louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01776502: Evaluation of Non Specific Symptoms and Quality of Life Before and After Surgery for Mild Primary Hyperparathyroidism
Official title: A Prospective, Non Randomized, Open, Multicenter Trial to Evaluate Non Specific Symptoms and Quality of Life (SF 36) Before and After Surgery for Mild Primary Hyperparathyroidism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Hyperparathyroidism
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2013-01-28
Enrollment: 116
Sex: ALL
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A prospective, non randomized, open, multicenter trial to evaluate non specific symptoms and quality of life (SF 36) before and after surgery for mild primary hyperparathyroidism

Brief summary: The purpose of this study is to evaluate the evolution of the non specific symptoms for 116 patients with mild primary hyperparathyroidism before and 3, 6 and 12 months after surgery. A clinical score predicting clinical improvement at one year will be created.


Eligibility criteria: Inclusion Criteria:

* Subjects with known moderate HPTI will be considered for participation.

Patients with sporadic mild HPTI defined by:

* calcemia \> 2.6 mmol/L , PTH \> 25 ng/L and creatininemia \< 160µmol/L OR
* calcemia between 2.5 and 2.6 mmol/L and PTH \> 35 ng/L
* calcemia ≤2.85 mmol/L
* urine calcium level / 24 hours \< 10 mmol (400 mg),
* decrease of the creatinin's clearance : 30% lower than normal population with the same age
* patients younger than 50
* patients who can't be followed

Exclusion Criteria:

* familial hypercalcemia
* multiple endocrinal neoplasia
* treatment with lithium or thiazides
* impossibility for the patient to complete the forms
* impossibility to follow the patient
* patient with serious disease which impact the quality of life

Primary outcomes:
measure: assessment of the evolution of neuropsychic disorders, digestive disorders, asthenia and polydipsia symptoms (non specific symptoms) one year after surgery for patients with moderate HPTI.
timeFrame: one year after surgery
Secondary outcomes:
measure: Evaluation of the quality of life with a quality of life questionnaire (SF36) given preoperatively and at months 3, 6, 12
timeFrame: preoperatively and at months 3, 6, 12
measure: evaluation of the evolution of neuropsychic disorders, digestive disorders, asthenia and polydipsia symptoms (non specific symptoms) at months 3 and 6
timeFrame: at months 3 and 6
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
city: Limoges
country: France
facility: Limoges University Hospital
city: Marseille
country: France
facility: Marseille University Hospital
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Eric MIRALLIE, PU¨-PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00791102: Topical ASP-1001 (Contrast Media Formulation) and the Acute Response to Nasal Allergen Challenge (NAC)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial of Topical ASP-1001 (Contrast Media Formulation) in the Prevention of the Signs and Symptoms of the Acute Response to Nasal Allergen Challenge (NAC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Allergic Rhinitis
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Asphelia Pharmaceuticals
First posted: 2008-11-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see whether ASP-1001 when given as a nasal spray is safe and can reduce the signs and symptoms of allergic rhinitis (hayfever) following nasal challenge with antigen.


Eligibility criteria: Inclusion Criteria:

1. Males and females between 18 and 55 years of age.
2. History of grass and/or ragweed allergic rhinitis.
3. Positive skin test to grass and/or ragweed antigen.
4. Positive response to screening nasal challenge.

Exclusion Criteria:

1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
2. Pregnant or lactating women.
3. Upper respiratory infection or sinusitis within 14 days of study start.
4. Use of nasal steroids, antihistamines in the last 2 weeks.
5. FEV1\<80% of predicted at screening for subjects with history of mild asthma
6. current smokers or recent ex-smokers
7. Any social or medical condition that, in the opinion of the investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Primary outcomes:
measure: Change in Sneezing Symptom
timeFrame: 10 minutes after diluent challenge and 10 minutes after each antigen challenge
measure: Change in Runny Nose Symptom
timeFrame: 10 minutes after diluent challenge and 10 minutes after each antigen challenge
measure: Change in Stuffy Nose Symptom
timeFrame: 10 minutes after diluent challenge and 10 minutes after each antigen challenge
measure: Change in Itching Symptom
timeFrame: 10 minutes after diluent challenge and 10 minutes after each antigen challenge
Secondary outcomes:
measure: Nasal Peak Inspiratory Flow Measurements
timeFrame: 15 minutes after diluent challenge and 15 minutes after each antigen challenge
measure: Change in Nasal Peak Inspiratory Flow Measurements From Before to After Treatment
timeFrame: 15 minutes prior to treatment and 15 minutes post antigen challenges
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: Robert Naclerio, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01183702: Corneal Biomechanics With Hydration in Normal and LASIK Eyes
Official title: Analysis of Corneal Biomechanics Based Upon Central and Peripheral Corneal Thickness in Normal and Post Refractive Surgery Eyes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laser Corneal Surgery
Keywords: LASIK vs. non-LASIK
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2010-08-18
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The research will utilize LASIK and non-LASIK populations to analyze the biomechanical differences between these corneas.

Detailed description: The research will utilize LASIK and non-LASIK populations to analyze the biomechanical differences between these corneas. Subjects' corneas will be swelled with warmed, humidified nitrogen using modified diving goggles to assess structural changes due to a two hour swelling period. Subjects will be examined prior to swelling by a registered ophthalmologist to ensure that the cornea is healthy enough to undergo the swelling procedure. Pre-swelling and post-swelling data will be compared for parameters such as elasticity, density, thickness, axial and tangential curvature, hydration, and intraocular pressure in the central, paracentral, and peripheral regions. Analysis of pre-swelling and post-swelling data will allow for a better understanding of the structural changes created by LASIK. In addition, this project will allow for a better understanding of how common fluctuations in hydration levels affect normal corneal parameters as given by common devices in both populations to allow for corrections for more accurate measurements.

Eligibility criteria: Inclusion Criteria:

* Healthy cornea without LASIK surgery as determined by a registered ophthalmologist.
* Healthy cornea with LASIK surgery as determined by a registered ophthalmologist.

Exclusion Criteria:

* Children under 18.
* Unhealthy cornea as determined by a registered ophthalmologist.

Primary outcomes:
measure: Corneal hydration (swelling)
timeFrame: Two hours
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ophthalmology Department (Gowdy Field Building, 5th Floor)
state: Ohio
Study officials:
affiliation: Ohio State University
name: Deborah M Grzybowski, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00164502: Limb Loss Self-Management Program
Official title: Limb Loss Self-Management Program: "Promoting Amputee Life Skills"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Congenital or Acquired Limb Deficiency
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
First posted: 2005-09-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The goal of the project is to develop and test the efficacy of a community-based self-management intervention for reducing pain, depression, and improving self-efficacy and function in person with limb loss

Detailed description: Approximately 1.2 million Americans are living with the loss of a limb and the incidence is increasing due to increases in the prevalence of diabetes. Pain, emotional distress, reduced functional abilities are common conditions following limb loss and reduce quality of life. Self-management interventions have been found to be effective in reducing the secondary conditions associated with arthritis and diabetes. Self management uses the principles of cognitive-behavioral therapy including education, self monitoring, problem solving, and skill acquisition.

The goal of the project is to develop and test the efficacy of a community based self management intervention for reducing pain, depression, and improving self efficacy and function in persons with limb loss using a randomized controlled design.

50 groups of 8-10 persons will be randomized to either a control group or a treatment group.

Eligibility criteria: Inclusion Criteria:

* age 18 or older congenital or acquired limb loss

Exclusion Criteria:

-

Primary outcomes:
measure: self-reported pain
measure: depressed mood
measure: positive affect
Secondary outcomes:
measure: increase in activities and participation
measure: improved quality of life
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Puget Sound Health Services
state: Washington
Study officials:
affiliation: Johns Hopkins University
name: Ellen MacKenzie, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04180202: Comparison of Non-invasive Vs. Invasive Hemodynamic Measurements
Official title: Comparison Study of EzCVP and CVP
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Heart Failure，Congestive
Lead sponsor: Nihon Kohden
Sponsor class: INDUSTRY
First posted: 2019-11-27
Enrollment: 8
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: Patients admitted to the El Camino Hospital ICU with central venous catheter.

Brief summary: Comparison of a non-invasive method of measuring central venous pressure to the conventional modality of invasive central venous pressure.

Detailed description: The conventional method used to measure central venous pressure has limitations since it is an invasive procedure that requires a central venous catheter. To overcome this challenge, a new technology to assess CVP non-invasively using an oscillometric method is being developed. It is called enclosed zone central venous pressure (ezCVP). A comparison study of ezCVP and CVP is needed to determine accuracy and reproducibility.

Eligibility criteria: Inclusion Criteria:

1. Adult age over 18 years.
2. Arm circumference is 23 cm to 55 cm
3. Subject will have an existing central venous catheter during their ICU stay
4. Subject or legally authorized representative (LAR) is able to understand the risks and potential benefits of participating in the study and is willing to provide written informed consent
5. Subject or LAR is willing and able to comply with protocol procedures

Exclusion Criteria:

1. Finger and/or upper arm anatomical anomaly or disease that may interfere with attaching a pulse oximeter sensor and/or blood pressure cuff.
2. Pregnant (self-reported)
3. Upper extremity deep venous thrombosis currently being treated
4. Severe skin disease involving the upper arm(s)
5. Study investigator may exclude patients based on clinical judgement

Primary outcomes:
measure: Non-invasive pressure indicator
timeFrame: 12-72 hours
Secondary outcomes:
measure: Direction of change
timeFrame: 12-72 hours
measure: Correlation with invasive CVP
timeFrame: 12-72 hours
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: El Camino Hospital
state: California
Study officials:
affiliation: Palo Alto Foundation Medical Group
name: Zachary Edmonds, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01107002: Comparison of 5 Day Embryo Transfer With 2-3 Day Transfer in Patients With Previous In Vitro Fertilization Failure
Official title: Comparison of 5 Day Embryo Transfer With 2-3 Day Transfer in Patients Who Failed to Conceive in Two or More Day 2-3 Embryo Transfer Cycle in Royan Institute
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Infertility
Keywords: infertility
Embryo transfer
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2010-04-20
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether embryo transfer on day 3 versus day 5 shows a significant difference in implantation, clinical pregnancy, live birth, miscarriage and multiple pregnancy rates among women with at least two previous IVF failures

Detailed description: A total of 200 infertile women with at least two previous IVF failures will enroll in this prospective randomized clinical trial study and will randomly be divided into two groups. Random permuted blocks with a block size of 4 will be used to ensure randomization and complete allocation concealment.

The study protocol will be assessed by an independent institutional review board and Royan ethics committee.

Ovarian stimulation protocol will include the use of a GnRH agonist (Superfact; Aventis Pharma Deutshlan, Frankfurt, Germany) administered in the long (down-regulation) protocol and the subsequent addition of FSH (Gonal F, Sereno, Switzerland). Embryos will be initially cultured in G1.V5 medium) Vitrolife-Sweden)TM on day 1 and 2, being transferred from this medium to G2.V5 ) Vitrolife-Sweden)TM on day 3. Embryos will be transferred on day 5, depending on the degree of expansion of the blastocyst.

Main outcome measures will be implantation, clinical pregnancy and live birth rates.

Eligibility criteria: Inclusion Criteria:

* Age fewer than 40
* Normal uterine cavity and patent tubes by either hysterosalpingogram or laparoscopy and hysteroscopy
* Two previous or more failed IVF/ICSI cycles

Exclusion Criteria:

* Women with submucous myoma
* Women with intra mural or subserous myoma greater than 3 cm
* Women with Endometriosis or Endometrioma
* Hydrosalpinx

Primary outcomes:
measure: Clinical Pregnancy rate
timeFrame: 6-8 weeks after oocyte retrieval
measure: Live birth rate
timeFrame: After 37 weeks of gestational age
Secondary outcomes:
measure: Implantation rate
timeFrame: 4 weeks after embryo transfer
measure: Miscarriage rate
timeFrame: 18 weeks after fertilization
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: Royan Institute
name: Mahnaz Ashrafi,, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00055302: Arimidex in McCune Albright Syndrome
Official title: An Open-label Study Evaluating the Safety and Efficacy of Anastrozole™ (ARIMIDEX) in the Treatment of Precocious Puberty in Girls With McCune-Albright Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: McCune-Albright Syndrome
Keywords: vaginal bleeding
advanced bone age
fibrous dysplasia
MAS
McCune-Albright Syndrome
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2003-02-26
Enrollment: 40
Sex: FEMALE
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the safety and efficacy of anastrozole 1 mg given once daily in subjects with McCune-Albright Syndrome.


Eligibility criteria: Inclusion Criteria:

* informed written consent of parent/legal guardian and subject assent (as needed by local requirements)
* females less than or equal to 10 years of age
* diagnosed with McCune-Albright Syndrome
* have progressive precocious puberty

Exclusion Criteria: Any one of the following is regarded as a criterion for exclusion from the study:

* any prior treatment of MAS associated with progressive precocious puberty with a third generation aromatase inhibitor (anastrozole, letrozole, exemestane) in which no clinical response was seen
* concomitant treatment of precocious puberty associated with MAS, with the exception of bisphosphonates for polyostotic fibrous dysplasia and LHRH analogues in the case of central precocious puberty
* liver function tests at screening visit (AST, ALT) \> or = 3x the upper limit of the reference range for age
* known hypersensitivity to any component of study medication

Primary outcomes:
measure: The efficacy of study treatment will be assessed based on the change from baseline measurements relating to vaginal bleeding, bone age, and growth velocity
timeFrame: 12 months or until the subject demonstrates the lack of efficacy bases upon progression of primary endpoints or experiences serious drug-related toxicity requiring withdrawal
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Erlangen
country: Germany
facility: Research Site
city: Osnabrück
country: Germany
facility: Research Site
city: Torino
country: Italy
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Arimidex Medical Science Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03557502: Heat Therapy Versus Exercise Training in Hypertension
Official title: Heat Therapy Versus Exercise Training in Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Cardiovascular Diseases
Arterial Hypertension
Keywords: Stage 1 hypertension
Arterial Stiffness
Lead sponsor: University of Oregon
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
First posted: 2018-06-15
Enrollment: 44
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized parallel study design
Primary purpose: PREVENTION

Brief summary: This is a clinical trial to determine whether 30 sessions of heat therapy in the form of hot water immersion is better than 30 sessions of traditional aerobic exercise training on blood pressure reduction in people with elevated or Stage 1 hypertension.

Detailed description: Hypertension accounts for more cardiovascular disease related deaths than any other modifiable risk factor. While exercise training can be effective at reducing blood pressure in some individuals, many people do not respond to exercise training, and many more are unwilling to undergo regular exercise training. Alternative options need to be explored. This is a clinical trial to determine whether 30 sessions of heat therapy in the form of hot water immersion is better than 30 sessions of traditional aerobic exercise training on blood pressure reduction in people with elevated blood pressure (hypertension). The investigators will evaluate known biomarkers of cardiovascular health. It is hypothesized that heat therapy will be superior to exercise training on blood pressure reduction.

Eligibility criteria: Inclusion Criteria:

* Systolic Blood Pressure 120 mmHg or greater and less than 180 mmHg or Diastolic Blood Pressure of 80mmHg or greater and less than 120mmHg

Exclusion Criteria:

* Secondary hypertension; diagnosed cardiovascular disease other than hypertension; taking anti-hypertensive drugs; BMI of 35 or greater; fasting glucose greater than 125 mg/dl; women who are pregnant, nursing, or desiring to become pregnant.

Primary outcomes:
measure: Blood Pressure Reduction: Change in Systolic and Diastolic Ambulatory Blood Pressure (mmHg) After 30 Sessions of Intervention
timeFrame: 10 weeks
Secondary outcomes:
measure: Arterial Stiffness: Change in Carotid-femoral Pulse Wave Velocity (m/s) From Pre (Baseline) to Post (After 30 Sessions of Intervention)
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Eugene
country: United States
facility: University of Oregon
state: Oregon
Study officials:
affiliation: University of Oregon
name: Christopher T Minson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04078802: 0050-19-RMB CTIL - VNOTES Compared to VH for Vaginal Apex Prolapse
Official title: Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) Compared With Traditional Vaginal Utero-sacral Ligament Suspension for Vaginal Apex Prolapse
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vaginal Prolapse
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 60
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: VNOTES (Transvaginal natural orifice transluminal endoscopic surgery) is a relatively new surgery for Hysterectomy and Uterosacral ligament suspension to treat Vaginal prolapse. The investigators wish to run a randomized control trial comparing it to classic Vaginal hysterectomy for the same indication.

Detailed description: The investigators will recruit 60 women with indication for surgery to treat uterine prolapse. 30 women will undergo VNOTES surgery and 30 women will undergo classic vaginal hysterectomy. The investigators will compare outcomes of the surgeries such as surgery time, bleeding and clinical outcomes after 3 and 6 months post operation.

Eligibility criteria: Inclusion Criteria:

* women with vaginal prolapse
* capable of having a surgery - assessed by an anesthesiologist
* women who approve of having the surgery

Exclusion Criteria:

* BMI over 40
* women who have recurrent PID (pelvic inflammatory disease)
* women with oncology records

Primary outcomes:
measure: surgery time
timeFrame: from admission up to 6 hours post operation
Secondary outcomes:
measure: bleeding
timeFrame: from admission up to 6 hours post operation
measure: hospital days
timeFrame: from admission up to 96 hours post operation
measure: PISQ12 score - Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire
timeFrame: from admission up to 6 hours post operation
measure: PFDI score - Pelvic Floor Disability Index
timeFrame: from admission up to 6 hours post operation
Other outcomes:
Locations:
Study officials:
affiliation: Rambam Health Care Campus
name: Omer Mor, MD
role: PRINCIPAL_INVESTIGATOR
References: