cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of ALT-801 in the Treatment of Obesity

This study will evaluate the efficacy and safety of ALT-801 once-weekly versus placebo as an adjunct to a reduced-calorie diet and increased physical activity in patients with obesity/overweight.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent signed prior to entry into the study
* Male or female age 18 to 75 years, inclusive
* Body mass index (BMI) ≥ 30 kg/m2 or BMI ≥ 27 kg/m2 combined with at least one obesity-related comorbidity
* At least one unsuccessful weight loss attempt per investigator judgement
* Agreement to comply with the study-required life-style intervention and treatment during the full duration of the study
* Female subjects of childbearing potential who are not pregnant or breastfeeding, do not plan to become pregnant during the study, and agree to use effective birth control

Exclusion Criteria:

* Weight gain or loss \> 5% in the 3 months prior to randomization or \>10% in the 6 months prior to screening
* Diabetes and related conditions:

  1. History or clinical evidence of diabetes mellitus of any type, including Type 1, Type 2, or mature onset diabetes of the young (MODY)
  2. HbA1c \> 6.5%, fasting glucose ≥ 126 mg/dL (6.9 mmol/L), and/or random glucose of ≥ 200 mg/dL (11.0mmol/L) at screening
* Obesity and related conditions:

  1. Obesity induced by known genetic causes or endocrine disorders (eg, Cushing Syndrome, inadequately treated hypothyroidism, defined as thyroid-stimulating hormone \[TSH\] \> 6 mIU/L)
  2. History of bariatric surgery or other surgical treatment for obesity (eg, gastric banding, gastric bypass), or planned surgery or surgical treatment during the study. Liposuction and/or abdominoplasty performed \>1 year before screening is allowed. Endoscopically placed intragastric balloons will be allowed if removed \> 1 year before screening.
* Gastrointestinal conditions:

  1. History of acute or chronic pancreatitis within 1 year (365 days) before screening
  2. History of or acute significant gastrointestinal (GI) disorder (eg, peptic ulcers, severe gastroesophageal reflux disease \[GERD\],
  3. History of GI surgery, including cholecystectomy and antrectomy. Surgery for appendicitis and small bowel resection \>20cm is acceptable.
  4. History of inflammatory bowel disease, celiac disease or any medical condition or surgery that could affect gastric emptying, stool frequency or stool consistency. (Irritable bowel syndrome is permitted provided that bowel frequency and consistency are normal off treatment.)
* Mental health conditions:

  1. Untreated depressive disorder, defined as a Patient Health Questionaire-9 (PHQ-9) score of ≥ 15 at screening
  2. Suicide ideation, defined as type 4 or 5 on the Columbia-Suicide Severity Rating Scale(C-SSRS) at screening, lifelong history of a suicide attempt, or suicidal behavior within 30 days before screening
  3. Other severe psychiatric disorder (eg, schizophrenia, bipolar disorder)
A Multiple-Dose Study of BLU-5937 in Chronic Pruritus Associated With Atopic Dermatitis

This is a multicenter, randomized, double-blind, placebo-controlled, parallel design study of BLU-5937 for the treatment of chronic pruritus in adult subjects with atopic dermatitis (AD).

The study will consist of a 37-day Screening period (including a 7-day Run-In period), a 4-week Treatment period followed by a Follow-Up visit approximately 2 weeks after the last dose of study drug.

Eligibility Criteria:
Inclusion Criteria:

* Willing to participate and is capable of giving informed consent
* Clinically confirmed diagnosis of active AD with at least a 6-month history of AD
* Chronic pruritus related to AD for at least 3 months
* Moderate to severe itch associated with mild to moderate AD
* Female of childbearing potential must agree to use a highly effective contraceptive method during the study and until at least 4 weeks after the last study drug administration

Exclusion Criteria:

* History of skin disease or presence of skin condition that would interfere with the study assessments
* Clearly defined etiology for pruritus other than AD, including but not limited to: urticaria, psoriasis, or other non-atopic dermatologic conditions, hepatic or renal disease, psychogenic pruritus, drug reaction, uncontrolled hyperthyroidism, and infection
* Presence of any acute skin condition other than AD which may risk inducing a pruritus flare/worsening during the course of the study, including but not limited to: impetigo, active herpes simplex infection, or allergic contact dermatitis
* Subject is \>65 years of age and has developed pruritus at age of ≥50 years
* History of cancer or lymphoproliferative disease within 5 years with the exception of successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix
* Known history of, or active, parasitic infection, including skin parasites such as scabies within 12 months prior to Screening
* Known history of chronic infectious disease (e.g. hepatitis B, hepatitis C, or human immunodeficiency virus \[HIV\])
* Known history of clinically significant drug or alcohol abuse in the last year
* Previous participation in a BLU-5937 trial
Long Term Nitric Oxide Bioavailability on Vascular Health in Chronic Obstructive Pulmonary Disease

Chronic obstructive pulmonary disease (COPD) affects up to 14 million people and is among the top five leading causes of death worldwide. Although COPD is a disease of the lungs, recent evidence indicates that COPD is associated with multiple systemic consequences including vascular endothelial dysfunction. Recently, it has been suggested that more patients with COPD die from cardiovascular disease and coronary heart disease than of direct pulmonary complications. Examination of the mechanisms that contribute to a reduction nitric oxide (NO) bioavailability resulting in vascular endothelial dysfunction in patients with COPD are important as endothelial dysfunction has been indicated to be an independent predictor of future atherosclerotic cardiovascular disease and events.

Researchers have found a link between chronic obstructive pulmonary disease (COPD) and heart disease; however, a link is all they have found. In a previously funded grant, using a double blind, randomized experimental design, the investigators explored the effect of an acute dose of Kuvan or an antioxidant cocktail (1000mg of vitamin C, 600IU of vitamin E, and 600mg alpha-lipoic acid) on vascular health in patients with COPD. Consequently, the investigators found in separate experiments, that a single dose of both antioxidants and Kuvan transiently improves vascular health in patients with COPD. The current project is an attempt to expand on the investigator's previous findings and explore the effects of sub-chronic use of antioxidants and Kuvan on sustaining the improvements in vascular health in COPD.

Eligibility Criteria:
Inclusion Criteria:

* patients with medically diagnosed COPD
* apparently healthy controls

Exclusion Criteria:

* FEV1/FVC \>0.7 (normal lung function in patients only)
* Clinical diagnosis of heart disease or diabetes
* Vasoactive medications (i.e. nitrates, beta-blockers, Viagra etc.)
* uncontrolled high blood pressure
* high blood pressure in your lungs
* thyroid problems
* Fluid in the lungs
* Sleep apnea
* Anemia
* Raynaud's Phenomenon
* GI bleeding
* Gangrene of the digits
* History of low platelets or coagulopathies
* Phenylketonuria (PKU)
* Any allergy to Kuvan
Physical Therapy Students' Reflective Thinking With Narrative Photography in Heart Transplantation

Physical therapy students must learn about heart transplantation, and must be able to communicate with patients using empathy and moral sensitivity. The aim of the study is to compare the narrative photography (NP) and traditional learning (TL) methods applied to heart transplantation physical therapy, as they relate to physical therapy students' knowledge, empathy, satisfaction, and moral sensitivity.

Physical therapy students must learn about heart transplantation. They need to know how to attend to the needs and emotions of these patients using empathy and moral sensitivity. The aim of the study is to compare the narrative photography (NP) and traditional learning (TL) methods applied to heart transplantation physical therapy, as they relate to physical therapy students' knowledge, empathy, satisfaction, and moral sensitivity.

This is a randomized contorlled trial with 117 participants of third year of Physiotherapy Degree. Students were divided into two groups: i) NP group (n = 56), and ii) TL group (n = 61).

Physical therapy knowledge in heart transplantation, empathy, and moral sensitivity were measured pre-intervention and post-intervention in both groups. Satisfaction was measured post-intervention in the NP group.

Eligibility Criteria:
Inclusion Criteria:

* Third-year physical therapy students who were studying the heart transplantation physical therapy course in a Physical therapy Degree.

Exclusion Criteria:

* Who did not meet the above inclusion criteria.
Evaluation of Memantine Versus Placebo on Ischemic Stroke Outcome

The researchers aim to investigate the effect of memantine on stroke outcome in a randomized double-blind placebo-controlled clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Presentation at first 24hrs of disease onset
* Confirmation of ischemic stroke in MCA territory by imaging.
* Accepted consent form

Exclusion Criteria:

* Allergy history to memantine
* Stage 4 -5 renal failure base on Acute Kidney Injury Network criteria
* Moderate to severe hepatic failure (Child-Pugh criteria, grade B and C)
* History of epilepsy
* History of dementia
* History of memantine use in recent 6 months
* Pregnancy or breastfeeding
* Severe drug adverse effects
Phase I, Healthy Subject, Safety, Tolerability and Pharmacokinetic Study of an M1 Agonist to Treat Cognitive Impairment

The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics in young and elderly healthy volunteers of HTL9936, a selective M1 receptor agonist intended for the treatment of cognitive disorders.

The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics in young and elderly healthy volunteers of HTL9936, a selective M1 receptor agonist intended for the treatment of cognitive disorders. This study is a single ascending dose study.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index of ≥19 and ≤ 30kg/m²
* Healthy subject free from any clinically significant illness or disease
* Female subjects must be ≥65 years

Exclusion Criteria:

* Subject who is predicted to be a CYP2D6 poor or ultra rapid metabolizer
* History of hypersensitivity to study drug
* History of epilepsy or seizures
* Subject with previous history of suicidal behavior
* Subjects with significant hearing impairment
* Subjects with an abnormal EEG
Pilot Study - Putative Penetration of Nanoparticles in Sunscreen in Intact or Sunburned Skin

The investigators want to study if nanoparticles of titaniumdioxide are penetrating skin when the skin is intact and when the skin is sunburned. The hypothesis is "Does nanotitandioxide penetrate intact or sunburned skin?"

In this pilotstudy there are two human volunteers. The study comprises two phases. The first phase: The volunteers are applying a commercially available sunscreen lotion containing titanium dioxide nano particles 6 times a day for one week in an area of the back that is 30x20 cm. Before the first application a 2mm punch biopsy is to be taken and examined by scanning electron microscopy. After applying sunscreen lotion for a week, a new biopsy will be taken in order to see how far down in the skin the particles have penetrated. In the second phase: An artificial sunburn will be induced in the same area of the back. They will thereafter apply the sunscreen lotion 6 times a day like in the first phase. After two days (estimated time of maximum skin irritation) a biopsy will be taken in order to see if the nanoparticles have penetrated down in the layers of the skin, and the investigators will also take a biopsy after a full week of applying the sunscreen lotion. The investigators will also examine the urine, before and after the use of sunscreen, to see if the investigators can find the particles there.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men above 50 years old
Long-Term Outcomes of LAA Contrast Flow in CT Scans After Endocardial LAA Closure: The CF-CT Registry

This study is intended to assess the incidence and correlation to the development of peri-device leaks (PDLs), device related thrombosis (DRTs) and cerebral vascular accident (CVA)/transient ischemic attacks (TIAs) in association with left atrial appendage contrast flow (LAA-CF). It will be a multi-center, retrospective study. Approximately 100 subject charts will be reviewed.

Although the clinical significance of long-term left atrial appendage contrast flow (LAA-CF) in computerized tomography (CT) scan is unknown, study by Lim et al reported that 45 days are not enough for complete left atrial appendage (LAA) seal-off after left atrial appendage occlusion (LAAO) in humans and anatomic closure may not necessarily ensure treatment success. Long-term monitoring is warranted in high-risk patients with LAAO after switching from anticoagulation to antiplatelet therapy. They reported possible explanations for residual LAA-CF after LAAO to be related to peri-device gaps, incomplete endothelialization on the device surface, an off-axis device, fabric leak through the non-endothelialized portion of the device.

To this date no studies or registries exist on long term follow up and association of Left Atrial Appendage Contrast Flow (LAA-CF). In this study with two FDA approved devices (Watchman/Watchman FLX and Amplatzer Amulet), it is hypothesized that the LAA contrast-flow (CF) rate is related to lack of endothelization of the implanted devices and potentially associated with peri-device leaks (PDLs), device related thrombosis (DRT).

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be at least 18 years of age.
* Subjects underwent LAA closure with Watchman/Watchman FLX or Amplatzer Amulet at our institution from January 2019 till June 2022

Exclusion Criteria:

* No definite exclusion criteria are defined for the study as all patients with Watchman-FLX or Amplatzer Amulet will be included in the study.
Combining Observational and Physiologic Sedation Assessment Tools

When a physiologic tool to measure the patient's hypnotic state is added to current practice tools is there a decrease in the amount of drug the patient receives.

The purposes of this study were to examine the effect of combining a physiologic measure of consciousness (BIS) with observational assessment of sedation (Ramsay) on infused sedation drug volumes, undersedation events, and the recovery time to arouse from sedation, in a group of neurocritically ill patients. During a 12-hour data collection period, patients received sedation assessment and management with either the current standard of care (sedation assessment with the Ramsay scale), or the standard of care plus the addition of physiologic data from BIS monitoring. Planned research questions explored how BIS monitoring impacts short-term sedation-related outcomes.

Research Questions

* Is there less sedation drug use for patients when nurses monitor sedation with BIS augmentation of Ramsay than when nurses monitor patients with Ramsay alone?
* Is sedation assessment augmented by BIS use associated with a decreased time to wake-up (recovery time) when nurses are instructed to interrupt sedation and obtain a neurologic examination, compared to use of Ramsay alone?
* Are there differences in the number of events associated with undersedation (e.g., self-extubation) for patients assigned to BIS augmentation compared to patients assigned to Ramsay alone?

Eligibility Criteria:
Inclusion Criteria:

* Adult
* admitted with a neurological or neurosurgical diagnosis
* intubated and on mechanical ventilatory support
* receiving continuous sedation with propofol
* Glasgow Coma Score \<12

Exclusion Criteria:

* bifrontal brain injury
* status epilepticus
* barbiturate coma therapy
* continuous benzodiazepine administration
A Study to Investigate the Safety, Tolerability, PK, PD, and Efficacy of ONO-7018 in Patients With R/R NHL or CLL

This is a Phase 1, open-label, multicenter study. This will be the first-in-human clinical study for ONO-7018 and will be conducted in two phases: a Dose Escalation Phase (Part 1) and a Dose Expansion Phase (Part 2).

ONO-7018 is a selective inhibitor of mucosa associated lymphoid tissue protein 1 (MALT1) and is expected to exhibit antitumor activity in NHL and CLL. The purpose of this study is to determine the MTD and to evaluate the safety, tolerability, PK, pharmacodynamics (biomarkers), and efficacy of ONO-7018 in patients with relapsed or refractory NHL or CLL.

Eligibility Criteria:
Inclusion Criteria:

1. Patient aged ≥ 18 years
2. Written informed consent by the patient or the patient's legally authorized representative
3. Patient with histologically/cytologically confirmed diagnosis of NHL or CLL
4. Patient with relapsed or refractory disease who has no available therapeutic options known to provide clinical benefit
5. Patient who has measurable disease
6. All acute toxic effects of any prior antitumor therapy, including investigational therapy, resolved to Grade ≤ 1 before the start of study therapy
7. Eastern Cooperative Oncology Group Performance Status 0 to 2
8. Adequate bone marrow, renal and hepatic functions

Exclusion Criteria:

1. History of lymphoid malignancy other than those allowed per inclusion criteria
2. Patient with central nervous system involvement
3. Patient with systemic and active infection
4. Any serious or uncontrolled medical disorder that may increase the risk associated with study participation or study treatment, or interfere with the interpretation of study results
5. Prior treatment with a MALT1 inhibitor
6. Patient receiving any other investigational drug within 4 weeks prior to study entry
7. Patient is unable to swallow tablets
8. Patient is found to be otherwise ineligible for the study by the investigator or sub investigator
A Pilot Study of Romidepsin in Relapsed or Refractory Extranodal NK/T-cell Lymphoma

Extranodal NK/T-cell lymphoma is a rare disease entity with aggressive clinical course and poor prognosis. Currently, there is no treatment option for relapsed or refractory extranodal NK/T-cell lymphoma. Romidepsin is a histone deacetylase inhibitor which was approved for cutaneous T-cell lymphoma. A recent phase II study of romidepsin for relapsed/refractory peripheral T-cell lymphoma reported an overall response rate of 38% (95% confidence interval 24%-53%). The median duration of overall response was 8.9 months. Considering the median number of previous treatments in these patients was three (range 1-11), romidepsin has single agent activity against relapsed/refractory T-cell lymphoma. Thus, if the single agent activity of romidepsin is demonstrated, it could be a therapeutic agent for combination with salvage treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Patient should belong to any one of following clinical situations

   1. Relapsed after salvage chemotherapy
   2. Relapsed after autologous stem cell transplantation
   3. Refractory to salvage chemotherapy or autologous stem cell transplantation
2. Adequate organ function as defined by the following criteria:

   1. Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase (SGOT)) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase (SGPT)) ≤2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy
   2. Total serum bilirubin ≤ 1.5 x ULN
   3. Absolute neutrophil count (ANC) ≥1500/µL
   4. Platelets ≥ 75,000/µL
   5. Hemoglobin ≥ 9.0 g/dL (may be transfused or erythropoietin treated)
   6. Serum calcium ≤ 12.0 mg/dL
   7. Serum creatinine ≤ 1.5 x ULN
3. At least one measurable lesion
4. ECOG PS 0-2
5. Written informed consent
6. Over 20 years and under 80 years of age

Exclusion Criteria:

1. Previously received allogeneic stem cell transplantation
2. History of or known carcinomatous meningitis, or evidence of symptomatic leptomeningeal disease or secondary CNS involvement on CT or MRI scan.
3. Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2.
4. Pregnancy or breastfeeding.
5. Any Known cardiac abnormalities
6. HBV carrier
7. Positive for HIV
Adapting and Implementing a Nurse Care Management Model to Care for Rural Patients With Chronic Pain

Chronic pain affects over 20% U.S. adults and has debilitating effects on quality of life and physical and mental health. Individuals living in rural communities experience higher rates of chronic pain as well as poorer health outcomes due to pain. The 46 million Americans who live in rural areas frequently lack access to evidence-based, non-pharmacologic treatments for chronic pain. As such, a critical need exists to implement effective, comprehensive programs for pain management that include treatment options other than medications. Nurse care management (NCM) has been successfully used to enhance care for individuals with other long-term health issues. The study teams proposes to adapt, pilot, and implement a NCM model that includes care coordination, cognitive behavioral therapy (CBT), and referrals to a remotely delivered exercise program for rural patients with chronic pain.

Care managers will provide care coordination to help patients address their health holistically and help link them key resources in the community. In addition, the care managers will be trained to deliver cognitive behavioral therapy (CBT) to address unhelpful thought patterns and behaviors around chronic pain and also facilitate patients' participation in EnhanceFitness (tele-EF), an evidence-based exercise program that can be accessed from home. The rationale is that both tele-EF and CBT have been independently shown to improve pain, functioning, and quality of life and that care managers could support patients in accessing and engaging in these services.

This phase allows the study team to prepare for a randomized controlled trial to test the adapted NCM model with rural patients who have chronic pain. Investigators plan to test the intervention in rural serving health care systems using two practice-based research networks with substantial rural presence, the WWAMI (Washington, Wyoming, Alaska, Montana, and Idaho) region Practice and Research Network and Mecklenburg Area Partnership for Primary Care Research in North Carolina. In combination, recruitment in these two networks will allow the study team to reach ethnically diverse participants across broad rural geographies.

Eligibility Criteria:
Inclusion Criteria:

* Current primary care patient with one care visit in the last year
* Experience pain for at least 3 months
* Live in a rural area
* Proficient in English
* A mean score ≥ 4 on the Pain, Enjoyment, and General Activities scale

Exclusion Criteria:

* Pain is cancer-related
* Has plans for major surgery in the next 6 months
* Has received skills training or education for pain management in the past 6 months
* Moderate or severe cognitive impairment (documented diagnosis or score 12 or lower on the telephone Montreal Cognitive Assessment)
* Living in a nursing home or inpatient treatment facility