cyrilzakka/clinical-trials huggingface dataset:
Study of Protein Metabolism in Healthy Older Subjects

This is a randomized, double-blinded, crossover study to evaluate muscle protein metabolism during fasting and feeding in healthy older subjects.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60 and ≤ 75 years
* Body Mass Index (BMI) \> 23.0 to \< 30.0
* Ability (with or without the aid of an assistive device) to climb a flight of 10 stairs or walk an equivalent of 1 city block without assistance
* Currently not participating in a formal exercise or training program and agrees to refrain from intense physical activity from screening through the completion of the study.

Exclusion Criteria:

* Diagnosis of diabetes
* Active pursuit of weight loss
* Poorly controlled hypertension or hypotension
* Untreated hypothyroidism or hyperthyroidism
* Anemia or abnormally functioning kidneys or liver
* A significant cardiovascular event within ≤ 6 months; or stated history of congestive heart failure; or evidence of clinically active cardiovascular disease assessed during the screening EKG
* Peripheral arterial disease or other diseases that preclude proper limb blood flow
* Chronic, contagious, infectious disease
* Current infection or corticosteroid treatment within the last 3 months
* Clotting or bleeding disorders, stated history of Deep Vein Thrombosis (DVT) and/or a known hypercoagulable condition
* In condition deemed unsuitable for study based upon study physician assessment
* Surgery requiring \>2 days of hospitalization in the last 3 weeks and/or planned elective surgery requiring \>2 days of hospitalization during the course of the study
* Current active malignant disease or was treated within the last 6 months for cancer
* An amputee
* Obstruction of the gastrointestinal tract, inflammatory bowel disease, short bowel syndrome or other forms of gastrointestinal disease
* Diagnosed with, or has a history of severe dementia or delirium, eating disorder, history of significant neurological or psychiatric disorder, alcoholism, substance abuse
* Cannot refrain from taking

  * High doses of fish oil, or omega-3 supplements, or high doses of vitamin D
  * Medications/dietary supplements/herbals or substances that are considered anabolic, or reduce weight
  * Any pulmonary anti-inflammatory medication or bronchodilators on the day of and 48 hours prior to study visits 1 and 2
  * NSAIDS or acetaminophen on the day of and 48 hours prior to study visits 1 and 2
* Chronic use of nicotine
* Allergic or intolerant to any ingredient found in the study products
MR Guided Laser Interstitial Thermal Therapy for the "Minimal Invasive" Treatment of Brain Metastasis and Primary Brain Tumors

The purpose of this study is to determine if the stereotactic, MR guided, laser interstitial thermal therapy treatment technique can be safety and efficiently used for human brain metastasis and primary brain tumors.

This new "minimally invasive" technique has been tested so far, with success, on animal brain tumor models and on human liver metastasis.

The main purpose of this study is to determine if the stereotactic, MR guided, laser interstitial thermal therapy treatment technique can be safety and efficiently used for the human brain metastasis and primary brain tumors.

As secondary objectives for this clinical study, the following are to be explored:

* Eventual evaluation of the eventual mid and long term post-intervention complications,
* Evaluate the contra indication for the technique,
* Evaluate and optimize clinical and logistic intervention protocols,
* Evaluate the mean duration for the procedure,
* Evaluate the mean cost for the procedure

The clinical trial will include a statistical sample of 12-18 treatments and will run over a period of 18 months. The inclusion period will be for 6 months and the patients will be followed up during 12 months post intervention.

The clinical trial will be performed at the Lariboisiere University Hospital of Paris and the patients will be coming from all the Assistance Publique de Paris ( APHP ) hospitals

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older
* Patients with brain metastasis located in the brain hemispheres
* Patient with a brain metastasis smaller or equal to 4 cm in diameter
* Patient with primary brain tumor smaller or equal to 4 cm in diameter
* Patient previously treated with other therapeutic techniques ( radio-therapy, chemotherapy, immunotherapy) which have failed.

Exclusion Criteria:

* Patients less than 18 years old,
* Patients presenting contra indication for MRI studies
* Patient for which the primary cancer is melanoma or kidney tumors
* Patients having a mean life duration longer than 3 months (due to the primary cancer)
Implementation of Internet-Based Psychotherapy for OCD in Primary Health Care in Two Cities in the State of São Paulo

The aim of this study is to assess the implementation of Internet-based Cognitive Behavioral Therapy (I-CBT) treatment in a Brazilian sample.

Researchers will compare 140 participants (70 with I-CBT and 70 in usual care to see if the treatment is feasible.

Participants will undergo online treatment for OCD, lasting 10 to 14 weeks.

Obsessive-compulsive disorder (OCD) affects 2 to 3% of the adult population worldwide. The efficacy of pharmacological therapy with IRS and cognitive-behavioral therapy (CBT) is well recognized, but the clinical spectrum of OCD symptoms makes it difficult for patients to engage in sessions outside the home, decreasing treatment adherence. CBT is a psychological intervention increasingly delivered over the internet, with studies showing its efficacy in patients with OCD. The present study aims to verify the efficacy of implementing internet-based psychotherapy (I-CBT) in the context of a developing country, identifying the barriers and facilitators of this implementation. It will be a pragmatic, randomized-controlled, parallel, open-label, two-arm clinical trial. The implementation will be carried out in the cities of Indaiatuba and Jaguariúna, state of São Paulo, in all their Basic Health Units, in which 140 participants will be randomized between the I-CBT and usual treatment (UT) groups. Results will be assessed post-treatment and at 3- and 12-month follow-up. The hypothesis is that I-CBT is an effective and feasible treatment modality for OCD in a large Brazilian sample.

Eligibility Criteria:
Inclusion Criteria:

* primary diagnosis of OCD according to the DSM-5 (American Psychiatric Association, 2013);
* internet access.

Exclusion Criteria:

* acute suicide risk, assessed by a positive response (1, 2 or 3) to item 9 of the PHQ-9 and considered serious (suicidal imminence) in the suicide risk assessment protocol (S-RAP);
* psychotic symptoms;
* dependence on alcohol or other known psychoactive substances;
* recent bereavement;
* significant cognitive impairment;
* terminal illness for clinical reasons (based on their knowledge of the patient);
* illiterate patients or those unable to read (for example, due to severe dyslexia or visual impairment);
* patients without access to the internet or an electronic device to access the treatment platform.
Orexigenic Therapy With Delta-9-tetrahydrocannabinol in Advanced Cancer Patients With Chemosensory Abnormalities - a Pilot Study

To investigate delta-9-tetrahydrocannabinol's (THC) ability to increase food intake and improve food enjoyment for advanced cancer patients with taste and/or smell (chemosensory) abnormalities.

Appetite stimulants are the common treatment for cancer-induced anorexia. However, only 30% of advanced cancer patients respond and benefit from appetite stimulants, which may be due in part to sensory abnormalities, as a person who is experiencing food aversion due to taste and smell changes may be unable to respond to these agents. Of the appetite stimulants available for use in clinical practice only Marinol, or THC, has the potential to increase food intake by improving appetite as well as by amplifying the taste of food through the brain's reward pathway.

A 22-day, double blind, randomized, placebo-controlled trial will be conducted. Participants will start at 2.5mg of THC or placebo once daily for the first 3 days and then increase to 2.5mg of THC or placebo twice daily before lunch and supper. Participant's will complete the following survey tools pre and post-treatment: Taste and Smell Survey to assess the severity and change in chemosensory complaint scores; 3-day dietary record to determine the change in caloric intake and shift in food preference by macronutrient analysis; 24-hour urine collections to validate the 3-day dietary record; Satiety Labelled Intensity Magnitude scale for subjective appetite ratings; Food Preference Checklist to assess objective shifts in macronutrient and flavor preferences; Functional Assessment of Anorexia/Cachexia Therapy questionnaire to assess participant's QOL; interview to determine the cause and effects of chemosensory alterations; Edmonton Symptom Assessment Scale to assess nausea; and Side Effect Survey to document the tolerability of the drug (post-treatment only). Participants will complete the survey tools with the aid of the researcher. All tools are short and easy to complete, which minimizes patient burden.

Eligibility Criteria:
Inclusion Criteria:

* advanced cancer patients (defined as locally recurrent or metastatic) over 18 years old with a decreased food intake for at least 2 weeks (reported by physician or subject)
* able to complete questionnaires in English
* able to provide informed consent
* life expectancy of greater than 2 months (as determined by physician)
* chemosensory complaint score \> 1

Exclusion Criteria:

* receiving enteral or parenteral feedings
* allergies or sensitivity to THC and/or sesame seed oil
* history of substance abuse or psychotic episodes
* mechanical obstruction of alimentary tract, mouth or nose
* received chemotherapy in the last 2 weeks
* received radiation therapy to the head/neck area
* brain tumor
* nausea score greater than 5 on ESAS
* history of tachyarrhythmias, angina pectoris or hypertension
* current diagnosis of liver impairment
* use of marijuana within 30 days prior to start of trial
Registry of Patients Having Received oNKord®

ReKORD is an observational study (Registry) enrolling participants who have received at least one dose of oNKord® (allogeneic ex vivo-generated Natural Killer \[NK\] cells from CD34+ umbilical cord blood progenitor cells) in a clinical trial. Participants from multiple previous clinical trials of oNKord® can be enrolled in this Registry.

To be eligible for this Registry, participants must have received at least one dose of oNKord® in a clinical trial. Eligible participants will be enrolled after signing the informed consent form (ICF). Participant characteristics, treatment history, and clinical trial outcome data at clinical trial discontinuation/completion will be collected. On a yearly basis after the last clinical trial visit, the investigator will collect the participants' medical status and enter them in the Registry database. Major clinical events, including concomitant medication or therapy, that occurred since the previous assessment will be recorded. No protocol-specific visits or interventions will be required. Participants will be followed up until 3 years after the first oNKord® infusion.

Eligibility Criteria:
Inclusion Criteria:

* Receipt of at least one dose of oNKord® in a clinical trial
* Participation must be within 3 years after the first infusion of oNKord®
* Signature of ICF

Exclusion Criteria:

* N/A
SKIPping With PAX: An Integrated Gross Motor and Social-Emotional Skill Intervention

The purpose of this study was to test the effects of an integrated intervention on the gross motor and social-emotional development of rural preschool boys and girls. A secondary purpose was to examine intervention effects on physical activity and sedentary behavior. An exploratory aim was to examine the role of executive functioning skills on intervention outcomes. This study featured a repeated measures (baseline, six-month posttest, three month retention \[nine-month follow-up\]), control group, experimental design. Classrooms were randomly assigned to either the experimental or control groups. Experimental participants received intervention while control participants received business as usual curricula.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the early childhood center, aged 4-5 years

Exclusion Criteria:

* Enrolled in special education classroom
Feasibility Study of the ReVENT Sleep Apnea System

This is a prospective, multi-center, single arm, feasibility study to evaluate the safety and effectiveness of the ReVENT Sleep Apnea System for the treatment of Obstructive Sleep Apnea.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of OSA with AHI 15-40
* Body Mass Index (BMI) ≤ 32
* Refused or failed Continuous Positive Airway Pressure (CPAP)
* Evidence of airway collapse at soft palate and/or base of tongue

Exclusion Criteria:

* Prior OSA surgery
* Anatomy unable to accommodate implants
* Chronic immunosuppressive therapy or known problems with wound healing
* Type I or II diabetes
* Active systemic infection
* Pregnancy
* Other major medical conditions that could confound outcome measures or interfere with study completion
Long-term Symptomatic Follow-up of Patients with Long COVID Syndrome

The goal of this observational study is to learn about the long-term evolution of long COVID.

The main question it aims to answer is:

Does the main symptoms of the patients diagnosed with long COVID aproximate to those of patients who have had COVID acute infection without devoloping long COVID? Participants will answer mailed survey questions about their main symptons.

Scales, indexes and questionnaires were mailed to 40 patients with long COVID to evaluate their main symptoms. Fatigue, emotional disorders, sleep disorders, cognitive impairments, dyspnea, physical activity, quality of life and pain were analyzed. The patients were reassessed after three years. The same scales, indexes and questionnaires were also sent to a control group of 40 volunteers of the same age and sex as the cases.

Eligibility Criteria:
Inclusion Criteria:

* patients older than 18 years old and younger than 75 years old
* patients who accepted to participate in the study
* patients who have had COVID acute infection
* patients who have long COVID (cases)

Exclusion Criteria:

* patients who refused to participate in the study at any time of the study
* patients whose diagnosis of long COVID was revoked during the study (cases)
Impact of Dietary Nitrate Supplementation on VO2max During Ramadan Fasting in Healthy Adults

The goal of this clinical trial is to determine if beetroot juice supplementation changes exercise performance following one week of Ramadan fasting in young, healthy adults. The main question it aims to answer is:

Does daily beetroot juice supplementation change VO2 max in fasting individuals during the first week of Ramadan?

Participants will:

Visit the lab before the start of Ramadan and after one week of fasting If assigned to intervention group, consume daily shots of beetroot juice (70ml) during the first week of Ramadan fasting Perform maximal exercise testing on a cycle ergometer

Recent literature demonstrates data showing a decrease in VO2max during the first week of Ramadan fasting. This is a practice observed by millions around the world every year, where individuals abstain from food and water from sunrise to sunset, dictated by the lunar calendar. Dietary nitrate consumption has been shown to increase VO2max and exercise performance. Therefore, the primary purpose of this study is to investigate whether dietary nitrate, in the form of beetroot juice, can help mitigate the decrease in VO2 max during the first week of Ramadan fasting.

24 young healthy adults will be recruited to undergo these two visits. The first visit will assess maximal oxygen uptake to determine aerobic fitness and metabolic exercise intensity zones under non-fasting conditions. The second visit will be completed after one week of Ramadan fasting. If assigned to the intervention group, participants will consume one shot (70ml) of Blonyx - Beet It Sport Nitrate 400 beetroot juice every day. Each shot contains 400mg of nitrates. Urine Specific Gravity will be measured after each visit to assess hydration status. The intervention group will also undergo Single Blood Draws after each visit to assess nitrate concentrations before and after a week of consumption.

Eligibility Criteria:
Inclusion Criteria:

* Free of known cardiovascular or metabolic diseases or sleep disorders
* No history of smoking (within the past 3 months)
* Able to engage in physical activity assessed through the physical activity readiness questionnaire (PAR-Q+)
* No prescription of chronic medications other than oral contraceptives
* Able to abide by fasting protocols for all visits
* Individuals who are not allergic to ultrasound gel or beetroot juice
* Individuals who are not pregnant

Exclusion Criteria:

* Individuals diagnosed with cardiovascular or metabolic disease or sleep disorders
* Has a history of smoking (within the past 3 months)
* Not ready to engage in physical activity as assessed by the PAR-Q+
* Individuals prescribed chronic medications other than oral contraceptives
* Unable to abide by fasting protocols for any testing visit
* Allergic to ultrasound gel or beetroot juice
* Pregnancy
A Longitudinal Study of Colorectal Cancer Patients With Metastatic Disease in Middle-Norway

The main objective is to provide original research results that may change clinical practice related to metastatic colorectal cancer. The study will evaluate treatment and patient care at different stages of the disease trajectory and the use of health care for this large group of patients. It will be possible to compare the effectiveness of chemotherapy, radiotherapy and symptomatic treatment given to "real life" patients with the efficacy reported in randomised clinical trials. By using longitudinal information on imaging, biomarkers, clinical staging and place of care it will be possible to improve patient classification at various stages of the disease. Based on this, a more appropriate, individualized treatment for colorectal cancer may be recommended during the phases of the disease trajectory. Participation in this project will not influence the treatment for colorectal cancer. All patients will be treated and followed-up according to current regional and national guidelines.

The available evidence-based knowledge of patient management is translated into regularly updated clinical guidelines for diagnosis, staging and treatment. The guidelines represent the basis for oncology care in Norway, and health care providers are expected to follow these guidelines. Current guidelines are derived from studies where patients are highly selected and not representative for the whole cohort of patients with metastatic disease. One can speculate if the results of trials conducted in regional centers can be generalized to whole populations in a region. In this respect it will be valuable to study advanced colorectal cancer in the whole population of Middle-Norway, with both one regional center and all other hospitals in the area. More knowledge is needed for the optimal selection of treatment for individual patients. In relation to symptom relief, physical and psychological functioning and overall quality of life, there is clearly a lack of high quality research.

A longitudinal follow-up of a large number of metastatic colorectal cancer patients with regular assessments has not been previously launched. The existing infrastructure in Norway makes the study feasible and will provide high internal and external validity related to clinical outcomes. The study will constitute a unique platform for comprehensive research aimed at this patient group. It also provides a concept that can be transferred to other major diseases, and it can be extended to other health regions of Norway.

Eligibility Criteria:
Inclusion Criteria:

* Colon or rectal cancer with synchronous metastases.
* Colon or rectal cancer with metastatic relapse after curative primary treatment (for localized disease or maximum one operation for distant metastases)
* Localized colon or rectal cancer that due to tumor or patient related factors are not treated with a curative intent
* Written informed consent. In patients not able to consent due to cognitive impairment consent can be by proxy

Exclusion Criteria:

-
Relief of Lumbar Spinal Stenosis Symptoms

The aim of this study was to compare the efficacy of caudal epidural steroid injection and caudal epidural pulsed radiofrequency stimulation in the relief of symptoms of lumbar spinal stenosis.

This evaluation used the numerical rating scale (NRS) to assess pain relief and the Medication Quantification Scale III (MQS III) to assess the effectiveness of the interventions on medication consumption. The rates of adverse events related to the interventions were also compared.

Low back pain (LBP) is one of the leading causes of disability worldwide. Lumbar spinal stenosis is one of the three most common diagnoses of lower back and leg pain, along with intervertebral disc herniation and degenerative spondylolisthesis. Numerous treatment modalities have been proposed for the management of lumbar spinal stenosis, including drug therapy and complex surgical fusion. Epidural injections are a nonsurgical intervention commonly used in the treatment of spinal stenosis. Saline, local anesthetics, steroids, hylaze, platelet-rich plasma, and pulsed radiofrequency (PRF) administered to the caudal epidural space have been reported to be effective in the treatment of pain.

Among these, caudal epidural PRF has been applied in a limited number of chronic painful conditions (failed back surgery syndrome, chronic distal symmetrical polyneuropathy, postherpetic neuralgia, and coccygodynia), and no randomized controlled studies have been conducted. PRF produces a nonthermal effect that modulates the transmission of pain signals by delivering a short-term high-voltage electric current to the target nerve. RFT provides a continuous current that heats the target tissue and causes coagulation necrosis in nerves.

The primary aim of this study was to compare the efficacy of caudal epidural RFT and caudal epidural steroid injections in patients with lumbar spinal stenosis. The secondary aim was to determine the effects of the interventions on drug consumption and interventional safety, based on adverse events.

A total of at least 50 patients will be enrolled for comparison, with 25 in each group. NRS and MQS III scores will be compared both within and between groups before and 1, 2, and 3 months after treatment.

Eligibility Criteria:
Inclusion Criteria:

Among the patients with lumbar spinal stenosis findings and narrowing of the spinal canal detected by examination and imaging methods, those whose back and leg pain persists for at least 3 months

Exclusion Criteria:

Previous lumbar surgery, pregnancy, history of ongoing malignant disease, autoimmune diseases, active infection of the injection site, hematologic disorders, antiplatelet drug use