cyrilzakka/clinical-trials huggingface dataset:
Does the Single Use of Intravenous Dexamethasone Enhance Analgesic Quality of Pudendal Analgesia in Children Undergoing Hypospadias Surgery?

Hypospadias is a congenital malformation that occurs in an embryological process, and occurs with an incidence of about 1/300 in male children. The caudal block was the most commonly performed method for pain control after hypospadias surgery, and showed very good analgesic effect in the immediate postoperative stage. However, the caudal block is a neuraxial block that has a limitation in its duration with single shot and shows complications and adverse effects. In recent studies, the pudendal nerve block has been suggested as an alternative method. In children undergoing hypospadias surgery, the pudendal nerve block showed a longer duration compared to the caudal block, decreased the use of analgesics within 24 hours after surgery, and showed higher parental satisfaction. On the other hand, there have been many studies to prolong the duration of the relatively short duration of caudal block. Among them, dexamethasone administered intravenously is known to improve the duration of various regional blocks and reduce the administration of additional analgesics. The aim of this study is to verify whether a single administration of dexamethasone can enhance the effect of the pudendal nerve block in children 0.5-3 years of age undergoing hypospadias surgery.


Eligibility Criteria:
Inclusion Criteria:

1. pediatric patients aged 6 months to 3 years who are planning to undergo hypospadias surgery
2. American Society of Anesthesiologists (ASA) classification 1\~2

Exclusion Criteria:

1. patients who are having uncorrected heart deformity
2. patients who are having vertebrae deformity in which the pudendal nerve block cannot be performed
3. patients with blood coagulopathy
4. patients with diagnosed diabetes
5. patients with diagnosed adrenal disease
6. patients with fever above 37.5 degrees before surgery
7. patients currently taking steroids
8. patients contraindicated for dexamethasone administration
Identification of Changes in Gastric Volume and Content by Ultrasound Before and After Chewing Gum

To identify by ultrasound the possible changes in gastric volume and content after chewing gum for an hour in volunteers with complete fasting (more than 8 hours).


Eligibility Criteria:
Inclusion Criteria:

* adults older or equal than 18 years old
* Minimum of 8 hours of fasting
* must work/study at Fundacion Santa Fe

Exclusion Criteria:

* Comorbidities such as obesity, renal failure, diabetes
* Gastrointestinal Disease
Efficacy, Safety, and Tolerability of Selonsertib (GS-4997) in Participants With Diabetic Kidney Disease

The primary objective of this study is to determine the effect of selonsertib (formerly GS-4997) on estimated glomerular filtration rate (eGFR) decline in participants with diabetic kidney disease (DKD). Participants will be randomized with a 1:1:1:1 allocation to receive 1 of 3 doses of selonsertib (2 mg, 6 mg, or 18 mg) or matching placebo.


Eligibility Criteria:
Key Inclusion Criteria:

* Adult male or females with prior diagnosis of Diabetic Kidney Disease
* Type 2 diabetes mellitus diagnosis for at least 6 months
* eGFR (MDRD) at screening ≥ 15 mL/min/1.73m\^2 to \< 60 mL/min/1.73m\^2
* Urine albumin to creatinine ratio (UACR) as follows:

  * Stage/Stratum 3a: eGFR range 45 to \< 60 mL/min; UACR ≥ 600 mg/g
  * Stage/Stratum 3b: eGFR range 30 to \< 45 mL/min; UACR ≥ 300 mg/g
  * Stage/Stratum 4: eGFR range 15 to \< 30 mL/min; UACR ≥ 150 mg/g
* Receiving angiotensin-converting-enzyme inhibitor (ACEi) or angiotensin receptor blockers (ARB) at a minimum dose deemed appropriate for the individual by the investigator and be at a stable dose for the last three months

  * Individuals not on ACEi/ARB may be screened if there is documented intolerance to ACE inhibitor and/or ARB

Key Exclusion Criteria:

* Type 1 diabetes mellitus
* HbA1c \> 9.5%
* Non-diabetic kidney disease
* UACR \> 5000 mg/g on any measurement during screening
* End stage renal disease (ESRD; receiving peritoneal dialysis, hemodialysis, or status post renal transplantation) or anticipated to occur within the treatment period
* Unstable cardiovascular disease
* Pregnant or lactating females

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Accuracy of Noninvasive Hemoglobin Measurement (SpHb) Using Rainbow DCI Pulse Oximeter Sensor

In this study, the concentration of hemoglobin within the subject's blood is affected by fluid status changes. The fluid status is affected by fluid loss during surgery for hospitalized study subjects or controlled administration of fluids intravenously for healthy study volunteers. The accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparing with blood sample analysis.


Eligibility Criteria:
Healthy Volunteers

Inclusion Criteria:

* Has physical status between ASA 1 or 2
* Able to communicate in English

Exclusion Criteria:

* Pregnant or sexually active without birth control.
* Hemoglobin less than 11g/dL
* Known alcohol or drug abuse
* Skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection
* Nail polish
* Head injury with loss of consciousness within the last year
* Known neurological and psychiatric conditions.
* Known concurrent chronic usage of psychoactive or anti-convulsive drugs within the last 90 days, or use in the last 7 days (i.e. tricyclic antidepressants, MAO inhibitors, lithium, neuroleptics, anxiolytics or antipsychotics. Except SSRIs
* Subject has any medical condition which, in the judgement of the investigator, renders them inappropriate for participation in this study, such as Reynauds syndrome
* Hypertension: Systolic BP \>= 140 mmHg or Diastolic BP \>= 90 mmHg
* Baseline heart rate \<50 beats per minute

Surgical Subjects

Inclusion Criteria:

* Age \> 18 years old
* Scheduled for surgery requiring frequent schedule blood draws as a part of their routine care

Exclusion Criteria:

* Pregnant or lactating women
* Skin abnormalities at the planed application sites that would interfere with transilluminating the finger, or other measurement sites, like burns, scar tissue, nail polish, infections etc.
Cross-over Study of Three Modular Devices for Aid in Patient Standing and Transfer

The main objective of this study is to evaluate via a physiological analysis of the movements involved in standing, the level of forward flexion of the spine (in cm on the horizontal axis) obtained with the apparatus "Tina" and to compare levels obtained in the same patients with stander/transfer devices "Turner" and "Vertic'Easy".

Secondary objectives of this study are to compare the three devices in terms of:

* the level recovery of the spine on the vertical axis (vertical displacement C7, cm)
* standing time, defined by the time between the start of the forward flexion and the beginning of the vertical stabilization phase (seconds)
* the success rate of the verticalization of the patient (the attempt is considered successful when the vertical position is held for 10 seconds).

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is in stable medical condition (no complications in the last 10 days)
* The patient is unable to stand up by his/her self and requires help during transfers
* The patient has muscular force (quadriceps) \> 3 out of 5.

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient, or breastfeeding
* The patient has a limited support from at least one lower limb
* The patient has an unstable fracture
* The patient has a fragile heart
* The patient has joint pain localized in the knee, hip or ankle.
* The patient has already used one of three mechanisms to help with standing and transfer used in this study
* Behavioral problems (opposition, agitation)
Artificial Intelligence Use for the Detection of Atrial Fibrillation Drivers

pilot clinical study, multicenter, prospective, open, nonrandomized

The hypothesis is that ablation targeting PVI alone for the treatment of persistent AF is less efficient that ablation targeting electrophysiologic areas with spatio-temporal-dispersion with or without PVI

Eligibility Criteria:
Inclusion Criteria: major patient with an indication of AF or AT ablation -

Exclusion Criteria:

-
The Real World Study of Apatinib for Gastric Cancer Treatment in Anhui Province

The investigators conduct the real world study to explore the efficacy and safety of Apatinib in gastric cancer .


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients .
2. Confirmed by Pathology or histology of Gastric cancer
3. Patients should be voluntary to the trial and provide with signed informed consent
4. The researchers believe patients can benefit from the study.

Exclusion Criteria:

1. Patients with a known history of allergic reactions and/or hypersensitivity attributed to apatinib or its accessories
2. Pregnant or lactating women
3. Patients with Apatinib contraindications
4. Patients of doctors considered unsuitable for the trial
Curcumin-Simvastatin-EDTA in the Treatment of Periodontitis

Among the root conditioning materials is the Ethylenediaminetetraacetic acid (EDTA). EDTA exposes the collagen fibers on dentin surfaces and also enhances early cell colonization. Statins have an anti-inflammatory effect, inhibit the bone resorption and stimulate the bone formation. Curcumin is effective in preventing periodontal disease destruction by targeting both bacteria and host inflammatory cells. Curcumin has anti- inflammatory, antioxidant, anticarcinogenic, antiviral, and antimicrobial functions. This study will be carried out to examine the effect of simvastatin-curcumin paste following EDTA root surface etching when used in conjunction with open flap debridement treating deep periodontal pockets (suggesting that it may have positive effect)

The present study entailed thirty patients having stage II or stage III, Grade A periodontitis with 30 intrabony defects. Patients were divided into three groups; group I was subjected to open flap debridement only. Group II was subjected to open flap debridement followed by application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin). Group III was subjected to open flap debridement followed by 24% EDTA root surface etching and application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).Clinical parameters including plaque index, sulcus bleeding index, probing depth and clinical attachment level were recorded pre-surgical. Moreover, radiographic examination was performed by cone beam computed tomography (CBCT) just before the surgery . Vertical bone defects were exposed by full thickness mucoperiosteal flap following intrasulcular incision and thorough debridement was performed. Group II received local application of curcumin-simvastatin paste .Group III received curcumin-simvastatin paste after debridement and 24 % EDTA. The same initial clinical parameters were recorded three and six months postoperatively. Radiographic measurements were recorded six months post surgically.

Eligibility Criteria:
Inclusion Criteria:

* Patient suffering at least a single posterior 2-3 wall periodontal Pocket of depth ≥ 5 mm, attachment loss ≥3 mm, intrabony component ≥3 mm, plaque index ≤1 (Sillness and Loe, 1964) and sulcus bleeding index ≤1 (Mühlemann \& Son, 1971). All these criteria were determined after phase I conventional periodontal therapy.
* Systemically healthy as evidenced by burket's oral medicine health history question questionnaire (Glick et al., 2008).
* Patients available during follow-up periods

Exclusion Criteria:

* Smoking
* Patient unwilling to comply with periodontal hygienic instructions
* Patients under any long-term chronic medication
* Vulnerable individuals
Nutritional Risk and Use of Health Care Services

This longitudinal observation study investigates associations between nutritional risk in adults aged 65+ and use of health services, morbidity and mortality. The first hypothesis is that older service users at nutritional risk will use a higher number of services/consultations and have a higher morbidity and mortality, compared to older patients not at nutritional risk. Further, the study evaluates the usefulness of the tool 'nutrition plan'. The second hypothesis is that older service users at nutritional risk who have a nutrition plan have lower subsequent morbidity and mortality, compared to older service users at nutritional risk without a nutrition plan.

The study is divided into two main parts, based on two different populations.

Study A: Article 1 is based on 'The Undernutrition Registry' in Helse Bergen Local Health Authority, Norway. The Undernutrition registry is a cohort of patients (n=20 000) screened for nutritional risk at Haukeland University Hospital (HUS) during point prevalence surveys between 2008 and 2018. The point prevalence surveys included all adult patients in somatic departments, and were performed 2-4 times per year. Detailed descriptions of the data collection can be found in Tangvik et al. (2012). Previous analysis showed that 43% of the patients in the sample were above 70 years, thus we expect the sample in the study to constitute approx. 9000 patients ≥ 65 years. Nutritional risk was determined by 'Nutritional Risk Screening 2002' (NRS2002). Information on nutritional risk will be linked to data on health care use and outcomes from the hospital's patient administrative electronic database (length of stay, number of hospital stays, morbidity in terms of number and severity of diagnoses and death).

Study B: Articles 2 and 3 are based on a cohort of older service users (≥65 years) with information on nutritional variables from the 'Kommunalt pasientregister' (KPR)-registry in the period 2016-2018 (N=270,560). Municipalities report data on nutritional risk screening and nutritional plan for individual service users in KPR. These nutritional data will be linked to data from 'The Norwegian Patient Registry' (NPR). NPR includes information about diagnosis and use of specialist services for all patients who have received or are waiting for treatment/consultations in specialist health care services (hospitals and outpatient clinics).

Nutritional status and use of 'nutritional plan' will be entered as independent variables in regression and survival analysis models with health service use (type, extent) or mortality as outcome variables.

Eligibility Criteria:
Inclusion Criteria:

* Study A. Patients in hospital aged 65+
* Study B. All service users in municipalities aged 65+

Exclusion Criteria:

* Age \<65 years
Influence of Ribavirin on the Initial Virological Response in Treatment Naïve Patients With Hepatitis C Genotype 1 Infection

This study examined the influence of ribavirin on the initial virological response in treatment-naïve participants with chronic hepatitis C, genotype 1. Participants were randomized to 1 of 3 treatment groups to receive placebo, ribavirin monotherapy 1000 milligrams (mg) to 1200 mg orally daily depending on body weight or pegylated interferon (PEG-IFN) alfa-2a (Pegasys®) 180 micrograms (mcg) subcutaneously (SC) weekly, for 6 weeks. Following the initial 6 weeks, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin (Copegus®) for 12 weeks. If there was an initial virological response after 12 weeks of combination therapy, treatment could be continued for a further 36 weeks outside of the study.


Eligibility Criteria:
Inclusion Criteria:

* Caucasians, male or female aged between 18 and 70 years
* Indication: serological proof of a chronic hepatitis C infection with positive result of anti-Hepatitis C virus (HCV) test and detectable HCV- Ribo Nucleic Acid (RNA) in serum
* Proven HCV genotype 1 by means of the reverse hybridization assays
* Proven histological infection activity within the liver with or without proven compensated cirrhosis within the last 24 months prior to start of the study (Child-Pugh degree A)
* Participants without previous anti-HCV therapy

Exclusion Criteria:

* Known hypersensitivity to interferon or ribavirin or any of the other component parts
* Pregnant or nursing women, women with child bearing potential and without using a high effective method of contraception. The urine and serum pregnancy test at visit 0 in fertile participants or cohabitants of participants must show a negative result
* Male partners of pregnant women
* Infection with HCV genotype 2, 3, 4, 5, or 6
* Pretreatment with interferon and/or ribavirin
* Immunocompromised participants
* Treatment of systemic anti-neoplastic or immunomodulatoric medication (including supraphysiological doses of steroids or radiation therapy) within the last 6 months prior to the start of treatment and during the complete time interval of study treatment
* Chronic hepatitis due to hepatitis C virus (e.g. haemochromatosis, autoimmunohepatitis, metabolic or alcohol-related liver disease)
* Decompensated liver cirrhosis or liver disease Child-Pugh degree B or C or condition after decompensation
* Signs of a hepatocellular carcinoma within 2 months prior to randomization in case of a cirrhosis or a transition to cirrhosis
* Ascites or esophagus varices with bleedings as documented in anamnesis
* Any medical condition that questions in the opinion of the investigator the participant's enrollment and participation in the trial
* Hemoglobin \<13 grams/deciliter (g/dl) in females and \<14 g/dl in males in screening phase
* Patients with an increased anemia risk (e.g. thalassemia, spherocytosis, etc.) or patients which would be at a particular medical risk in case of an anemia
* Diagnosed neutropenia \<1.500/microliter (mcl) or thrombocytopenia \<90.000/mcl in screening phase
Screening Protocol for Children and Adolescents With Attention Deficit Hyperactivity Disorder

The objective of this protocol is to establish a comprehensive screening process to evaluate the eligibility of potential pediatric subjects for appropriate ADHD clinical research studies.

The ADHD Clinical Research Program at Massachusetts General Hospital currently offers a range of protocols addressing different aspects of ADHD in children and adolescents. Although these protocols have received prior IRB approval, potential participants present with a widely varied set of complaints not always discernable in a telephone screening interview. This state of affairs often makes it difficult to ask subjects and their parents to sign a specific protocol's consent form without obtaining additional clinical information. Because of this, we are proposing that potential subjects and their parents undergo an in-depth clinical assessment that will allow them to be screened by a clinician for eligibility to a diverse clinical research program.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females ages 6-17
2. Family/guardian contacting the Clinical Research Program in Pediatric Psychopharmacology, with concerns regarding ADHD symptoms in his/her child

Exclusion Criteria:

1. History of significant head trauma with loss of consciousness, organic brain disorders, seizures, or neurological intervention
2. Any significant medical condition, in the judgment of the investigator
3. Mental retardation
4. Pregnancy or lactation
5. Subjects with current, uncontrolled (within the past 3 months) illicit drug or alcohol dependence
6. Sensory difficulties such as deafness or blindness
Perfusion Index in the Success of Peripheral Nerve Block

After a successful peripheral nerve block, blockade of sympathetic nerve fibers results in local vasodilatation, increased local blood flow, and increased skin temperature.Increased permeability index; Can be used as a reliable tool for evaluating block activity.


Eligibility Criteria:
Inclusion Criteria:

* Over 65 years old
* ASA I-III

Exclusion Criteria:

* Patients under 65 years old
* Patients contraindicated in regional anesthesia
* Patients with local anesthetic allergy
* Patients with injection site infection
* Patients who do not accept the procedure
The Effect of Mindfulness Compassionate Living Training on Ruminative Thinking and Sleep Quality

This study was planned to evaluate the effects of Mindfulness Compassionate Living training on ruminative thinking and sleep quality in informal caregivers of patients in a palliative clinic in Turkey. The data of the study will be conducted between November 2024 and April 2025 in the Palliative Clinic of Atatürk University Health Research and Application Center located in the city center of Erzurum. The universe of the study will consist of individuals between the ages of 18 and 45 who are caregivers of patients in the palliative clinic during the specified date range. The sample size of the study was calculated using the GPower computer program. In the calculation made with the power analysis at α=0.05 level, the effect size was 150, 153 (d=0.8) and the power of the study was 90%, it was calculated that at least 68 patients should be included in the sample. Patients who meet the research criteria and agree to participate in the study will be randomly assigned to one experimental and one control group.An introductory information form prepared by the researcher in line with the literature, containing the socio-demographic data of patients and their caregivers in the palliative clinic, the Ruminative Thinking Style Scale to assess the general thought tendency of individuals, the Level 2 Sleep Disorder Adult Short Form (PROMIS) to assess sleep quality, the Self-Compassion Scale Short Form (SCI-S) to assess self-compassion, and the Mindful Awareness Scale (MMIS) to assess conscious awareness will be used.

Research data will be collected face to face by the researcher. The study will be conducted with informal caregivers who meet the inclusion criteria (being a caregiver of the patient in a palliative clinic, being willing to participate in the research, being open to communication and cooperation). Pre-test measurement tools will be applied to the informal caregivers participating in the study. Then, Mindfulness Compassionate Living Training will be applied. Eight After the session application process, the final test data will be applied.

Eligibility Criteria:
Inclusion Criteria:

1. Being a caregiver of a patient in a palliative clinic,
2. Being between the ages of 18 and 45,
3. Being willing to participate in the study
4. Being open to communication and cooperation

Exclusion Criteria:

1. Having a psychiatric problem in the caregiver of a patient in a palliative clinic.
2. Not being open to communication and cooperation,