cyrilzakka/clinical-trials huggingface dataset:
The Relationship of Abdominal Circumference and Trunk Length With the Level of Spinal Anesthesia in Obstetric Patients

The body shape might have influence on the spinal level. In this research we plan to investigate the relationship of abdominal circumference, trunk length and the level of spinal anesthesia in obstetric patients during Cesarean section.

The level of spinal anesthesia in obstetric patients had been investigated in several studies. Increased cephalad spread of local anesthetics had been demonstrated with increased intra-abdominal pressure, changes in anteroposterior spinal curves and lumbar lordosis. Theoretically the body shape might have contribution to the above factors and might have influence on the spinal level. In this research we plan to investigate the relationship of abdominal circumference, trunk length and the level of spinal anesthesia in obstetric patients during Cesarean section. Only those C/S patients indicated and scheduled for spinal anesthesia will be observed. The spinal anesthesia will be performed as routine practice. This study will not change the clinical plan in any aspect. We will only passively record the abdominal circumference, trunk length and the level of spinal anesthesia and calculate the correlation between them.

Eligibility Criteria:
Inclusion Criteria:

* Obstetric patients for C/S

Exclusion Criteria:

* With major systemic diseases
SAPHIR : Assessment of Predictive Factors for Persistence of Treatment After Initiation of Adalimumab With a Biosimilar (Adalimumab Fresenius KaBI or Substitution of Reference Adalimumab With the Fresenius Kabi Adalimumab Biosimilar in Patients With Chronic Inflammatory Diseases

A prospective, longitudinal, multicentre, observational cohort follow-up study conducted in France.

In a population of adult patients who are targeted to initiate adalimumab or previously treated with Humira® to get switched to a biosimilar (FK adalimumab) and followed up for a period of 12 months under routine medical practice conditions.

* Primary objective: to define predictive factors for the persistence of treatment
* Secondary objectives:

  * To assess the therapeutic benefit and the tolerability of the treatment
  * To describe the reasons for treatment discontinuations occurring during follow-up

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 years or over
* Patient who have been informed of the objectives and the conditions of the study and who did not object to its participation
* Patient diagnosed with one chronic inflammatory rheumatological (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) or chronic inflammatory bowel (Crohn's disease, ulcerative colitis) diseases
* Patient for whom the investigator has decided, with patient's agreement and prior to inclusion:
* Or to initiate adalimumab by prescribing a biosimilar (Adalimumab FK)
* Either to replace Humira® with a biosimilar (AdalimumabFK)

Exclusion Criteria:

* Patient enrolled in an interventional therapeutic trial at the time of inclusion
* Patient refusing or unable to comply with the study follow-up procedures (patient not contactable by telephone, unable to complete the self-administered questionnaire, or having poor French language skills, etc.)
Data Collection Study for RFP (Respiration From Plethysmogram)

The study will be conducted in hospitalised patients who undergo spot-check monitoring of vital signs as part of their routine care.

In an additional spot-check measurement procedure, the study will measure oxygen saturations through different Philips SpO2 finger sensors. Patients will wear a nasal cannula linked to a CO2 measuring device at the same time. The data from both devices will be used to design and improve algorithms for measurement of respiratory rate with the saturation probe and the Philips FAST pulse oximeter system. The study will include 50 adult patients and 25 pediatric patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects (aged 18 years or older) willing and able to understand and provide written informed consent
* Paediatric subjects aged 16 years and older willing and able to understand and provide written informed consent
* Paediatric subjects aged approx. 4-16 years and their legal guardians, willing and able to understand and provide written informed consent/assent
* Subject weight within intended use of at least one SpO2 sensor under test at time of enrolment (M1191T: adult patients \>50kg, M1196T: adult patients \>40kg, M1192A: paediatric patients 15-50kg)
* Willing and able to wear study devices during study procedures
* Subject undergoing regular spot-check measurements as per the site's standard of care

Exclusion Criteria:

* Palliative patients
* Critically ill patients with severe physiological instability (NEWS ≥9)
* Injury/wounds or physical malformation of sensor application site (i.e. fingers, toes, hands, feet)
* Subjects with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors (self-reported)
* Unwillingness or inability to remove coloured nail polish or artificial nails from application site
* Nail fungus on application site
* Severe dermatitis or hyperkeratosis (e.g. ichthyosis) at sensor application site
Study of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants With Both Chronic Hepatitis B and HIV

The study aims to assess safety and tolerability of oral toll-like receptor (TLR) 8 agonist Selgantolimod (SLGN) administered for 24 weeks in participants with both CHB and HIV who have been receiving suppressive antiviral therapy for both viruses for ≥5 years and have qHBsAg level \>1000 (3 log10) IU/mL at screening. The study will also evaluate if TLR8 stimulation with SLGN will reduce hepatitis B surface antigen (HBsAg) titers in the blood.

A5394 is a phase II, double-blinded, placebo-controlled trial. Forty-eight study participants will be randomized 3:1 to receive SLGN or its placebo (36 active and 12 placebo), and randomization will be stratified by HBeAg status. One-half of the study participants will be HBeAg positive (n=24) at screening, and the other half will be HBeAg negative (n=24). All participants will remain on their non-study-provided antiviral therapy throughout the study.

Eligibility Criteria:
Inclusion Criteria:

1. HIV-1 infection
2. Effective antiviral therapy for HIV (ART) and HBV that includes TDF, TAF, TDF/FTC, TDF/3TC (tenofovir disoproxil fumarate plus lamivudine), TAF/FTC, or entecavir (ETV), for ≥5 years immediately prior to study entry. ART is defined as including a minimum of two anti-HIV antivirals.
3. CD4+ cell count ≥350 cells/mm3
4. HIV-1 RNA \<50 copies/mL measured on at least two occasions at least 12 weeks apart, with no documented value \>200 copies/mL, over the 12 months prior to study entry.
5. Positive or negative HBeAg
6. Negative anti-HDV
7. Current CHB infection
8. HBV DNA level \<50 IU/mL measured on at least two occasions at least 12 weeks apart, with no documented value ≥50 IU/mL, over the 12 months prior to study entry.
9. Quantitative HBsAg \>1000 IU/mL
10. Hepatitis C virus (HCV) antibody negative, or if the participant is HCV antibody positive, an undetectable HCV RNA.
11. Participants age ≥18 years and ≤70 years at study entry
12. Participants must agree to stay on an effective antiviral therapy for HIV (ART) and HBV throughout the study.

Exclusion Criteria:

1. Receipt of treatment for HCV within 24 weeks prior to study entry
2. Evidence of advanced fibrosis or cirrhosis (Metavir ≥F3 or equivalent).
3. Current or prior history of clinical hepatic decompensation (e.g., ascites, encephalopathy, or variceal hemorrhage)
4. History of HCC or cholangiocarcinoma
5. Malignancy within 5 years prior to study entry. NOTE: A history of non-melanoma skin cancer (e.g., basal cell carcinoma or squamous cell skin cancer) is not exclusionary.
6. History of solid organ transplantation
7. Presence of any active or acute AIDS-defining opportunistic infections within 60 days prior to study entry
8. History of uveitis or posterior synechiae
9. Breastfeeding
Barbed Suspension of the Tongue Base for Treatment of Obstructive Sleep Apnea Patients

Obstructive sleep apnea syndrome (OSAS) is a common clinical condition in which the throat narrows or collapses repeatedly during sleep, causing obstructive sleep apnea events.

One of the most common sites for collapse during sleep is hypo-pharyngeal space. It was founded in 50% of OSA patients those have moderate and severe apnea.

DeRowe et al invented the Tongue base suspension operation in 1998 for sleep disordered breathing.


Eligibility Criteria:
Inclusion Criteria:

* BMI of patients less than 35 kg/m2.
* Patients who have symptoms and signs of OSA.
* Moderate to severe OSAHS confirmed by formal polysomnography (defined as an AHI ≥15).
* Friedman tongue position III or IV.
* Documented failure/refusal of attempts of conservative treatment measures (not limited to continuous positive airway pressure).
* The presence of retrolingual collapse confirmed preoperatively with flexible fiberoptic endoscope during Muller maneuver.
* Patients have macroglossia as defined by posterior airspace (PAS) of ≤10mm.

Exclusion Criteria:

* Failure to attend postoperative follow-up polysomnography within 6 months of surgery.
* Previous surgery to the base of the tongue or other surgical treatment of OSAHS.
* A history of malignancy or infection of the head and neck region, laryngeal trauma, or other previous oropharyngeal/laryngeal surgery.
* Patients have retrognanthia sella-nasion-supra mentale (SNB) ≥76º.
* Huge lymphoid tissue of the tongue and/or lingual tonsil.
Biomarkers in Predicting Neurotoxicity in Patients With Colorectal Cancer Receiving Oxaliplatin

RATIONALE: Studying samples of blood in the laboratory from patients receiving oxaliplatin for cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to neurotoxicity.

PURPOSE: This phase II trial is studying biomarkers in predicting neurotoxicity in patients with colorectal cancer receiving oxaliplatin.

OBJECTIVES:

Primary

* Correlate predictive genetic, proteomic, and/or neurotrophic markers with neurological manifestations related to the administration of oxaliplatin in patients with colorectal carcinoma.

Secondary

* Differentiate between risk factors predictive of acute and chronic neurotoxicity.
* Establish a possible relationship between acute and chronic neurotoxicity.

OUTLINE: This is a multicenter study.

Patients receive oxaliplatin every 2 weeks as part of a FOLFOX chemotherapy regimen.

Blood samples are collected 15 days prior to beginning chemotherapy, prior to each course of chemotherapy, and at 1 month after completion of chemotherapy for pharmacogenetic and laboratory biological studies. Patients with chronic neurotoxicity undergo additional blood sample collection at 3, 6, 9, and 12 months after completion of chemotherapy. Samples are analyzed for the detection of gene variants involved in the oxalate and fluorouracil metabolic pathway; neurotrophic factors; proteomic analysis of plasma proteins and peptides; and for biological testing of neurotoxicity.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed colorectal cancer
* Requires treatment with oxaliplatin (as part of a FOLFOX regimen)
* No brain metastases or symptomatic meningitis

PATIENT CHARACTERISTICS:

* WHO performance status 0-2
* Life expectancy \> 3 months
* ANC ≥ 1 x 10\^9/L
* Platelet count ≥ 100 x 10\^9/L
* Total bilirubin ≤ 2 times upper limit of normal (ULN)
* Transaminases ≤ 3 times ULN
* Alkaline phosphatase ≤ 5 times ULN
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No prior or concurrent clinical neuropathy (regardless of the etiology)
* No dihydropyrimidine dehydrogenase deficiency
* No psychiatric illness that would preclude comprehension of the study or of the informed consent
* No other severe illness that may worsen during treatment, including unstable cardiac disease, myocardial infarction within the past 6 months, or active uncontrolled infection
* No psychological, social, familial, or geographical reason that would preclude study follow-up
* Other cancer within the past 5 years allowed provided treatment did not include platinum derivatives or taxanes

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* Prior chemotherapy allowed (except for platinum derivatives or taxanes)
Phase 1 Study of Topical Ocular PAN-90806 for Neovascular AMD

The objective of this study is to assess the safety and tolerability of topical ocular PAN-90806 in patients with active, subfoveal choroidal neovascularization associated with neovascular Age-Related Macular Degeneration (AMD).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis in the study eye of active, pathologic, newly diagnosed and previously untreated, subfoveal choroidal neovascular (CNV) lesions secondary to neovascular AMD
* Aged 50 years or older
* Demonstrate the ability, or have a family member who is willing and able, to instill topical ocular drops in the study eye

Exclusion Criteria:

* No prior ocular or systemic treatment or surgery for neovascular AMD in the study eye
* History of or current clinical evidence in the study eye of:

  * aphakia
  * diabetic macular edema
  * any ocular inflammation or infections
  * pathological myopia
  * retinal detachment
  * advanced glaucoma
  * significant media opacity, including cataract
* History or evidence of the following surgeries in the study eye:

  * penetrating keratoplasty or vitrectomy;
  * corneal transplant;
  * corneal or intraocular surgery within 3 months of Screening
* Uncontrolled hypertension despite use of antihypertensive medications
* Participation in any investigational drug or device study, systemic or ocular, within past 3 months
* Women who are pregnant or nursing
* Known serious allergies or hypersensitivity to the fluorescein dye used in angiography or to the components of the PAN-90806 formulation
COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80

A multi-center adaptive randomized placebo-controlled platform trial evaluating the efficacy and safety of anti-thrombotic strategies in COVID-19 adults not requiring hospitalization at time of diagnosis

The COVID-19 Outpatient Thrombosis Prevention Trial is a multi-center adaptive randomized double-blind placebo-controlled platform trial to compare the effectiveness of anti-coagulation with anti-platelet agents and with placebo to prevent thrombotic events in patients diagnosed with COVID-19 who have evidence of increased inflammation based on elevated D-dimer and hsCRP levels, yet are not admitted to hospital as COVID-19 related symptoms are currently stable. Participants will all be adults between 40 and 79 years who will be enrolled from approximately 100 facilities, such as emergency rooms and other settings where a physician is present to evaluate the patient for inclusion and exclusion criteria.

Eligibility Criteria:
Inclusion:

* COVID-19+ in past 14 days
* Platelets \> 100,000
* eGFR \> 30ml/min

Exclusion:

* Hospitalized
* Contradiction/ other indication for anti-coagulation
* Pregnancy
* Active cancer
Oral Versus Vaginal Progesterone in the Luteal Support in Cryo-warmed Embryo Transfer Cycles

In IVF/ICSI cycles, the progesterone levels induced by ovarian stimulation are low, therefore the luteal phase is supported by progesterone. The use of progestogens in IVF is associated with an improvement in the live birth rate Standard protocol for luteal phase support has not yet been established. Currently vaginal progesterone is widely used, since the classic oral progesterone seems to result in a low bioavailability and a lower pregnancy rate. However, vaginal administration of progesterone is associated with vaginal irritation, discharge and bleeding. For all these reasons, there is a need for an effective, well tolerated, and safe treatment that can improve patient satisfaction and compliance.

Many studies have observed similar pregnancy rate results with dydrogesterone and micronized vaginal progesterone. A new RCT including a total of 1143 patients by Tournaye, showed that dydrogesterone treatment had a similar safety profile to micronized vaginal progesterone (MVP) for luteal support as part of ART treatment. The crude pregnancy rates at 12 weeks were 37.6% and 33.1% in the dydrogesterone and MVP treatment groups respectively.

Regarding the administration route of progesterone, intramuscular and transvaginal routes are the two conventional progesterone administration techniques. However, very few studies have compared the advantages of oral dydrogestrone with vaginal progesterone for luteal support in ART cycles.

The objective of the investigator's study is to demonstrate the superiority of oral dydrogesterone (Duphaston) 10 over MVP (Utrogestan) used for luteal supplementation in cryo-warmed embryo transfer cycles. Upon consent, 224 patients women will be randomly allocated into either one of the study groups using a simple randomization method by computer-generated random numbers. Group I will receive the oral dydrogesterone, while group II will receive the vaginal microprogesterone.


Eligibility Criteria:
Inclusion Criteria:

* Normal uterine cavity
* Normal Hormonal investigation: TSH,PRL,FBS
* Frozen embryo transfer cycles: at least 2 embryos
* Primary or secondary infertility: tubal occlusion, male factor, unexplained, endometriosis, ovarian factors...
* Body mass index (BMI) ≥18 to ≤30 kg/m2

Exclusion Criteria:

* Preexisting untreated medical condition (thyroid disease, diabetes mellitus, hypertension, pulmonary conditions, cardiac condition...)
* History of three or more consecutively failed In Vitro Fertilization (IVF) cycles after embryo transfer
* History of three or more miscarriages
* Previous allergy reactions to progesterone products
Study on the Effect of Target-controlled Infusion for General Anesthesia in Cardiac Surgery

The purpose of the study was to evaluate whether individualized general anesthesia with target-controlled infusion could help patients wake up early for extubation and reduce the incidence of postoperative complications, and to investigate the effectiveness and safety of its application in patients undergoing cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* All patients aged 18 years and older who underwent cardiac surgery

Exclusion Criteria:

* Mechanical ventilation support before surgery;
* Combined with any type of non-cardiac surgeries;
* Second exploratory thoracotomy after surgery;
* Died or discharged within 48 h after surgery;
* Missing clinical data
Study of AT-527 in Healthy Subjects (R07496998)

This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-527 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
* Females must have a negative pregnancy test at Screening and prior to dosing
* Minimum body weight of 50 kg and body mass index (BMI) of 18-32 kg/m2
* Willing to comply with the study requirements and to provide written informed consent

Exclusion Criteria:

* Pregnant or breastfeeding
* Infected with hepatitis B virus, hepatitis C virus, HIV or COVID-19
* Abuse of alcohol or drugs
* Use of other investigational drugs within 28 days of dosing
* Other clinically significant medical conditions or laboratory abnormalities
MAPS PrEP Van Study

For this study the investigators aim to see if giving participants an oral HIV prevention medication on a medical van, is a good option of care for individuals who inject drugs and/or are sexually active and therefore at a higher risk of contracting HIV.

The purpose of this study is to evaluate a pilot program that provides Pre-Exposure Prophylaxis (PrEP) for people who use drugs (PWUD) and are at risk for contracting HIV. Given the ongoing overdose crisis and the risk of HIV among PWUD, this study aims to assess weather offering oral PrEP on a Medical Mobile Unit (MMU) is a viable strategy for preventing HIV transmission in high-risk populations. The other goal of this study is to assess community perceptions of PrEP and perceived HIV risk among Syringe Service Program (SSP) clients visiting a MMU.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older, active drug injection user and/or sexually active, referred from the Syringe Service Program

Exclusion Criteria:

* positive HIV status
Physician Assessment of the Clinical Utility of a Patient-Specific 3D Electro-Anatomical Heart Model in VT Ablation

ACE-VT is a clinical pilot study designed to evaluate the ability of the CardioSolv Software System to generate an output for the physician to review in a timely fashion, consistent with the standard of care VT ablation workflow. This study will assess the acute effectiveness of using the CardioSolv Software System output as additional supporting information during ablation.


Eligibility Criteria:
Inclusion Criteria:

1. Participant meets standard criteria for VT ablation and is scheduled for VT ablation by their cardiologist or electrophysiologist
2. 18 to 85 years of age
3. VT and ischemic cardiomyopathy
4. A pre-procedure MRI with LGE is available (performed within 1 year of procedure, unless an MI has occurred since MRI) with adequate image for analysis
5. Participant is able and willing to provide written informed consent

Exclusion Criteria:

1. Contradiction to MRI (except those with MRI compatible pacemaker/ICD/CRT devices implanted or site has approved procedure for MRI of non-compatible devices).
2. Participant implanted with an LVAD.
3. Enrolled in another non-imaging intervention assignment study that could confound the results of this study.
The Effect of Teleyoga in Liver Transplant Patients

Online yoga practices will be applied in liver transplant patients and the effects of online yoga on balance, frailty, cognition and quality of life of transplant patients will be examined.

The study will include liver transplant patients who applied to Dokuz Eylül University Faculty of Medicine, Department of Surgical Medical Sciences, Department of General Surgery Outpatient Clinic. The aim of the study is to investigate the effect of online yoga practice on balance, frailty, cognition and quality of life levels in liver transplant patients. The study will include 26 patients with liver transplantation who meet the criteria. Participants will first be informed about the study and individuals will be included in the study after signing the informed consent form. Demographic information of liver transplant patients will be obtained and their balance, frailty, cognition and quality of life levels and post-transplant symptoms (symptoms seen in people) will be evaluated.

Online yoga practices will be applied to liver transplant patients for 8 weeks, 2 days a week, 30 minutes a day. Online yoga (teleyoga) will be performed via video call with people who meet the inclusion criteria. After 8 weeks of yoga intervention, balance, frailty, cognition and quality of life levels and post-transplant symptoms will be re-evaluated.

Balance measurements will be evaluated with Biodex Balance System (BSS). Frailty levels will be assessed by Short Physical Performance Battery and FRAIL frailty questionnaire. Cognition will be assessed by trail making test and stroop test. Quality of life will be evaluated with Short Form-36 quality of life scale and post-transplantation symptoms will be evaluated with Modified Post-Transplantation Symptom Occurrence and Discomfort Status-58-Item Scale-Turkey.

The evaluations are planned to last 1-2 hours.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-65
* Liver transplantation at least 6 months ago
* Individuals with a Mini Mental Test score greater than 24

Exclusion Criteria:

* Pregnancy
* Central Nervous System Dysfunction
* Musculoskeletal deformity
* Vestibular dysfunction
* Specific neurological pathology (Parkinson's, stroke, epilepsy)
* Those with severe systemic diseases