louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05349045: Angiogenesis Inhibitor Plus Anti-PD-1/PD-L1 Antibody in Advanced Esophageal Cancer
Official title: Containing Angiogenesis Inhibitor Plus Anti-PD-1/PD-L1 Antibody in Anti-tumor Treatment of Chinese Patients With Unresectable Locally Advanced / Recurrent or Metastatic Esophageal Cancer: a Real World Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Esophageal Neoplasms
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Esophageal cancer confirmed by histopathology or cytology

Brief summary: The combination of an anti-PD-1/PD-L1 antibody with an angiogenesis inhibitor has shown efficacy in many cancers.The purpose of this study is to confirm that the combination of these two drugs can benefit patients with advanced esophageal cancer.


Eligibility criteria: Inclusion Criteria:

1. Esophageal cancer confirmed by histopathology or cytology
2. Unresectable locally advanced/recurrent or metastatic esophageal cancer, or progression after neoadjuvant or adjuvant therapy
3. Esophageal cancer patients who benefit from the use of an anti-PD-1/PD-L1 antibody with an angiogenesis inhibitor evaluated by the researchers
4. Patients who sign informed consent and voluntarily join the study

Exclusion Criteria:

1. Patients who are recommended not using an anti-PD-1/PD-L1 antibody or an angiogenesis inhibitor in the instructions, or other patients who are judged by the investigators to be unsuitable in the study
2. Patients who are undergoing treatment regimen of blind trial

Primary outcomes:
measure: PFS
timeFrame: From date of admission 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: OS
timeFrame: From date of admission until the date of death from any cause, assessed up to 24 months
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
References:
Clinical trial NCT05338645: Sexual Functions and Marital Adjustment for Spouses in Menopause
Official title: The Effect of Menopause on the Sexual Functions and Marital Adjustment of the Spouses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menopause
Lead sponsor: Hitit University
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 127
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population of this study, which was planned as a cross-sectional descriptive study, consisted of women who applied to the menopause polyclinic of a university hospital between 08.11.2017 and 29.12.2017. The sample of the study consisted of women aged between 45-65 years. Accordingly, the number of couples to be taken into the sample was determined as 125, and a total of 254 individuals, 127 of whom were menopausal women and their spouses, were included in the study.

Brief summary: Objective: This study was conducted as a cross-sectional descriptive study in order to determine the effect of menopause on the SFs and marital adjustment of the spouses.

Detailed description: Objective: This study was conducted as a cross-sectional descriptive study in order to determine the effect of menopause on the SFs and marital adjustment of the spouses.

Materials and Methods: The sample of the study consisted of a total of 254 people, 127 of whom were postmenopausal women and their spouses. The data were collected with The Descriptive Information Form (DIF), The Female Sexual Function Scale (FSFS) and the Arizona Sexual Experiences Scale (ASES), The Marital Adjustment Scale (MAS). T test was used for two-group comparison of parametric data, Mann Whitney U test was used for two-group comparison of non-parametric data, and Kruskal Wallis Test was used for non-parametric data comparison of more than two groups. In addition, the relationship between the mean scores of FSFS, ASES and MAS was evaluated with Spearman's rho Correlation analysis.

Eligibility criteria: Inclusion Criteria:

* The sample of the study consisted of women aged between 45-65,
* who were aged between 45-65,
* had at least 1 year of menopause,
* had no communication barriers,
* volunteered to participate in the research, -lived in the same house with their spouses, -
* had sexual activity in the last four weeks,
* selected using the simple random sampling method.

Exclusion Criteria:

* have diabetes,
* have hypertension,
* have depression

Primary outcomes:
measure: Descriptive Information Form (DIF)
timeFrame: 3 mounths
measure: Female Sexual Functioning Scale (FSFS)
timeFrame: 3 mounths
measure: Arizona Sexual Experiences Scale-Male Form (ASES)
timeFrame: 3 mounths
measure: Marriage Adjustment Scale (MAS)
timeFrame: 3 mounths
Secondary outcomes:
Other outcomes:
Locations:
city: Çorum
country: Turkey
facility: Fatma Yıldırım
Study officials:
affiliation: Hitit University
name: Fatma Yıldırım
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00422045: Assessment of Low Level Laser Therapy for Late Postoperative Pain After Lumbar Fusion Surgery
Official title: Assessment of Low Level Laser Therapy for Late Postoperative Pain After Lumbar Fusion Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Surgery
Lead sponsor: University of Toledo
Sponsor class: OTHER
First posted: 2007-01-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess whether or not low level laser therapy (LLLT) decreases pain in post-operative orthopedic patients following lumbar fusion surgery.

Detailed description: Lumbar fusion surgery patients typically experience significant post-operative pain for several weeks and their rehabilitation does not start until 8 - 12 weeks postoperatively. We hypothesize that LLLT beginning 4 weeks postoperatively will provide significant reduction in postoperative pain.

Eligibility criteria: Inclusion Criteria

* Age \> 18 and \< 85 years
* Post-operative lumbar fusion surgery
* Currently resides within 100 miles of UMC

Exclusion Criteria

* Pregnant
* Pacemaker
* Medications that have heat or light-sensitivity contraindications (such as: steroids, some antibiotics)
* Two or more cardiac risk factors
* Intraoperative complications
* Wound infection
* Spinal fluid leakage
* Open wound

Primary outcomes:
measure: FACES Pain Rating Scale
timeFrame: baseline (2 weeks after surgery), then 6,12, and 24 weeks from baseline
measure: Oswestry Low Back Pain Disability (ODQ) Questionnaire
timeFrame: baseline visit (2 weeks after the patient's surgery date) then 6,12, and 24 weeks thereafter
measure: Quality of Life - The Quality of Life Short-Form Survey (SF-36)
timeFrame: baseline visit (2 weeks after the patient's surgery date) then 6,12, and 24 weeks thereafter
Secondary outcomes:
measure: Pain medication usage
timeFrame: baseline (2 weeks after surgery), then 6,12, and 24 weeks from baseline
measure: Improvement measured by serial photographs of surgery appearance and rate of healing
timeFrame: 2 weeks after surgery, then 6, 12, and 24 weeks after surgery
Other outcomes:
Locations:
city: Toledo
country: United States
facility: University of Toledo, Health Science Campus
state: Ohio
Study officials:
affiliation: University of Toledo Health Science Campus
name: Ashok Biyani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04214145: The Effect of Vasopressors on Cerebral Oxygentaion During Off Pump CABG
Official title: The Effect of Phenylephrine, Norepinephrine and Vasopressin on Cerebral Oxygentaion During Off Pump CABG: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Oxygen Saturation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 90
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to analyze the changes in cerebral oxygen saturation during the use of three vasopressors, phenylephrine, norepinephrine, and vasopressin, which are currently used during coronary artery bypass grafting.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing off pump coronary artery bypass.

Exclusion Criteria:

* Patient refusal
* Preoperative vasopressor use
* Preoperative mechanical circulatory support
* Concurrent cerebrovascular or head and neck surgery
* Technical difficulty of measuring brain oxygen saturation
* Redo coronary artery bypass surgery

Primary outcomes:
measure: Cerebral oxygen saturation (%)
timeFrame: during surgery
Secondary outcomes:
measure: blood pressure
timeFrame: during surgery
measure: heart rate
timeFrame: during surgery
measure: cardiac index
timeFrame: during surgery
measure: Total amount of infused drug
timeFrame: during surgery
measure: Input/output
timeFrame: during surgery
measure: Sublingual microscopy
timeFrame: 1) After induction, 2) lateral wall or posterior wall anastomosis (if possible) 3) skin closure
measure: Vascular occlusion test
timeFrame: 1) After induction, 2) lateral wall or posterior wall anastomosis (if possible) 3) skin closure
measure: Troponin I
timeFrame: during surgery, at ICU admission, 24 hours / 48 hours after ICU admission
measure: lactate
timeFrame: during surgery, at ICU admission, 24 hours / 48 hours after ICU admission
measure: creatinine
timeFrame: during surgery, at ICU admission, 24 hours / 48 hours after ICU admission
measure: albumin
timeFrame: during surgery, at ICU admission, 24 hours / 48 hours after ICU admission
measure: NGAL
timeFrame: during surgery, at ICU admission, 24 hours / 48 hours after ICU admission
measure: MACCE
timeFrame: until 1 year after surgery
measure: AKI/RRT
timeFrame: until 1 year after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Seoul National University Hospital
Study officials:
References:
Clinical trial NCT03452345: MEDITOXIN® Treatment in Subject With Benign Masseteric Hypertrophy
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center, Phase 3 Study to Evaluate the Efficacy and Safety of MEDOTIXN® in Subject With Benign Masseteric Hypertrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Masseter Muscle Hypertrophy
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2018-03-02
Enrollment: 180
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of MEDITOXIN in subjects with benign masseteric hypertrophy compared with placebo


Eligibility criteria: Inclusion Criteria:

* subject who aged 20 to less than 65 years
* subject with benign masseteric hypertrophy

Exclusion Criteria:

* subject not appropriate for participating in this study according to the investigator's opinion
* subject with known an anaphylactic response to BoNT/A and other involved ingredients of Investigational product

Primary outcomes:
measure: changes in the thickness of the masseter muscle during maximum clenching measured using ultrasound at week 12 from baseline
timeFrame: 12 week follow-up visit
Secondary outcomes:
measure: changes in the thickness of the masseter muscle as usual measured using ultrasound at week 12 from baseline
timeFrame: 12 week follow-up visit
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
Study officials:
References:
Clinical trial NCT04836845: Comparation of Radial and Focused Extracorporeal Shock Waves in Calcaneal Spur: A Randomised Sham-controlled Trial
Official title: Comparative Effects of Radial and Focused Extracorporeal Shock Wave Therapies on Calcaneal Spur: A Randomised Sham-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Calcaneal Spur
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 92
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 date, focused and radial types of ESWT have been effectively used in calcaneal spur. However, studies directly addressing a comparison between radial and focused types of ESWT in calcaneal spur have not been done. Therefore, this study aims to evaluate comparative effects of radial and focused ESWT options on calcaneal spur.


Eligibility criteria: Inclusion Criteria:

* Clinical and radiological diagnosis of plantar calcaneal spur
* be aged ≥18 at the time of diagnosis
* be give informed consent

Exclusion Criteria:

* have not completed the assessment process.
* foot deformity
* psychological disease

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 1 min.
measure: American Orthopedic Foot and Ankle Score
timeFrame: 5 min.
measure: FOOT FUNCTION INDEX
timeFrame: 7 min.
Secondary outcomes:
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Yuzuncu Yil University
Study officials:
affiliation: Yuzuncu Yıl University
name: Şeyhmus Kaplan
role: STUDY_DIRECTOR
References:
Clinical trial NCT01402245: Targeting of Immune Response After Pneumococcal Vaccination
Official title: Comparison of Immune Response in Pneumococcal Pneumonia and After Vaccination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pneumococcal Pneumonia
Keywords: pneumonia
pneumococcal polysaccharide vaccine
pneumococcal conjugate vaccine
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2011-07-26
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Pneumococcal polysaccharide vaccine does not confer protection against noninvasive pneumonia. The study aims to compare lymphocyte homing in pneumonia and in those receiving Pnc polysaccharide vaccine (PPV) or Pnc conjugate vaccine (PCV)

Detailed description: Pneumococcal polysaccharide vaccine does not confer protection against noninvasive pneumonia. The study compares the homing profiles of Pnc-specific plasmablasts in 15 patients with pneumonia and in 15 volunteers receiving Pnc polysaccharide vaccine (PPV) and 12 volunteers receiving Pnc conjugate vaccine (PCV)

Eligibility criteria: Inclusion Criteria:

* Males and females ≥ 18 and \<65 years of age.
* General good health.
* Written informed consent.
* No previous vaccination against Pnc
* No previous history of Pnc pneumonia
* In pneumonia: Diagnosis of Pnc pneumonia within a week

Exclusion Criteria:

* \< 18 years, ≥65 of age.
* In vaccinees: Acute disease at the time of enrollment.
* Pregnancy or lactation.
* Known immunodeficiency or immune suppressive treatment.
* Any chronic illness that might interfere with the immune response
* Alcohol or drug abuse
* Any clinically significant history of known or suspected anaphylaxis or hypersensitivity (based on the investigator's judgement).

Primary outcomes:
measure: Expression of homing receptors on circulating plasmablasts in Pnc pneumonia and after vaccination
timeFrame: Day 0 and Day 7-10
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: University of Helsinki, Haartman institute, Dept. of Bacteriology and Immunology
city: Helsinki
country: Finland
facility: Division of Infectious Diseases, HUCH
city: Helsinki
country: Finland
facility: Division of Microbiology, HUSLAB, Helsinki University Central Hospital
city: Turku
country: Finland
facility: University of Turku
Study officials:
affiliation: Helsinki University Central Hospital
name: Anu Kantele, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01640145: Effect of Low Intensity Exercise and Protein Intake on Skeletal Muscle Protein Synthesis in Elderly
Official title: Impact of Acute Low Intensity Exercise and Protein Intake on Skeletal Muscle Protein Synthesis in Elderly: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skeletal Muscle Protein Synthesis in Elderly
Protein Kinetics
Sarcopenia
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2012-07-13
Enrollment: 30
Sex: MALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Maintenance of skeletal muscle mass is crucial during lifespan to retain health and functional autonomy. Sarcopenia, being the loss of muscle mass during aging, is a well-known phenomenon in the elderly and a major challenge viewed from an individual, and a socioeconomic point of view. Nevertheless, several studies have proved muscle tissue to be markedly affected by physical activity and nutritional interventions even at old age. Recently, a study in young individuals showed that an acute bout of easily tolerated low intensity exercise can prolong the muscle building effects of a milk protein intake compared to a non-exercised situation. Therefore, the major aim of the present project is to evaluate, whether a low intensity exercise regime in conjunction with milk protein supplementation can induce positive adaptations on parameters related to muscle size and function in elderly.

The study focuses on the acute muscle protein synthesis response to low intensity exercise and protein supplementation measured with stable isotope tracer techniques. It is hypothesized that light muscle activity can augment and prolong the effects of protein feeding.

If a light resistance exercise protocol as investigated in the present project can prove beneficial, elderly, frail elderly, and individuals undergoing rehabilitation can challenge sarcopenia in a new and tolerable way.


Eligibility criteria: Inclusion Criteria:

* Male
* \>65 year old
* Healthy
* BMI \<28

Exclusion Criteria:

* Smoker
* Type II diabetic
* Intake of medicine or supplements which will affect skeletal muscle protein synthesis
* Alcohol intake \>21 units/week.
* Frequent exercise or hard physical labor

Primary outcomes:
measure: Skeletal muscle protein synthesis
timeFrame: 6 months
Secondary outcomes:
measure: Gene expression
timeFrame: 1.5 years
measure: Intracellular signaling
timeFrame: 1.5 years
measure: Amino acid transporter
timeFrame: 2 years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Institute of Sports Medicine Copenhagen
Study officials:
References:
Clinical trial NCT06477445: Visual Feedback Balance Training System Combined with RFE in Stroke
Official title: Effect of Visual Feedback Balance Training System Combined with Repetitive Facilitative Exercise on Fall Risk After Stroke: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Nanjing Mingzhou Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if visual feedback balance training system combined with repetitive facilitative exercise (RFE) work to treat stroke in adults. The main questions it aims to answer are:

Does visual feedback balance training system combined with RFE reduce the fall risk of participants? Can the combination of intelligent rehabilitation robot training system and RFE achieve better effects?

Researchers will compare 3 groups (RFE, visual feedback balance training system under RFE, and conventional therapy) to see if visual feedback balance training system and RFE works to treat stroke.

Participants will:

Receive treatment for 4 weeks Receive scale and instrument testing before and after treatment


Eligibility criteria: Inclusion Criteria:

* patients (18 to 74 years old) who suffered a first or second unilateral stroke
* chronic stroke (over 6 months from the onset)
* moderate or higher risk of falls (TUG \> 15s, or 10-MWT ≤ 0.8m/s)
* ability to understand and follow simple directions

Exclusion Criteria:

* pregnant or lactating
* lower extremity contracture, pain, or trauma
* perceptual, apraxic, or cognitive deficits that lead to inability to follow verbal instructions
* unable to maintain standing posture
* cerebellar lesion
* clinically unstable medical disorders
* inability to provide informed consent

Primary outcomes:
measure: time up and go test (TUG)
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: 10-meter walk test (10-MWT)
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Center of gravity loss index
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Deviation of bilateral center of gravity movement area
timeFrame: From enrollment to the end of treatment at 4 weeks
Secondary outcomes:
measure: functional ambulation category scale (FAC)
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Fugl-Meyer Assessment (FMA)
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Berg balance scale (BBS)
timeFrame: From enrollment to the end of treatment at 4 weeks
Other outcomes:
Locations:
Study officials:
References: