louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02038621: The Maintenance Therapy of Capecitabine of Advanced Gastric Cancer
Official title: Phase II Clinical Study of the Maintenance Therapy of Capecitabine Afer the XELOX in Treatment of Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Advanced Gastric Cancer
Lead sponsor: The Second People's Hospital of Sichuan
Sponsor class: OTHER
First posted: 2014-01-16
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To confirm the efficacy and safety of XELOX with capecitabine maintenance in treatment of advanced gastric cancer (AGC)


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* male or female
* Patients with stage IV gastric cancer by pathology or cytology and imaging diagnosis , or after previous surgery or radiotherapy or chemotherapy in patients with stage IV gastric cancer progression , there RECIST criteria evaluable lesions ;
* ECOG performance status score 0-2 ;
* Expected survival time more than three months ;
* Adequate hematologic parameters and liver and kidney function ;
* Bone marrow : absolute neutrophil count (ANC) ≥ 1.5 × 109 / L, platelets ≥ 75 × 109 / L, hemoglobin ≥ 80g / L;
* Liver: bilirubin ≤ 1.5 times the upper limit of normal , ALT AST values ≤ 2.5 times the upper limit of normal ;
* Renal : serum creatinine ≤ ULN ;
* Informed consent of patients or their agents , and signed informed consent.

Exclusion Criteria:

* For patients allergic to capecitabine ;
* Patients with CNS metastases
* Undermine the integrity of the upper gastrointestinal tract , malabsorption syndrome , or unable to take oral medication ;
* Patients with coronary heart disease , angina , myocardial infarction , arrhythmia, cerebral thrombosis, stroke and other serious cardiovascular and cerebrovascular disease ;
* Or in combination with other anti-tumor therapy in patients participating in clinical trials of other interventions ;
* Pregnancy or breast-feeding patients , or fertility without taking adequate contraceptive measures were ;
* The researchers believe that this test is not suitable for those who participate .

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary outcomes:
measure: overall survival (OS)
timeFrame: from the date of randomization until death from any cause or up to 1 year
measure: adverse events (AE)
timeFrame: from date of randomization to 28 days after the last chemo dosage
measure: health-related quality of life (HRQOL
timeFrame: evaluate every 6 weeks from the date of randomization until 28 days after the last chemo dosage
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04591821: Bowel Dysfunction 3 Years After Anterior Resection a in a Swedish National Cohort
Official title: Bowel Dysfunction 3 Years After Anterior Resection a in a Swedish National Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Anterior Resection Syndrome
Rectal Cancer
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with rectal cancer that have undergone anterior resection for rectal cancer between Q1 2015 and Q4 2017 in Sweden

Brief summary: The primary objectives are to evaluate the prevalence of LARS and Quality of Life in rectal cancer patients 3 years after anterior resection, to investigate if anastomotic technique is a risk factor for major LARS and to study the prevalence of colostomy 3 years after anterior resection and evaluate stoma function according to the stoma scale in EORTC QLQ-CR29.

Detailed description: All patients who have undergone anterior resection for rectal cancer between Q1 2015 and Q4 2017 have been identified in the Swedish Colorectal Cancer Registry (SCRCR). Three years after surgery the patients were sent a questionnaire including the LARS (Low Anterior Resection Syndrome)-score, the quality of life questionnaire EORTC QLQ 30 and CR29 in addition to a questionnaire regarding prevalence of remaining stoma.The patient cohort will be divided into two groups operated with total (TME) or partial (PME) mesorectal excision for further analyses. Patients with a stoma will be analysed separately.

Prevalence of major LARS and Quality of Life, QoL, 3 years after anterior resection will be assessed by the EORTC QLQ-C30 and by calculation of LARS Score with categories "no" (0-20 points), "minor" (21-29) and "major" (30-42). The LARS score will be dichotomized into the categories no/minor and major LARS.

Stoma function will be evaluated by the stoma scale in EORTC QLQ-CR29.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of rectal cancer in Sweden
* Operated on with anterior resection between Q1 2015 and Q4 2017 in Sweden, with or without defunctioning stoma

Exclusion Criteria:

* Age \<18 years
* Dementia,
* Unable to understand Swedish language

Primary outcomes:
measure: Low Anterior Resection Syndrome score ( LARS Score)
timeFrame: 3 years
measure: QoL
timeFrame: 3 years
Secondary outcomes:
measure: Correlation LARS score QoL
timeFrame: 3 years
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Skane university hospital
Study officials:
affiliation: Dept of surgery, Skåne university hospital, Malmö, Sweden
name: Marie-Louise Lydrup, Assoc prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05409521: Immediate Effects of Kinesio Taping Applied to the Thoracic Region in Adult Individuals
Official title: Immediate Effects of Kinesio Taping Applied to the Thoracic Region in Adult Individuals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kinesio Taping
Healthy Adults
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of the study is to search immediate effects of kinesio taping applied to the thoracic region on proprioception, posture and trunk muscle endurance in adult individuals.

Detailed description: Kinesio tape applications are one of the frequently used interventions within the scope of physiotherapy and rehabilitation. Kinesio taping is a non-invasive treatment method performed for several reasons such as reducing pain, relieving abnormal muscle and fascia tension and correcting biomechanical alignment. Kinesio taping consists of muscle, fascia, ligament, mechanic, functional and lymphatic correction techniques depending on therapeutic purposes.

Although kinesio tape applications on different regions such as abdomen or neck may have positive effects on posture, proprioception and trunk muscle endurance, there has not been found any study searching the effectiveness of kinesio taping applied to thoracal region on posture, proprioception and trunk muscle endurance in adult individuals. Thus, there is a need to investigate this issue.

Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 35 years,
* Volunteer to paticipate to the study

Exclusion Criteria:

* Musculoskeletal pain problems in the last 6 months
* Spinal fractures
* History related to spinal surgery
* Spinal deformity (scoliosis etc)
* Any chronic disease (cancer, diabetes mellitus, hypertension etc. )
* Body mass index\>35 kg/m2
* Mental or psychologic problems
* Any dermatologic disease
* Allergy to kinesio tape

Primary outcomes:
measure: Trunk position sense
timeFrame: immediately after the intervention
Secondary outcomes:
measure: Joint position sense of cervical spine
timeFrame: immediately after the intervention
measure: Thoracic kyphosis
timeFrame: immediately after the intervention
measure: Head-neck posture
timeFrame: immediately after the intervention
measure: Trunk extensor muscle endurance
timeFrame: immediately after the intervention
Other outcomes:
Locations:
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: Seyda Toprak Celenay
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00500721: Study Evaluating the Pharmacokinetics of the Potential Drug Interaction Between HCV-796 and Desipramine
Official title: An Open-Label, Single-Dose Desipramine, Multiple-Dose HCV-796, Sequential 3-Period Study to Determine the Pharmacokinetics of the Potential Drug Interaction Between HCV-796 and Desipramine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: healthy subjects
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
Collaborators: name: ViroPharma
First posted: 2007-07-13
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: To evaluate the potential pharmacokinetic (PK) interaction of multiple oral doses of HCV-796 and a single dose of desipramine when coadministered to healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead ECG.

Primary outcomes:
measure: Pharmacokinetic (PK)
timeFrame: 21 days
Secondary outcomes:
measure: Safety
timeFrame: 29 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
state: Pennsylvania
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02366221: Upper-Extremity Bone or Joint Surgery: Long Term Outcome
Official title: Upper-Extremity Bone or Joint Surgery: Long Term Outcome
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Upper Extremity Fractures
Upper Extremity Non-Fracture Bone and Joint Conditions
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2015-02-19
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with a history of complex arm or leg trauma who have completed their normal care in the Orthopaedic Hand and Upper Extremity Service

Brief summary: The specific aim of the study is to obtain long-term follow-up information on patients who have completed their standard clinical care in the Orthopaedic Hand and Upper Extremity Service. The study will help to qualify and quantify long-term recovery and outcomes from uncommon upper extremity fractures, as well as non-fracture bone and joint conditions. The hypotheses vary, but generally focus on the patterns of injury, the results of treatment and the complications encountered.


Eligibility criteria: Inclusion Criteria:

* Subjects with a history of complex arm or leg trauma who have completed their normal care in the Orthopaedic Hand and Upper Extremity Service

Exclusion Criteria:

* Vulnerable populations

Primary outcomes:
measure: Range of Motion
timeFrame: 5 years (expected average)
Secondary outcomes:
measure: Upper Extremity Function
timeFrame: 5 years (expected average)
measure: Pain Interference
timeFrame: 5 years (expected average)
measure: Depression
timeFrame: 5 years (expected average)
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: Neal Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01321021: Influence of Losartan and Diphenhydramine on Emotional and Cognitive Functions in Healthy Human Subjects
Official title: Influence of Losartan and Diphenhydramine on Emotional and Cognitive Functions in Healthy Human Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Memory, Long-Term
Memory, Short-Term
Lead sponsor: University of Basel
Sponsor class: OTHER
Collaborators: name: Clinical Trial Unit, University Hospital Basel, Switzerland
First posted: 2011-03-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This project aims at identifying novel pharmacological targets for the treatment of memory disorders.

Detailed description: To investigate the effects of the histamine H1 receptor antagonist diphenhydramine and the angiotensin II receptor antagonist losartan on emotional and cognitive functions in healthy human subjects.

Eligibility criteria: Inclusion Criteria:

* healthy
* native or fluent German-speaking
* BMI between 19 and 27 kg/m2
* able and willing to give written informed consent and comply with the requirements of the study protocol
* willing to donate saliva sample for DNA-analysis
* female: willing to perform a pregnancy test at the beginning of both test visits

Exclusion Criteria:

* acute or chronic psychiatric or somatic disorder
* pathological ECG
* known hypersensitivity to the IMP under investigation (losartan, diphenhydramine)
* hypotension (RR \< 110/70 mmHg)
* bradycardia (\< 50 bpm)
* pregnancy, breast-feeding
* long-term medication within last 3 months (oral contraceptives are disregarded)
* smoking (\> 3 cigarettes per day)
* concurrent participation in another study
* participation in one of our previous studies using the same memory tests
* inability to read and understand the participant's information

Primary outcomes:
measure: Primary Outcome Measures
timeFrame: during cognitive testing at study days
Secondary outcomes:
measure: Secondary Outcome Measures
timeFrame: during cognitive testing at study days
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University of Basel, Division of Cognitive Neuroscience
Study officials:
affiliation: University of Basel, Faculty of Psychology and Medecine, Division of Cognitive Neuroscience
name: Dominique de Quervain, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00417521: Open Trial of Family-Based Treatment for Anorexia Nervosa
Official title: Pilot Study of Manualized Family Therapy for Adolescents With Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anorexia Nervosa
Keywords: Adolescents
Anorexia
Eating disorder
Family therapy
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2007-01-01
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial seeks to investigate the feasibility and effectiveness of delivering a newly manualized family-based treatment for adolescents with anorexia nervosa

Detailed description: This open trial seeks to investigate the feasibility and effectiveness of delivering a newly manualized family-based treatment for adolescents with anorexia nervosa at a site beyond the treatment's origin. Adolescents ages 12-17 with anorexia nervosa or subthreshold anorexia nervosa were treated with up to one year of this approach.

Eligibility criteria: Inclusion Criteria:

* Age 12-17
* Diagnosis of full or subthreshold anorexia nervosa
* At least one parent or guardian willing to participate in treatment

Exclusion Criteria:

* Bipolar Disorder, Psychotic Disorder, Substance Dependence
* Mental Retardation
* Acute suicidal risk
* Acute or unstable, poorly controlled chronic medical illness
* Weight below 75% ideal body weight

Primary outcomes:
measure: weight
timeFrame: end of treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: New York State Psychiatric Institute
name: Jennifer Jones
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02293421: Evaluation of the STOP-BANG Screening Questionnaire in a Sleep Clinic
Official title: Evaluation of the STOP-BANG Screening Questionnaire in a Sleep Clinic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Umeå University
name: Uppsala University Hospital
name: Stockholm Heart Center, Sweden
name: Sunderbyn Hospital
First posted: 2014-11-18
Enrollment: 449
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Although obstructive sleep apnea (OSA) is common, most of the patients are undiagnosed. OSA is associated with a large number of co-morbidities, and thus, it is of great importance to identify the patients and start treatment in order to reduce the risks for complications. Current screening tools are quite unspecific and the golden standard methodology for diagnosis, polysomnography, is expensive and time consuming, thus not suitable for screening. In perioperative medicine the STOP BANG screening questionnaire is currently the recomended screening tool, however this questionnaire has only been evaluated in a sleep clinic in a very limited numbers of patients.


Eligibility criteria: Inclusion Criteria:

* More than 18 years old
* First or part of the first visit to a sleep clinic
* Planned or just conducted polysomography

Exclusion Criteria:

* Not able to understand the information and sign informed consent

Primary outcomes:
measure: STOP BANG
timeFrame: At diagnosis, one time
measure: Snore question
timeFrame: At diagnosis, one time
measure: Polygraphy
timeFrame: At diganosis, one time
Secondary outcomes:
measure: Pulseoximetry
timeFrame: At dignosis, one time
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Anesthesiology, Surgical Sciences and Intensive Care Medicine, Karolinska University Hospital, Solna
Study officials:
affiliation: Karolinska Institutet
name: Malin Jonsson Fagerlund, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Christensson E, Franklin KA, Sahlin C, Palm A, Ulfberg J, Eriksson LI, Lindberg E, Hagel E, Jonsson Fagerlund M. Can STOP-Bang and Pulse Oximetry Detect and Exclude Obstructive Sleep Apnea? Anesth Analg. 2018 Sep;127(3):736-743. doi: 10.1213/ANE.0000000000003607.
Clinical trial NCT00590421: Carotid Atherosclerotic Disease Following Childhood Scalp Irradiation
Official title: Carotid Atherosclerotic Disease Following Childhood Scalp Irradiation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-01-10
Enrollment: 295
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study was designed to include 150 persons who were treated as children for Tinea Capitis by scalp irradiation in the 1950's and 150 subjects who were not exposed to radiation. This sample size was determined under the following assumption: power of ≥95%, alpha error level of 5%, 10% prevalence of carotid stenosis in the non exposed group and minimal OR of 2.5.

Brief summary: Background: During the first half of the 20th century, scalp irradiation was a standard treatment for induction of epilation in children suffering from Tinea Capitis. These children are now more than 50 years old and the aim was to investigate the possible association between their childhood low dose irradiation exposure and development of carotid atherosclerotic disease in adulthood.

Methods: The study included 145 individuals treated by irradiation in their childhood, and 150 matched control subjects with no history of irradiation. B-mode ultrasound imaging and US Doppler were used to measure carotid and femoral stenosis and Intima-Media Thickness (IMT). Blood samples were taken for lipid profile and homocysteine evaluation.


Eligibility criteria: Inclusion Criteria:

* age 18 or older
* childhood scalp irradiation or mach controls
* writen informed consent

Exclusion Criteria:

* inability to give written informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf Harofeh Medical Center
Study officials:
affiliation: Assaf-Harofeh Medical Center
name: Shai Efrati, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06744621: Glucose Frequent of A1GDM in Labor
Official title: Glucose Monitoring for A1GDM
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gestational Diabetes, Controlled by Diet
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with A1GDM (diet controlled gestational diabetes)

Brief summary: This is a prospective double arm study in patients with Gestational Diabetes Mellitus (GDM) utilizing frequent (single fingerstick on admission) vs infrequent glucose monitoring in labor (q 4 hours in latent labor and every 2 hours in active labor). Primary Objective: The primary outcome is glucose value of the neonate at birth. Secondary Objectives: Determine rates of insulin requirements within different monitoring techniques. Determine if there is a difference in neonatal intensive care unit (NICU) admission within different monitoring techniques. Determine neonatal blood glucose concentrations at 24 hours of life, number of glucose treatments, and neonatal hyperbilirubinemia. Secondary characteristics to be viewed for each diagnosis; BMI, race, age, and parity.


Eligibility criteria: Inclusion Criteria:

* All female patients of reproductive age (menarche-menopause: 18-51 years) who have the diagnosis diet controlled GDM
* Patient with singleton gestation presenting in labor or for induction
* Patients who had "good" glucose control and were A1GDM. Good Control;

  * - Patient with overall outpatient glucose average of less than 100
  * - No evidence of fetopathy, large for gestational age or polyhydramnios.
  * - Hgb A1c \<5.7

Exclusion Criteria:

• If patient's admission accu check is \>120

Primary outcomes:
measure: Neonatal glucose level
timeFrame: at 24 hours
Secondary outcomes:
measure: Number of neonates requiring insulin
timeFrame: at 24 hours
measure: Number of NICU admissions
timeFrame: at 24 hours
measure: Number of glucose treatments
timeFrame: at 24 hours
measure: Number of neonatal with hyperbilirubinemia
timeFrame: at 24 hours
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai West
state: New York
Study officials:
affiliation: Mount Sinai West
name: Thomas Owens, MD
role: PRINCIPAL_INVESTIGATOR
References: