louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00070967: Acupuncture to Improve Quality of Life in Patients With Advanced Cancer
Official title: Effects of Acupuncture on Pain, Nausea, Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Keywords: Acupuncture
Quality of Life
Complementary Therapies
TCM
Traditional Chinese Medicine
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2003-10-13
Enrollment: 40
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will test the feasibility of acupuncture as a complementary therapy for advanced cancer by comparing symptoms and quality of life before and after 8 weeks of acupuncture treatments.

Detailed description: A large percentage of the practice and use of complementary and alternative medicine (CAM) in the United States is focused on cancer. Whether the CAM use is aimed at reducing one's risk of developing cancer or improving the quality of life of a cancer patient during treatment or at the end of life, the public focus on CAM and cancer has created a driving force for cancer centers to address the efficacy and science of these methods.

Currently, the majority of cancer patients do not receive adequate palliative care. Acupuncture has been shown to be effective in the treatment of pain and nausea and has also been shown to improve one's general well-being. Acupuncture also has some effectiveness in relieving symptoms of anxiety and depression. This study will evaluate the efficacy of acupuncture by Traditional Chinese Medicine clinicians to address the quality of life and symptoms of patients with incurable cancer.

Women with recurrent metastatic ovarian cancer and similar patients with advanced cancer who are ambulatory and receiving conventional palliative care will be enrolled in this study. Patients will continue to receive high-quality, conventional clinical interventions, including chemotherapy and pain and symptom reduction programs. Patients will also receive 8 weeks of acupuncture. Evaluation tools such as Satisfaction with Life Domains Scale for Cancer (SLDS-C), Brief Pain Inventory, and Rotterdam Symptom Check List will be used to assess the acupuncture intervention.

Eligibility criteria: Inclusion Criteria

* Advanced cancer patients, primarily ovarian cancer patients
* Undergoing palliative care treatment
* Ambulatory
* Symptomatic with pain, nausea, and/or an inadequate quality of life
* Platelets \> 25,000/mm3
* ANC \> 500 cells/mm3

Exclusion Criteria

* Acupuncture treatment during the 6 months prior to study entry
* History of bleeding disorder, such as hemophilia or von Willebrand disease
* Acute psychosis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: David S. Rosenthal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05186467: Pain After Laparoscopy Results From the Incision, Manipulation of the Abdominal Organs, and Retained CO2(Back Pain)
Official title: Comparing the Analgesic Effect of Intraperitoneal and Intravenous Magnesium Sulphate in Diagnostic Gynecological Laparoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Post Operative Pain, Acute
Keywords: mgso4,laparoscopy ,intraperitoneal
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 44
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Postoperative pain after laparoscopy may be localized pain resulting from incision due to many (two or three) punctures (somatic pain) or due to manipulation of the intra-abdominal organs as ovaries, uterus, omentum, and intestine (visceral pain) or shoulder and back pain caused by retained CO2 in the peritoneal cavity with its irritation effect on the diaphragm.Patients will be divided into two groups:

Intraperitoneal (IP) group (20 patients):They will receive 100 ml normal saline infused over 10 min immediately before the induction of anesthesia and then continuous infusion of 500 ml normal saline intraoperatively then intraperitoneal wash of 100 ml normal saline containing 30 mg/kg MgSO4 at the end of laparoscopy.

Intravenous (IV) group (20 patients):They will receive 100 ml normal saline containing MgSO4 30 mg/kg infused over 10 min immediately before the induction of anesthesia and then continuous infusion of 500 ml normal saline containing MgSO4 (8mg/kg) intraoperatively then intraperitoneal wash using 100 ml normal saline at the end of laparoscopy


Eligibility criteria: Inclusion Criteria:

20-44 years old females, (ASA) class I-II

Exclusion Criteria:

* Patient refusal
* Allergy to MgSO4
* Atrio-ventricular conduction abnormalities
* Drug abuse
* Renal or hepatic or cardiovascular dysfunction
* Prior long-term treatment with calcium channel blockers or magnesium

Primary outcomes:
measure: Time for first dose of rescue analgesia
timeFrame: 8 hours
measure: total analgesic doses
timeFrame: 8 hours
Secondary outcomes:
measure: post operative pain
timeFrame: 8 hours
measure: sedation
timeFrame: 8 hours
measure: adverse events
timeFrame: 8 hours
measure: serum mgso4 level
timeFrame: 2 hours
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Fouad Soliman
Study officials:
affiliation: Sohag University
name: Fouad Soliman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04269967: A Pilot Tele-rehabilitation Trial for Breast Cancer Survivors
Official title: A Pilot Feasibility Study of a Tele-rehabilitation System Among Women Who Undergo a Unilateral Mastectomy for Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer Female
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: Singapore General Hospital
name: National Cancer Centre, Singapore
First posted: 2020-02-17
Enrollment: 40
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults female who are undergoing or underwent a unilateral breast surgery (wide excision or simple mastectomy) with lymph nodes removed at two participating sites in Singapore.

Brief summary: Breast cancer is the leading cancer affecting women in Singapore. Breast cancer survivors commonly experience declined physical function and quality of life, due to their upper limb morbidity and wound issues post-surgery. Rehabilitation therapy can address the aforementioned issues that the survivors may experience during their recovery. No therapy however, can be effective if patients do not utilize them. Home-based telehealth (e.g., tele-rehabilitation) self-managed by patients and guided by healthcare professionals can potentially improve the service use and recovery. This study aims to understand the lived experience of post-mastectomy tele-rehabilitation and recovery process among female patients who undergo a unilateral mastectomy for breast cancer.


Eligibility criteria: Inclusion Criteria:

* Female 21 years and over
* Underwent a recent unilateral breast surgery (wide excision or simple mastectomy) with lymph nodes removed
* Speak and write English or Mandarin;
* No psychiatric history or chronic psychiatric condition as assessed by referring clinician

Exclusion Criteria:

* Having breast reconstruction
* Having legal blindness or severe visual impairment
* Having life expectancy of less than three months (12- weeks)
* Having previous upper limb injury or conditions that limit passive ranges of shoulder flexion (\<150°), elbow extension/flexion (0/145°)

Primary outcomes:
measure: The experience of rehabilitation (i.e., drain care, exercise and massage)
timeFrame: 12 weeks from the baseline assessment
measure: Shoulder range of motion
timeFrame: Pre rehabilitation (week 0) and post-rehabilitation (week 12)
measure: Arm circumference
timeFrame: Pre rehabilitation (week 0) and post-rehabilitation (week 12)
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Miho Asano
Study officials:
affiliation: SSHSPH NUS
name: Miho Asano
role: PRINCIPAL_INVESTIGATOR
References:
citation: Asano M, Koh GC, Madhukumar P, Teng GYH, Liew PLL, Nagalingam S, Tan MLM, Ng YS, Tan BKT. Study protocol: a pilot quasi-experimental trial of tele-rehabilitation and tele-drain care post-mastectomy. Pilot Feasibility Stud. 2021 Feb 1;7(1):39. doi: 10.1186/s40814-021-00776-5.
Clinical trial NCT05195567: System Accuracy of a Blood Glucose Monitoring System GlucoSpark/GlucoScore
Official title: Evaluierung Der Systemgenauigkeit Des Blutglucosemonitoring Systems GlucoSpark / GlucoScore gemäß DIN EN ISO 15197:2015.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Institut fur Diabetes Karlsburg GmbH
Sponsor class: OTHER
Collaborators: name: Beurer GmbH
First posted: 2022-01-19
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study assesses the system accuracy a blood glucose monitoring systems pursuant to ISO 15197

Detailed description: This study assesses the system accuracy the blood glucose monitoring systems for personal use GucoSaprk/GlucoScore as outlined in DIN EN ISO 15197:2015.

Eligibility criteria: Inclusion Criteria:

* Male or female patients with clinical indication for blood glucose testing
* Signed form of consent
* Minimum age of 18 years
* Subjects are legally competent and capable to understand character, meaning and consequences of the study

Exclusion Criteria:

* Pregnancy or lactation
* Severe acute disease (at study physician's discretion)
* Acute or chronic diseases with inherent risk of aggravation by the procedure (at study physician's discretion)
* Current constitution that does not allow participating in the study (e.g. hematocrit out of the devices's specifications, medication known to influence blood glucose measurements; Appendix A of ISO 15197)
* Being unable to give informed consent
* Age younger than 18 years
* Legally incompetent

Primary outcomes:
measure: Analysis of system accuracy based on DIN EN ISO 15197
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Karlsburg
country: Germany
facility: Institut für Diabetes Karlsburg GmbH
state: Mecklenburg Vorpommern
Study officials:
affiliation: Institut fur Diabetes Karlsburg GmbH
name: Eckhard Salzsieder, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03311867: Prolene Versus Ethibond for Cervical Cerclage
Official title: Prolene Versus Ethibond for Cervical Cerclage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Incompetence
Lead sponsor: Rutgers University
Sponsor class: OTHER
First posted: 2017-10-17
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the proposed study is to examine the relationship between cerclage suture material of Ethibond and Prolene and its effect on the vaginal microbiome in a prospective randomized control trial. Ethibond is another commonly used suture material for performing cervical cerclage that shares some characteristics with previously studied suture materials. It is braided like the Mersilene, but thinner like the monofilament Prolene. The investigators will study whether Ethibond causes the vaginal microbiome to be adversely affected like Mersilene or whether there is a healthy microbiome like Prolene. This study will allow the investigators to determine whether it is advisable to continue to use Ethibond for cervical cerclage in clinical practice, or whether obstetricians should avoid its use as now done with Mersilene.


Eligibility criteria: Inclusion Criteria:

* Greater than18 years of age
* Singleton pregnancy
* History of preterm delivery between 17 0/7 weeks - 33 4/7 weeks with painless cervical

dilation or cervical insufficiency

Exclusion Criteria:

* younger than 18 years of age
* multiple gestation
* iatrogenic preterm delivery
* pregnancies with fetal anomalies

Primary outcomes:
measure: Change in Vaginal Microbiome
timeFrame: At time of cerclage placement (11-14 wks gestation) and cerclage removal (35-36 weeks gestation)
measure: Change in Vaginal Cytokine Expression
timeFrame: At time of cerclage placement (11-14 wks gestation) and cerclage removal (35-36 weeks gestation)
Secondary outcomes:
measure: Rate of preterm birth
timeFrame: Delivery between 24-26 weeks gestation
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Division of Maternal Fetal Medicine
state: New Jersey
city: New Brunswick
country: United States
facility: High Risk Obstetrics Clinic
state: New Jersey
Study officials:
affiliation: Rutgers Robert Wood Johnson Medical School
name: Meike Schuster, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04697667: Exercise and PRP vs Exercise Alone in Patients With Knee Osteoarthritis
Official title: The Combination of Exercise and PRP vs Exercise Alone in Patients With Knee Osteoarthritis: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 84
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a prospective randomized controlled study of different treatments for knee osteoarthritis and aims to investigate the efficacy of exercise combined platelet rich plasma (PRP) injection versus only exercise or only PRP treatments.


Eligibility criteria: Inclusion Criteria:

* Adults 40-70 years of age,
* Grade 2-3 according to Kellgren Lawrence osteoarthritis classification,
* No medication for knee osteoarthritis in the past three months,
* Subjects who understand and sign the consent form for this study.

Exclusion Criteria:

* Patients who have received an invasive procedure, intra-articular application and / or physiotherapy in the target knee within three months,
* Previous partial or total knee replacement of the target knee,
* Body mass index \> 30 kg/m2,
* Having any cardiovascular diseases, neurological disorders, rheumatic diseases, malignancy or psychiatric diseases,
* Impaired cognition that impacts the ability to give informed consent,
* Participation in another clinical trial.

Primary outcomes:
measure: Pain intensity
timeFrame: 6th week
measure: Pain intensity
timeFrame: 3rd month
measure: Function
timeFrame: 6th week
measure: Functional performance - 40m fast-paced walk test
timeFrame: 6th week
measure: Functional performance - 10-step stair-climb test
timeFrame: 6th week
measure: Function
timeFrame: 3rd month
measure: Functional performance - 40m fast-paced walk test
timeFrame: 3rd month
measure: Functional performance - 10-step stair-climb test
timeFrame: 3rd month
Secondary outcomes:
measure: Range of motion
timeFrame: 6th week
measure: Range of motion
timeFrame: 3rd month
measure: Health related quality of life
timeFrame: 6th week
measure: Health related quality of life
timeFrame: 3rd month
measure: Patient Satisfaction
timeFrame: 6th week
measure: Patient Satisfaction
timeFrame: 3rd month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
References:
Clinical trial NCT01632267: Retrospective Analysis of Outcomes With a Pharmacogenomic Algorithm
Official title: A Retrospective Analysis of Outcomes in Outpatients With Major Depressive Disorder (MDD) in a Staff Model HMO: Pharmacogenetic Algorithm for Psychotropic Pharmacotherapeutic Applications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Anxiety
Lead sponsor: Assurex Health Inc.
Sponsor class: INDUSTRY
First posted: 2012-07-02
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects under the care of a psychiatrist at Union Health Services, Chicago, IL

Brief summary: Antidepressants are among the most widely prescribed medications, yet only 35-45% of patients achieve remission following an initial antidepressant trial. The financial burden of treatment failures in direct treatment costs, disability, decreased productivity, and missed work may in part derive from a mismatch between optimal, and actual, medications prescribed. The present one year retrospective study seeks to evaluate the indirect and direct healthcare costs for 96 patients with a DSM-IV-TR depressive or anxiety disorder, in relation to an interpretive reporting system designed to predict antidepressant responses based on DNA variations in cytochrome P450 genes (CYP2D6, CYP2C19, CYP1A2), the serotonin transporter gene (SLC6A4), and the serotonin 2A receptor (5HTR2A) genes.


Eligibility criteria: Inclusion Criteria:

* Major Depressive Disorder
* Dysthymic Disorder
* Depressive Disorder NOS
* Obsessive Compulsive Disorder (OCD)
* Generalized Anxiety Disorder
* Panic Disorder
* Anxiety Disorder NOS
* Post-Traumatic Stress Disorder (PTSD)
* Social Phobia

Exclusion Criteria:

* Bipolar Disorder
* Schizophrenia
* Schizoaffective Disorder
* Previous pharmacogenomic testing

Primary outcomes:
measure: Number of Outpatient Visits
timeFrame: During the one year study window (April 1, 2010 to April 1, 2011)
Secondary outcomes:
measure: Number of Medical Absence Days
timeFrame: During the one year study window (April 1, 2010 to April 1, 2011)
measure: Number of Disability Claims
timeFrame: During the one year study window (April 1, 2010 to April 1, 2011)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Union Health Services
state: Illinois
Study officials:
affiliation: Union Health Services
name: Aida Spahic-Mihajlovic, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01689467: Efficacy and Safety of Fermented Velvet Antler Extract on Fatigue Recovery After Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Fatigue Syndrome
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2012-09-21
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Fermented Velvet Antler extract on fatigue recovery after exercise. The investigators measured fatigue recovery parameters , including lactate, ammonia, inorganic phosphorus, creatine kinase and LDH, and monitored their blood pressure.


Eligibility criteria: Inclusion Criteria:

* Males and females 19-60 years old
* Hemoglobin concentration between 13 and 14 g/dL(men), 12 and 13 g/dL(women)
* Able to give informed consent

Exclusion Criteria:

* Allergic or hypersensitive to any of the ingredients in the test products
* History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
* Participation in any other clinical trials within past 2 months
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
* Pregnant or lactating women etc.

Primary outcomes:
measure: Changes in lactate
timeFrame: 12 weeks
measure: Changes in ammonia
timeFrame: 12 weeks
measure: Changes in inorganic phosphorus
timeFrame: 12 weeks
measure: Changes in creatine kinase
timeFrame: 12 weeks
measure: Changes in Lactage dehydrogenase(LDH)
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in Multidimensional Fatigue Scale(MFS)
timeFrame: 12 weeks
measure: Changes in 36-Item Short-Form Health Survey(SF-36)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
References:
Clinical trial NCT05980767: Short Duration Electrical Stimulation to Improve Outcomes After Cubital Tunnel Release (SELECT) Trial
Official title: Short Duration Electrical Stimulation to Improve Outcomes After Cubital Tunnel Release (SELECT) Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neuropathy;Peripheral
Lead sponsor: Epineuron Technologies Inc.
Sponsor class: INDUSTRY
Collaborators: name: Federal Economic Development Agency for Southern Ontario (FedDev Ontario)
First posted: 2023-08-08
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A novel temporary peripheral nerve stimulation system that delivers electrical stimulation therapy in a cubital tunnel release model will be evaluated for feasibility.


Eligibility criteria: Inclusion Criteria:

* Ulnar neuropathy at the elbow

Exclusion Criteria:

* Peripheral neuropathy outside of nerve of interest
* Patients with any active implanted device

Primary outcomes:
measure: Eligibility Rate
timeFrame: 1.5 years
measure: Recruitment Rate
timeFrame: 1.5 years
measure: Retention Rate
timeFrame: 1.5 years
Secondary outcomes:
Other outcomes:
measure: Electromyography (EMG) Denervation Absence/Presence
timeFrame: 1.5 years
measure: Nerve Conduction Study (NCS)
timeFrame: 1.5 years
measure: Semmes-Weinstein Monofilament Test
timeFrame: 1.5 years
measure: Static Two-Point Discrimination
timeFrame: 1.5 years
measure: Grip strength
timeFrame: 1.5 years
measure: Pinch strength
timeFrame: 1.5 years
measure: Patient Rated Ulnar Nerve Evaluation (PRUNE)
timeFrame: 1.5 years
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
References: