cyrilzakka/clinical-trials huggingface dataset:
Randomized-controlled Trial (RCT) on CPAP-withdrawal and Microvascular Function in OSA

Randomized controlled trial (therapeutic vs. placebo CPAP) including 46 patients with obstructive sleep apnea (OSA) to define the physiological effects of continuous positive airway pressure (CPAP) therapy withdrawal on myocardial perfusion and dermal and renal microvascular function during a 2 week period.


Eligibility Criteria:
Inclusion criteria:

* Objectively confirmed OSA (at the time of original diagnosis) with an oxygen desaturation index (ODI, =4% dips) of \>20/h and an ESS of \>10.
* Currently \>20/h oxygen desaturations (=4% dips) during an ambulatory nocturnal pulse oximetry performed at the end of a 4-night period without CPAP.
* Treated with CPAP for more than 12 months, minimum compliance 4h per night, AHI\<10 with treatment (according to CPAP machine download data).
* Current ESS \<10.

Exclusion criteria:

* Previous ventilatory failure (awake SpO2 \<93% and PaCO2\>6kPa).
* Unstable, untreated coronary or peripheral artery disease, severe arterial hypertension or hypotension (\>180/110 or \<90/60mmHg)
* Previously diagnosed with Cheyne-Stokes breathing.
* Current professional driver; Any previous sleep related accident.
* Age \<20 or \>75 years at trial entry.
* Acute inflammatory disease
Comparison of Detection of SARS-CoV2 (COVID-19) Between Nasopharyngeal Swab Specimens and Those Obtained by Salivary Sputum

Multicenter observational study of diagnostic test validation (Research Involving the Human Person, type 3) In addition to the diagnosis by the reference method (nasopharyngeal swab), the patient will be asked to provide a saliva sample via a salivary spit. The clinical circumstances of the diagnosis, the age of the patient, the associated terrain (diabetes, immunodepression, pregnancy) will be noted. The nasopharyngeal and saliva samples will be analyzed in Cayenne and the remaining samples will be frozen and stored at the CRB before being sent to the University Hospital of Caen for analysis and concordance verification.

The expected benefits are:

Possibility of repeating tests in the same person more easily due to the absence of pain and thus reduce the barriers to diagnosis and screening.

Possibility of self-sampling, which could simply be sent to the laboratory, which would relieve the diagnostic sites that mobilize staff and require a fairly heavy organization. Avoid long waiting lines that can be an obstacle and lead to a renunciation of the diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Patient with an indication to perform a COVID diagnostic test (symptomatology, contact case, systematic screening etc...)
* Men and women at least 3 years old

Exclusion Criteria:

* Refusal of the patient or his legal representative,
* Taking treatments that reduce salivary volume (anticholinergic activity)
* Impossibility to perform the nasopharyngeal test
* Patient under guardianship or curatorship, persons placed under protective measures
B'More Healthy; Communities for Kids (BHCK)

The BHCK study will develop, implement, and evaluate a community-based obesity prevention program, which operates at multiple levels of an urban food system (policy, wholesaler, corner stores, carryout, household, individual; in Baltimore, MD), and will improve the healthy food supply chain to increase affordability, availability, purchasing and consumption of healthy foods within low-income, minority neighborhoods.

Our overarching goal is to develop and evaluate a community-based obesity prevention program, which operates at multiple levels of an urban food system (policy, wholesaler, corner stores, carryout, household, individual; in Baltimore, MD), and will improve the healthy food supply chain to increase affordability, availability, purchasing and consumption of healthy foods within low-income minority neighborhoods. Our research will include stakeholders/ partners at different levels, e.g., the policy, wholesaler, retailer, adult caregiver, and individual child levels, and then develop, implement, and assess a two year multi-level systems-based child obesity prevention strategy targeting minority and low-income children (predominantly AA). Thirty low-income, predominantly AA geographic zones will be identified ("healthy eating zones"). Half of these zones will be randomized to intervention, while the other half will be control. Within each intervention zone we will work with 3-5 small food stores and prepared food sources to increase access to healthy foods through wholesaler discounts, display point of purchase promotional materials, and provide nutrition and food preparation education targeting youth and caregivers. We will work with local policymakers to institutionalize and sustain these changes.

The project will evaluate the impact of the program on: a) healthy food pricing and availability, b) low income African American adult food purchasing and preparation, and c) low-income African American youth diet, and associated psychosocial factors.

Eligibility Criteria:
Inclusion Criteria for Child participants:

9-14 years of age Living within one of the intervention neighborhoods Family does not anticipate moving outside of the study area during the duration of intervention

Inclusion Criteria for Adult Caregiver participants:

Parent/ legal guardian of a child ages 9-14 years of age Living within one of the intervention neighborhoods Family does not anticipate moving outside of the study area during the duration of intervention

Exclusion criteria:

Families that do not have a child within the age range Families that do not live within the neighborhoods in the study area Families who will move outside the study area within the intervention timeframe
Evaluation of VX-828 in Healthy Participants and in Participants With Cystic Fibrosis

The purpose of the study is to evaluate safety, tolerability, and pharmacokinetics of VX-828 and VX-828 in triple combination (TC) with Tezacaftor (TEZ) and VX-118 in healthy participants and in participants with cystic fibrosis (CF).

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility Criteria:
Key Inclusion Criteria:

Parts A-D:

* Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2)
* A total body weight of more than (\>) 50 kg
* Nonsmoker or ex-smoker for at least 3 months before screening with current nonsmoking status confirmed by urine or blood cotinine at screening

Part E:

* Confirmed diagnosis of CF as determined by the investigator
* A total body weight of more than or equal to (\>=) 35 kg
* Participants must be heterozygous for F508del with a second CFTR allele carrying a minimal function mutation that is not responsive to ELX/TEZ/IVA therapy
* Participants must have a forced expiratory volume in 1 second (FEV1) of greater than or equal to (≥) 40% of predicted normal for age, sex, and height

Key Exclusion Criteria:

Parts A-D:

* History of febrile illness or other acute illness within 14 days before the first dose of study drug
* Any condition possibly affecting drug absorption

Part E:

* An acute illness not related to CF (e.g., gastroenteritis) within 14 days before the first dose of study drug
* History of solid organ or hematological transplantation
* History of clinically significant cirrhosis with or without portal hypertension
* Lung infection with organisms associated with a more rapid decline in pulmonary status

Other protocol defined Inclusion/Exclusion criteria will apply.
Uterus Transplantation by Robotics - Gothenburg III

Robotic assisted organ procurement and robotic assisted transplantation in live donor uterus transplantation

Inclusion; absolute uterine factor infertility, age between 18 and 38, BMI less than 28, non-smoker

Eligibility Criteria:
Inclusion Criteria:

Uterine factor infertility, age 18-38 years, psychological stable, in steady relationship.

Exclusion Criteria:

Smoking, systemic disease, psychological instability
A Post-marketing Study on the Safety of Abatacept Treatment in Denmark Using the Danish Database

The purpose of this study is to expand on the ongoing post-marketing monitoring of abatacept to include all participants with rheumatoid arthritis (RA) and psoriatic arthritis (PsA) treated with abatacept captured in Danish Database for Biologic Therapies (DANBIO).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of rheumatoid arthritis (RA) or psoriatic arthritis (PsA)
* Receiving treatment with abatacept
* Receiving treatment with non-targeted DMARD
* Receiving treatment with targeted DMARD

Exclusion Criteria:

-Not applicable
Comprehensive Geriatric Assessment in Elderly Non-Small Cell Lung Cancer Patients

Lung cancer is responsible for one of the highest incidences of cancer-related mortality globally, and non-small cell lung cancer (NSCLC) accounts for the biggest subtype of lung cancer. In recent years, the use of immunotherapy has revolutionised the management of NSCLC, with better response rates and survival outcomes reported in the literature, compared to traditional cytotoxic chemotherapy. Despite this, doubts remain regarding the true efficacy of immunotherapy in patients \> 75 years old, given that this age subgroup is mis-represented in prospective phase III trials, in terms of numbers and baseline functional status, compared to real-world experience.

Furthermore, the use of immune checkpoint inhibitors (ICIs) is associated with a spectrum of immune-related adverse events (irAEs), affecting a range of organ systems. Once again, there are doubts about the safety of the use of these agents in patients \> 75 years old, and whether baseline performance status and comorbidities are good predictors of efficacy and safety outcomes in this elderly patient subgroup.

Comprehensive Geriatric Assessment (CGA) and the vulnerable elders survey (VES-13) are assessment tools that provide a good indication of functional status in elderly patients, in a similar capacity to performance status and comorbidities. This study therefore aims to prospectively examine patients \> 70 years old with a diagnosis of NSCLC, commencing immunotherapy. It will assess CGA and VES-13 scores at baseline, and correlate this with certain outcomes such as the incidence of severe adverse effects from immunotherapy at 3 and 6 months, any admissions to hospital arising from immunotherapy toxicities (and the subsequent length of inpatient stay), and mortality within 30 days. In doing so, it will help to determine if CGA and VES-13 scores can be used as a reliable indication of possible future efficacy and toxicity outcomes in this elderly patient subgroup.


Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥70 years old with advanced NSCLC due to start first or second line ICI therapy.
2. Patients able to give informed consent.

Exclusion Criteria:

1. Patients already on treatment with ICIs.
2. Patients with CNS or leptomeningeal spread / disease progression.
3. ECOG performance status III/IV.
4. Patients with severe autoimmune diseases.
5. Patients who are recruited and then stop treatment after receiving ≤3 cycles of ICI therapy, secondary to disease progression.
Effects of Malnutrition on Respiratory and Renal Functions in Patients Undergoing Peroral Endoscopic Myotomy (POEM)

The hypothesis of this study is to investigate cardiorespiratory and renal complications in patients under general anesthesia undergoing POEM surgery.

The primary purpose of this study is to define mild, medium and severe risk groups for malnutrition by using preoperative albumin values and MUST score in achalasia patients planned for POEM operation, and to determine the relationship of malnutrition/degree as well as demographic characteristics and comorbidities with postoperative respiratory and renal complications.

The secondary aim of this study was to determine persistent respiratory and renal outcome at 3 months after POEM procedure.

Eligibility Criteria:
Inclusion Criteria:

* Criteria for inclusion in the study:
* Patients diagnosed with achalasia and suitable for POEM treatment by gastroenterology physicians
* ASA 1-3
* Between the ages of 18-80

Exclusion Criteria:

* Criteria for exclusion from the study:
* Those with a known history of active lung infection, advanced COPD, or respiratory failure
* Patients with EF below 40%, severe ischemic heart failure, presence of valve disease
* Those with bleeding diathesis and severe thrombocytopenia (limit 30-50 thousand)
* severe kidney dysfunction
* In the presence of known intolerance or allergy to certain medications for sedation, analgesia, or both
* Pre-existing increased intracranial pressure
* Having a BMI \>30
* Severe uncorrected hypovolemiaHistory of radiotherapy to the esophagus
* History of mucosal resection or ablation in the area where POEM will be applied
* Presence of cirrhosis and portal hypertension.
Safety and Tolerability Study of K0706 in Subjects With Parkinson's Disease

This is a safety, tolerability and pharmacokinetic study in subjects with Parkinson's disease


Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to give written, and dated, informed consent (or legally acceptable representative/impartial witness when applicable) and is available for the entire study
2. Willing and able to comply with the scheduled visits, treatment plan, laboratory testing, study procedures, and restrictions (in the Investigator's opinion), and be accessible for follow-up
3. Male or female aged 18 to 65 years (both inclusive)
4. Diagnosed with Parkinson's disease

Exclusion Criteria:

1. Clinical diagnosis of genetic form of Parkinson's disease, or drug-induced parkinsonism
2. Diagnosis of Parkinson's disease Dementia (probable, possible)
3. Presence of severe dyskinesias
4. History of brain surgery for Parkinson's disease
Two Biologically and Clinically Distinct Entities: Progressive Versus Stable Multiple Myeloma (MM) Precursor Conditions

The key aim of the study is to define the two biologically and clinically distinct entities: progressive versus stable myeloma precursor conditions.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of MGUS and SMM will be made in accordance with the clinical diagnostic criteria set forth by the 2014 International Myeloma Working Group (IMWG) Revised Criteria.2
2. The diagnoses will be confirmed by either serum/urine protein electrophoresis, immunofixation and light-chain assays; or immunohistochemistry analyses of the bone marrow biopsy, or a combination of these tests.
3. Age greater than or equal to 18 years.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
5. The patient must be competent to sign an informed consent form.

Exclusion Criteria:

1. A diagnosis of MM as defined as any patient with detectable M-protein in blood and/or urine, monoclonal plasma cells in the bone marrow, and evidence of end-organ damage based on the Calcium Elevation, Renal Failure, Anemia, and Bone Disease (CRAB) criteria and/or myeloma-defining events.

   * Patients who have received previous therapy for MM.
   * Patients with known plasma cell or related lymphoid (e.g. lymphoplasmacytic lymphoma, Amyloid Light chain (AL) amyloidosis)
2. Confirmation of pathological diagnosis is required either from the initial pathology review report or review from the UM/SCCC Hematopathologist in accordance with the clinical diagnostic criteria set forth by the International Myeloma Working Group (IMWG) or World Health Organization (WHO). Tumor tissue that has been previously collected and is available for study or that can be collected with minimal additional risk to the patient during sampling required for routine patient care or required testing on a University of Miami (UM) /Sylvester Comprehensive Cancer Center (SCCC) research protocol will be used for diagnosis.
3. Active symptomatic major organ disorder that would increase the risk of biopsy or other procedure, including but not limited to ischemic heart disease, recent myocardial infarction, active congestive heart failure, pulmonary dysfunction.

   * Active concomitant medical or psychological illnesses that may increase the risk to the patient or inability to obtain informed consent, at the discretion of the Principal Investigator.
   * Pregnant or breast-feeding women will not be eligible for any aspect of this protocol.
   * Prisoners will be excluded.
Urological Physical Therapy in HTLV-1 With Urinary Symptoms

Urological physical therapy is described to improve urinary symptoms in patients with myelopathy or neurological dysfunction and to increase the quality of life. Although it was never tested on HTLV-1 associated overactive bladder syndrome, an disabling disease that is common seen in HAM/TSP patients but can also appear as an isolated form. Our hypothesis is that urological physical therapy can improve urinary symptoms like incontinence, urgency and nocturia in HTLV-1 infected population with those complains.

The T-lymphotropic virus type 1 (HTLV-1) is an human retrovirus that was proved to be the main agent of the acute T cell lymphoma/leukemia (ATLL) and a progressive neurological disease called HTLV-1 associated myelopathy/ tropical spastic paraparesis (HAM/TSP).

The HTLV-1 was first isolated in 1980 and it is endemic in Japan, Caribbean, Africa and South America. It is estimated that about 20 million people is infected worldwide. In Brazil it is present in all states with variable prevalences. The factors associated with HTLV-1 transmission in Brazil are related to the social and demographic condition, characterized by rural exodus and increase of urban population in the coast areas.

Several studies based in Brazil reported that the epicenter of HTLV-1 infection is on Bahia, Maranhão and Pernambuco with the highest prevalence of 1,8% in Salvador, Bahia capital.

The urinary incontinence is a bladder-sphincter disturbance often found in HTLV-1 patients. In this infection the most common pathology finding is overactive bladder syndrome due detrusor overactivity and sphincter-detrusor dyssynergia and the symptoms are urgency, nocturia and incontinence.

This disabling disease is associated with psychosocial issues like loss of self confidence, social isolation and reduced quality of life.

The physical therapy treatment have the objective of promote social adequacy and reestablish the bladder function. It is based on resources like: bladder reeducation, biofeedback, kinesiotherapy of the pelvic wall, utilization of vaginal cones and electrostimulation.

Those can be associated or not with anticholinergic drugs and bladder catheterization.

The need of urologic and gynecologic physical therapy follow up in patients with HTLV-1 and neurogenic bladder is important to reduce disability, preserve pelvic muscles and renal function.

Eligibility Criteria:
Inclusion Criteria:

* Patients with HTLV-1 with more than 18 years and neurogenic bladder defined by urodynamic study.

Exclusion Criteria:

* Diabetes Mellitus,
* Stroke,
* Multiple Sclerosis,
* Parkinson disease,
* use of pacemaker,
* urinary infection.
Clinical Readiness Skin Punch Biopsy Sample Collections

This is a clinical readiness skin punch biopsy sample collection study. This will allow to reduce manufacturing time when patients are identified as eligible to receive product under separate interventional treatment protocol.

This is a clinical readiness skin punch biopsy sample collection study. This will allow to reduce manufacturing time when patients are identified as eligible to receive product under separate interventional treatment protocol.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Congenital heart disease
* Likely to qualify for an active clinical trial under IND 28611 in the future

Exclusion Criteria:

* Previous cardiac transplantation
* Unable or unwilling to consent
* HIV diagnosis
* Hepatitis diagnosis
Incidence, Risk Factor, Treatment and Overall Survival of Locally Recurrent Rectal Cancer

Data on disease recurrence was collected for all primary rectal cancer patients diagnosed in the Netherlands over the first six months of 2015. Three-year cumulative incidence, risk factors, treatment and three-year OS of locally recurrent rectal cancer were determined.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed stage I-III primary rectal carcinoma;
* Diagnosed between January 1st and June 30th of 2015;
* TME resection of primary rectal carcinoma.

Exclusion Criteria:

* Neuroendocrine tumor morphology;
Cervical Ripening for Induction of Labor: Misoprostol Versus Oxytocin in Conjunction With Foley Balloon

The purpose of this study is to specifically investigate the efficacy of an alternative pharmacologic cervical ripening agent, misoprostol, versus the standard oxytocin, as an adjunct to Foley balloon for induction of the unfavorable cervix.

The design of this study is a randomized, controlled study with two arms. Both groups will undergo placement of a Foley catheter, through the external and internal os of the cervix, according to standard practice. In group A, receiving intravenous infusion of oxytocin, will serve as the control group as it is standard protocol at Aultman Hospital. Group B, intravaginal placement of misoprostol, will serve as the experimental group. The expected duration of participation begins at induction of labor and concludes at time of delivery.

Eligibility Criteria:
Inclusion Criteria:

* Participant or surrogate is capable of giving informed consent
* Anticipated number - 50 patients with 25 in each study arm Female with singleton gestation, live intrauterine pregnancy
* Participant is undergoing an indicated induction of labor
* Participant is found to have cervical Bishop score ≤5 on initial cervical exam
* Participant has no medical or obstetrical contraindications to induction of labor

Exclusion Criteria:

* Participant has ≥2 painful contractions in 10 min in 2 subsequent 10 min periods
* Manufacturer's contraindications to misoprostol or oxytocin
to Translate and Validate the TOPAS TORONTO PSORIATIC SCREENING QUESTIONNAIRE)Into Spanish

TO TRANSALETE AND VALIDATE DE TORONTO PSORIATIC ARTHRITIS SECREENING QUESTIONAIRE INTO SPANISH

THIS IS PART OF THE COLOMBIAN REGISTRY OF PATIENTS WITH PSORIASIS AND PSORIATIC ARTHRITIS

Eligibility Criteria:
Inclusion Criteria:

* ADULT WITH PSORIASIS IN THE DERMATOLOGY CLINIC

Exclusion Criteria:

* ADULT WITH OTHER AUTOIMMUNE DISEASE