louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02691572: Transversus Abdominis Plane Block Versus Wound Infiltration for Postcesarean Analgesia
Official title: Comparison Between Transversus Abdominis Plane Block and Wound Infiltration for Analgesia After Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postcesarean Analgesia
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2016-02-25
Enrollment: 80
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will compare the analgesic efficacy of transversus abdominis plane block and wound infiltration in parturients undergoing cesarean delivery under spinal anesthesia.

Detailed description: This randomized, controlled, double-blind study will be conducted on ASA physical status II parturients with full-term singleton pregnancy undergoing elective cesarean delivery under spinal anesthesia. Patients will receive either ultrasound-guided transversus abdominis plane block or wound infiltration at the end of surgery. After delivery, all patients will receive standard analgesia (intravenous ketorolac and oral paracetamol) and patient-controlled analgesia with intravenous fentanyl. Total fentanyl consumption at 24 h, pain scores at 2, 4, 6, 12, and 24 h, side effects, and patient satisfaction will be compared between the 2 groups.

Eligibility criteria: Inclusion Criteria:

1. American Society of Anesthesiologists physical status II
2. Full-term singleton pregnancy

Exclusion Criteria:

1. Age \<19 or \> 40 years
2. Height \<150 cm
3. Weight \<60 kg
4. Body mass index ≥40 kg/m2
5. Contraindications to spinal anesthesia (patient refusal, increased intracranial tension, coagulopathy, uncorrected hypovolemia)
6. Hypersensitivity to any of the drugs used in the study
7. Significant cardiovascular, renal, or hepatic disease
8. Known fetal abnormalities
9. Emergency situations

Primary outcomes:
measure: Cumulative Fentanyl Dose
timeFrame: 24 h
Secondary outcomes:
measure: Cumulative Fentanyl Dose
timeFrame: 2, 4, 6, 12 h
measure: Time to the First Postoperative Fentanyl Administration
timeFrame: 24 h
measure: Pain Scores at Rest and Movement
timeFrame: 2, 4, 6, 12, and 24 h
measure: Number of Patients With Nausea and/or Vomiting
timeFrame: 24 h
measure: Level of Sedation
timeFrame: 24 h
measure: Number of Patients With Pruritis
timeFrame: 24 h
measure: Level of Patient Satisfaction
timeFrame: 24 h
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Department of Anesthesia, Mansoura University Hospitals
state: Dakahlia
Study officials:
affiliation: Mansoura University Hospital
name: Mohamed M Tawfik, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06647472: Proteomic Analysis on Myopic Children Using Orthokeratology Lenses With Good or Poor Myopic Control
Official title: Proteomic Analysis on Myopic Children Using Orthokeratology Lenses With Good or Poor Myopic Control. The ProMOC Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Myopia
Healthy
Orthokeratology
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
Collaborators: name: University of Aarhus
First posted: 2024-10-17
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children who are currently being treated with orthokeratology lenses at the Ophthalmic Department, Vejle Hospital, University Hospital of Southern Denmark.

Brief summary: The key objective of the study is to gain an understanding of the biochemical processes that contribute to orthokeratology lenses being more effective in specific individuals compared to others. With this knowledge, we hope to optimize treatment effectiveness in those currently experiencing less favorable outcomes from treatment in the future.

The primary aim is to investigate differences in protein levels in children using orthokeratology lenses with various effects of myopia control.

Hypothesis: There is a significant difference in the expression of molecules in children with various effects of myopia control.


Eligibility criteria: Inclusion Criteria:

* Children treated with orthokeratology lenses.
* Children on or above the 95th percentile of myopia growth curves for European children at the time of treatment initiation.
* Treatment and follow-up duration ≥ 6 months.

Exclusion Criteria:

* Current use of eye drops.
* Objective signs of dry eyes on slit-lamp examination.
* Active eye infection.

Primary outcomes:
measure: Difference in protein levels measured by mass spectrometry label-free quantification (LFQ) between children using orthokeratology lenses with different levels of myopia control effectiveness
timeFrame: At baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Vejle
country: Denmark
facility: Øjenafdelingen, Vejle Sygehus
Study officials:
References:
Clinical trial NCT03329872: Neuro-Orthopedic Registry of the University Hospital of Toulouse
Official title: Neuro-Orthopedic Registry of the University Hospital of Toulouse
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurologic Disorder
Keywords: Neuro-Orthopedics
Register
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Ipsen
First posted: 2017-11-06
Enrollment: 976
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with central or peripheral nervous system disorders with orthopedic consequences.

Brief summary: Neuro-orthopedics corresponds to the evaluation and therapeutic management of the orthopedic consequences of damage to the central or peripheral nervous system. In case of neurological impairment, there may be joint, motor, sensory and cognitive impairments that limit the patient's activities. The management of these orthopedic problems falls within the specific framework of neuro-orthopedics because in the presence of neurological, problems are different and more complex than in classical orthopedics. In this context, a well-conducted evaluation is a prerequisite for appropriate treatment.


Eligibility criteria: Inclusion Criteria:

Patient with a neurological condition that benefits:

* An injection of botulinum toxin in the context of spasticity : about 20 / week
* Pre or post-therapeutic clinical evaluation (botulinum toxin or surgery): approximately 10 / week
* Clinical or instrumental evaluation of the walking or upper limb (Physiological Functional Explorations): about 10 / week
* A medical and surgical multidisciplinary consultation about spasticity : about 15 / month
* A discussion during neuroorthopedic multidisciplinary consultation meeting about the patient's file and anomalies of walking: about 8 / month
* Implementation of a Baclofen pump (Neurosurgery): about 2 / month
* Functional surgery of the upper or lower limb (locomotor institute, orthopedic surgery and traumatology): about 4 / sem

Exclusion Criteria:

Patient (or the legal representative) who opposes the data collection.

Primary outcomes:
measure: Neurologic symptoms
timeFrame: Each year until five years
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU de Toulouse
state: Midi-Pyrénées
Study officials:
affiliation: University Hospital, Toulouse
name: David Gasq
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04185272: Butyrophilins Role in Colon Cancer
Official title: Role of Butyrophilins in Colon Cancers Aggressiveness Evaluation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colonic Cancer
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: colon cancer patients and metastatic colon cancer patients will be included in this study. We expect that BTNL molecules expression is different depending of the aggressiveness of the illness
Primary purpose: BASIC_SCIENCE

Brief summary: quantification of BTNL molecules in colon cancer in order to determinate if their could be used as a prognostic marquer


Eligibility criteria: Inclusion Criteria:

* Patient is older than 18 years old,
* Signed participation consent,
* Non-metastatic colon cancer immediately resectable or metastatic and liver synchronous for which it was decided a combined colic and liver surgery (metastatic patient at the outset) in multidisciplinary consultation meeting.
* Performance Status (PS) 0 or 1
* affiliated to the social security or beneficiary

Exclusion Criteria:

* Rectal cancer, colon cancer recurrence
* Emergency of colon cancer Surgery
* History of inflammatory disease of the digestive tract (Crohn's disease or ulcerative colitis)
* Patient who received neoadjuvant therapy other than chemotherapy
* Patient treated with immune-suppressors or long-course corticosteroids \<12 months
* Pregnant women or likely to be pregnant (without effective contraception) or breastfeeding,
* Person in urgent situation, person under legal protection measure, or unable to express his / her consent,
* Impossibility of submitting to the medical examination of the test for geographical, social or psychological reasons

Primary outcomes:
measure: evaluation of BTNL3, BTNL8 and BTNL9 expression by transcriptomics and immunohistochemistry
timeFrame: 8 years
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli-Calmettes
Study officials:
References:
Clinical trial NCT00139672: A Study To Investigate The Effect Of PD-217,014 On Abdominal Pain/Discomfort In Patients With IBS.
Official title: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Investigate The Effect Of Pd-217,014 In Patients With Irritable Bowel Syndrome (IBS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-08-31
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 determine the effectiveness of PD-217,014 in the treatment of abdominal pain/discomfort associated with irritable bowel disease.


Eligibility criteria: Inclusion Criteria:

* Males and females having Irritable bowel syndrome as defined by the Rome II criteria.
* Patients must have had normal examination of colon anatomy within the last 5 years

Exclusion Criteria:

* Patient with an organic gastrointestinal disease.
* Patients with poor renal function.
* Patients with severe constipation.

Primary outcomes:
measure: Assess the effect of PD-217,014 on the relief of abdominal pain/discomfort in patients with irritable bowel syndrome. Primary endpoint is a responder, defined by having adequate relief for > or = 50% of the active treatment period (4 weeks).
Secondary outcomes:
measure: Assess the effect of PD-217,014 on the patient's global assessment of IBS symptoms, stool frequency & consistency and on abdominal bloating (change from baseline to week 4).
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02436772: Utilization of the OncoCEE™ Platform to Evaluate Selected Biomarker Alterations in CTCs Isolated From Patients With MBC
Official title: Utilization of the OncoCEE™ Platform to Evaluate Selected Biomarker Alterations in CTCs Isolated From Patients With MBC
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Breast Cancer
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
First posted: 2015-05-07
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 100 metastatic breast cancer patients from 1 clinic in Tennessee

Brief summary: This study evaluates the performance of a blood test for detecting biomarkers in metastatic breast cancer patients at one clinic against standard testing.

Detailed description: The primary objective of this pilot study is to detect the expression of FGFR1 and AR on circulating tumor cells (CTCs) isolated from the peripheral blood of metastatic breast cancer (MBC) patients using the OncoCEE™ platform. No procedures will be associated with this study, as these mutations will be evaluated from the leftover blood that has already been sent for standard of care ER and HER2 using the same platform. Results from this testing will be correlated with results obtained from standard testing to calculate the rate of concordance between tests.

Eligibility criteria: Inclusion Criteria:

* Current patient at participating clinic
* Metastatic breast cancer diagnosis
* 18 years of age or older

Exclusion Criteria:

None

Primary outcomes:
measure: Concordance with standard test
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
Study officials:
affiliation: SCRI
name: Erika Hamilton, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03160872: Anti-Müllerian Hormone is Not Predictive of Pregnancy in Donor Insemination Cycles in Non-infertile Women
Official title: Ovarian Reserve Does Not Predict Pregnancy in Non-Infertile Women: An Assessment Using the Donor Sperm Insemination Model
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: Donor sperm insemination
Anti Mullerian Hormone
Ovarian reserve
Antral follicle count
Lead sponsor: Fundacion Dexeus
Sponsor class: OTHER
First posted: 2017-05-19
Enrollment: 143
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Non Infertile women who undergo a donor sperm insemination due to absence of male partner or complete azoospermia or the presence of a genetic condition in the partner that made the couple opt for donor sperm.

Brief summary: To evaluate if ovarian reserve (measured by means of anti-mullerian hormone -AMH- and antral follicle count -AFC-) can predict pregnancy in donor insemination cycles (dIUI) performed in non-infertile women.


Eligibility criteria: Inclusion Criteria:

* absence of male partner
* complete azoospermia or the presence of a genetic condition in the partner that made the couple opt for donor sperm
* absence of previous history of infertility.
* d ta on AMH and AFC assessment before the first dIUI cycle.

Exclusion Criteria:

* previous history of infertility.
* Presence of any gynaecological condition that could impair the inseminations results:

  * endometriosis, hydrosalpinx,...

Primary outcomes:
measure: Clinical Pregnancy
timeFrame: 6 weeks after insemination procedure
Secondary outcomes:
measure: Miscarriage rate
timeFrame: Evaluated until 15 weeks after insemination procedure
Other outcomes:
Locations:
Study officials:
References:
citation: Catteau-Jonard S, Roux M, Dumont A, Delesalle AS, Robin G, Dewailly D. Anti-Mullerian hormone concentrations and parity in fertile women: the model of oocyte donors. Reprod Biomed Online. 2017 May;34(5):541-545. doi: 10.1016/j.rbmo.2017.02.010. Epub 2017 Mar 1.
citation: Hvidman HW, Bentzen JG, Thuesen LL, Lauritsen MP, Forman JL, Loft A, Pinborg A, Nyboe Andersen A. Infertile women below the age of 40 have similar anti-Mullerian hormone levels and antral follicle count compared with women of the same age with no history of infertility. Hum Reprod. 2016 May;31(5):1034-45. doi: 10.1093/humrep/dew032. Epub 2016 Mar 9.
citation: Somigliana E, Lattuada D, Colciaghi B, Filippi F, La Vecchia I, Tirelli A, Baffero GM, Paffoni A, Persico N, Bolis G, Fedele L. Serum anti-Mullerian hormone in subfertile women. Acta Obstet Gynecol Scand. 2015 Dec;94(12):1307-12. doi: 10.1111/aogs.12761. Epub 2015 Sep 16.
Clinical trial NCT04090372: Digital Preop-planning of Total Hip Arthroplasties
Official title: Digital Preop-planning of Total Hip Arthroplasties in Orthopedic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthopedic Disorder
Keywords: Osteoarthritis
Hip
Total hip arthroplasty
leg discrepancy
preoperative planning
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2019-09-16
Enrollment: 300
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: Residual leg length discrepancy is a common issue after total hip arthroplasty(THA). Digital preoperative planning may improve the accuracy of the surgical procedure and may help the surgeon to precisely predict implants sizes

Detailed description: Total hip arthroplasties (THAs) are used to restore locomotion. More than 150,000 THAs are performed each year in France. Better outcomes require a restoration of limb lengths and anatomy. Post-operative discrepancy is the main cause of complaints and financial compensation in the US after THA. As such, the investigators aim to use preoperative digital planning using TraumaCad to optimize the restoration of the center of rotation of the hips. Preoperative planning are usually performed using anteroposterior standard radiographs, which are scaled to an inaccurate scale. The TraumaCad system (Brainlab®) allows the adjustment of the scales to each patient and the virtual positioning of the implants in order to simulate the intervention for the restitution of the geometrical parameters of the hip.

Eligibility criteria: Inclusion Criteria:

* being older than18 years,
* osteoarthritis as the indication for THA

Exclusion Criteria:

* THAs after femoral neck fractures,
* revision surgery,
* major architectural anomaly (Bone tumor, prior fracture of the pelvis, hip dysplasia),
* patients under legal protection,
* pregnancy or breast-feeding

Primary outcomes:
measure: postoperative residual discrepancy
timeFrame: day 3
Secondary outcomes:
measure: comparisons of the reproducibility of the femoral implants sizes
timeFrame: day 3
measure: comparison of pelvis parameters
timeFrame: day 3
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: CHU de Toulouse, France
name: Nicolas Reina, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01244672: Trans-anal Hemorrhoidal Dearterialization (THD) vs. Hemorrhoidectomy
Official title: Trans-anal Hemorrhoidal Dearterialization (THD) vs. Hemorrhoidectomy for 3rd and 4th Degree Hemorrhoids in at Least Three Quadrants: A Prospective Randomized Control Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemorrhoids
Keywords: Hemorrhoids
THD
Ferguson
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2010-11-19
Enrollment: 40
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: The purpose of this study is to compare the frequency and severity of postoperative( after surgery) pain between two surgical techniques for treating severe hemorrhoids. The two techniques are called: transanal hemorrhoidal dearterialization (THD) and standard surgical excision (removal) of the hemorrhoids

Detailed description: The THD technique involves using ultrasound equipment to identify the arteries that are feeding blood into the hemorrhoids. Once located, stitches are placed around those arteries to cut off the blood supply to the hemorrhoids, which destroys them.

In the standard surgical excision technique, the hemorrhoids are removed by cutting them out with a scalpel.

Both techniques are widely used in many hospitals today. However, there have been no formal studies comparing the two techniques regarding outcomes, particularly regarding pain after the procedure. We plan to enroll 60 patients in this study here at Stony Brook; 30 patients will have THD and 30 will have the standard surgical excision of hemorrhoids.

Eligibility criteria: Inclusion Criteria:

Patients visiting colorectal outpatient office at Stony Book Medical Center, with the diagnosis of 3rd or 4th degree hemorrhoids requiring hemorrhoidectomy will be invited to participate in this study. The diagnosis of hemorrhoids will be established by a colorectal surgeon based on following criteria:

1. physical exam
2. anoscopy or proctoscopy

Exclusion Criteria:

1. first and second degree hemorrhoids
2. recurrent hemorrhoids after previous surgical treatment
3. history of HIV
4. history of inflammatory bowel disease
5. inability to give informed consent due to mental disability
6. age younger than 18
7. history of colon, rectal or anal cancer
8. thrombosed hemorrhoids
9. pregnant women
10. non English speaking patients

Primary outcomes:
measure: Post operative pain
timeFrame: 14 days
Secondary outcomes:
measure: complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: State University Hospital Medical Center
state: New York
Study officials:
affiliation: Stony Brook University Medical Center
name: Roberto Bergamaschi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03618472: Comparison of the Effectiveness Metformin for Deceasing Proliferative Marker in Endometrial Cancer Cells
Official title: Effect of Metformin for Deceasing Proliferative Marker in Endometrial Cancer Cells : a Randomized Double Blind Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metformin
CA Endometrium
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2018-08-07
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of the effectiveness metformin versus placebo for deceasing proliferative marker Ki-67 expression in endometrial tumours when given for 4 weeks before hysterectomy in endometrial cancer cells.

Detailed description: Endometrial cancer is one of the most common gynecological cancers. Preclinical studies in endometrial cancer (EC) show that metformin reduces cellular proliferation by PI3K-AKT-mTOR inhibition. The investigators tested the hypothesis that short-term presurgical metformin reduces cellular proliferation in endometrial cancer. However, no good quality of evidence base supports the effectiveness of metformin for deceasing proliferative marker in endometrial cancer.

Eligibility criteria: Inclusion Criteria:

* Women with endometrial cancer who undergoing complete surgical staging and agrees to participate in this study

Exclusion Criteria:

* Women without diabetes type 1 and 2
* Women who have allergy Biguanide
* Women who have hypoglycemic medication
* Women who have GFR \<45 ml/min/1.73 m2
* Women who have evidence of stage 3 or 4 of endometrial cancer

Primary outcomes:
measure: Change of Ki-67 expression in endometrial tumor
timeFrame: 4 weeks
Secondary outcomes:
measure: Change of grade in endometrial tumor
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
Study officials:
References: