louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02982356: Prenatal Screening, Diagnosis and Intrauterine Intervention of Fetal Abnormal Chromosome and Structure in Twins Pregnancy
Official title: Prenatal Screening, Diagnosis and Intrauterine Intervention of Fetal Abnormal Chromosome and Structure in Twins Pregnancy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chromosome Abnormality
Twin Pregnancy With Antenatal Problem
Lead sponsor: Shanghai First Maternity and Infant Hospital
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Fudan University
name: International Peace Maternity and Child Health Hospital
First posted: 2016-12-05
Enrollment: 1300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The risk of abnormal chromosome and structure is much higher in twins than in singletons, and traditional early pregnancy screening strategy for single pregnancy is not suitable for twins. Based on our management experience of fetal medicine at twin pregnancy, and multi-center cooperation, the study will carry out the following clinical studies:

1. to explore a suitable, early, noninvasive and accurate prenatal screening strategy for twin pregnancy.
2. fetal chromosomal abnormalities


Eligibility criteria: Inclusion Criteria:

* ultrasound diagnosis as twin pregnancy
* at 11-14 gestational weeks

Exclusion Criteria:

* Multiple pregnancies (three or more)
* Maternal history of chromosome aneuploidy abnormality or tumor

Primary outcomes:
measure: Success rate for the operation
timeFrame: 1 week
Secondary outcomes:
measure: long-term complications after surgery
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04312256: Thumb vs Great Toe Recovery
Official title: Comparison of Flexor Hallicus Brevis and Adductor Pollicis as Sites for Neuromuscular Monitoring With Electromyography (Thumb vs Great Toe) After Sugammadex Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Residual Neuromuscular Blockade
Keywords: Neuromuscular Blockade
Tetragraph
AMG
EMG
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Researches are comparing the accuracy of measuring muscle relaxation in the thumb versus the great toe.


Eligibility criteria: Inclusion Criteria:

* Age \> or = 18 years old
* Patients willing to participate and provide an informed consent
* Patients undergoing an elective surgical procedure that requires use of non-depolarizing NMBA agents administered intraoperatively.
* Patients with planned administration of sugammadex as a neuromuscular blocking reversal agent.

Exclusion Criteria:

* Patients with disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or any similar wrist injury.
* Patients with systemic neuromuscular diseases such as myasthenia gravis
* Patients with significant organ dysfunction that can significantly affect pharmacokinetics of neuromuscular blocking and reversal agents, i.e., severe renal impairment or end-stage liver disease.
* Patients having surgery that would involve prepping the arm or leg into the sterile field

Primary outcomes:
measure: Onset Time of Muscle Relaxation for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles
timeFrame: Up to 1 hour postoperatively
measure: Recover Time for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles
timeFrame: Up to 1 hour postoperatively
Secondary outcomes:
measure: Onset Time of Reversal Agent Administered for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles
timeFrame: Up to 1 hour postoperatively
measure: Recover Time of Reversal Agent Administered for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles
timeFrame: Up to 1 hour postoperatively
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: J.Ross Renew, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00647556: Adapalene Gel 0.3% Versus Tretinoin 0.05% Emollient Cream for Treatment of Photodamage
Official title: A Comparative Study of Adapalene Gel 0.3% Versus Tretinoin 0.05% Emollient Cream, for the Treatment of Photodamage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Photoaging
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2008-03-31
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to compare the efficacy of adapalene (Differin®) gel 0.3% and tretinoin 0.05% emollient cream for the treatment of signs of photodamage, with tolerability assessment as a secondary objective.

Detailed description: Same as above.

Eligibility criteria: Inclusion Criteria:

* Male or Female aged 40 years of age and older with Fitzpatrick skin types I through III
* Clinically moderate to severe photodamage

Exclusion Criteria:

* Subjects with history of laser resurfacing, dermabrasion, medium or deep chemical peel of the face
* Subjects with diagnosis of skin cancer within 3 months of study entry
* Subjects who have had superficial chemical peels, exfoliation or microdermabrasion of the face within 3 months of study entry
* Subjects who have had botulinum toxin for facial rejuvenation within 6 months of study entry and are unwilling to refrain from botulinum toxin treatments during the study

Primary outcomes:
measure: Change From Baseline in Overall Integrated Assessment of Photodamage at Week 24
timeFrame: baseline to week 24
Secondary outcomes:
measure: Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
timeFrame: baseline, week 12 and week 24
measure: Number of Participants Who Improved (a Decrease of at Least One Point) in Overall Integrated Assessment of Photodamage From Baseline to Week 12.
timeFrame: baseline to week 12
measure: Number of Participants in Each Category of the Subject Evaluation of Improvement at Week 12 and Week 24
timeFrame: week 12 and week 24
measure: Number of Participants in Each Category of the Investigator Evaluation of Global Response (Improvement) at Week 12 and Week 24
timeFrame: week 12 and week 24
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Department of Dermatology
state: Michigan
Study officials:
affiliation: Galderma R&D
name: Ronald W Gottschalk, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00573456: Far Infrared Radiation Treatment for Diabetes
Official title: Phase 1 Study to Evaluate the Efficacy of Using Energy Specific Far Infrared Radiation Treatment for Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Diabetes Mellitus
Keywords: Thye 1 Diabetes
Type 2 Diabetes
Lead sponsor: GAAD Medical Research Institute Inc.
Sponsor class: OTHER
First posted: 2007-12-14
Enrollment: 2
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A study to determine the use of far infrared (FIR) radiation for treatment of diabetes.

Detailed description: Diabetes mellitus is a disease in which glucose is not sufficiently metabolized. This results in high glucose levels in blood and glucose in the urine. Cells can starve because glucose is not being metabolized.

Both types of diabetes can cause dangerous complications, including blindness, heart and blood vessel disease, and kidney failure. A decrease in circulation may eventually require the amputation of limbs.

We are postulating that energy specific electromagnetic radiation of the central nervous system, the viscera and the endocrine system has the potential to enhance the immune system; thereby improving the health of the patients.

Eligibility criteria: Inclusion Criteria:

* Persons with type 1 or type 2 diabetes

Exclusion Criteria:

* None

Primary outcomes:
measure: The primary end point is to determine the therapeutic effects of far infrared radiation on all types of diabetes.
timeFrame: 2 years
Secondary outcomes:
measure: The secondary end point of the study is to evaluate the therapeutic effects of far infrared radiation on other types of diabetes complications including blindness, heart and blood vessel disease and kidney failure.
timeFrame: 2 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Centre for Incurable Diseases
state: Ontario
Study officials:
affiliation: GAAD Medical Research Institute Inc.
name: Ken Nedd, M.D.
role: STUDY_DIRECTOR
affiliation: GAAD Medical Research Institute Inc.
name: Kwasi Donyina, Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT01172015: NATURAL KILLER CELLS IN IMMUNOLOGIC THROMBOCYTOPENIC PURpura of Adults
Official title: NK-ITP STUDY : NATURAL KILLER CELLS IN IMMUNOLOGIC THROMBOCYTOPENIC PURPURA OF ADULTS.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immunologic Thrombcytopenic Purpura (ITP) Adults
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2010-07-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Immunologic thrombcytopenic purpura (ITP) affects both children and adults. The incidence is estimated in adults about 1,6/100 000/per year. Chronic and relapsing forms of the disease that represent 70% of adult cases are associated with impairment of quality of life related to treatments side effects and bleeding. ITP is secondary to the destruction of circulating platelets through an auto-immune process and to a decrease of platelet production in bone marrow. Auto antibodies are usually directed against epitopes of the GPIIb/IIIa, expressed by platelets. The destruction of the platelets seems to occur mainly in the spleen through antibody dependent cytotoxicity. Both macrophages and cytotoxic T lymphocytes subsets participate to the platelet destruction through the CD16, the low affinity receptor for the Fc of IgG. Thus the CD16 "pathway" is a target for treatments in ITP as for example intravenous immunoglobulins and more recently inhibitors of the syk kinase.

Detailed description: Natural Killer cells (NK) cells, who are now implicated in the pathophysiology of several autoimmune diseases, express CD16 and display antibody dependent cytotoxicty. Moreover NK cells are present in human spleen. However their role in ITP has not been studied so far. NK could represent a new target for treatments in ITP. We propose thus to conduct a study to characterizes NK cells changes in patients with ITP.

Eligibility criteria: Inclusion Criteria:

* ITP patients,platelets less than 50000 G/L

Exclusion Criteria:

* Secondary ITP (VIH, VHC...)
* treatment with Immunosuppressive agents except corticoids (10 mg/day)
* treatment with Ig IV less than 3 weeks
* treatment with Rifuximab less than 6 months

Primary outcomes:
measure: Compare NK cells functions, phenotypic changes and transcripts from ITP patients and controls in a case control, multicentric study
timeFrame: 24 months
Secondary outcomes:
measure: Influence of the Ig (IV) treatment on ITP patients' NK cells
timeFrame: 24 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: APHM
Study officials:
affiliation: APHM
name: Schleinitz Nicolas
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01573715: Effects of Neuromuscular Blocking Agents (NMBA) on the Alteration of Transpulmonary Pressures at the Early Phase of Acute Respiratory Distress Syndrome (ARDS)
Official title: Effects of NMBA on the Alteration of Transpulmonary Pressures at the Early Phase of ARDS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Respiratory Distress Syndrome
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2012-04-09
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: Mortality in Acute Respiratory Distress Syndrome is high (40 to 60 %). Protective mechanical ventilation, until 2010, was the cornerstone of the ARDS therapeutic strategies. Recently, a prospective multicenter study demonstrates that a 48h continuous infusion of neuromuscular blocking agents (NMBA) have a positive impact on mortality of ARDS patients. (Papazian et al. ACURASYS Study. NEJM 2010; 363:1107-16). The mechanisms through which NMBAs could improve survival remain speculative. They are as follows:

* reduction of the consumption of oxygen linked to ventilatory workload;
* increase of chest wall compliance improving mechanical ventilation during ARDS and better adaptation to the protective ventilation strategy;
* anti-inﬂammatory effect contributing to a reduction in pulmonary inﬂammation and improvement in oxygenation,
* reduction of the variations of transpulmonary pressure (TPP) by the way of better synchronisation between patient and the ventilator.

The use of NMBA could also reduce the ventilator induced lung injury by a better control of TPP.


Eligibility criteria: Inclusion Criteria:

* Early (\< 48H) Severe ARDS: PaO2 / FiO2 ratio \< 150 with PEEP \>= 5 cmH20

Exclusion Criteria:

Age \< 18 ans Patient already under continuous infusion NMBA. Known NMBA Allergy or intolerance Contra-indication to introduction of nasogastric tube

Primary outcomes:
measure: Delta TPP
timeFrame: 27 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique hôpitaux de Marseille
name: BERNARD BELAIGUES
role: STUDY_DIRECTOR
References:
Clinical trial NCT04762615: Impact of Underlying Renal Disease and Immunosuppressive Regimen on Ovarian Reserve in Renal Patients
Official title: Impact of the Immunosuppressive Treatment, X-ray Exposition and Renal Pathology on Ovarian Reserve in Young Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anti-Mullerian Hormone Deficiency
Immunosuppression
Ovarian Reserve
X-rays; Effects
Keywords: AMH
Immunosuppression
Ovarian Reserve
X-Ray effects
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 153
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Regularly menstruating female patients suffering from renal pathology or after renal transplantation

Brief summary: Aging, renal pathology (eg SLE, ADPKD), X-ray exposition and pharmacological treatments, especially previous strong immunosuppression, may negatively influence the ovarian reserve in childbearing age women. Anti-Müllerian hormone (AMH) is regarded as biomarker for ovarian reserve.

Every female with renal disease regularly menstruating that met exclusion criteria could have participated. The aim was to assess ovarian reserve in female patients with normal menstrual cycle and kidney disease, including kidney transplant recipients.


Eligibility criteria: Inclusion Criteria:

* Conscious written approval
* Autoimmunological disorder with kidneys affection/ kidney transplant recipient- Regular menstrual cycles
* Age above 18 years old

Exclusion Criteria:

* Irregular menstrual cycles
* Menopause
* PCOS
* Chemiotherapy or radiotherapy in the past
* Surgical interventions within ovaries
* Hypogonadotropic hypogonadism
* Folliculoma
* Age under 18 years old

Primary outcomes:
measure: To compare AMH levels between three groups
timeFrame: 1 day
measure: Potential impact of X-ray exposition on ovarian reserve
timeFrame: 1 day
measure: Potential impact of antiproliferative drugs on ovarian reserve
timeFrame: 1 day
measure: Potential impact of underlying kidney disease on ovarian reserve
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Wrocław
country: Poland
facility: Nephrology and Transplantation Clinic University Hospital in Wrocław
Study officials:
affiliation: Wroclaw Medical University
name: Julia Rasała, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02900885: Study of Ocular Torsion in Patients Suffering From Palsy of the Superior Rectus Extraocular Muscle
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Superior Rectus Palsy
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-09-14
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patiente suffering from unilateral muscular palsy of the superior rectus extraocular muscle

Brief summary: Retrospective medical chart and medical imaging file review of patients suffering from palsy of the superior rectus extraocular muscle


Eligibility criteria: Inclusion Criteria:

* Patient with unilateral muscular palsy of the superior rectus muscle
* Patient must have a binocular vision as characterized by Lang test

Exclusion Criteria:

* bilateral impairment of the superior rectus muscle
* presence of an orbital lesion (orbital trauma, tumor or pseudo-tumor)
* thyroid orbitopathy
* No binovular vision

Primary outcomes:
measure: Excyclotorsion of the eye as measured in angle degrees by retinophotography
timeFrame: Within 1 week prior to corrective surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00256685: Study Evaluating DVS-233 SR to Treat Vasomotor Systems Associated With Menopause
Official title: A Double-Blind, Randomized, Placebo-Controlled Efficacy and Safety Study of DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Menopause
Hot Flashes
Sleep Disorders
Keywords: Menopause
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-11-21
Enrollment: 568
Sex: FEMALE
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of desvenlafaxine succinate (DVS) for treatment of moderate to severe vasomotor symptoms (VMS) that are associated with menopause, and also to assess the effects of DVS on sleep parameters and health outcomes indicators.


Eligibility criteria: Inclusion Criteria:

* Generally healthy, postmenopausal women who seek treatment for hot flushes
* Minimum of 7 moderate to severe hot flushes per day or 50 per week recorded for 7 consecutive days during screening
* Body Mass Index (BMI) less than or equal to 40 kg/m2

Other inclusions apply.

Exclusion Criteria:

* Hypersensitivity to Venlafaxine
* History of seizure disorder
* History of myocardial infarction or unstable angina within 6 months

Other exclusions apply.

Primary outcomes:
measure: Reduction in average daily number of moderate & severe hot flushes and average daily severity score at weeks 4 & 12
Secondary outcomes:
measure: Sleep, mood
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00209885: Optimal Multimodal Analgesia in Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cholecystolithiasis
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To test the current standard of care (SOC) treatment for laparoscopic cholecystectomy with a group receiving SOC + additional perioperative analgesics in terms of postoperative abilities, PONV, pain and discharge time from the PACU

Detailed description: Aim of the study: to compare postoperative complaints (PONV, pain, etc) and PACU discharge time between two groups:

* A: standard of care (SOC)receiving intraoperative dexamethasone, ondansetron, ketorolac, and general anaesthesia with propofol, remifentanil and cisatracurium
* B: SOC + preoperative gabapentin, intraoperative lidocain infusion, s-ketamin and droperidol.

Primary endpoints:

* postoperative abilities over time
* discharge time from PACU according to fixed criteria
* consumption of analgesics and antiemetics in the PACU

Secondary endpoints:

* degree of nursing requirements at the PACU
* General tolerability of the regimes

Eligibility criteria: Inclusion Criteria:

* Elective laparoscopic cholecystectomy
* Age above 18 years
* Written informed consent
* ASA class I-III

Exclusion Criteria:

* Planned abdominal cholecystectomy
* Intraoperative conversion of laparoscopic to laparotomic cholecystectomy
* Allergy to part of the treatment regimens
* Previous reactions to opioids (nausea, cognition)

Primary outcomes:
measure: 1. postoperative abilities over time in PACU
measure: 2. discharge time from PACU according to fixed criteria
measure: 3. consumption of analgesics and antiemetics in the PACU
Secondary outcomes:
measure: 1. Degree of nursing requirements in the PACU
measure: 2. General tolerability of the regimens
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dept of Anaesthesia, Hvidovre Hospital
state: Hvidovre
Study officials:
affiliation: Dept of Anaesthesia, Acute Pain Service, Hvidovre Hospital, Copenhagen, Denmark
name: Kenneth Jensen, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of Anaesthesia, Hvidovre Hospital, Copenhagen, Denmark
name: Claus Lund, dr.med.sci
role: STUDY_CHAIR
References: