cyrilzakka/clinical-trials huggingface dataset:
Influence of Different Anesthetic Procedures on Sleep Disorder Breathing

Obstructive sleep apnea (OSA) is a common form of sleep disordered breathing characterized by partial or complete upper airway obstructions during sleep. OSA is associated with major comorbidities and perioperative complications. These complications are caused not only by the OSA itself, but also by exacerbations of this syndrome during the perioperative period (1). Benzodiazepines, volatile anesthetics and opioids may lead to lower hypoxia and hypercapnia sensitivity and may cause respiratory depression (2-5). Therefore, preference of neuraxial blockades and avoidance of opioids has been suggested for patients with OSA (6). However, there is still lack of evidence to evaluate the effects of various anesthesia procedures on OSA (6,7). We hypothesize different anesthetic procedures will have different effect on OSA exacerbations in the postoperative period. Accordingly, the aim of this study is to compare the number of sleep disordered breathing episodes in the postoperative period in patients with different anesthetic procedures.


Eligibility Criteria:
Inclusion Criteria:

* elective orthopedic surgery

Exclusion Criteria:

* already diagnosed sleep disorder breathing
* continuous positive airway pressure therapy
* tracheostomy
* American Society of Anesthesiologists class IV-V
The Effects of Water Walking on Spirometry Values

The objective of this study was verify if there are differences in spirometry values in children aged between 6 and 12 years who practice swimming complemented with water walking at the end of each session and those who only practice swimming.

Spirometry is a standard pulmonary function test that measures how an individual inhales or exhales volumes of air as a function time. It is the most important and most frequently performed pulmonary function testing procedure, having become indispensable for the prevention, diagnosis and evaluation of various respiratory impairments. However, there have been only a few studies addressing the effect of physical activity on pulmonary function test results and investigating the association between body composition and respiratory parameters in sports activities \[1,2,3\]. The objective of this study was verify if there are differences in spirometry values in children aged between 6 and 12 years who practice swimming complemented with water walking at the end of each session and those who only practice swimming. In this study participated 28 subjects (mean age, 7.68 ± 1.16 years) and was divided into two groups: swimming group (SG) (N=9) and swimming complemented with water walking group (SWWG) (N=19). The study was performed in 12 weeks with 3 moments of evaluation (M1, M2 and M3) , with two sessions per week of 45 minutes each, we wanted to identify the benefits in pulmonary function - Forced Vital Capacity (FVC), Forced Expiratory Volume in 1 second (FEV1) and Peak Expiratory Flow (PEF). The water walking activity occurred in the end of each session for 6 minutes, performed in straight line with the water level at the children's chest. The spirometry tests were realized with the microQuark Spirometer®. For the analysis of the results, we used descriptive statistics, the Shapiro Wilk test for testing the normality of the sample and for the inferential statistics the Mann-Whitney tests, Friedman's Anova, and d-Cohen for the magnitude of effect.

Eligibility Criteria:
Inclusion Criteria:

* classes of the level of adaptation to the aquatic environment

Exclusion Criteria:

* Students who did not belong to this age group, that is, less than 6 years old or over 12, who attended classes only once a week, were athletes at a competitive level, and children with a 6 months and / or more than 12 months.
Clinical Trial to Evaluate Short-term Efficacy of Palliative Methylphenidate in Asthenia in Advanced Cancer Patients

Fatigue is the most prevalent symptom in advanced cancer patients, interfering functional capacity, social relations, wellbeing, and quality of life. Methylphenidate is a central nervous system stimulant that has traditionally been used in cancer patients to manage depression, opioid-induced sedation, hypoactive delirium due to multiorgan failure, and cognitive disorder associated with brain tumors. Although there is evidence from prospective studies of the efficacy of this drug in cancer-related fatigue, the only one randomised clinical trials gave non-conclusive results. In order to define the real efficacy of methylphenidate in this setting, the investigators designed a new clinical trial comparing methylphenidate and placebo in cancer-related fatigue, assessed both by the verbal numeric scale (VNS) included in the Edmonton Symptom Assessment System (ESAS) and the subscale for fatigue of the Functional Assessment of Cancer Therapy (FACT-F). The investigators will include 122 advanced cancer patients with fatigue ≥ 5/10 (VNS, from 0 to 10) and hemoglobin ≥ 9 g/dl. Patients will be randomized to methylphenidate or placebo. Doses will be adapted to response within a range from 10 mg at morning time and 5 at noon, to 25 mg/day. Assessment of response will be performed on day 3 and day 6 with ESAS and FACT-F. Drug-induced adverse events will be checked. The VNS of fatigue on day 6 will be consider the primary endpoint.


Eligibility Criteria:
Inclusion Criteria:

* Advanced cancer; including metastatic, locally advanced or relapsed not amenable for curative treatment.
* Mini.mental status examination results within normal limits.
* Informed consent.
* Estimated life expectancy of at least one month.
* Hemoglobin \>= 9 g/dl.
* Asthenia \>= 5 (0-10; numeric verbal scale).

Exclusion Criteria:

* History of psychosis.
* Structured suicidal ideation.
* Severe anxiety.
* Severe renal, hepatic or cardiac (arrythmia, hypertension, ischemic heart disease) failure.
* Simultaneous treatment with drugs that may interact with methylphenidate as: coumarinics, anticonvulsivants (phenobarbital, phenitoin, primidone), phenylbutazone, inhibitors of mono-amine-oxidase, guanethidine.
* History of glaucoma.
* Hyperthyroidism.
* History of hypersensibility to methylphenidate.
* Clinical suspicion of: infection, hypercalcemia, hypothyroidism or renal failure.
The Effects of a Ficus Carica on Improvement in Bowl Movements in Female Volunteer With Functional Constipation

This trial is being conducted to look for following changes when fig paste is taken by female subjects with functional constipation:

To evaluate the improvement of the bowel

To assess the quality of life and impact on female reproductive function

To evaluate the influence on glucose, cholesterol, HDL-cholesterol, LDL-cholesterol


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are female volunteers (unmarried), 19\~40 years
* Subject who have functional constipation by ROME IIII criteria
* Subject who have over 36 hour colonic transit time
* Subject must provide written informed consent to participate in the study

Exclusion Criteria:

* Subject with a history or evidence of clinically significant gastrointestinal, anorectal, hepatic, renal, neurological, pulmonary, endocrine, blood tumor, psychiatric, Cardiovascular disease
* Subjects who have a gastrointestinal (GI) disease (Crohn's disease, etc.) that would increase the influence with absorbance medication or a GI surgery excluding appendectomy and hernia surgery
* Subject with uterine fibroids at ultrasonography
* Subject is pregnant, planning to become pregnant, or breast-feeding
* Subjects with childbearing potential (i.e. pre-menopausal, not surgically sterile) not willing to use a medically accepted contraceptive (oral contraception) regimen
* Known history of moderate to severe hepatic impairment (i.e., serum ALT\>1.5×ULN, AST\>1.5×ULN)
* Subjects with uncontrolled hypotension (indicated by a sitting systolic blood pressure ≤ 95 mmHg or diastolic blood pressure ≤ 60 mmHg measured) and hypertension (indicated by a sitting systolic blood pressure≥ 150 mmHg or diastolic blood pressure≥ 95 mmHg measured) at vital sign measurement
* Subjects with significant hypersensitivity about Ficus carica
* Subjects who received certain medications that cause the alteration of bowel movement within the past 2weeks prior to first administration
* Subjects who participated in other clinical investigation within 2 months prior to first administration
* Subject who drink constantly (21 units/week over)
* Subject who have Irritable bowel syndrome by ROME IIII criteria
* Any significant condition that, in the opinion of the investigator, could interfere with the subject's participation or compliance in the study (i.e., laboratory test and others)
Investigations Into ISCU Myopathy or Iron Sulfur Scaffold U Protein Myopathy

Background:

- A mutation in a gene known as ISCU was found to be the cause of a rare myopathy that affects the muscles. Researchers collected clinical samples from people with this myopathy. More research is being done to develop a therapy for this disease. Researchers are asking for permission to study the samples already collected.

Objectives:

- To allow researchers to use clinical samples collected to study new treatments for ISCU myopathy.

Eligibility:

- People with ISCU myopathy who have provided clinical samples for study.

Design:

* Participants will allow researchers to study clinical samples already collected. Blood, urine, muscle, and cell samples may be used. Medical records and photographs may also be studied.
* Treatment will not be provided as part of this study.

In 2008, NIH investigators collaborated to find a mutation in the human gene, ISCU, which is the official human gene name for a gene involved in assembly of iron sulfur clusters, and is abbreviated from Iron Sulfur Cluster assembly protein, U, which was identified as the cause of a rare myopathy that affected about 25 patients in Sweden. This protocol is intended to allow for the collection and analysis of clinical specimens and medical information from several research subjects who previously participated in studies that led to identification of the disease gene.

Eligibility Criteria:
* INCLUSION CRITERIA:
* Subjects will be eligible for this study if they have ISCU myopathy or carry a mutation in ISCU.

No exclusions will be made based on gender or, ethnicity and adults

will be the only patients included.
Expanded Access to Nivolumab (Opdivo)

At BMS, we work with physicians/investigators to make investigational products available to patients with life-threatening diseases that have exhausted other treatment options and where there is a reasonable expectation of benefit over risk.

When contacted by a treating physician, BMS will consider requests for providing early patient access to Nivolumab in pediatric patients exhibiting a high mutational load.

Choosing to participate in an early patient access program is an important personal decision. Talk with your doctor and family members or friends about deciding to join an early patient access program.

To learn more about early patient access programs, your doctor may contact BMS using the information provided below.

Eligibility Criteria:
Specific eligibility criteria must be met for access outside of a clinical trial.

These inclusion criteria include:

* The illness must be serious or life threatening
* There are no other viable options (including approved products or active clinical trials)
* There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks based on what is known at the time
* Other defined inclusion/exclusion criteria could be applicable.
The Duke-Reinvestment Partners Community Collaborative (DRC)- Healthy Homes

The goal of this open-label, single arm home intervention feasibility study is to improve quality of life for children ages 4-16 years with asthma.

The main questions it aims to answer are:

* How can Home-Based Environmental Interventions (HEI) improve home air-quality problems in the home?
* How can HEI improve asthma outcomes in children?

Participants will be receiving HEI and completing asthma surveys.

All participants will receive an Intervention Kit, which could help with reducing environmental exposures. Participants will be monitored closely with up to 2 clinic visits, 2 home visits and up to 4 phone call visits. During the home visits, a study team will ask questions about your home and asthma, conduct home assessments, and provide training on use of the home kit.

Participants may benefit from participation in this study through Home-Based Environmental Interventions by improving home air-quality and asthma outcomes. Study duration is approximately 24-30 weeks with 8 weeks of intervention, which includes baseline interview, questionnaires, spirometry testing, and participants receiving an Intervention Kit.

Eligibility Criteria:
Inclusion Criteria:

* Parent/legal guardian has provided informed consent (child has provided assent if needed)
* 4-16 years of age with medical provider -diagnosed asthma
* Evidence of recent poor asthma control, defined as either:

  1. Asthma exacerbation requiring systemic steroids within 3 month of consent OR
  2. ACQ6 \> 1.0; or ACT/cACT ≤ 19 during ambulatory visit within 3 months of consent
* Family lives in one of the following Central NC counties: Alamance, Chatham, Durham, Franklin, Granville, Johnston, Lee, Orange, Person, Vance, or Wake counties
* Family is not planning to move out of one of the approved counties accessible to Reinvestment Partners in the next 6 months

Exclusion Criteria:

* Lack of informed consent
* Any major chronic illness that in the opinion of the Principal Investigator (PI) would interfere with participation in the intervention or completion of the study procedures
* Inability to complete baseline measurements in a satisfactory manner according to the judgment of the research coordinator or PI
* Parent/Caregiver unable to consent in English or Spanish
* Sensitivity or allergy to silicone
Treatment of Infertility in Women With Polycystic Ovary Syndrome

Polycystic Ovary Syndrome (PCOS) is a common endocrine disorder affecting up to 10% of women. The primary symptoms of PCOS are menstrual irregularities, increased body and facial hair, acne, and infertility. This study will test a combination of medications in women with PCOS to determine which works best to overcome infertility.

PCOS is characterized by excess circulating androgen levels and chronic anovulation. The fundamental pathophysiologic defect is unknown, but PCOS is characterized by insulin resistance and compensatory hyperinsulinemia. Improvements in insulin sensitivity in PCOS women, either through lifestyle changes or through pharmaceutical intervention, have consistently resulted in a marked improvement in the reproductive and metabolic abnormalities in PCOS. Resumption of ovulation occurs in up to 70% of women treated for PCOS. This study will evaluate the safety and effectiveness of clomiphene citrate and metformin XR in achieving a successful pregnancy in infertile PCOS women.

Women with PCOS who are seeking pregnancy will be enrolled in this study. Women will be randomized to one of three different treatment arms: A) metformin XR 1000 mg twice/day; B) clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle); or C) metformin XR 1000 mg twice/day with clomiphene citrate 50 mg/day for 5 days (day 3-7 of cycle). Women will continue on study medications for 30 weeks, 6 treatment cycles, or until they become pregnant. Progesterone levels will be drawn weekly to monitor ovulation.

Eligibility Criteria:
Inclusion Criteria

* Eight or fewer menstrual cycles in the past year or intermenstrual periods of 45 days or longer
* Elevated testosterone level
* Good general health
* Sperm concentration in partner of 20 million/ml or greater
* Ability to have intercourse 2-3 times per week
* One functional fallopian tube and normal uterine cavity
Evaluation of an eHealth System to Reduce Depression and Increase Resilience After SCI

The availability of symptom monitoring and self-management (SMSM) interventions is especially important for civilians and military populations with spinal cord injuries (SCI). High rates of depressive disorders (20-40%) and anxiety disorders (20-25%) have been found in both civilian and military populations and are significant contributors to both quality of life and well-being after SCI. Previous self-management interventions targeting physical activity and self-reliance in individuals with SCI have demonstrated significant health and lifestyle benefits. However, it has been shown that the injured individual's psychological outlook and mood can either enable or hinder self-management efforts and that currently available SCI-specific self-management programs may be inadequate. Developing interventions to reduce mental health symptoms following SCI is therefore critical to improve the lives of individuals, alleviate resource strain on military and civilian health care systems, and potentially reduce the rate of mortality by suicide in Veterans and civilians living with SCI. The current study will build on prior work developing an intervention platform to assess the effectiveness of this eHealth SMSM system and will test the feasibility and effectiveness of the intervention platform.


Eligibility Criteria:
Inclusion Criteria:

* Access to the internet and an internet-enabled device
* Diagnosis of a sudden-onset (i.e. not due to a degenerative disease such as ALS or MS) SCI (either traumatic or non-traumatic)
* Discharged from initial inpatient rehabilitation and living in the community for at least 3 months
* Age 18 or older at the time of enrollment
* Age at least 16 years at the time of their spinal cord injury
* Current symptoms (no more than two weeks from the time of consent) of at least mild depression and/or anxiety, as determined by a score of ≥5 on the eight-item Patient Health Questionnaire depression scale (PHQ-8) and/or seven-item Generalized Anxiety Disorder measure (GAD-7).

Exclusion Criteria:

* Male and female participants younger than 18 years old
* A lack of English proficiency needed to comprehend and complete study measures and review online study content.
* Current cognitive impairment that would limit comprehension of informed consent or study procedures, as determined by the member of the study team conducting informed consent.
* Lack of access to the internet and an internet-enabled computer or smart device.
* A spinal cord injury that is due to a degenerative disease (e.g. ALS, MS) and not sudden onset.
Application of Early Physical Therapy Regimens in Patients With Veno-venos Extracorporeal Membrane Oxygenation

Promote early recovery through the application of early physiotherapy programs for VV-ECMO patients

This study is intended to construct early physiotherapy programs for VV-ECMO patients, including multidisciplinary team building, safety assessment, early active physiotherapy, respiratory physiotherapy, with a view to promoting early recovery of patients, early withdrawal of ventilator-assisted ventilation, shortening ECMO auxiliary time, improving patients' exercise level and respiratory function, reducing complications, and improving the quality of near-term and long-term survival.

Eligibility Criteria:
Inclusion Criteria:

* VV-ECMO assisted support
* lung failure (e.g. ARDS)
* age ≥18 years
* sober
* informed consent to this study

Exclusion Criteria:

* unstable blood flow mechanics
* active bleeding
* mental disorders that do not work together
* people waiting for lung transplants
* people at the end of life (e.g. advanced lung cancer)
Hemodynamic Optimisation Guided With Transcranial Doppler in Septic Shock

Randomized, controlled, prospective trial, including ICU patients with Sepsis or septic Shock, at the early phase.

patients will be randomized in 2 groups regarding the hemodynamic management and catecholamin doses:

* Group 1: standard hemodynamic goals and catecholamin infusion to achieve: mean arterial pressure \> or equal to 65 mmHg and diastolic arterial pressure \> ou equal to 50 mmHg within the first 60 minutes.
* Group 2: personalized hemodynamic goals and catecholamin infusion until normal transcranial doppler: IP\<1,2.

Randomized, controlled, prospective trial, including ICU patients with Sepsis or septic Shock, at the early phase.

patients will be randomized in 2 groups regarding the hemodynamic management and catecholamin doses:

* Group 1: standard hemodynamic goals and cathecolamin infusion to achieve: mean arterial pressure \> or equal to 65 mmHg and diastolic arterial pressure \> ou equal to 50 mmHg within the first 60 minutes.
* Group 2: personalized hemodynamic goals and cathecolamin infusion until normal transcranial doppler: IP\<1,2.

For the 2 groups, standard management including: microbiological sampling, early broad spectrum anti infective therapy, fluid management and decreasing of blood lactate levels, will be aimed within the first 60 minutes.

For the Group 2 patients: personalized hemodynamic management will be maintained during 72 hours.

Eligibility Criteria:
Inclusion Criteria:

* All ICU patients presenting septic shock
* No criteria of traumatic or vascular brain injury

Exclusion Criteria:

* Patients with refractory septick shock
* rapid fatal evolution: before 72 hours
* No individualisation of the MCA ultrasonographic window
Effectiveness of Testofen Compared to Placebo on Long COVID Symptoms

This is a double blind, randomised, placebo-controlled trial to evaluate orally-dosed Testofen (a specialised extract of Trigonella foenum-graecum (Fenugreek) seed) compared to placebo on post COVID-19 symptoms in otherwise healthy participants 18 years and over.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years and over
* Able to provide informed consent
* Diagnosed with COVID-19 infection (RAT or PCR test) \>4 weeks, but \< 12 months and experiencing post COVID symptoms (1)
* Agree not to participate in another clinical trial while enrolled in this trial

  1. Common post COVID symptoms may include fatigue, cough, chest pain, hair loss, weakness, joint pain, cardiac issues, neurocognitive impairment including memory loss, and decreased quality of life

Exclusion Criteria:

* Symptoms resulting from vaccination (2)
* Unstable or serious illness (e.g., serious mood disorders, neurological disorders such as MS, kidney disease, liver disease, heart conditions, diabetes, thyroid gland dysfunction) (3)
* Current malignancy (excluding BCC) or chemotherapy and radiotherapy treatment for malignancy within the previous 2 years
* Receiving/prescribed coumandin (Warfarin), heparin, dalteaparin, enoxaparin or other anticoagulation therapy
* Receiving pharmaceutical treatment for anxiety, libido, low energy
* Active smokers, nicotine use, alcohol, or drug (prescription or illegal substances) abuse
* Chronic past and/or current alcohol use (\>14 alcoholic drinks per week)
* Allergic to any of the ingredients in the active or placebo formula
* Known pregnant or lactating women
* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
* Participants who have participated in any other related clinical study during the past 1 month
* History of infection in the month prior to the study

  (2) Symptoms must be as a direct result of having contracted COVID. If symptoms only appeared within 2 weeks of a vaccination it will be considered a vaccine injury and not classed as a result of COVID.

  (3) An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.