louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01581944: Gonadotropin-releasing Hormone Agonist Prior to Myomectomy
Official title: Phase 3 Study of Experience With a Gonadotropin-releasing Hormone Agonist Prior to Myomectomy - Comparison of 2 Versus 3 Monthly Doses.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fibroids
Keywords: myomectomy
GnRH
blood loss
Lead sponsor: Mt. Hope Maternity Hospital
Sponsor class: OTHER
First posted: 2012-04-20
Enrollment: 68
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fibroids are common in the West Indian population (30-40% of reproductive women).Fibroids are benign growth in the womb or uterus and in order to preserve the fertility of women they, require an operation called myomectomy or shelling out of the fibroid. This procedure can be associated with large blood loss.

In current practice some obstetricians use a gonadotropin releasing hormone agonist prior to the operation to reduce blood loss. Gonadotropin releasing hormone agonist is used in current gynaecological practice to treat women with heavy periods.

In this study the investigators randomised women to either 2 or 3 doses of the gonadotropin agonist prior to their operation and no treatment. The intraoperative blood loss was measured. The study hypothesis: To determine whether administration of gonadotropin releasing hormone agonist prior to myomectomy reduces intraoperative blood loss.

Detailed description: Variables noted preoperatively:

* Age
* Parity
* Ethnicity
* Ultrasound findings

Variables noted intra-operatively:

* Size of largest fibroid
* Estimated blood loss

Eligibility criteria: Inclusion Criteria:

* Women between the age of 20 and 45
* Symptomatic fibroids
* Presence of regular menstrual cycles
* Ultrasound confirmation of fibroids
* Normal cervical smear

Exclusion Criteria:

* Pregnancy
* The length of hospital stay was calculated in number of days from the date of the to the date of discharge
* Presence of endometriosis Previous myomectomy Ovarian, uterine or cervical malignancy female factor for subfertility

Primary outcomes:
measure: Intraoperative blood loss
timeFrame: 3 months
Secondary outcomes:
measure: Blood transfusion requirement
timeFrame: Intraoperatively and in the postoperative period
measure: The level of difficulty in enucleation of the fibroid and in achieving hemostasis.
timeFrame: Immediately after the operation
measure: Length of operation
timeFrame: Immediately after operation
measure: Length of hospital stay
timeFrame: Number of days from operation date to discharge date
Other outcomes:
Locations:
city: Champs Fleurs
country: Trinidad and Tobago
facility: Gynaecological Outpatient Clinic; Mt. Hope Maternity Hospital
Study officials:
affiliation: Mt. Hope Maternity Hospital
name: Dr Bharat Bassaw, MBBS FRCOG
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04171544: Streamline Occipito-Cervico-Thoracic System Post-Market Clinical Follow-up
Official title: Streamline Occipito-Cervico-Thoracic System Post-Market Clinical Follow-up (OCT PMCF)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Stenosis Occipito-Atlanto-Axial
Spinal Disease
Spinal Stenosis Cervical
Spinal Stenosis Cervicothoracic Region
Spinal Instability
Lead sponsor: RTI Surgical
Sponsor class: INDUSTRY
First posted: 2019-11-21
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects implanted with the OCT System.

Brief summary: This is a multi-center, post-market, retrospective study design to collect safety and performance data for patients implanted with the Streamline OCT System.

Detailed description: This is a multi-center, post-market, retrospective study design to collect safety and performance data for patients implanted with the Streamline OCT System. The study will include a minimum of 58 patients at a minimum of 3 sites in the United States. The study will enroll at a minimum of 5 subjects implanted with the occipital plate.

Eligibility criteria: Inclusion Criteria:

* Subject must have had an implant of the OCT System.

Exclusion Criteria:

* No exclusion criteria.

Primary outcomes:
measure: Evaluate time to demonstration of fusion.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Las Vegas Neurosurgical Institute
state: Nevada
city: Reno
country: United States
facility: Spine Nevada
state: Nevada
Study officials:
References:
Clinical trial NCT01132144: Endometrial Injury for Assisted Reproduction
Official title: Endometrial Injury Prior Ovulation Induction for Assisted Reproductive Techniques: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Infertility
Keywords: Reproductive Techniques
Embryo Implantation
Endometrium
Ultrasonography
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2010-05-27
Enrollment: 158
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the effect of endometrial injury performed prior ovulation induction for assisted reproductive techniques main outcomes.


Eligibility criteria: Inclusion Criteria:

* Women who will start assisted reproductive techniques with planned fresh embryo transfer.
* Age between 18 and 38 years.
* Written informed consent.

Exclusion Criteria:

* None

Primary outcomes:
measure: Live Birth
timeFrame: 1 year
Secondary outcomes:
measure: Clinical Pregnancy
timeFrame: 3 months
measure: Ongoing Pregnancy
timeFrame: 6 months
measure: Miscarriage
timeFrame: 9 months
measure: Implantation Rate
timeFrame: 3 months
measure: Endometrial Thickness
timeFrame: 1 month
measure: Endometrial Volume
timeFrame: 1 month
measure: Three-dimensional Doppler Indices From Endometrium (VFI)
timeFrame: 1 month
measure: Procedure Related Pain
timeFrame: Immediately after procedure
Other outcomes:
Locations:
city: Ribeirao Preto
country: Brazil
facility: Setor de Reproducao Humana do HC-FMRP-USP
state: Sao Paulo
Study officials:
affiliation: Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo
name: Wellington P Martins, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lensen SF, Armstrong S, Gibreel A, Nastri CO, Raine-Fenning N, Martins WP. Endometrial injury in women undergoing in vitro fertilisation (IVF). Cochrane Database Syst Rev. 2021 Jun 10;6(6):CD009517. doi: 10.1002/14651858.CD009517.pub4.
Clinical trial NCT01207544: Fitball Program Versus Task-oriented Motor Program on Improving Postural Control in Developmental Coordination Disorder
Official title: The Effectiveness of Fitball Program Versus Task-oriented Motor Program on Improving Postural Control and Motor Proficiency in Children With Developmental Coordination Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Developmental Coordination Disorder
Keywords: motor
balance
developmental
physiotherapy
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Kowloon Hospital, Hong Kong
First posted: 2010-09-23
Enrollment: 22
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Children with developmental coordination disorder (DCD) often have poor postural control and motor skills that affect their activities of daily living and participation in school activities. The aim of this randomized controlled trial is to compare the effects of fitball training versus task-oriented motor training for children with DCD.


Eligibility criteria: Inclusion Criteria:

* diagnosis of DCD according to DSM-IV criteria
* Poor motor skills (Movement Assessment Battery for Children score \<15 percentile, or any two or more of subtests in BOT II \< 1.5 SD)
* aged between 6-12 years old

Exclusion Criteria:

* have attended treatment for motor problems in the previous 6 months
* any major co-morbid medical / neurological / sensory problems such as moderate to severe mental disability, profound visual or hearing impairment, severe sensory problems, or had any major behavioral problems.

Primary outcomes:
measure: Brunininks-Oseretsky Test of Motor Proficiency II
timeFrame: Week 0
measure: Brunininks-Oseretsky Test of Motor Proficiency II
timeFrame: Week 8
Secondary outcomes:
measure: Sensory Organization Test (SOT)
timeFrame: Week 0
measure: Sensory Organization Test (SOT)
timeFrame: Week 8
Other outcomes:
Locations:
city: Kowloon
country: Hong Kong
facility: The Kowloon Hospital
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Marco YC Pang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00699244: Comparison of Central Versus Peripheral Placement of Local Anesthetic
Official title: Selective Local Anesthetic Placement Using Ultrasound-guidance and Neurostimulation for the Infraclavicularbrachial Plexus Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Surgery
Elbow Surgery
Forearm Surgery
Wrist Surgery
Keywords: forearm
hand
elbow
wrist
brachial plexus
infraclavicular block
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2008-06-17
Enrollment: 218
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: Does ultrasound increases the success rate and if there is a difference in success rate between placing the local anesthetic centrally versus peripherally.

Detailed description: A comparison of the infraclavicular placement of local anesthetic either centrally (posterior cord) vs peripheral placement (lateral or medial cord) using ultrasound guidance. This will be done to determine if ultrasound increases the success rate and if there is a difference in success rate between placing the local anesthetic centrally versus peripherally.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) Class I-III.
* Patient is undergoing elective hand or forearm surgery.
* Patient is an adult, 18 years old or older.

Exclusion Criteria:

* Morbid obesity (calculated body mass index \> 35 kg/m2).
* Patient unable to cooperate.
* Patient with a known brachial plexus injury.
* Medical contraindication to anesthetic technique (allergy, cardiac condition, neurologic condition, localized infection, bleeding disorder).
* Patients who are pregnant.

Primary outcomes:
measure: increase success rate of the block to produce surgical anesthesia and analgesia
timeFrame: during and following surgical procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Orthopedic Surgicenter
state: Tennessee
Study officials:
affiliation: clifford.bowens@vanderbilt.edu
name: Clifford Bowens, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03772444: Use of Beetroot Juice to Protect Against Postoperative Ileus (POI) Following Colorectal Surgery: a Pilot Study.
Official title: Use of Beetroot Juice to Protect Against Postoperative Ileus (POI) Following Colorectal Surgery: a Pilot Study.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Postoperative Ileus
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: University Ghent
First posted: 2018-12-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The BEET IT study investigates the possible protective effect of beetroot juice on POI following colorectal surgery in (partially) blinded single-center phase 2 randomized trial (pilot study).

Detailed description: Postoperative ileus (POI) is a transient impairment of gastrointestinal motility following abdominal surgery, which leads to increased morbidity, prolonged hospitalization and increased healthcare cost. The pathogenesis of POI involves inflammation and oxidative stress, similar to ischemia/reperfusion injury that can be counteracted with beetroot juice. Beetroot juice is a source of inorganic nitrate, which by conversion of nitrate to nitrite in the body, exerts its protective effect. We before demonstrated in a preclinical model that administration of exogenous nitrite was shown to protect against POI. The aim of this pilot study is to investigate the possible protective effect of beetroot juice ingestion on POI following colorectal surgery.

Eligibility criteria: Inclusion Criteria:

• All patients undergoing colonic or upper rectum laparoscopic surgery.

Exclusion Criteria:

* Pregnancy or breast feeding
* Psychiatric pathology capable of affecting comprehension and judgment faculty
* History of metastatic disease
* History of prior abdominal bowel surgery
* Abdominal radiation treatment
* Chronic constipation (defined as two or fewer bowel movements per week)
* Gut motility influencing agents (e.g. tricyclic antidepressants, chronic use of laxatives)
* Frequent use of mouthwash, as this affects the enterosalivary circulation of nitrate
* Current use of broad-spectrum antibiotics, which will affect the oral flora and likely affect the nitrate reductase activity
* More than one bowel anastomosis during this surgery

Primary outcomes:
measure: Time until recovery of gastrointestinal function.
timeFrame: up to 30 days after surgery
Secondary outcomes:
measure: Time until passage of stool, flatus or until tolerance of (semi-)solid oral diet (in days).
timeFrame: up to 30 days after surgery
measure: Overall post-operative complication rate defined according to the Clavien-Dindo Classification.
timeFrame: 3 months postoperatively
measure: Presence of prolonged postoperative ileus.
timeFrame: up to 30 days after surgery
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Ghent University Hospital
Study officials:
References:
Clinical trial NCT02226744: Study to Measure Relaxation From Different Types of Focused Breathing Exercises
Official title: Focused Breathing Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Breathing
Mind-body Practices
Yoga
Meditation
Keywords: breathing
mind-body practices
yoga
meditation
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2014-08-27
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mind-body practices, such as yoga, ta'i chi, mindfulness and biofeedback, commonly use slow breathing techniques to induce physiological and mental relaxation. Medical research suggests that slow breathing techniques induce physiological relaxation. This 6 week study will compare the effects of different types of breathing. The hypothesis is that different breathing techniques produce different physiological and mental changes.


Eligibility criteria: Inclusion Criteria:

* Age 30 to 50 years
* English speaking

Exclusion Criteria:

* Hypertension
* Heart disease: history of coronary artery disease, myocardial infarction, significant valvular disease, or congestive heart failure
* Diabetes
* Renal Disease
* Anxiety Disorder
* Depression
* Other psychiatric conditions including schizophrenia or bipolar disorder
* Attention-deficit-disorder or Attention-deficit-hyperactivity disorder
* Musculoskeletal condition limiting capacity to perform yoga such as chronic lower back pain, chronic neck pain
* Asthma
* Chronic Obstructive Lung Disease
* Obstructive Sleep Apnea
* Smoker
* Currently taking blood pressure medications, oral diabetic medication or insulin
* Current participation in a mind-body practice/program
* Current cancer other than non-melanoma skin cancer
* Regular swimmer
* Plays wind or brass musical instruments

Primary outcomes:
measure: Magnitude of changes in heart rate response to upright position
timeFrame: 10 minutes at baseline, 2 weeks and 6 weeks
Secondary outcomes:
measure: Magnitude of changes in heart rate variability measured as ratio of low frequency to high frequency ratio components (Hz)
timeFrame: Baseline, 2 weeks, and 6 weeks
measure: Magnitude of changes in catecholamines in response to upright position
timeFrame: 10 minutes at baseline, 2 weeks, and 6 weeks
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Gurjeet S Birdee, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02992444: Evaluation of the Influence of Output on Skin Covered by Adhesives
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy - Stoma
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2016-12-14
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study investigates the impact real output has on peristomal skin covered by an adhesive


Eligibility criteria: Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have had an ileostomy for more than one year
4. Have intact skin on the area used in the evaluation
5. Has an ileostomy with a diameter up to (≤) 35 mm
6. Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)

Exclusion Criteria:

1. Currently receiving or have within the past 2 month received radio- and/or chemotherapy
2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
3. Are pregnant or breastfeeding
4. Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)
5. Participating in other interventional clinical investigations or have previously participated in this evaluation

Primary outcomes:
measure: Trans epidermal water loss
timeFrame: 4 - 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebaek
country: Denmark
facility: Coloplast A/S
Study officials:
affiliation: Senior R&D Scientist
name: Lene Feldskov, M. Sci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04365244: Pruritus and Melanoma and Cutaneous Carcinomas Treated With Immunotherapy
Official title: Pruritus and Melanoma and Cutaneous Carcinomas Treated With Immunotherapy (PRURICHECKPOINT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pruritus
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients treated with ICIs (nivolumab, pembrolizumab, ipilimumab or cemiplimab)

Brief summary: Immune checkpoint inhibitors (ICIs) are commonly used in the therapeutic arsenal of metastatic melanoma, Merkel cell carcinoma and cutaneous squamous cell carcinoma, thanks to their inhibiting effects on cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA4) and anti-programmed death-1 (anti-PD1) respectively. These treatments can induce numerous cutaneous and non-cutaneous adverse effects that are mainly due to their immunological action. Their most frequent adverse effects are dysthyroidism, autoimmune hepatitis, colitis and skin disorders. Among those, pruritus is frequently reported as a side effect of these treatments. Its incidence has been estimated between 11% and 47%. Pruritus can deeply affect the patient's quality of life and may lead to treatment discontinuation. Until now, ICI-related pruritus has been poorly studied and it is not understood. In the literature, data on the presence and characteristics of pruritus in patients treated by ICIs were provided, without analyzing the causes of this pruritus. Indeed, it is not known if the occurrence of pruritus is related to direct or indirect effects of ICIs. Some authors reported a correlation between the occurrence of cutaneous adverse events under ICIs and the survival. The principal aim of our study was to analyze the putative causes of pruritus occurring in patients treated with ICIs for melanomas and cutaneous carcinomas. The other objectives were to assess the association between the occurrence of pruritus and survival, and between the other adverse events and pruritus.


Eligibility criteria: Inclusion Criteria:

* age 18 years and older,
* treated with ICIs (nivolumab, pembrolizumab, ipilimumab, cemiplimab) for melanoma, squamous cell carcinoma or Merkel cell carcinoma
* not having formulated any opposition

Exclusion Criteria:

* age under 18 years,
* adults not legally competent,
* presence of pruritus at the inclusion,
* participation refusal

Primary outcomes:
measure: putative causes of pruritus
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: presence of other side effects
timeFrame: through study completion, an average of 1 year
measure: survival
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
city: Landerneau
country: France
facility: CH de Landerneau
Study officials:
References: