cyrilzakka/clinical-trials huggingface dataset:
A Study To Investigate The Effectiveness Of AH234844 (Lavoltidine) Compared With NEXIUM And Ranitidine.

Current treatment for gastroesophageal reflux disease (GERD) confirms an unmet need in patients, based on slow onset of action and an inability to provide 24-hour gastric-acid suppression. Clinical data on AH234844 demonstrates a rapid onset of action, high potency, and prolonged duration of effect. The present study endeavors, in part, to compare lavoltidine to two GERD drugs, NEXIUM and ranitidine.

A three-part study in healthy male volunteers to determine the most effective of four different lavoltidine doses on gastric pH and to compare the most effective dose with NEXIUM (esomeprazole) 40mg for the inhibition of gastric-acid secretion and with ranitidine (300mg/day) for the amount of pharmacodynamic tolerance

Eligibility Criteria:
Inclusion criteria:

* Subject must have a Body Mass Index (BMI) from 19-30 kg/m2
* Subject does not present with abnormal clinical lab findings
* Subject is able to tolerate a nasogastric pH electrode.

Exclusion criteria:

* Subject is Helicobacter-positive on a C13 urea breath test
* Subject has a baseline median 24-hour gastric pH\>3
* For Part B of the study, subjects are CYP 2C19 poor metabolizers.
Rituximab Plus Combination Chemotherapy in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma

RATIONALE: Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining rituximab with chemotherapy may kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of rituximab plus combination chemotherapy in treating patients who have HIV-related non-Hodgkin's lymphoma.

OBJECTIVES:

* Determine the response rate of patients with poor-prognosis, HIV-related non-Hodgkin's lymphoma treated with rituximab combined with prednisolone, vincristine, and bleomycin.
* Determine the toxicity of this regimen in these patients.
* Determine the time to progression and survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive chemotherapy comprising vincristine IV and bleomycin IV on day 1 and oral prednisolone every other day beginning on day 1. Treatment repeats every 3 weeks for 6 courses. Patients also receive rituximab on days 14, 21, 28, and 35. Patients who achieve complete response (CR) receive 2 additional courses of chemotherapy after CR.

Patients are followed every 1-2 months.

PROJECTED ACCRUAL: A total of 10-20 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of poor-prognosis, HIV-related non-Hodgkin's lymphoma (HIV-NHL)

  * Previously untreated
* More than 1 of the following criteria:

  * Prior diagnosis of AIDS
  * ECOG performance status 3-4
  * CD4 count less than 100/mm3
* No primary cerebral lymphoma

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* See Disease Characteristics

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy for HIV-NHL
* At least 1 year since prior chemotherapy for Kaposi's sarcoma (KS)

Endocrine therapy:

* Not specified

Radiotherapy:

* Prior radiotherapy for HIV-NHL allowed
* At least 1 year since prior radiotherapy for KS

Surgery:

* Not specified
Clinical Study on Acetyl-L-Carnitine

Chemotherapy-induced peripheral neuropathy (CIPN) is a common clinical dose-limiting adverse drug reaction, and the primary manifestations are different degree of neuromotor, sensorineural and autonomic nervous dysfunction.

This multicenter, randomized, double-blind, placebo-controlled and parallel clinical trial is to observe the efficacy and safety of the Acetyl-L-Carnitine Hydrochloride enteric-coated tablets in treatment of peripheral sensory neuropathy that anti-cancer chemotherapeutics induce.

Eligibility Criteria:
Inclusion Criteria:

* Patients had signed the Informed Consent Form
* Male or Female
* Age 18-75 years old
* Patients who have treated with Taxoids, Satraplatin and Vincristine; The peripheral sensory neuropathy grading after chemotherapy was \>/=grade 3 or grade 2 lasting for one month
* The course of neuropathy was \</=6 months
* No need to continue chemotherapy according to the condition nor refusing chemotherapy
* At least one of the neuroelectrophysiological examine results were abnormal
* Physical Condition Score (KPS) \>/=60
* Anticipated lifetime\>/=60.

Exclusion Criteria:

* Patients whose peripheral sensory neuropathy was induced by medicines except of the Taxoids, Satraplatin and vincristine anti-cancer chemotherapeutics
* Diabetics
* Peripheral sensory neuropathy was induced by Vitamin deficiency, infections, trauma, toxicosis, compression, and ischemia
* Peripheral sensory neurologic dysfunction that induced by lesions of central nervous system; hereditary neuropathy
* Patients who have treated by other medicines for peripheral sensory neuropathy in 30 days
* Patients had treated by other clinical trial medicines or participated into other trials in 30 days
* Patients had active infections
* Any clinical problems out of control
* Women in pregnancy and lactation, Subjects with no compliance.
Role of Intraoperative Beta Blocker for Morbid Obese Patients Undergoing Laparoscopic Bariatric Surgery

Using esmolol during anesthetic maintenance of laparoscopic bariatric surgery significantly decreases anesthetic, analgesic requirements, postoperative pain, PNV and postoperative hypoxia.

Postoperative pain, nausea, vomiting (PNV) and hypoxia are common in relation to laparoscopic bariatric surgery. Sympatholytic drugs might decrease the need for intravenous or Inhalation anesthetics and opioids. In this study we wanted to analyze effects of esmolol on intraoperative anesthetic-analgesic requirements, postoperative analgesic requirements, postoperative pain, PNV and hypoxia.

Methods: Sixty patients have been included. Propofol, fentanyl and rocuronium were used for induction. Study groups were as follows; group E Esmolol infusion was added to maintenance anesthetics (Sevoflurane and fentanyl), group N only Sevoflurane and fentanyl was used during maintenance. They have been monitored during the intraoperative period and postoperatively for 24 h for analgesic requirements and PNV. Visual analog scale (VAS) scores for pain was also been assessed.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) I - II patients
* age between 18-59 years
* both genders
* body mass index (BMI) \> 45 kg/m2

Exclusion Criteria:

* Patients with -hepatic
* renal
* cardiac
* respiratory diseases
* patients with a history of drug abuse or who were dependent on opioid drugs.
Family-Based Interoceptive Exposure for Avoidant Restrictive Food Intake Disorder

This project aims to establish the feasibility and acceptability of a comprehensive mind and body intervention; specifically a mindfulness-based interoceptive exposure (MBIE) for families of youth diagnosed with avoidant/restrictive food intake disorder (ARFID). This project will: (1) explore the feasibility of recruitment, retention, and data collection procedures with youth with ARFID at end of treatment, (2) establish the acceptability and adherence of the MBIE intervention, and (3) evaluate the number of MBIE sessions required to observe changes in the number of foods avoided and mindfulness skills.

A total of 57 individuals with ARFID ages 12-18 will be enrolled to outpatient mindfulness-based interoceptive exposure (MBIE). MBIE targets increasing psychological flexibility and acceptance by decreasing avoidance and attempts to control distressing or undesired internal experiences, and includes psychoeducation, targeted mindfulness practice, in vivo exposures, and counter-conditioning. MBIE will be administered in 20 sessions. Interview, self-report, anthropometrics, laboratory feeding, and behavioral task data will be used to characterize the sample to their response to treatment over time. Follow-up assessments will be completed at session 5, 10, 15, and 20. The final assessment will take place 3 months after treatment ends. Total participation will last 9 months.

Eligibility Criteria:
Inclusion Criteria:

Patient:

* Aged 12-18
* Speaks English
* Permission from pediatrician or equivalent to receive outpatient care, including that the patient does not meet criteria for hospitalization based on the American Psychiatric Association guidelines
* Diagnosis of Avoidant Restrictive Food Intake Disorder, as assessed by the EDA-5

Parent:

* Has a child aged 12-18 with a diagnosis of ARFID
* Speaks English

Exclusion Criteria:

* Comorbid psychotic or bipolar disorder
* Psychiatric medication initiated or with a dosage change in the two weeks prior to baseline testing
* Active suicidal ideation
* Major medical condition (e.g., diabetes mellitus, pregnancy)
* Current substance dependence, as evidenced by tolerance and withdrawal
* Evidence of anatomical findings by imaging (e.g., swallow study) that would prevent safe consumption of the shake or those with a percutaneous endoscopic gastrostomy or other similar feeding tube insertion
* Children with visual or physical limitations that would preclude watching a screen and using a finger to respond with mouse clicks (e.g., blindness, epilepsy if exposure to flashing lights at certain intensities or to certain visual patterns can trigger seizures).
Inspiratory and Expiratory Muscle Training in Adolescent Volleyball Players

This study will investigate the effects of inspiratory and expiratory muscle training on respiratory muscle strength, pulmonary function, and performance status in adolescent athletes

In the literature, it has been shown in a limited number of studies that respiratory muscle training in sports such as football, cycling, swimming, and rugby reduces athletes' perceived exertion levels. However, the effects of inspiratory and expiratory muscle training on respiratory muscle strength, pulmonary function, and performance status in adolescent athletes are still unclear. Therefore, this study has been planned.

Eligibility Criteria:
Inclusion Criteria:

* Athletes aged 12-18 who train at a submaximal level at least 3 days a week

Exclusion Criteria:

* Adolescents with any history of chronic lung disease
* unable to comply with the test and training
* unwilling to participate in the study
MK0476 Study in Adult Patients With Acute Asthma (0476-322)

This study evaluates the efficacy and safety of MK0476 intravenous administration in adult patients with acute asthma.


Eligibility Criteria:
Inclusion Criteria:

* Adult Patients With Acute Asthma Attacks

Exclusion Criteria:

* Patient Has Any Known Or Suspected, Acute Or Chronic Cause For Their Pulmonary Symptoms Other Than Asthma (E.G., Copd, Chronic Heart Failure, Etc.)
* Patient Has A Smoking History (20 Cigarettes Per Day) Of More Than 15 Years
* Patient Has A Disease Of The Cardiovascular, Hepatic, Renal, Hematologic Systems, Or Other Severe Disease
Lean Body Weight-adjusted Rocuronium Dose and Intubation Conditions

In this study, researchers wiil administer rocuronium, based on either the lean body weight or the total body weight in patients with body mass index (BMI) of 18.5 to 34.9 and compared the duration of action of the drug and its effects on tracheal intubation conditions and hemodynamic parameters..

The whole body will be routinely monitored with electrocardiogram, oximetry oximetry, and non-invasive arterial monitoring. For anesthesia induction, intravenous (IV) fentanyl 50-100 µg and propofol 2mg/kg will be ventilated 100% by lightning. After optimal general anesthesia was achieved, the ulnar nerve was adapted and monitored at the wrist with TOF-Watch® SX (Organon, Swords Co., Dublin, Ireland). LBW lower content of 0.6 mg/kg rocuronium will be administered. K subgrade similar a dose based on TBW will be administered. The time to duration of rocuronium TOF responses will be measured (T1 (seconds)). All consumers will be intubated with a Macintosh laryngoscope diameter with endotracheal sold with inner tubes of 7.5 8.0 mm and 7 mm to 7.5 mm. A single air anesthetist will evaluate the intubation target according to the Han-Raulo intubation scoreboard. Anesthesia will be provided with sevoflurane and an additional dose of phenyl. Monitoring with TOF was continued until the initial fasciculation power (T2=min) of the adductor pollicis decreased to 25% and was approached to an additional rocuronium dose of 0.3mg/kg. All anesthetic agents for operation will be discontinued and extubated when the TOF value reaches 90%.

Eligibility Criteria:
Inclusion Criteria:

Patients who will receive general anesthesia Operations that will take less than 6 hours Patients to be provided with rocuronium neuromuscular blockade

Exclusion Criteria:

Renal, hepatic, neuromuscular, and metabolic diseases Craniotomies, cardiac, thoracic, and large vessel surgeries Those who did not want to participate in the study will be excluded from the study
Selective Neuromuscular Electrical Stimulation on VMO

The purpose of this study is analyze the immediate effect of selective neuromuscular electrical stimulation of vastus medialis obliquus (VMO) in the electrical activity of VMO and vastus lateralis (VL) and in the isokinetic performance of women with patellofemoral pain syndrome.


Eligibility Criteria:
Inclusion Criteria:

* For Healthy group:
* with no history of osteomyoarticular lesion or surgery in the lower limbs in the previous six months
* non-corrected neurological, vestibular, visual and/or hearing impairment
* For Patellofemoral pain syndrome group:
* clinical diagnosis of patellofemoral pain syndrome
* absence of other disorders in the knee
* refer pain at leafs two of the following activities: when remain seated for a long period, squat, kneel and go up or down stairs.

Exclusion Criteria:

* Individuals experiencing pain during collection procedures
* do not perform exercises as instructed by the researches
Tempromandibular Joint Reconstruction Via Computer-Assisted Surgery Simulation

This study was planned to evaluate the accuracy of virtual surgical planning and three-dimensional (3D) printed templates in reconstruction of temporomandibular joint (TMJ) with costochondral graft.

Eight patients (15-45) years diagnosed with TMJ deformities were included. A composite skull model was obtained with data from computed tomography. A virtual surgical simulation was performed using Dolphin Imaging 11.7 Premium. Then, the virtual plan was transferred to the operative field using 3D (CAD-CAM) printed surgical template. These templates were designed by 3D printing using data from the virtual surgical simulation for optimum selection of the rib graft, accurate tailoring of chondral and costal graft and as an osteotomy guide.

The preoperative measurement including mouth opening, facial asymmetry and differences between the actual mandibular position and the virtual plan were analyzed

Eligibility Criteria:
Inclusion Criteria:

* TMJ deformity due to osteoarthrosis, ankylosis, injury, and pathology
* medicaly free patients

Exclusion Criteria:

* bilateral TMJ deformity
* patients medically compromised
BAY43-9006 Phase II Study for Renal Cell Carcinoma

To evaluate efficacy, safety, and pharmacokinetics of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer (RCC) who have failed at least one cytokine containing regimen.


Eligibility Criteria:
Inclusion Criteria:

* Patients who suffer from unresectable and/or metastatic, measurable RCC histologically or cytologically documented.
* Patients with rare subtypes of RCC, such as pure papillary cell tumor, mixed tumor containing predominantly sarcomatoid cells, Bellini carcinoma, medullary carcinoma, or chromophobe oncocytic tumors, are excluded from study participation.

Exclusion Criteria:

* More than three regimens of previous treatment for RCC
Quantitative Sensory Psychophysical Correlates of Pain in Pregnant Women With OUD

This is a prospective observational case-control study comparing quantitative sensory testing data preformed during the third trimester of pregnancy and within 24 hours postpartum in women on medication-assisted treatment for opioid use disorder (OUD) to a gestational age-controlled cohort of women who do not have OUD.

The primary goal is to measure elements of quantitative sensory testing including temperature pain threshold, temperature pain tolerance, and thermal and mechanical temporal summation for patients with opioid use disorder on medication-assisted treatment (MAT), and compare these results to gestational age matched controlled pregnant patients not on MAT.

The objective of this study is to measure elements of quantitative sensory testing including temperature pain threshold, temperature pain tolerance, and thermal and mechanical temporal summation for patients with opioid use disorder on medication-assisted treatment (MAT), and compare these results to gestational age matched controlled pregnant patients not on MAT.

The hypothesis is that women requiring maintenance opioids during pregnancy will have a significant difference in pain sensitivity in the third trimester and immediately postpartum as compared to women who did not require maintenance opioids during pregnancy.

Eligibility Criteria:
Inclusion Criteria:

Subjects that will be included in the prospective cohort group:

* individuals at least 18 years of age
* at least 28 weeks gestation (third trimester)
* on medication-assisted treatment for opioid use disorder, including methadone or suboxone.

Patients who will be included in the control group:

* individuals at least 18 years of age
* at least 28 weeks gestation (third trimester)
* have not been on been on opioids in the past 12 months.

Exclusion Criteria:

* Those who are unable to participate in informed consent discussions,
* Unable to give informed consent for any reason,
* Not fluent in English (surveys are validated in English language)
* Unable to participate fully in all study procedures for any reason including sensory deficits, scar tissue, or infection at any QST sites.
Placebo Development and Validation for Healing Water

The study aimed to develop and validate an easy-to use cheap method capable of producing placebo from tap water.

Introduction: The beneficial health effects of healing waters have been reported by numerous studies. However, the lack of proper placebo substance makes the "medication-like" investigation of healing waters difficult. The investigators aimed to develop and validate an easy-to use cheap method capable of producing placebo from tap water.

Methods: Both medical water and tap water will be colored. The temperature and the pH of the tap water will be adjusted to the temperature pH of the healing water. The patients will be divided into two groups, colored healing water and placebo group. A single 20 minutes-long treatment will be performed in bath tubs. Considering the healing waters odor, the treatment will be given in the same room. Patients will be asked to tell whether they are treated with colored healing water or placebo or could not tell. Questions will be asked before the treatment, 10 minutes after the beginning of the treatment, immediately after the end of the treatment and after shower. The study will be performed in a double blind setup. Patients will be scored, one point for each correct answer.

Target patient number:174

Eligibility Criteria:
Inclusion Criteria:

* willingness to participate in the study
* age between 18-80 years

Exclusion Criteria:

* patients physically unable to enter or exit the bath tub
* autoimmune diseases
* any kind of malignity
* acute inflammation
* infection
* acute coronary syndrome or recent surgical interventions (6 month before enrollment)
Effect of Combined Therapy on Neglect Syndrome in Stroke Patients

The purpose of the current study is to evaluate motor and neglect recovery of stroke patients produced by CIT using kinematic and oculomotor assessment, together with conventional clinical measures.

This project will be carried out using a short term constraint and training protocol targeting at subacute and chronic patients with motor and perceptual deficits. The outcome measures will include kinematic and oculomotor analyses, which have not been employed yet.

Eligibility Criteria:
Inclusion Criteria:

* a clinical cerebrovascular of right cerebral accident patients
* the age over 18-year-old
* demonstration of Brunnstrom stage III of the affected upper extremity
* patients with perceptual deficits
* no severe cognitive disorder, could understand and follow orders
* no severe equilibrium problems which will influence the intervention

Exclusion Criteria:

* recurrent of the stroke or epilepsy during the intervention
* patients with the neurological or psychical history, for example, alcoholism, drug poisoning or bipolar disorder
* injected the Botox into the affected upper extremity during the past 6 months
* participate in the other interventional study in the same time
* refuse subscribed the informed consent
Comparison of Biolimus-eluting Biodegradable Polymer, Everolimus-eluting and Sirolimus-eluting Coronary Stents

To compare the safety and efficacy of coronary stenting with everolimus-eluting stent (Promus Element®) and biolimus-eluting stent with biodegradable polymer (Nobori®)


Eligibility Criteria:
Inclusion Criteria:

* Significant coronary artery stenosis (\> 50% by visual estimate)
* Stable angina, unstable angina, Non-ST elevation myocardial infarction (NSTEMI) and documented silent ischemia
* Patients eligible for intracoronary stenting
* age ≥ 20 years old

Exclusion Criteria:

* ST segment elevation myocardial infarction (within 24 hours)
* Low ejection fraction (\< 25%)
* Cardiogenic shock
* History of bleeding diathesis or known coagulopathy
* Limited life-expectancy (less than 1 year) due to combined serious disease
* Contraindication to heparin, sirolimus, everolimus and biolimus
* Contraindication to aspirin and clopidogrel
* Pregnancy
OMAR Opioid Use Disorder

The goal of this research study is to examine the endocannabinoid (eCB) function in vivo in individuals with opioid use disorder (OUD) by measuring cannabinoid receptor 1 (CB1R) availability.

The investigators will image brain cannabinoid receptors using Positron Emission Tomography (PET) imaging and the radioligand \[11C\] OMAR, in healthy individuals and individuals diagnosed with opioid use disorder. Research participants may complete screening, MRI, PET scan and follow up visits.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent
* Male and female 18 years and older
* DSM-5 diagnosis of opioid use disorder (for OUD group)
* Physically healthy i.e., no clinically unstable medical conditions
* Written informed consent and have capacity to consent and comply with study procedures

Exclusion Criteria:

* Current neuro-psychiatric illness or severe systemic disease (opioid use disorder is permitted in the OUD group).
* Presence of ferromagnetic metal in the body or heart pacemaker
* Have had exposure to ionizing radiation that in combination with the study tracer would result in a cumulative exposure that exceeds recommended exposure limits
* Are claustrophobic