cyrilzakka/clinical-trials huggingface dataset:
Nebulized RNS60 for the Treatment of Amyotrophic Lateral Sclerosis

The purpose of this study is to determine whether nebulized RNS60 is effective in the treatment of amyotrophic lateral sclerosis (ALS).


Eligibility Criteria:
Inclusion Criteria:

* Probable, probable-laboratory supported, or definite ALS, either sporadic or familial according to modified El Escorial criteria
* Disease duration \< 3 years
* Age 18 to 80
* Able to provide informed consent and to comply with study procedures
* Subjects must not have taken riluzole for at least 30 days, or be on a stable dose of riluzole for at least 30 days, prior to screening (riluzole-naïve participants are permitted in the study)
* Women must not be lactating or able to become pregnant (e.g. post menopausal, surgically sterile, or using adequate birth control) for the duration of the study, and for 3 months after study completion
* Men should practice contraception for the duration of the study and for 3 months after completion

Exclusion Criteria:

* Diagnosis of a motor neuron disease other than ALS (e.g., primary lateral sclerosis, progressive muscular atrophy, progressive bulbar palsy)
* Clinically significant unstable medical condition (other than ALS) that would pose a risk to the participant if they were to participate in the study or that would impact survival or functional disability in the next 12 months
* Abnormal liver function defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 3 times the upper limit of the normal
* Renal insufficiency (Glomerular Filtration Rate \< 60)
* Active pulmonary disease
* Prior poor compliance with an inhalation device
* The presence of unstable psychiatric disease, cognitive impairment, or dementia that would impair ability of the participant to provide informed consent, according to judgment by the principal investigator.
* History of human immunodeficiency virus (HIV) infection, clinically significant chronic hepatitis, or other active infection.
* Active participation in another ALS clinical trial within 30 days of the Screening Visit
* Other experimental treatments or anti-inflammatory/immunomodulatory medications used in the preceding 3 months
Treatment Chronic UTI Post Kidney Transplant

Urinary tract infections (UTIs) with extended-spectrum -lactamase (ESBL)-positive Enterobacteriums (ESBL-E) are a common infectious complication of renal transplant recipients, with 10% of patients suffering from UTIs with ESBL-E within the first year posttransplant. Moreover, recurrence rates of UTI caused by ESBL-E are almost three times higher than those by cephalosporin-susceptible Enterobacteriums demonstrating the decreased efficacy of antibiotics in the treatment of these UTIs.

According to each patient's urine culture, resistant urinary tract infections will be treated with specific phages and patients will be followed up with their urine cultures for response to therapy.

Eligibility Criteria:
Inclusion Criteria:

* Stable Kidney Transplant Recipients
* Stable Immunosupression Dose
* Stable Renal Function
* Resistant Urinary Infection with Positive UC

Exclusion Criteria:

* Rejection periods
* Frail Patients
A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium)

To assess the relative efficacy of oral versus intravenous hydration during foscarnet sodium (Foscavir) induction therapy, as determined by changes in creatinine clearance. To estimate the timing and volume of oral fluid hydration required to establish a diuresis before and during intravenous Foscavir therapy. To assess the general tolerance of two hydration regimens by the adverse event profile associated with each.

Patients are randomized to receive oral hydration versus intravenous hydration therapy during concomitant intermittent intravenous Foscavir therapy for treatment of cytomegalovirus (CMV) retinitis. Treatment continues during 2 or 3 weeks of induction Foscavir therapy.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Documented HIV infection.
* Recent diagnosis of CMV retinitis, by ophthalmoscopic appearance, that requires induction therapy.
* No corneal, lens, or vitreous opacification that precludes examination of the fundi.
* No evidence of other end organ CMV infection.
* No evidence of tuberculous, diabetic, or hypertensive retinopathy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Clinically significant cardiac, pulmonary, neurologic, gastrointestinal or renal impairment that would prevent adequate voluntary oral hydration (e.g., intubation, coma, status post-gastrectomy, colon resection, gastrointestinal tumors, malabsorption, chronic diarrhea) OR with which hydration would be hazardous (e.g., congestive heart failure).
* Known allergy to foscarnet or related compounds.
* Considered noncompliant or unreliable for study participation.

Concurrent Medication:

Excluded:

* Any investigational drug.
* Potentially nephrotoxic drugs (e.g., amphotericin B, aminoglycosides, cisplatin).

Prior Medication:

Excluded:

* Any investigational drug within 28 days prior to study entry.
* Potentially nephrotoxic drugs (e.g., amphotericin B, aminoglycosides, cisplatin) within 7 days prior to study entry.
A Microdose Evaluation Study of ABY-029 in Primary Sarcoma

The primary study objective is to determine if microdoses of ABY-029 (up to 6X) lead to detectable signals (defined as signal-to-noise ratio, SNR ≥10, with the Odyssey NIR scanner in sampled tissues with an EGFR pathology score ≥ 1 based on histological staining and compare SNR to tissues with an EGFR pathology score \< 1).

The secondary study objective is to assess if the spatial patterns of EGFR expression correlate with the tumor targeting of ABY-029 detection by NIR scanner relative to histopathology diagnosis, and other indicators (e.g. proliferation, infiltration, etc.) as the gold standard, and to measure the molecular uptake and concentration of ABY-029 in resected specimens.

The investigators plan to enroll a minimum of 6 and a maximum of 12 adult patients with a diagnosis of primary soft-tissue sarcoma in this open label, single center, clinical trial of ABY-029. The study will enroll patients with an EGFR pathology score ≥ 1.

Initial diagnostic biopsy specimens will be analyzed for EGFR positivity by immunohistochemistry following routine diagnostic processing by Pathologist. Patients will be administered a single intravenous dose of ABY-029 1-3 hours before surgery. Following tumor excision, the tumor will be transported to the Pathologist and will be inked and sectioned. Following sectioning the tumor will be imaged using near-infrared imaging systems. Quantitative measurements of fluorophore concentration will be measured for tumors with EGFR pathology score ≥ 1 and compared to those with EGFR pathology score \< 1. Quantitative mapping of fluorophore concentration will be correlated with local EGFR concentration and blood vessel density. Upon specimen analysis, fluorophore measurements will be taken from normal, marginal tissues (e.g. skeletal muscle, adipose) in addition to the tumor. Average EGFR concentration and blood vessel density will be determined for each tumor through histological analysis of sections by routine sarcoma protocol and analysis guided by regional variations in ABY-029 concentration based upon near-infrared scan results.

The protocol is not a safety study since no physiological effects are expected at microdose levels of ABY-029. No diagnostic or therapeutic intent is proposed, and administration of the study drug is not intended to alter the extent of planned tumor resection during the surgical procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Preoperative histological diagnosis of primary sarcoma.
2. Tumor judged to be suitable for open surgical resection based on preoperative imaging studies.
3. Valid informed consent by subject.
4. Age ≥ 18 years old.

Exclusion Criteria:

1. Pregnant women or women who are breast feeding.
2. Patients on any experimental anti-EGFR targeted therapies, either investigational or FDA approved.
Reliability and Validity of HHIRS General Quality of Life Questionnaire

Quality of life is conceded by copious musculoskeletal and neurogenic conditions which are evaluated by manifold questionnaires. These questionnaires are obtainable in English and many other languages but in Pakistan, these cannot be applied due to differences in languages, lifestyles, culture, and activities of daily living (ADL's). In relation to the culture of Pakistan, there are many accomplishments such as offer prayers and other domestic obligation which cannot be executed appropriately if any Musculoskeletal and neurogenic disorders are existing. All these disorders can be assessed appropriately by questionnaires previously accessible but not in a single tool.

HHIRS developed a general quality of life questionnaire in the Urdu language for the expediency of patients. Relation of the questionnaire with upper limb has been identified but there is no clear relation with other body regions. Consequently, the purpose of this research is to evaluate the validity and reliability of the HHIRS-General-QOL Questionnaire in the Urdu Speaking Population of Pakistan.

Eligibility Criteria:
Inclusion Criteria:

* participants able to read and write Urdu
* neurological disorders
* musculoskeletal pain
* systemic diseases

Exclusion Criteria:

* communication disorder
* cognitive disorder
Antioxidant Status During Burn Rehabilitation

It is believed that children with a prior history of significant burn injury continue to manifest low levels of antioxidants well into their convalescence.The purpose of this study is to examine malondialdehyde (an oxidative lipid marker) and vitamins E, C and beta carotene status in reconstructive burn patients.


Eligibility Criteria:
Inclusion Criteria:

* Greater than 3 but less than 19 years
* Reconstructive or followup outpatient care at least 1 year postburn
* Initial burn size \> 40%
* Written informed consent and HIPAA authorization

Exclusion Criteria:

* History of multivitamin or steroid use, liver disease, preburn malnutrition
A Randomized Pilot Study to Evaluate the Effects of a Short Course of Metformin Versus No Therapy in the Period Prior to Hysterectomy for Grade 1-2 Adenocarcinoma of the Endometrium in Obese Non-Diabetic Women

The purpose of this research is to determine the effects of Metformin, a well tolerated drug widely prescribed for treatment of Type 2 Diabetes Mellitus, on endometrium cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Histological confirmed diagnosis of grade I or II adenocarcinoma of the endometrium
* Must be obese as defined by a body mass index (BMI) greater than or equal to 30 kg/m2
* Candidate for surgical removal of their uterus as part of their endometrial cancer treatment
* Subjects must have signed informed consent
* Age 42 - 65 years of age
* Electrocorticogram (ECOG) Performance status of 0 - 2
* History of adequate renal, liver, and bone marrow function:

  * Hb: (adequate for surgical intervention, with transfusion if necessary) White Blood Cell (WBC): (normal range)
  * Platelets: (180K/cmm)
  * Liver Function Test(LFTs): Normal bilirubin (\<2.0mg/dL), AST/ALT (2xULN)
  * Renal function: creatinine less than 1.4
* Female subjects must either not be of child-bearing potential or must have a negative urine pregnancy test within 7 days of randomization to Metformin. Subjects are considered not of child-bearing potential if they are surgically sterile or they are postmenopausal for greater than 12 months.

Exclusion Criteria:

* Poorly differentiated cancer or any of the high-risk subtypes of endometrial cancer including serous, clear cell, or carcinosarcoma
* History of diabetes mellitus Type 1 or Type 2.
* Receiving metformin prior to enrollment
* Known hypersensitivity to metformin.
* Unable to swallow and retain oral medication.
* Pregnant or lactating.
* Previous or concurrent malignancies, except non-melanoma skin cancers, unless curatively treated and with no evidence of recurrence for \> 5 years
* If the physician feels that the candidate is not suitable for the study, he/she will be excluded.
* Currently taking biguanides, sulfonylurea drugs, thiazolidinediones, insulin, or mTOR or DPP-4 inhibitors or having taken any of these medications during the 12 weeks prior to study participation.
* Clinical symptoms of gastrointestinal obstruction or bleeding and consideration for immediate surgery or immediate neoadjuvant chemoradiation.
* History of lactic or other metabolic acidosis.
* Uncontrolled infectious disease.
* History of positivity for human immunodeficiency virus (HIV).
* History of congestive heart failure requiring pharmacologic treatment.
* History of excessive alcohol abuse, defined by a habitual intake of more than three drinks daily.
* Mal-absorption syndrome, disease affecting gastrointestinal function, or previous resection of the stomach or small bowel.
* Current use of medications for weight loss.
* Currently taking cimetidine, thiazide diuretics or cephalexin. If a patient needs some of these agents, alternative agents should be substituted.
Controlled Trial to Test the Efficacy of Lipid-based Nutrient Supplements to Prevent Severe Stunting Among Infants

This study tests the hypothesis that infants receiving milk-powder containing fortified spread (lipid-based nutrient supplement) as a complementary food for one year have lower incidence of severe stunting (poor length gain) than infants who are provided with no extra food supplements or maize-soy flour for complementary porridge.

Poor growth and severe childhood stunting is very common in rural Malawi and elsewhere in Sub-Sahara Africa. To date, few interventions have proven successful in promoting linear growth in early childhood. Our preliminary results from Malawi suggest that a year-long daily complementary feeding of infants with a high-energy, micronutrient-fortified spread (FS) may markedly reduce the incidence of severe stunting before the age of 18 months. In the present study the investigators will more carefully analyze the efficacy in linear growth promotion and other health benefits of this product when provided as a complementary food to infants between 6 and 18 months of age.

The study will be conducted in Lungwena area, Mangochi District, rural Malawi. Six-month old healthy infants are identified through community surveys in the study area. 840 infants meeting set criteria are randomized into receiving the following intervention between 6 and 18 months of age: 1) standard treatment ie no extra food supplements (but dietary supplementation between 18 and 30 months of age) (ST-DI, control group), 2), "standard" fortified spread with milk-powder as the protein source (FSm), 3) modified fortified spread with soy-powder as the protein source (FSs), or 4) fortified maize-soy flour (likuni phala, LP). The families receive the food supplements at 2-weekly intervals and the participants undergo an anthropometric and developmental evaluation and laboratory analyses at 12-week intervals. Outcome analyses are done at 18 and at 36 months of age.

The impact of the dietary interventions will be primarily assessed by comparing the incidence of severe stunting in the four study groups. Secondary outcomes include a number of anthropometric variables, morbidity, developmental milestones, and laboratory parameters. The study will also produce descriptive data on possible mechanisms for growth failure among the trial subjects.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent from at least one guardian
* Age 5.50 months to 6.49 months
* Availability during the period of the study.
* Permanent resident of Lungwena Health Centre or Malindi Hospital catchment area

Exclusion Criteria:

* Existing or imminent severe stunting (HAZ \< -2.8)
* Weight for length (WFH) \< 80% of the reference median or presence of oedema
* Severe illness warranting hospital referral.
* History of allergy towards peanut
* History of anaphylaxis or serious allergic reaction to any substance, requiring emergency medical care
* Concurrent participation in any other clinical trial
An Investigational Immunotherapy Study of BMS-986301 Alone or in Combination With Nivolumab, and Ipilimumab in Participants With Advanced Solid Cancers

The main purpose of this study is to characterize the safety, tolerability, dose limiting toxicities, best route of administration, maximum tolerated dose, maximum administered dose, or alternative dose of BMS-986301 alone or in combination with nivolumab and ipilimumab in participants with cancers that have failed to respond to T cell checkpoint inhibiting antibodies.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed advanced unresectable/metastatic malignancy of the squamous cell carcinoma of the head and neck (HNSCC), non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma (RCC), triple negative breast cancer (TNBC), and urothelial carcinoma (UCC), that are refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant
* Must have experienced radiographically documented progressive disease on or after the most recent therapy
* Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
* Women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial

Exclusion Criteria:

* Primary central nervous system (CNS) malignancy
* Other active malignancy requiring concurrent intervention
* Uncontrolled or significant cardiovascular disease

Other protocol defined inclusion/exclusion criteria apply
A Study of Concomitant Camrelizumab With Chemoradiation for Locally Advanced Head and Neck Cancer

The goal of this study is to determine the efficacy and safety of camrelizumab given concomitantly with chemoradiation in participants with unresectable, locally advanced head and neck squamous cell carcinoma (LA-HNSCC). All participants will receive camrelizumab in addition to chemoradiation, the standard treatment for LA-HNSCC.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Has a pathologically proven new diagnosis of head and neck squamous cell carcinoma
* Has unresectable disease and is eligible for definitive chemoradiation based on investigator decision
* Has Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Has evaluable tumor burden (measurable and/or non-measurable tumor lesions) based on RECIST version 1.1
* Has adequate organ function as defined
* Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study therapy
* Female and male participants of reproductive potential must agree to use adequate contraception throughout the study period and for up to 180 days after the last dose of study therapy

Exclusion Criteria:

* Has cancer outside of the oropharynx, larynx, and hypopharynx or oral cavity, such as nasopharyngeal, sinus, other para-nasal, or other unknown primary head and neck cancer
* Is currently participating or has participated in a study with an investigational agent or using an investigational device within 4 weeks of the first dose of study therapy
* Has history of a diagnosed and/or treated hematologic or primary solid tumor malignancy, unless in remission for at least 5 years prior to randomization
* Has a history of severe hypersensitivity reaction to camrelizumab, Cisplatin or radiotherapy
* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study therapy
* Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody or has previously participated in clinical studies with camrelizumab
* Has received a live vaccine within 30 days prior to the first dose of study therapy
* Has had prior systemic therapy, targeted therapy, radiotherapy treatment or radical surgery for head and neck cancer under study
* Has not recovered from major surgery prior to starting study therapy
* Has known active Hepatitis B or C
* Has known history of Human Immunodeficiency Virus (HIV)
* Has a significant cardiovascular disease
* Has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is not considered a form of systemic treatment
* Has had previous allogeneic tissue/solid organ transplant
* Has active infection requiring systemic therapy
* Is pregnant or breast feeding
Correlation of Visual and Motor Deficits in Stroke Patients

This is a prospective study of patients with stroke with accompanying motor and visual deficits. There will be patients' evaluations at 2 time points at the acute and subacute period after the stroke. Statistical correlation of the improvement of their deficits will be conducted


Eligibility Criteria:
Inclusion Criteria:

acute phase stroke patients with motor and visual deficits

Exclusion Criteria:

previous stroke, neurologic disease or visual deficit
Observational Study of Preoperative Screen for Substance Abuse

Substance abuse is a growing problem world wide, and treatment of substance abusers in the perioperative period, especially for emergency operation is challenging. The objectives of this study are to determine the proportions of substance abusers in the trauma patients undergoing emergency operation by preoperative screen, observe the differences of consumption of anesthetics and other medications during perioperative period between substance abusers and non-abusers, as well as postoperative complications, and explore an optimal scheme for substance abusers.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 16\~70 years；
* Informed consent signed

Exclusion Criteria:

* Aged\<16 years or \>70 years；
* Refuse to sign consent;
* Other conditions that may preclude the patients from the study, such as language barrier, psychiatric disorders, unable to attend research center for follow up.
* Patients who enrolled to another research study or are taking experimental medication in last 3 months prior to this study.
* Not suitable for the study, after assessment by the investigators.
Safety Study of Combining Ultrasound Microbubbles and Chemotherapy to Treat Malignant Neoplasms of Digestive System

Ultrasonic sonoporation can increase the release of chemotherapeutics, thus increasing the therapeutic effects. The main purpose is to identify the safety of combining ultrasonic microbubbles and chemotherapeutics to treat malignant neoplasms of hepatic metastases from alimentary system and pancreatic carcinoma.

Ultrasonic sonoporation can increase the release of chemotherapeutics, thus increasing the therapeutic effects.

1. Main purpose

   1. To identify the safety of combining ultrasonic microbubbles and chemotherapeutics to treat malignant neoplasms of hepatic metastases from alimentary system and pancreatic carcinoma.
   2. To explore the largest mechanical index and ultrasonic treatment time which patients can endure.
2. Secondary purpose

   1. To observe tumor clinical benefit rate (CR+PR+SD).
   2. To evaluate the preliminary effect,such as time to failure(TTF), time to death(TTD)

Eligibility Criteria:
Inclusion Criteria:

* Pathological diagnosis of liver metastases from alimentary system and pancreatic carcinoma
* Failed routine chemotherapy
* Neoplasms can be evaluated by imaging
* ECOG《2

Exclusion Criteria:

* Have systematic chemotherapy in 2 weeks
* Be allergic to ultrasonic microbubbles and chemotherapeutics
* Uncontrolled high blood pressure, cardiovascular disease
* Active bleeding
* Have serious mental and psychological disease