: 1) Unable to perform tests due to inability to communicate verbally/blindness, inability to write and read in English (the study questionnaires are in English and do not exist in validated form for other languages). 2) Cognitive impairment; cognitively impaired patients may not be able to comply with the protocol). 3) History of a diagnosed non-insomnia sleep disorder, such as sleep apnea or circadian rhythm disorder 4) Upper extremity motor impairment that would preclude MBAT therapy (e.g., quadriplegia).
Short-Term Outcomes Of Subaxial Cervical Injuries

The subaxial cervical spine consists of levels C3 through C7 and includes both the bony anatomy as well as the ligamentous anatomy. Injuries to the subaxial cervical spine can be bony, discoligamentous or a combination of both (1). Cervical spine trauma is common resulting from high energy trauma such as falling from height and motor vehicle accident (2). Devastating sequelae of subaxial cervical spine trauma include quadriplegia, functional loss, and permanent disability

Initially, all patients with subaxial cervical spine fractures require immobilization in a rigid cervical orthosis (2). Patients receiving conservative treatment are often prescribed a rigid cervical or cervicothoracic orthosis for 6 to 12 weeks with regular follow-up and interval radiographs to assess alignment.

Patients with fractures deemed unstable or neurologic compromise should undergo decompression and stabilization. Intervention within 24 hours of injury leads to better improvement in ASIA scores (3). The recent AO Spine Subaxial Classification system relies essentially on MSCT evaluation (Reference). However, MRI is superior to CT scans for evaluating the spinal cord, nerve roots, disc, and ligamentous structures in the cervical spine (4).

Even though the investigators receive and treat a large number of patients with various subaxial cervical injuries in Assiut University Hospital each year, there is no consensus about the best treatment options and uncertainty about the outcome of these treatments.

In this study, the participants will assess the short-term outcomes of all patients with subaxial cervical fractures who will be admitted to the participants' center regardless of the neurological status or treatment type used.

The participants will also create a detailed prospective database to be used for another later study on the long-term outcome

Eligibility Criteria:
Inclusion Criteria:

* All patients presenting with subaxial cervical spine injuries with and without cervical cord injury between January 2022 and December 2022.

Exclusion Criteria:

* 1- Patients who refuse to participate in the study 2- Patients who are not available for 6 weeks follow up
A Trial of Dalotuzumab in Combination With Irinotecan Versus Cetuximab and Irinotecan for Participants With Metastatic Rectal Cancers (mRC) (MK-0646-025)

The purpose of this adaptive trial is to compare the progression-free survival of participants with metastatic rectal carcinoma when treated with intravenous (IV) dalotuzumab (MK-0646) + irinotecan therapy relative to participants treated with IV cetuximab + irinotecan. The primary hypothesis is that administration of dalotuzumab in combination with irinotecan to participants with wild-type KRAS metastatic rectal carcinoma with high insulin growth factor (IGF)-1/low IGF-2 expression levels improves progression-free survival compared to patients treated with cetuximab in combination with irinotecan.


Eligibility Criteria:
Inclusion Criteria:

* Has metastatic colorectal cancer with primary tumor originating from the rectum
* Has an available archival (recent or remote) tumor, or newly obtained formalin-fixed tissue available for analysis for biomarker studies
* Has at least one measurable lesion greater than or equal to 10 mm
* Disease has progressed after treatment with both irinotecan- and oxaliplatin-containing regimens and should have progressed on or within 3 months of completing their last line of therapy
* Has a performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale

Exclusion Criteria:

* Has poorly-controlled diabetes
* Has received chemotherapy or biological therapy within 2 weeks prior to initial dosing on this study, or whose toxicities from agents administered 2 weeks earlier have not resolved to at least grade 1 or baseline, or who is within 3 weeks from a prior surgery
* Has received radiotherapy within 2 weeks prior to initial dosing on this study, unless the radiotherapy was for management of pain
* Is currently participating or has participated in a study with an investigational compound or device within 30 days or 5 half-lives of the investigational agent, whichever is longer, of initial dosing on this study
* Was unable to complete previous course of irinotecan due to intolerable toxicity, other than discontinuation due to fatigue following prolonged administration (\>4 months exposure)
* Has prior exposure to insulin-like growth factor 1 receptor (IGF-1R) inhibitors or epidermal growth factor receptor (EGFR) inhibitors
* Has a known central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has primary CNS tumor
* Has a history of a prior malignancy with the exception of cervical intraepithelial neoplasia; basal cell carcinoma of the skin; adequately treated localized prostate carcinoma; potentially curative therapy with no evidence of that disease for 5 years, deemed low risk for recurrence by treating physician.
* Is human immunodeficiency virus (HIV)-positive
* Has active hepatitis B or C infection and is receiving antiviral treatment regimens
* Has symptomatic ascites or pleural effusion
* Is concurrently using growth hormone (GH), or growth hormone inhibitors
Development in Children Diagnosed with Congenital Muscular Torticollis

It has been thought that head position may affect the shoulder, rib cage and abdominal muscles, which may have a negative effect on posture control and movement development, sensory-motor coordination and cause retardation in gross motor function. For these reasons, children with congenital muscular torticollis should be evaluated comprehensively in the early period. This study, which was planned to evaluate the motor development and sensory processing of children with torticollis, was designed according to the lack of literature.

Congenital muscular torticollis (CMT) is a common postural deformity that occurs shortly after birth and is typically characterized by ipsilateral cervical lateral flexion and contralateral cervical rotation due to unilateral shortening of the sternocleidomastoid (SCM) muscle. It is a non-neurological postural disorder that usually affects 3% to 16% of infants. Theories such as intrauterine stenosis, vascular causes, fibrosis of the peripartum hemorrhage area, difficult labor, and primary myopathy of the SCM muscle have been put forward for its causes. In tissue samples taken after surgery, edema, degeneration of muscle fibers, and fibrosis have been reported. It is thought that CMT affects the muscles as well as head and facial development, causing various asymmetries, delays in gross motor functions, and disorders in posture and balance control. A bent neck position can cause plagiocephaly. Characteristic craniofacial deformities include asymmetry in the brow and cheekbones, deviation of the chin and nose tip, inferior orbital abnormality on the affected side, asymmetry in ear placement, and shortening of the vertical dimension of the ipsilateral face. In later periods, it has been shown that it may cause asymmetry in the use of the upper extremities, delay in gross motor functions, and effects on posture and balance control in children. It is thought that head position may affect the shoulder, rib cage, and abdominal muscles, which may have a negative effect on posture control and movement development, sensory-motor coordination, and cause gross motor function retardation. For these reasons, children with congenital muscular torticollis should be evaluated comprehensively in the early period. This study, which was planned to evaluate the motor development and sensory processing of children with CMT, was designed according to the lack of literature.

Eligibility Criteria:
Inclusion Criteria:

* Infants diagnosed with congenital torticollis between 0-12 months of age,
* with parental consent,

Exclusion Criteria:

* Children with chromosomal abnormalities,
* serious congenital problems,
* vision-hearing problem
* children whose parents do not volunteer for the study will not be included in the study.
A Bronchoprovocation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CSJ117 in Adult Subjects With Mild Atopic Asthma

This is a non-confirmatory, randomized, subject and investigator blinded, placebo-controlled, parallel-design, multi-center bronchoprovocation study. Approximately 55 subjects with mild stable atopic asthma who exhibit an EAR and LAR to a common inhaled allergen will receive multiple once daily doses of inhaled CSJ117 or placebo over 12 weeks. Two sequential dose cohorts are planned for this study, Cohort 1 and Cohort 2. Cohort 2 will be split into two parts, Cohort 2a and 2b


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stable mild atopic asthma, as defined by the American Thoracic Society/ European Respiratory Society statement, who exhibit an early and late asthmatic response to a common inhaled allergen during the screening allergen inhalation challenge.
* Throughout the screening period and at baseline, only infrequent use of inhaled short-acting beta2-agonists (less than or equal to twice weekly) to treat asthma and/or prophylactic use prior to exercise. Inhaled short-acting beta2-agonist must be withheld for 8 hours before spirometry.

Exclusion Criteria:

* Hospitalization or emergency room treatment for acute asthma in the 6 months prior to screening or during the screening period.
* Any worsening or exacerbation of asthma (e.g., an event requiring a change in treatment) in the six weeks before screening or during the screening period.
* A history of any clinically significant chronic pulmonary disease other than mild atopic asthma, including but not limited to COPD, interstitial lung disease or bronchiectasis
* Use of immunosuppressive medications or allergen-specific immunotherapy within 6 months prior to screening.
Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery

This Phase 3 study will evaluate APP13007 in comparison to the matching vehicle placebo in a randomized, parallel-group, double-masked fashion. The subjects will have undergone routine cataract surgery on Day 0 of the study and will be assessed the next day (Post-operative Day 1; POD1) after uncomplicated surgery for eligibility for randomization to study treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older expected to undergo unilateral uncomplicated cataract extraction via phacoemulsification and posterior chamber intraocular lens implantation in one eye.
* Have a pin-hole corrected visual acuity without other correction of ≤ 1.3 logarithm of the minimum angle of resolution (logMAR) in the study eye to be operated and contralateral eye as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at Visit 1.
* Willing and able to comply with study requirements and visit schedule.
* Provide signed and dated informed consent.

Exclusion Criteria:

* Have a known sensitivity or allergy to clobetasol propionate, corticosteroids, or any of the study medication's components including benzalkonium chloride and soybean lecithin or any routine medication required during cataract surgery or for the conduct of study procedures
* Have an ACC count \> 0 or any evidence of intraocular inflammation (e.g., flare) in either eye at the Screening visit
* Have a Grade \> 0 on the Ocular Pain Assessment in either eye at the Screening visit

Note: Other inclusion/exclusion criteria apply.
Fenretinide in Treating Patients With Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

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

OBJECTIVES: I. Determine the maximum tolerated dose and toxicity of oral fenretinide in patients with solid malignant tumors. II. Determine the pharmacokinetics of fenretinide and its metabolites. III. Determine the preliminary antitumor activity of fenretinide in this patient population. IV. Determine the recommended phase II starting dose of fenretinide. V. Determine whether fenretinide induces apoptosis in clinical specimens.

OUTLINE: This is a dose escalation study. Patients receive oral fenretinide once daily on days 1, 8 and 9 and three times a day on days 2-7. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Treatment continues for up to 6 months following complete remission. Accessible tumors are biopsied on day 8. Cohorts of 3-6 patients receive escalating doses of fenretinide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.

PROJECTED ACCRUAL: Approximately 21 patients will be accrued for this study within 6-9 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven solid malignant tumors (carcinoma or sarcoma) Not eligible for any known treatment or regimen of higher potential efficacy No history of CNS tumors or prior CNS metastases

PATIENT CHARACTERISTICS: Age: 15 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/mL SGOT/SGPT no greater than 2 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/mL OR Creatinine clearance at least 60 mL/min Cardiovascular: At least 6 months since any acute myocardial infarction No congestive heart failure No New York Heart Association class III or IV heart disease No clinically significant cardiac arrhythmias Pulmonary: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception No gastrointestinal bleeding or bleeding tendency

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy (at least 6 weeks since nitrosoureas or mitomycin) and recovered No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: Not specified Other: No prior systemic retinoid therapy
Stereotactic Body Radiotherapy vs Conventional Palliative Radiotherapy for Painful Non-Spine Bone Metastases

This study is being done to answer the following question: Is Stereotactic Body Radiation Therapy or SBRT (a form of radiation therapy which can deliver high doses of radiation to the specific painful area of the body most affected by cancer, while keeping the radiation beams away from the healthy parts of the body that surround the cancer) better for pain relief than the standard treatment of conventional radiation therapy or CRT (a form of radiation therapy which delivers radiation to the painful area but can also negatively affect other parts of the body in the same area)

This is a multi-centre, phase III randomized controlled trial comparing SBRT to conventional palliative EBRT in patients with solid tumours and a dominant painful non-spine bone metastasis as defined by a worst pain score of 2 or greater. 230 participants will be enrolled to the study. Participants will have radiation for 5 treatments (conventional palliative EBRT 20Gy/5; SBRT 30Gy/5 or 35Gy/5) and then will be followed for pain response and radiological progression at 3 and 6 months post treatment.

Eligibility Criteria:
Inclusion Criteria:

* Histologic confirmation of solid tumour.
* Patient with a dominant painful non-spine bone metastasis and a worst minimum pain score of 2 using the BPI attributed to that dominant site
* Expected overall survival of greater than 6 months as determined by the treating physician
* Suitable for protocol defined SBRT and CRT.
* Stable pain with no immediate plan to alter analgesic regimen.
* ECOG performance status of 0-2.
* Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrolment in the trial to document their willingness to participate

Exclusion Criteria:

* Metastases of the hands, feet, cranium and spine (including sacrum).
* Bone metastasis arising from a small cell or germ cell.
* Radionuclide therapy within 30 days of randomization.
* Patient treated with prior palliative RT to the dominant painful bone metastasis site (prior radiation exposure is permitted if prior to development of the dominant metastasis and would not influence the applicability of either treatment arm of the current study).
* Received systemic chemotherapy within 1 week of the protocol RT, or who are expected/planned to receive chemotherapy within one week of completing protocol RT.
* Participants with an unstable pathologic fracture at the dominant painful bone metastasis, or for whom surgical fixation would be the preferred intervention if possible.
* Pregnant or lactating individuals.