louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01724255: Optimal Time for Staple/Dressing Removal
Official title: The Influence of the Timing of Staple and Dressing Removal After Cesarean Section on the Surgical Incision Healing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Wound Healing
Surgical Wound Infection
Patient Satisfaction
Keywords: Caesarian section
Surgical Wound
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2012-11-09
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing a cesarean section at our facility

Brief summary: The medical literature does not provide sufficient information or recommendation regarding the optimal time to remove the staples and the bandage after a cesarean section. The goal of this study is to compare 5 groups of patients:

1. staple removal on POD 4 and dressing removal on Post Operative Day (POD)1
2. staple removal on POD 4 and dressing removal on Post Operative Day (POD)4
3. staple removal on POD 7 and dressing removal on Post Operative Day (POD)1
4. staple removal on POD 7 and dressing removal on Post Operative Day (POD)7
5. staple removal on POD 4 and dressing removal on Post Operative Day (POD)7

Since there is no definite protocol for staple and dressing removal, we will adapt the above protocol each for a 3-4 month period of time. Patients will be contacted to either return for a follow up visit or to answer a telephone survey.


Eligibility criteria: Inclusion Criteria:

* patients undergoing a cesarean section at our facility

Exclusion Criteria:

* patients lost to follow up

Primary outcomes:
measure: Incidence of Wound infection and complications
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Drorith Hochner-Celnikier, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heinemann N, Solnica A, Abdelkader R, Gutman J, Nalbandian N, Raizman E, Hochner-Celnikier D. Timing of staples and dressing removal after cesarean delivery (the SCARR study). Int J Gynaecol Obstet. 2019 Mar;144(3):283-289. doi: 10.1002/ijgo.12757. Epub 2019 Jan 11.
Clinical trial NCT00523055: Ultrasound-guided Supraclavicular Brachial Plexus Blockade
Official title: Ultrasound-guided Supraclavicular Brachial Plexus Blockade: A Pharmacokinetic Study of Lidocaine and Adrenaline
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain
Keywords: Pain
Brachial Plexus Anesthesia
Plasma Lidocaine Levels
Ultrasound
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2007-08-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Pain Clinic patients undergoing physiotherapy for rehabilitation often have arm freezing performed. The quality of physiotherapy is felt to be superior with good pain control. The quality of the freezing is felt to be better when it is done with ultrasound guidance. We are able to use less drug to achieve the same result. For this reason, we are doing a study to look at the level of freezing drug that accumulates in the body. We feel that the drug levels will be significantly different. We also feel that the time-to-peak drug level will be different than with traditional arm freezing procedures.


Eligibility criteria: Inclusion Criteria:

* patients undergoing brachial plexus anesthesia as part of disease management who have consented to participate in the study

Exclusion Criteria:

* Contraindication to brachial plexus anesthesia
* Informed consent not obtained

Primary outcomes:
measure: Lidocaine drug level
timeFrame: 40 minutes
Secondary outcomes:
measure: brachial plexus block quality
timeFrame: 30 minutes
measure: Physiotherapy quality
timeFrame: within 2 hours
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Health Sciences Pain Management Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Eric N Sutherland, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Neal JM, Hebl JR, Gerancher JC, Hogan QH. Brachial plexus anesthesia: essentials of our current understanding. Reg Anesth Pain Med. 2002 Jul-Aug;27(4):402-28. doi: 10.1053/rapm.2002.34377. No abstract available.
citation: Norder H, Hammas B, Larsen J, Skaug K, Magnius LO. Detection of HBV DNA by PCR in serum from an HBsAg negative blood donor implicated in cases of post-transfusion hepatitis B. Arch Virol Suppl. 1992;4:116-8. doi: 10.1007/978-3-7091-5633-9_24.
citation: Soares LG, Brull R, Lai J, Chan VW. Eight ball, corner pocket: the optimal needle position for ultrasound-guided supraclavicular block. Reg Anesth Pain Med. 2007 Jan-Feb;32(1):94-5. doi: 10.1016/j.rapm.2006.10.007. No abstract available.
citation: Beach ML, Sites BD, Gallagher JD. Use of a nerve stimulator does not improve the efficacy of ultrasound-guided supraclavicular nerve blocks. J Clin Anesth. 2006 Dec;18(8):580-4. doi: 10.1016/j.jclinane.2006.03.017.
Clinical trial NCT02495155: Initial Assessment of an Internet-based Symptom Management Intervention in Early Stage Breast Cancer
Official title: Initial Assessment of an Internet-based Symptom Management Intervention in Early Stage Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Fatigue
Insomnia
Pain
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2015-07-13
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In order to determine the acceptability of a breast cancer-specific cognitive behavioral therapy intervention, as well as to obtain preliminary data to assess efficacy in managing symptoms, the investigators will ask 45 breast cancer survivors with moderate insomnia, fatigue, and/or pain to use the investigators' internet-based intervention for 8 weeks and to complete patient-reported outcomes assessments before and after the 8 week intervention.


Eligibility criteria: Inclusion Criteria:

* Female
* Stage 0-III invasive carcinoma of the breast
* Surgical resection and axillary assessment, radiation therapy, and/or chemotherapy, as indicated, completed at least 3 months prior to enrollment.
* Concomitant trastuzumab and anti-endocrine therapies are permitted. If taking anti-endocrine therapy must have been taking for at least 3 months prior to enrollment.
* Must report at least one of the following:

  1. Fatigue in the week prior to enrollment at least 4 on a 10 point scale (with 0 = not tired at all and 10 = extremely tired)
  2. Insomnia in the week prior to enrollment
  3. Pain in the week prior to enrollment at least 4 on a 10 point scale (with 0 = no pain and 10 = extremely severe pain)
* Has access to and is able to operate a computer with internet access.
* Able to read and understand English.
* Willing and able to sign an informed consent document.

Exclusion Criteria:

- Diagnosis of sleep apnea or restless leg syndrome that is currently interfering with sleep

Primary outcomes:
measure: Improvement in patient-reported symptom with use of PROSPECT for 8 weeks
timeFrame: 8 weeks
Secondary outcomes:
measure: Acceptability of the PROSPECT intervention based on patient self-report
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Norah L Henry, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03752255: Verbal and Visual Information Techniques on Anxiety in Third Molar Surgery
Official title: The Effects of Verbal and Visual Information Techniques on Anxiety in Impacted Third Molar Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impacted Third Molar Tooth
Keywords: Video
Anxiety
Lead sponsor: Konya Necmettin Erbakan Üniversitesi
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study was to evaluate preoperative anxiety levels using dental anxiety scale (DAS) and the Spielberger State-Trait Anxiety Inventory (STAI).

Detailed description: This study will based on a prospective, observational investigation of two different patient education techniques about the effect of third molar removal on patients' anxiety level. A total of 240 patients will be divided into two groups.

Information about operation procedures and a recovery will be given verbally in group 1 and information about operation procedures and recovery will be given in group 2. Anxiety levels were assessed by using DAS and (STAI).Paired t-test or Wilcoxon test will be used for intra-group comparison of anxiety levels.

Eligibility criteria: Inclusion Criteria:

* Impacted third molar (bone and mucosa retention, mesioangular position)
* Patients with any chronic disease and allergy

Exclusion Criteria:

* Pericoronitis
* Patients with visual impairment
* Patients with psychological disorders
* Smoking
* Pregnancy or lactation

Primary outcomes:
measure: The anxiety levels will be examined using DAS and STAI.
timeFrame: first day
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Necmettin Erbakan University
state: Karatay
Study officials:
affiliation: Necmettin Erbakan University
name: Dilek Menziletoglu, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02265055: Early Embryo Cleavage And Multiple Pregnancies After ICSI
Official title: Early Embryo Cleavage And Multiple Pregnancies After ICSI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Infertility
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2014-10-15
Enrollment: 193
Sex: FEMALE
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: To observe whether Number of early cleavage embryos can be a predictor for multiple pregnancies after ICSI.

Detailed description: A total of 193 infertile couples, attending the ART unit, International Islamic Center for Population Studies and Research (IICPSR), -Al- Azhar University in the period from December 2010 to September 2012, were included in this study.

The controlled ovarian hyperstimulation protocol was performed according to a long GnRH agonist protocol starting in the midluteal phase (day 21) of the preceding cycle. Embryos were assessed at 25 - 27 hr after ICSI for early cleavage. Embryos which reached the two cell stage at this interval were classified as Early Cleavage (EC) embryos, and the remaining as Non Early Cleavage (NEC) embryos. Embryos were assessed again at 64 - 68 hours post-ICSI for day-three embryo morphology. Day 3 embryo transfer was done. The best two or three embryos, according to day 3 embryo morphology were transferred. The patients were subdivided into two subgroups; one will transfer early cleavage embryos (EC) and the other will transfer non early cleavage embryo (NEC).

Eligibility criteria: Inclusion Criteria:

* BMI \>25 - 30 kg/m2
* Have two ovaries
* Regular cycles
* first ICSI cycle
* Long midluteal GnRH protocol.

Exclusion Criteria:

* uterine factor as a cause of female factor infertility
* pelvic masses or diseases (e.g: endometriosis, fibroids, hydrosalpnix, ...)
* history of medical disorders (e.g: hypertension, D.M, thyroid dysfunction, liver diseases, renal diseases,...)
* azoospermia as a cause of male factor infertility

Primary outcomes:
measure: clinical pregnancy
timeFrame: 6 weeks
Secondary outcomes:
measure: multiple pregnancy
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Al-Azhar University
name: mahmoud edessy, prof
role: STUDY_DIRECTOR
affiliation: Al-Azhar University
name: abd elnasr m ali, prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Al-Azhar University
name: ahmed fata, prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Al-Azhar University
name: wael hamed, dr
role: STUDY_CHAIR
References:
Clinical trial NCT02825355: Sentinel Node Mapping in Women With Cervical and Endometrial Cancer
Official title: Sentinel Node Mapping With Robotic Assisted Near Infra-red Fluorescent Imaging in Women With Cervical and Endometrial Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uterine Cervical Neoplasms
Uterine Neoplasms
Keywords: robotic surgery procedure
indocyanine green
sentinel lymph node mapping
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
name: Danish Cancer Society
First posted: 2016-07-07
Enrollment: 512
Sex: FEMALE
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: See above in eligibility criteria.

Brief summary: This study aims to evaluate the effect of SLN mapping on the incidence and severity of lymphedema in women with early stage cervical and endometrial cancer.


Eligibility criteria: Inclusion Criteria:

* Study IA: Cervical carcinoma, FIGO stage IB1, cervical tumour size \< 2 cm
* Study IB: Endometrial adenocarcinoma, presumed FIGO stage I, low- and intermediate risk: Type 1 grade 1 + 2, \> 50% myometrial invasion

Exclusion Criteria:

* Prior PL
* Known allergy towards ICG and/or iodine (ICG contains 5% sodium iodine)
* Women included in other studies affecting outcome-measures of the present study

Primary outcomes:
measure: Incidence of lymphedema
timeFrame: 3 years
measure: Severity of lymphedema
timeFrame: 3 years
Secondary outcomes:
measure: Detection rate of sentinel lymph node
timeFrame: 2 years
measure: Mapping of SLN in different types of lymph node stations
timeFrame: 2 years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
References:
citation: Bjornholt SM, Sponholtz SE, Markauskas A, Froding LP, Larsen CR, Fuglsang K, Schledermann D, Mogensen O, Jensen PT. Sentinel lymph node mapping for endometrial and cervical cancer in Denmark. Dan Med J. 2021 Mar 24;68(4):A11200886.
Clinical trial NCT01674855: Phase III Study of DA-3031(PEG-G-CSF) in Chemotherapy-induced Neutropenia
Official title: Randomized, Open, Multi-Center, Phase III Study to Evaluate Efficacy and Safety in Chemotherapy-induced Neutropenia of Once-per-cycle DA-3031(PEG-G-CSF) and Daily G-CSF in Patients With Malignancies Receiving Myelosuppressive Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chemotherapy Induced Neutropenia
Keywords: PEG-G-CSF
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-08-29
Enrollment: 74
Sex: ALL
Minimum age (years): 18
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 to determine whether once-per-cycle DA-3031(PEG-G-CSF) is not inferior to daily G-CSF in chemotherapy-induced neutropenia.

Detailed description: Eligible subjects are randomly assigned to receive once-per-cycle DA-3031(PEG-G-CSF) or daily G-CSF(up to 10 days). This study is conducted for 6 cycles of chemotherapy, that each cycle is repeated every 21 days.

Eligibility criteria: Inclusion Criteria:

1. Age : ≥18, ≤70
2. Diagnosis of stage II, III or IV breast cancer
3. ANC≥1,500/mm3, Platelet≥100,000/mm3, ECOG : 0 or 1
4. Creatinine \< 1.5 x ULN
5. Total bilirubin/AST/ALT \< 1.5 x ULN, ALP \< 2.5 x ULN
6. Have given a written, informed consent

Exclusion Criteria:

1. Prior chemotherapy
2. Prior bone marrow or stem cell transplantation
3. Other malignancy history within 5 years
4. Prior exposure to pegfilgrastim or filgrastim or other colony-stimulating factors
5. Received any other investigational drugs within 30 days of informed consent date
6. Radiation therapy within 4 weeks of informed consent date
7. Infective symptom before chemotherapy into this study
8. Received systemic antibiotics within 72 hours of randomization into this study.
9. HIV positive
10. Pregnant or lactating women

Primary outcomes:
measure: Duration of grade 4 neutropenia in cycle 1
timeFrame: 21 day
Secondary outcomes:
measure: ANC nadir in cycle 1
timeFrame: 21 day
measure: Time to ANC recovery in cycle 1
timeFrame: 21 day
measure: Incidence of febrile neutropenia
timeFrame: 126 day
measure: Incidence of IV antibiotics administration
timeFrame: 126 day
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University GURO hospital
Study officials:
affiliation: Korea University Guro Hospital
name: JaeHong Seo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02261155: Changes in Sensory Perception During Hypnotic Relaxation
Official title: Veränderungen Der Sensibilität Durch Medizinische Hypnose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2014-10-10
Enrollment: 23
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Changes in sensory thresholds and pain thresholds will be measured with quantitative sensory testing (QST) before and during hypnotic relaxation in healthy volunteers. Hypnotic susceptibility will be assessed before QST.

QST data before and during hypnosis will be compared. Observed sensory changes will be evaluated in relation to the assessed hypnotic susceptibility

Detailed description: Healthy volunteers will be recruited and tested regarding their hypnotic susceptibility with Harvard Group Scale. In a second session QST will be performed on the right hand.Then hypnosis will be induced with the fixation method. After that the hypnotherapist will ask them to focus their attention on imagining an individual situation of well-being and calmness the volunteers had described before hypnosis. Then QST will be performed a second time on the same location. Results be compared using student's ttest.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* health conditions of any Kind
* inability to read and/ or sign informed consent
* previous hypnosis experience

Primary outcomes:
measure: Changes in Quantitative Sensory Testing
timeFrame: 1 hour
Secondary outcomes:
measure: Observed sensory changes during hypnosis compared to hypnotic susceptibility
timeFrame: 1 hour
Other outcomes:
Locations:
Study officials:
affiliation: Multidisciplinary Pain Centre, Department of Anesthesiology, University of Munich
name: Dominik Irnich, Pd Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kramer S, Zims R, Simang M, Ruger L, Irnich D. Hypnotic relaxation results in elevated thresholds of sensory detection but not of pain detection. BMC Complement Altern Med. 2014 Dec 15;14:496. doi: 10.1186/1472-6882-14-496.
Clinical trial NCT01709955: The Effects of Glucomannan on Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Keywords: Obesity
Overweight
Glucomannan
Lead sponsor: Northeast College of Health Sciences
Sponsor class: OTHER
First posted: 2012-10-18
Enrollment: 43
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if the herb, Glucomannan, is an effective non-pharmacological appetite suppressant for overweight or Class I obese patients. The study design will not include any other lifestyle changes which enhance weight loss in order to completely isolate the effects of Glucomannan as a non-pharmacological appetite suppressant.


Eligibility criteria: Inclusion Criteria:Subjects will be recruited based upon the category of them wanting to lose 50 pounds.

Subjects must be able to swallow the capsule whole with water.

Exclusion Criteria:

1. Self-reported use of prescription medication other than hormonal birth control (such as medication for diabetes, hypertension hypothyroidism, heart disease, cancer, etc.)
2. Pregnancy
3. Age younger than 21 or older than 60 years of age.
4. Screening for hypertension during the first laboratory visit that reveals a systole greater than 120 and a diastole greater than 90.
5. BMI calculations based upon height and weight measurements at the first laboratory visit that reveal a BMI less than 25 or greater than 35.
6. Self-reported iron-deficiency anemia, osteoporosis, and hypoglycemia.

Primary outcomes:
measure: Weight Loss
timeFrame: 30 Days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03212755: Serum Immunoglobulin (G) as a Marker of Diabetic Nephropathy
Official title: Serum Immunoglobulin (G ) as a Predictive Marker of Early Renal Affection in Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Nephropathies
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 75
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Diabetes mellitus is a chronic disease that affects 366 million people worldwide ( 6.4 % of the adult population ) and is expected to rise to 522 million by 2030 . Diabetic nephropathy occurs in approximately one - third of all people with diabetes and is the leading cause of renal failure in developed and developing countries Diabetic nephropathy is a severe complication occurring in diabetic patients and it is associated with an increased risk of all- cause mortality , cardiovascular disease and progression to end stage renal disease , requiring costly renal replacement therapy in the form of dialysis or transplantation


Eligibility criteria: Inclusion Criteria:

* type 2 diabetic patients

Exclusion Criteria:

* patients with diabetes type 1 ,
* pregnant and lactating females ,
* patients with any congenital disease , Infection , Smokers , alcoholics , and drug abusers .

Primary outcomes:
measure: The number of patients with high level of immunoglobulin in serum
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: