cyrilzakka/clinical-trials huggingface dataset:
A Trial of AXS-05 in Patients With Major Depressive Disorder

A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of AXS-05 in patients with major depressive disorder (MDD).

This study will evaluate AXS-05 in a randomized, double-blind, placebo-controlled study in patients with MDD. Eligible patients will be randomized in a 1:1 ratio to treatment with AXS-05 or placebo for 6 weeks.

Eligibility Criteria:
Key Inclusion Criteria:

* Age 18 - 65
* Currently meets DSM-5 criteria for MDD
* Body Mass Index between 18 and 40 kg/m\^2, inclusive

Key Exclusion Criteria:

* Suicide risk
* History of treatment resistance in current depressive episode
* History of electroconvulsive therapy, vagus nerve stimulation, transcranial magnetic stimulation or any experimental central nervous system treatment during the current episode or in the past 6 months
* Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
Feasibility of Obtaining and Characterizing Circulating Tumorigenic Cells in Patients With Pancreatic Adenocarcinoma

The purpose of this study is to collect blood samples and study cancer cells found in these blood samples from patients with pancreatic cancer. Prior research has discovered that tumor cells can be collected from the blood of patients with pancreatic and other cancers.

The physicians have developed techniques for isolating and analyzing cancer cells using a simple blood test. They will study how these cells relate to how chemotherapy works. They hope to use this information to guide choices of treatment for patients in the future.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of pancreatic adenocarcinoma, confirmed at MSKCC.
* Patient eligible for chemotherapy treatment.
* Prior surgery, chemotherapy and/or radiation therapy for pancreatic adenocarcinoma is permitted.
* ECOG performance status 0-2.
* A minimum age of 18 years old.

Exclusion Criteria:

* Known to be HIV positive on antiretroviral therapy
* Prior organ allograft
* Any medical or psychiatric condition that may interfere with the ability to comply with protocol procedures
Effects of Heavy-load Resistance Training

The study aims to investigate effects of 8-weeks of heavy-load resistance training on mechanical muscle function and functional performance in elite female team handball players from the Danish Women's Handball League. Players will be randomly assigned to either a resistance training group (RT) or serves as training-as-usual controls (CON).

The study aims to examine how an eight-week heavy-load resistance training regimen affects both mechanical muscle function and functional performance in elite female team handball players. Given the sport's demands for rapid and forceful muscle actions, understanding the impact of such training on functional performance is crucial.

Players from four clubs in the Danish Women's Handball League, will be randomly block randomized (one block=one club) into two groups: the heavy-load resistance training group (RT), and the control group (CON). Each group contains players from 2 clubs. The study will conduct a battery of tests to evaluate various aspects of mechanical muscle function and performance, including isometric knee extensor and flexor peak torque, countermovement jump (CMJ) power/work, and functional measures like sprinting, jump height, and agility performance.

Eligibility Criteria:
Inclusion Criteria:

* Playing in the Danish Women's Handball League.

Exclusion Criteria:

* Absent from team handball training for more than two weeks due to injuries, within the six months preceding PRE-testing.
SPARQ and Core Proprioception

The purpose of this investigation is to determine the relationship of core stability to core proprioception

As no previous research has been reported correlating the SPARQtm method of athletic performance with the McGill Side Bridge test and core joint position error, this study is designed as a pilot. The subject's core stability will be measured with the SPARQtm method of athletic performance and the McGill Side Bridge test for core stability. Core proprioception will be determined using the standard test for proprioception, Joint Position Error (JPE) testing, with the Skill Technologies motion capture device. All participants will receive the SPARQtm method of athletic performance testing, the McGill Side Bridge test for core stability and the core joint position error tests twice, one week apart.

Eligibility Criteria:
Inclusion Criteria:

* college student, staff, or faculty members;
* History of thoracic / lumbar injuries for inclusion into the injured group.
* No history of thoracic / lumbar injuries for inclusion into the normal group.
* Ages 20 to 50
* History of previous athletic performance.

Exclusion Criteria:

* Previous lower extremity injury, surgery, visual or vestibular condition affecting balance
* Current acute illness that have an adverse effect on balance or core strength
* Local infection, injury or other malignancy
* Any unstable joints of the lower extremity or spine
* Any Spinal manipulation within 48 hours
* Prescription medication or supplement that affects blood pressure
* Pregnancy
* Diagnosis of severe hypertension (200-161/120-100 mmHg)
* Incapable of exercise for 15 minutes without hortness of breath
* Heart failure, kidney diseases and mental disorders
Smoking Prevention Program in Poland

Smoking Prevention Program is a pilot exploratory study with a standardized curriculum based on the Tobacco Prevention Toolkit from Stanford University and translated into Polish by the members of Students Scientific Association of Oncology at Wroclaw Medical University. The program will assess the effectiveness of a school-based smoking prevention curricula keeping children as never smokers and test the feasibility of engaging medical students and teachers in implementing and evaluating a validated program on smoking prevention within the Polish School System. The research protocols, methods and data collection instruments of a standardized classroom based valid tobacco prevention program from Stanford University will be used for the study. The smoking prevention program is centred on drug resistance, personal self-management and increasing social skills. The program increases knowledge and uses coaching and practice to provide students with the skills to resist social pressures around cigarette use. The secondary outcome of this study is to determine the change in attitudes by Polish Medical Student regarding Cancer Prevention Research. During Smoking Prevention Program workshops, the 5-Session Curriculum for primary schools will be translated, applied and evaluated for polish students.

This community-based pilot will engage medical students, the local school district and the local health authority. The Educational program meets the requirements set by Centers for Disease Control and Prevention (CDC) in Guidelines for School Health Programs to Prevent Tobacco Use and Addiction. Following parental consent, the program will be implemented with all 7th and 8th grade students (children age 12-15 years) from the Elementary School in Tyniec Mały. This project is supported by the Head of Lower Silesian Oncology Center, the Head of Department of Oncology of Wroclaw Medical University, the Health and Social Affairs Department of City of Wroclaw and under the patronage of the Lower Silesia Governor's Office, the Polish Society of Oncology, the Polish Society of Public Health, the Lower Silesian Department of Polish Society of Cardiology and the European Association for Cancer Education (EACE).

Smoking Prevention Program is funded by the READS Grant Program from the American Association for Cancer Education (AACE).


Eligibility Criteria:
Inclusion Criteria:

* Students from Tyniec Mały
* 7th and 8th graders of the elementary school
* Parental consent
* Students consent

Exclusion Criteria:

* Lack of parental consent
* Lack of students consent
Role of Stem Cells, Platelet Rich Plasma in Treatment of Scars

The Objectives of this randomized controlled trial aiming to establishing a protocol of post scar revision care and to Study the effect of PRP and/or Adipose derived Mesenchymal Stem cell injection in improvement of atrophic scar after scar revision.

Forty patients with atrophic scar since one to five years including 25 males and 15 females with ages ranging from ten to 35 years with main age of 22.68 will be divided into four groups each included ten patients. One group will be treated with scar revision only (control group or group I), 2nd group will be injected with PRP after scar revision, 3rd group will be injected with ADSCs after scar revision and the 4th group will be injected with a combination of PRP and ADSCs after scar revision. All groups were assisted pre-operative and six months post-operative. Complications, Scar width, Vancouver scar scale (VSS), surgeon assessment scar scale and patient assessment scar scale will be considered the outcome measurements.

Eligibility Criteria:
Inclusion Criteria:

* Patient with atrophic scar.
* Age group: 5 years up to 35 years.
* No previous medications, surgeries or laser therapy.

Exclusion Criteria:

* Patient with hypertrophic or pigmented scar.
* Patient with any blood disease.
* Patients with lipodystrophy.
Study to Evaluate Single Inhaled Doses of PT001, PT003, PT005 and PT001 Plus PT005 in Healthy Subjects

The purpose of this study is to evaluate the safety of a single dose of PT003 compared with single doses of PT001 and PT005, and compared with PT001 plus PT005 delivered together as two separate single doses in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Provide signed written informed consent
* 18-55 years of age
* Healthy subjects confirmed by medical history, physical examination, vital signs, pulmonary function tests, electrocardiogram and clinical laboratory tests
* Female subjects of child-bearing potential who are sexually active must be willing to undergo a pregnancy test and agree to use two forms of contraception
* Body mass index (BMI) between 18.5 and 30, inclusive
* Non-smokers for at least 6 months prior to screening
* Pulmonary function tests within normal limits
* Willing to remain at the study center for at least 12-24 hours on each test day
* Venous access in both arms to allow collection of numerous blood samples

Exclusion Criteria:

* Women who are pregnant or lactating
* Clinically significant medical conditions
* Viral illness within the last 30 days
* Symptomatic prostatic hypertrophy or bladder neck obstruction
* Known narrow-angle glaucoma
* History of bowel obstruction
* Clinically significant abnormal electrocardiogram
* Positive Hepatitis B surface antigen or positive Hepatitis C antibody
* Positive screening test for HIV antibodies
* History of hypersensitivity to any beta2-agonists, anticholinergics, or any component of the MDI
* Known or suspected history of alcohol or drug abuse within the last 2-years
* Greater than normal alcohol consumption
* Ingestion of any poppy seeds within the 48 hours prior to the screening
* Ingestion of any poppy seeds within the 48 hours prior to, or any alcohol, xanthines or grapefruit-containing foods or beverages within the 24 hours prior to, or during, each confinement
* Positive breath alcohol result
* Positive urine drug screen
* Use of any beta2-agonists,or anticholinergics prior to the recruitment interview
* Lower respiratory tract infections requiring antibiotics in the previous 6 weeks
* Use of any other prescription medication
* Use of any over the counter product, herbal product, diet aid, hormone supplement
* Donation \> 450 ml of blood within 8 weeks of first treatment dose
* Clinically significant vital sign abnormality
* Clinically significant biochemical, hematological or urinalysis abnormality
* Affiliations with investigator site
* Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives prior to screening, whichever is longer
Study of ALLN-177 in Patients Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia

Evaluate the efficacy and safety of ALLN-177 in reducing plasma and urinary oxalate levels in adult and pediatric patients with enteric hyperoxaluria and hyperoxalemia or primary hyperoxaluria

Phase 2, multi-center, open label, single arm study to evaluate the effect and safety of ALLN-177 in adult and pediatric patients aged 12 and older with enteric hyperoxaluria and hyperoxalemia or primary hyperoxaluria .

Approximately 15-20 evaluable subjects are planned to be enrolled in the study. Eligible subjects will administer ALLN-177 with each meal/snack 5 times per day for 12 consecutive weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Signed a informed consent form or an assent
2. Aged 12 or older with body weight ≥ 35kg
3. History of primary hyperoxaluria or enteric hyperoxaluria associated with a known underlying enteric disorder associated with malabsorption (e.g., bariatric surgery, Crohn's disease, short bowel syndrome, or other malabsorption syndrome)
4. Urinary oxalate ≥ 40mg/24h (normalized for body surface area in children) at Screening in patients with eGFR \>15 mL/min/1.73m2
5. In patients with enteric hyperoxaluria, eGFR \< 45mL/min/1.73m2 at Screening
6. In patients with enteric hyperoxaluria, plasma oxalate \> 5µmol/L at Screening
7. Patients on dialysis, must be stable for greater than 3 months

Exclusion Criteria:

1. Unable or unwilling to discontinue Vitamin C supplementation
Oxygen Extraction-guided Transfusion

In critically ill patients, optimized strategies for red blood cells transfusion (RBCT) are still controversial. Most recent guidelines suggest that clinical practice in ICU setting should follow a restrictive approach to RBCT (i.e., hemoglonim level \< 7.0 g/dL).In our previous study, oxygen extraction ratio (O2ER) has shown good performance as a marker to identify the correct timing for RBCT, potentially affecting 90-day mortality in non-bleeding, critically ill patients \[11\]. Moreover, our data suggested that an individualized strategy for RBCT may reduce the incidence of acute kidney injury (AKI), which is possibly related to a better delivery of oxygen and organ perfusion.


Eligibility Criteria:
Inclusion Criteria:

* Hb levels ≤ 9.0 g/dL (as confirmed through a blood test and/or through blood gas analysis)
* Presence of an arterial line and a central venous line (either jugular or subclavian), with confirmed correct position of the catheter tip at the atrio-caval junction (allowing correct estimation of central venous saturation, ScvO2).

Exclusion Criteria:

* Age \< 18 years;
* Pregnancy
* Clinical evidence of acute bleeding
* Diagnosis of haematological malignancy
* Diagnosis of sickle cell disease, or other diseases exposing the patient to chronic RCBTs
* Acquired or congenital disorders of coagulation
* Patients with ongoing AKI of stage 1 or worse and/or known chronic kidney disease (CKD) of stage G3a or worse, defined as glomerular filtration rate below 60 for a minimum of 3 months
Use of Patiromer to Transition Chronic Kidney Disease Patients With Hyperkalemia to a Plant-rich Diet.

The purpose of this proof-of-concept controlled-feeding study is to determine whether patiromer (Veltassa®, Relypsa, Inc., Redwood City, CA) can be used to maintain normal serum potassium concentrations in chronic kidney disease (CKD) patients who are transitioned to a plant-rich diet.


Eligibility Criteria:
Inclusion Criteria:

* Stages 3B-4 CKD (estimated glomerular filtration rate (eGFR) of 15-44 mL/min/1.73m2, not treated with dialysis)
* No prior treatment with patiromer
* Mild hyperkalemia (potassium 5.1 to \<6.5 mEq/L) on one of the last two blood tests
* No prior episodes of moderate-severe hyperkalemia (potassium ≥6.5 mEq/L) in the past 6 months
* Deemed appropriate for the intervention by the patient's nephrologist, considering the patient's prognosis, cognition and pending treatments (e.g., dialysis)

Exclusion Criteria:

* Change in medications that alter potassium homeostasis (e.g., RAAS inhibitors, diuretics, β-blockers) in the last month
* Diagnosed with bowel diseases or syndromes (e.g., bowel obstruction, major GI surgery, short-bowel syndrome, irritable bowel syndrome, inflammatory bowel disease, chronic diarrhea)
* Dietary restrictions (e.g., allergies) or otherwise unable/unwilling to adhere to study diets (excludes dietary restrictions on high-potassium foods)
* Pregnant (females) or planning to become pregnant (males and females) during the study
Clinical Performance and Safety Comparison of Stay Safe Link® With Stay Safe® in Patient on CAPD (CAPD-3)

This post-marketing study is undertaken to compare the clinical effectiveness and safety of two continuous ambulatory peritoneal dialysis produced by Fresenius Medical Care (FMC), i.e. Stay Safe® (STS) that is produced by a plant in Germany and Stay Safe Link® (SSL) that is produced in Malaysia. The study is an open labelled, randomised controlled trial where 434 patients in total will be randomised to either STS or SSL in a 1:1 ratio.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or above
2. End stage kidney failure receiving Stay Safe® PD system for at least 4 weeks
3. Written informed consent

Exclusion Criteria:

1. Requirement for 2.5L exchanges
2. Requirement for Stay Safe Balance®
3. PD-related infection (peritonitis, exit site or tunnel tract infection) in the preceding 8 weeks or during conversion
4. Malfunctioning of PD catheter
5. Planned transfer to automated peritoneal dialysis, haemodialysis or transplant within 90 days
6. Pregnancy
7. Any condition that compromises the integrity of the abdominal wall, abdominal surface, or intra-abdominal cavity, such as documented loss of peritoneal function
8. History of active alcohol or substance abuse in the previous 6 months
9. Other medical condition which, in the investigator's judgement, may be associated with increased risk to the subject or may interfere with study assessments or outcomes
Triggers for Post-Viral Parosmia

Background: Many people lose their sense of smell after they have had a cold, flu or sinus infection. Recovery (if at all) generally starts with a "parosmia" phase which means every-day smells become distorted and over-poweringly objectionable, and this can lead to malnutrition and depression. We do not know much about how or why parosmia happens, but there are key foods common to those who suffer from parosmia which seem to trigger the distortion.

Parosmia and COVID-19 Loss of smell has recently been recognised as an official symptom of COVID-19, and we are starting to get reports of people who have recently had COVID-19 developing parosmia. The triggers seem to be similar to those of the common cold, flu or virus infections, but the journey between loss of smell and parosmia is different.

Hypotheses

1. Triggers of distortion will be the same for all parosmics.
2. There may be additional trigger foods in different cultures.

Questions

1. What are the trigger foods and beverages for parosmia?
2. Are there regional/cultural variations?
3. Does Covid-19 parosmia differ from "standard" post-viral parosmia?

The overall aim of the project is to understand the mechanisms involved in parosmia. The approach is to identify foods and everyday aromas associated with parosmia and to determine whether they are the same across different continents/cultures/ethnic backgrounds, and whether Covid-19 parosmia is any different to non-Covid-19 parosmia. The questionnaire will ask about Covid-19 status, ethnic background, smell loss and parosmia, and the changes that occurred between smell loss and parosmia. The participants will then answer questions on up to 15 everyday smells, some of which our preliminary evidence shows are common triggers, and others which are not. The questionnaire will be globally distributed, for example through current collaborations in the UK, US, Germany, Iran, China, Japan and Brazil. It will be completed by participants who are currently experiencing parosmia.

All participants will be asked to record any foods that they find distorted and provide a list of aromas which returned undistorted.

The questionnaire will be sent out to those reporting early stages of parosmia as a result of post-viral infection, including post-COVID-19 infection. The questionnaire will record demographic data and ask about COVID-19 status, COVID-19 diagnosis and results of COVID-19 tests. It will ask about loss of smell, taste and chemesthesis (irritation from the heat of spices) and it will ask about the sequence of events leading to parosmia. Up to 15 everyday items will be rated for aroma description, intensity and valence. Participants will be asked to list other distorted foods, and also smells that returned undistorted. The questionnaire will be fully anonymous (unlinked anonymous) and voluntary. The questionnaire will be designed, distributed and data collected using the secure platform provided by Compusense.

Eligibility Criteria:
Inclusion Criteria:

* Individuals should be currently experiencing parosmia

Exclusion Criteria:

* Individuals below 18 years old will be excluded from the study
Safety and Efficacy Study of HO/03/03 10-40 Micro Grams to Treat Hard to Heal Wounds

This multicenter, prospective, open-label, outpatient study will assess the safety and efficacy of HO/03/03 10µg applied topically once daily for up to 24 weeks in up to 100 subjects with Hard to Heal documented chronic wounds of various etiologies (pressure ulcers, diabetic ulcers, post operational wounds surgical incisions ulcers of rheumatoid arthritis and trauma wounds) of at least 4 weeks documentation.

All subjects with a wound size of up to 56.25 cm2 (inclusive) will be administered 1 vial of 10 ml HO/03/03 10μg per administration. For each increase in wound size of up to 56.25 cm2 an additional vial of HO/03/03 10 μg will be added up to a maximal wound size area of 225 cm2 (will be measured by HealOr central reviewer) utilizing 40µg (4 vials) per administration. 15 min post treatment wounds will be dressed according to standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years old and above.
* Chronic wounds that have \< 30% change in area from Screening
* Have single / multiple wounds;
* Have a Hard-to-Heal wound(s) of various etiologies

Exclusion Criteria:

* Have a documented medical history of a significant cardiac, pulmonary, gastrointestinal, endocrine (other than Diabetes Mellitus type 1 or 2), hepatic or per the physician's discretion.