louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05181488: Intraoperative Radiation Therapy for Resectable Pancreatic Cancer
Official title: A Prospective, Phase II Study Evaluating the Efficacy of Intraoperative Radiotherapy After Neoadjuvant Chemotherapy in Patients With Resectable Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Resectable Pancreatic Cancer
Keywords: Pancreatic cancer
Intraoperative radiotherapy
neoadjuvant chemotherapy
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2022-01-06
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intervention: intraoperative radiotherapy
Primary purpose: TREATMENT

Brief summary: This phase II study is designed to investigate the efficacy of intraoperative radiotherapy after neoadjuvant chemotherapy in patients with resectable pancreatic cancer. The purpose of the study is to show the local recurrence rate after neoadjuvant chemotherapy and IORT is superior to that of surgical resection alone from the historical control. A total of 80 patients will be enrolled, and these patients will receive IORT of 10 Gy at 5 millimeter depth of the tumor bed, following neoadjuvant chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Histologically diagnosed with adenocarcinoma of the pancreas or clinically diagnosed with imaging examinations or tumor markers
* 20 years or older
* Performance status 0-2 based on Eastern Cooperative Oncology Group (ECOG)
* Patients with surgically resectable or borderline resectable and advanced pancreatic cancer that can be resected after neoadjuvant chemotherapy
* Patients who voluntarily decided to participate in this clinical study and signed a written informed consent

Exclusion Criteria:

* History of previous abdominal irradiation.
* When the treatment area is not included in the appropriate radiation field according to the judgment of the radiation oncologist or Durgeon
* Distant metastasis
* Other systemic conditions that, under the judgment of the attending physician, would be difficult to undergo surgery or radiiotherapy

Primary outcomes:
measure: 3-year local recurrence rate
timeFrame: 3 year after intraoperative radiotherapy
Secondary outcomes:
measure: post-operative complication
timeFrame: 3 year after intraoperative radiotherapy
measure: disease free survival
timeFrame: 1 year and 2 year after intraoperative radiotherapy.
measure: Overall survival
timeFrame: 1 year and 2 year after intraoperative radiotherapy.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
References:
Clinical trial NCT03607188: Study of Alkotinib in Patients With Advanced Non Small Cell Lung Cancer
Official title: A Phase I Tolerance, Safety and Efficacy Study of Alkotinib in Patients With Advanced ALK Positive /ROS1 Positive NSCLC and Previously Treated With Chemotherapy or Crizotinib
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2018-07-31
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: To explore the DLT of ZG0418 for Patients with Advanced ALK+ or ROS1+ NSCLC And Previously Treated with Chemotherapy or Crizotinib, and to determine the MTD or the R2PD.

Detailed description: The study is a randomized, double-blind phase 1 trial including 2 sequential parts: single ascending dose(SAD) part,multiple ascending dose(MAD) part. SAD and MAD are dose-escalated tolerant study designing. The aims of the study as below:

1. Evaluating the safety and tolerance of ZG0418 in ALK+ NSCLC.
2. Evaluating the fasting pharmacokinetic parameters of ZG0418 in ALK+ NSCLCJaktinib.
3. Evaluating the postprandial pharmacokinetic parameters of ZG0418 in ALK+ NSCLC.
4. Analysis the metabolites of ZG0418

Eligibility criteria: Inclusion Criteria:

1. Advanced ALK+ or ROS1+ NSCLC And Previously Treated with Chemotherapy or Crizotinib
2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 2.
3. Life expectancy of at least 12 weeks.
4. Ability to swallow and retain oral medication.
5. Adequate organ system function, defined as follows:

   1. Absolute neutrophil count (ANC) ≥1.5 x 10\^9/L
   2. Platelets ≥75 x 10\^9/L
   3. Hemoglobin ≥9 g/dL (≥90 g/L) Note that transfusions are allowed to meet the required hemoglobin level
   4. Total bilirubin ≤1.5 times the upper limit of normal (ULN)
   5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)

      ≤2.5 x ULN if no liver involvement or ≤5 x ULN with liver involvement.
   6. Creatinine 1.5 x ULN.
6. Brain metastases allowed if asymptomatic at study baseline.
7. Patients must have measurable disease per RECIST v. 1.1.

Exclusion Criteria:

1. chemotherapy, radiation therapy, immunotherapy within 4 weeks.
2. Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications.
3. uncontrolled mass of pleural effusion, pericardial effusion, and peritoneal effusion.

Primary outcomes:
measure: MTD
timeFrame: Day1 to Day25
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Eastern Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Eastern Hospital
name: Jin Li, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01079988: Study of Therapeutic Options for Subjects Discontinuing Efalizumab and Experiencing Disease Recurrence
Official title: A Phase IV Open Label, Multicentre, Investigational Study of the Therapeutic Options for Subjects Discontinuing Efalizumab Therapy and Experiencing Inflammatory Disease Recurrence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Keywords: Psoriasis
Discontinuation of efalizumab
Managing inflammatory recurrence
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2010-03-03
Enrollment: 41
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a pilot investigational study of the appropriate therapeutic regimens to treat subjects experiencing inflammatory recurrence (rebound) of psoriatic disease upon discontinuation of efalizumab therapy and of the biological mechanisms involved in inflammatory disease recurrence and control.


Eligibility criteria: Inclusion Criteria:

* Participation in Genentech study ACD2601g, Genentech study HUPA 600 or Serono study IMP24011.
* Inflammatory psoriasis disease recurrence occurring up to 2 months after discontinuation of efalizumab that required immediate therapeutic control in the opinion of the Investigator. Psoriasis had to be rapidly developing, symptomatic and inflammatory in nature.
* Written informed consent, given prior to any study-related procedure not part of the subject's normal medical care, with the understanding that the subject could withdraw consent at any time without prejudice to his or her future medical care.
* Female subjects had to be neither pregnant nor breast-feeding, and had to lack childbearing potential, as defined by either:

  * Being post-menopausal or surgically sterile, or
  * Using an accepted form of contraception.
* Confirmation that the subject was not pregnant had to be established by a negative urinary hCG test at SD1. A pregnancy test was not required if the subject was post-menopausal or surgically sterile.
* Outpatient status at the time of enrolment.

Exclusion Criteria:

* Disease recurrence that was part of the natural disease progression, was not inflammatory in nature, and was not related to efalizumab study medication in the previous study.

Primary outcomes:
measure: Physician's Global Assessment (PGA) of Change Over Time (Good or Better)
timeFrame: 12 weeks
Secondary outcomes:
measure: Patient's Global Psoriasis Assessment (PGPA)
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Serono SA
name: Patrick Natta, MD
role: STUDY_DIRECTOR
References:
citation: Papp KA, Toth D, Rosoph L, on behalf of the 25180 study group. Approaches to discontinuing efalizumab: results of an open-label study comparing different transitioning therapies. Abstract for presentation at EADV2005, Sofia, Bulgaria, 19-22 May 2005
Clinical trial NCT03806088: Prevalence of Electrolyte Imbalance in Chronic Kidney Disease:A Study at Tertiary Care Hospital in South Punjab,Pakistan
Official title: Prevalence of Electrolyte Imbalance in Chronic Kidney Disease: A Study at Tertiary Care Hospitals in South Punjab, Pakistan
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Kidney Diseases
Keywords: CKD
Lead sponsor: Islamia University of Bahawalpur
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 385
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: An observational cross sectional study is done on pakistani population while working in different tertiary care hospitals of south Punjab including Bahawal Victoria hospital Bahawalpur, kidney center Multan and many registered clinics, under the supervision of pathologists, pharmacologists,pharmacists,nephrologists,urologists and biostatistician.

Brief summary: an observational cross-sectional study is done to calculate the electrolyte imbalance at different stages of chronic kidney disease at tertiary care hospital.

Detailed description: an observational cross-sectional study is done to calculate the electrolyte imbalance at different stages of chronic kidney disease at tertiary care hospitals of south Punjab, Pakistan .The outcomes of chronic kidney disease and end stage of renal failure will be calculated according to standard protocol. Under the supervision of pathologists, pharmacologists, pharmacists, nephrologists, urologists and biostatistician. The standard protocol was authorized by ethical committee of each center. patient consent form was

Eligibility criteria: Inclusion Criteria:

* CKD patients ranging
* age from 20-80
* dialysis and pre-dialysis patients
* who provide written consent form

Exclusion Criteria:

* congenital one kidney patients
* organ or kidney donors and transplantation
* pregnant women
* renal injury during trauma

Primary outcomes:
measure: Serum potassium in mEq/L
timeFrame: 2days
measure: serum urea in mg/dl
timeFrame: 2days
measure: Serum creatinine in mg/dl
timeFrame: 2days
measure: Serum calcium in mg/dl
timeFrame: 2days
measure: Serum sodium in mEq/L
timeFrame: 2days
Secondary outcomes:
measure: Blood pressure in mm of Hg
timeFrame: 2days
measure: Blood glucose concentration in mg/dl
timeFrame: 2days
Other outcomes:
Locations:
city: Bahāwalpur
country: Pakistan
facility: Faculty of Pharmacy and Alternative Medicine Khawaja Freed Campus
state: Punjab
Study officials:
References:
Clinical trial NCT02867488: Dose-response Effects of Soybean Oil in Salad Dressing on Carotenoid/Fat-soluble Vitamin Bioavailability in Salad Vegetables
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biological Availability
Keywords: carotenoids
phylloquinone
tocopherols
vitamin A
Lead sponsor: Iowa State University
Sponsor class: OTHER
First posted: 2016-08-16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no

Brief summary: The objectives will be to evaluate the dose-response between the amount of soybean oil in salad dressing and the absorption of: 1) carotenoids, phylloquinone, and tocopherols in salad vegetables; 2) retinyl palmitate formed from the provitamin A carotenoids, alpha- and beta-carotene.


Eligibility criteria: Inclusion Criteria:

* General good health as determined by interview, blood biochemistry profile, complete blood count, and plasma lipid and lipoprotein profile

Exclusion Criteria:

* Cigarette smoking, frequent alcohol consumption
* Use of vitamin/mineral supplements
* Lactose intolerance
* Known food allergies
* Body mass index (BMI) 30 or higher
* Eating disorder or restrained eating
* Vegetarianism
* Hyperlipidemia
* Current or planned pregnancy
* Use of hormonal contraceptives (affects chylomicron clearance); use of plant sterols or medications known to affect lipid metabolism

Primary outcomes:
measure: Area under the curve for carotenoids, phylloquinone, tocopherols, and retinyl palmitate in the plasma chylomicron fraction
timeFrame: 0-9.5 hours postprandially
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: White WS, Zhou Y, Crane A, Dixon P, Quadt F, Flendrig LM. Modeling the dose effects of soybean oil in salad dressing on carotenoid and fat-soluble vitamin bioavailability in salad vegetables. Am J Clin Nutr. 2017 Oct;106(4):1041-1051. doi: 10.3945/ajcn.117.153635. Epub 2017 Aug 16.
Clinical trial NCT05884788: Study of the Life Stories of Patients Making a Request for Euthanasia, in the Context of Advanced Cancer.
Official title: Study of the Life Stories of Patients Making a Request for Euthanasia, in the Context of Advanced Cancer.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Cancer
Keywords: Euthanasia
Cancer
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We conduct our study in a French cancer center and a French public hospital. Patients requesting euthanasia will be informed about the possibility of participating in our study. If the patients agree, and if they meet the study criteria, they will be included.

Brief summary: This study wishes to focus on the life course of patients, beyond the moments of suffering experienced at the time of the request for euthanasia. It is based on the perspective that the patient's account of his or her life course can be a source of information for better understanding and accompanying patients requesting euthanasia.


Eligibility criteria: Inclusion Criteria:

* Major patients
* With cancer in the palliative phase, i.e. with an incurable disease according to current knowledge.
* Expressing a request for euthanasia in terms evoking a request for death with the intervention of an outside person.
* Non-opposition to the study after full written information.

Exclusion Criteria:

* Severe decompensated psychiatric pathology
* Vulnerable persons defined here as pregnant women, parturients and persons under legal protection or unable to express their consent
* Inability to conduct an interview

Primary outcomes:
measure: Description of the life stories of patients requesting euthanasia to explore which life experiences are brought forward when making this request, in a context of advanced oncological pathology.
timeFrame: One month
Secondary outcomes:
measure: Calculation of the Bartholomew score
timeFrame: One month
measure: Calculation of the distress thermometer's score
timeFrame: One month
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Léon Bérard
Study officials:
References:
Clinical trial NCT03295188: Effects of Plasmalogen on Obese Subjects
Official title: A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Effects of Scallop-derived Plasmalogen on Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Japanese Plasmalogen Society
Sponsor class: OTHER
First posted: 2017-09-27
Enrollment: 83
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 12-week, randomized, double-blind, placebo-controlled study to evaluate the effects of scallop-derived plasmalogen on brain fatigue, body weight and changes in blood plasmalogen in obese subjects aged 20-75 years old.


Eligibility criteria: Inclusion Criteria:

* Willingness to provide informed consent to participate in the study
* BMI ≥ 25 ㎏/㎡
* HbA1C ≺ 8% without antidiabetic medication in the previous 3 months
* Stable medication for 3 months prior to the enrollment, and expectedly throughout the course of study

Exclusion Criteria:

* Scallop allergy
* Symptomatic obesity, i.e., endocrinal, hypothalamic or drug-induced obesity
* Hypertension under medication with 4 or more drugs
* Hepatic disorder with AST ≥ 5 times upper limit of the normal range
* Mental disorder including schizophrenia and neurosis
* Alcohol dependence
* History of malignancy for which treatment completed in the past 5 years
* Inflammatory disease
* Use of plasmalogen supplement in the past 3 months
* Ineligible condition as determined by study physician

Primary outcomes:
measure: Change in Profile of Mood States 2nd Edition (POMS 2)
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in body weight
timeFrame: 12 weeks
measure: Change in waist diameter
timeFrame: 12 weeks
measure: Change in blood levels of plasmalogen
timeFrame: 12 weeks
measure: Change in Athens Insomnia Scale (AIS)
timeFrame: 12 weeks
measure: Changes in adiponectin, leptin, IRI, GA, and high sensitive quantitation of C-reactive protein
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: BOOCS Clinic Fukuoka
Study officials:
affiliation: BOOCS Clinic Fukuoka
name: Takehiko Fujino
role: STUDY_CHAIR
References:
Clinical trial NCT04077788: Change of Range of Motion of TMJ After Correction of Pelvic a Symmetry in Women With Cyclic Pelvic Pain
Official title: Change of Range of Motion of TMJ After Correction of Pelvic a Symmetry in Women With Cyclic Pelvic Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-09-04
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the participants will be divided randomly into two groups equal in numbers study group (group A) and control group (group B).

• Study group (group A): It will consist of fifteen subjects who will receive osteopathic technique six treatment ( sessions) around three cycles two treatment every month first treatment after the end of menstruation.second treatment before the next cycle. In addition to their medical treatment if needed non-steroidal anti-inflammatory drugs (NIAIDS).

• Control group (group B): It will consist of fifteen subjects who will reeive sham treatment,will take their medical treatment only non-steroidal anti- inflammatory drugs (NIAIDS) if needed.

Brief summary: Clinical experiences have shown that significant pain regression during a menstrual cycle has been often achieved by the use of spinal manipulative therapy (SMT) indicated in women with primary dysmenorrhea with coexisting functional disorders of lumbosacral (LS) spine. Namely, by activation of the nociceptive and vegetative system, LS spine disorders, before all segmental dysfunction and degenerative changes, can induce referred pain and reflex disturbances of pelvic organs (somatovisceral reflexes). Since significant improvement or disappearance of pain during a menstrual cycle is often achieved with adequate therapy of coexisting vertebral disorders in women with primary dysmenorrhea, it is important to recognise latent or manifest vertebral disorders in dysmenorrheic women using clinical examination (Grgić, 2009).


Eligibility criteria: Inclusion criteria:

* The age of the participants will be ranged from 25 to 35 years.
* Their body mass index will be ranged from 20 to 25 kg/m2.
* They will have regular menstrual cycle.
* They will not receive any hormonal therapy or taking any regular drugs.

Exclusion criteria:

The potential participants will be excluded if they meet one of the following criteria:

* Pelvic inflammatory diseases.
* Any pelvic pathological condition

Primary outcomes:
measure: Weight-Height Scale
timeFrame: 3 months
measure: Visual analogue scale (VAS)
timeFrame: 3 months
measure: Menstrual Distress Questionnaire (MDQ)
timeFrame: 3 months
measure: jaw movement
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Rovan Elbesh
Study officials:
References:
Clinical trial NCT06211088: Famotidine Versus Placebo in Emergency Pediatric Surgery As a Risk to Postoperative Nausea and Vomiting
Official title: Famotidine Versus Placebo in Emergency Pediatric Surgery As a Risk to Postoperative Nausea and Vomiting ꞉ a Comparative Study by Gastric Ultrasound Measurement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Keywords: nausea,vomiting
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to evaluate the difference of the gastric volume by quantitative measurements of gastric antrum preoperatively and postoperatively by using 5mg famotidine versus placebo as a risk factor of PONV.

Detailed description: Gastric ultrasound examinations will be performed preoperatively and postoperatively on patients undergoing emergency surgery in pediatric. Gastric cross-sectional area (CSA) will be measured, in order to estimate the gastric volume. The data that will be obtained will be used to evaluate a difference of the gastric volume between the two groups preoperatively and postoperatively and the possible relationship between the gastric volume difference and postoperative adverse event (PONV).

Eligibility criteria: Inclusion Criteria:

* Pediatrics patients aging between 2-13 years .
* pediatrics undergo urgent surgery (i.e., surgery that cannot be postponed for more than 48 h since clinical onset).
* PatientPediatrics come in trauma

Exclusion Criteria:

* PatientPediatrics severly shocked .
* PatientPediatrics with diffusely distended abdomen as this will obstacle gastric ultrasound .
* PatientPediatrics with history of hypersenstivity to famotidine .
* PatientPediatrics with hepatic or renal impairments

Primary outcomes:
measure: to evaluate the difference of the gastric volume by quantitative measurements of gastric antrum by gastric ultrasound preoperatively and postoperatively by using 5mg famotidine versus placebo as a risk factor of postoperative nausea and vomiting
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Zaher
Study officials:
References: