louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00391781: Warm Contrast Media for Pain Reduction During Hystersalpingography
Official title: Prospective Randomised Controlled Trian of Warmed vs. Room Temperature Contrast Media for Hystersalpingography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Keywords: mechanical infertility
hysterosalpingogram
hysterosalpingography
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2006-10-24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare between body-temperature to room-temperature contrast media used during hysterosalpingography. We hypothesize that warmed medium will reduce pain associated with the procedure.

Detailed description: Infertility occurs in about 15% of all couples. One of the common methods for evaluation of mechanical infertility is hysterosalpingography (HSG). Several reports have shown that this common procedure is associated with moderate pain, i.e. around 5 on a visual analog scale (VAS)of 1-10. It is therefore important to find modes for pain reduction for HSG. According to a report on sonohydrosonograpy, a similar technique using sonography, insertion of media warmed to body temperature into the uterus significantly reduced the pain during the procedure compared with media at room-temprature. The use of room-temperature media is the routine in our institution, as well as in many others. A comparison between the media at different temperatures has not been reported so far.

We plan to perform a prospective trial in which patients referred for HSG will be randomized to the procedure using either warmed or room-temperature media. we will asses pain levels using VAS during the procedure.

Eligibility criteria: Inclusion Criteria:

* Diagnosis: infertility
* sex: female
* age: 18-45

Exclusion Criteria:

* active pelvic inflammotory disease
* known sensitivity to contrast medium

Primary outcomes:
measure: Pain level
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: women's health center, Ramot Eshkol
Study officials:
affiliation: Shaare Zedek Medical Center
name: Avi Tsafrir, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nirmal D, Griffiths AN, Jose G, Evans J. Warming Echovist contrast medium for hysterocontrastsonography and the effect on the incidence of pelvic pain. A randomized controlled study. Hum Reprod. 2006 Apr;21(4):1052-4. doi: 10.1093/humrep/dei440. Epub 2005 Dec 22.
Clinical trial NCT01967381: Targeting GABA and Opioid Systems for a Pharmacotherapy for Methamphetamine Abuse
Official title: Targeting GABA and Opioid Systems for a Pharmacotherapy for Methamphetamine Abuse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Methamphetamine Abuse
Methamphetamine Dependence
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2013-10-22
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The research proposed in this application will determine the initial efficacy, safety and tolerability of a novel drug combination, oxazepam (Serax®) and naltrexone (Revia®), as a pharmacotherapy for methamphetamine (Desoxyn®) dependence. A rigorous, inpatient human laboratory study will be conducted. The proposed study is innovative and important because it will provide the impetus for the conduct of double blind, placebo-controlled trials to further demonstrate the efficacy of combined oxazepam and naltrexone for managing methamphetamine dependence.


Eligibility criteria: Inclusion Criteria:

* Lifetime methamphetamine use

Exclusion Criteria:

* Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant
* Current or past histories of substance abuse or dependence that are deemed by the study physicians to interfere with study completion
* History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation
* Females not currently using effective birth control
* Contraindications to methamphetamine (Desoxyn®), oxazepam (Serax®) or naltrexone (Revia®)

Primary outcomes:
measure: Reinforcing Effects
timeFrame: After at least four days of placebo, oxazepam (Serax®), naltrexone (Revia®) or oxazepam and naltrexone maintenance
Secondary outcomes:
measure: Subjective Effects
timeFrame: 12 sessions over approximately 4 week inpatient admissions
measure: Physiological and Side Effects
timeFrame: Daily over approximately 4 week inpatient admissions
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
Study officials:
References:
Clinical trial NCT04112381: Bilateral Treatment of Medication Refractory Essential Tremor
Official title: A Pivotal Clinical Trial to Evaluate the Safety and Efficacy of Staged Bilateral Exablate Treatment of Medication Refractory Essential Tremor
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Essential Tremor
Lead sponsor: InSightec
Sponsor class: INDUSTRY
First posted: 2019-10-02
Enrollment: 51
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if the MR-guided focused ultrasound (MRgFUS) thalamotomy procedure can be performed on both sides of the brain safely and effectively to reduce bilateral tremor.


Eligibility criteria: Inclusion Criteria:

1. Men and women age 22 years or older
2. Diagnosis of medication-refractory Essential Tremor
3. Has previously underwent an Exablate index procedure in a clinical trial or in a commercial setting at least 9 months prior to enrolling in this trial
4. Able to communicate sensations during the Exablate thalamotomy procedure

Exclusion Criteria:

1. Has experienced any non-transient neurological event or worsening following the Exablate index procedure
2. Presence of unknown or MR unsafe devices anywhere in the body
3. Non-transient hemiparesis as determined by physical examination
4. Clinically significant abnormal speech function as determined by a speech pathologist
5. Pregnant or breastfeeding
6. Unstable cardiac status
7. Behavior(s) consistent with ethanol or substance abuse
8. History of bleeding disorder
9. Has received anticoagulants within one month of Exablate procedure
10. Cerebrovascular disease
11. Intracranial tumor
12. Active or suspected acute or chronic uncontrolled infection
13. Has previously had deep brain stimulation or a prior stereotactic ablation of the basal ganglia or thalamus
14. Implanted objects in the skull or the brain
15. Currently in a clinical trial involving an investigational product or non-approved use of a drug or device or in any other type of medical research
16. Unable to communicate with the investigator and staff

Primary outcomes:
measure: Device and procedure related adverse events
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University, School of Medicine
state: California
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Columbus
country: United States
facility: The Ohio State University - Wexner Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
References:
Clinical trial NCT00130481: Pediatric Atorvastatin in Diabetes Intervention Trial (PADIT)
Official title: Pediatric Atorvastatin in Diabetes Intervention Trial (PADIT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
Keywords: Diabetes
Children
Adolescents
Arterial Compliance
Physiology Cardiovascular Endothelium
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2005-08-15
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if Atorvastatin can improve blood vessel stiffness and blood vessel function in children 10-18 years old with Type 1 and Type 2 diabetes. Subjects will receive atorvastatin 20mg or placebo daily for 3 months and will then switch therapies for the next 3 months.

Hypothesis: Atorvastatin will improve blood vessel function by decreasing arterial stiffness and improving blood flow.


Eligibility criteria: Inclusion Criteria:

* Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM) for more than 1 year
* Age 10-18 years.

Exclusion Criteria:

* Cardiovascular disease (CVD)
* Liver disease
* Pregnancy
* Use of cholesterol or triglyceride lowering drugs
* Perceived inability to comply with the study protocol
* Endocrinopathy other than diabetes

Primary outcomes:
measure: Augmentation Index (arterial stiffness)
measure: ENDO-PAT (Peripheral Arterial Tone) score (endothelial function)
measure: Low density lipoprotein
Secondary outcomes:
measure: Urine microalbumin
measure: Pubertal stage
measure: Body mass index (BMI)
measure: Blood pressure
measure: Glycated hemoglobin (HbA1c)
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Michael J Haller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haller MJ, Samyn M, Nichols WW, Brusko T, Wasserfall C, Schwartz RF, Atkinson M, Shuster JJ, Pierce GL, Silverstein JH. Radial artery tonometry demonstrates arterial stiffness in children with type 1 diabetes. Diabetes Care. 2004 Dec;27(12):2911-7. doi: 10.2337/diacare.27.12.2911.
citation: Haller MJ, Stein JM, Shuster JJ, Theriaque D, Samyn MM, Pepine C, Silverstein JH. Pediatric Atorvastatin in Diabetes Trial (PADIT): a pilot study to determine the effect of atorvastatin on arterial stiffness and endothelial function in children with type 1 diabetes mellitus. J Pediatr Endocrinol Metab. 2009 Jan;22(1):65-8. doi: 10.1515/jpem.2009.22.1.65.
Clinical trial NCT06001281: Predictive Value of Soluble CD146 in Glioblastoma Patients
Official title: Predictive Value of Soluble CD146 in Patients With Recurrent Glioblastoma Treated by Bevacizumab
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glioblastoma
Keywords: glioblastoma
CD146
bevacizumab
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 55
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: Glioblastoma is the most common malignant primary brain tumor with poor prognosis because of its diffusive and infiltrative nature. The FDA approved the use of the anti-VEGF antibody bevacizumab in recurrent GBM. However, resistance to this anti-angiogenic reagent is frequent and fails to enhance patients' overall survival. The investigators previously identified one novel mechanism responsible for bevacizumab-resistance in CD146-positive glioblastoma (Joshkon et al. Acta Neuropathol Commun, 2022).

Now, the investigators objective is to prospectively monitor the soluble CD146 value in plasma from patients treated by bevacizumab for recurrent glioblastoma.

The investigators will collect plasma at baseline, before the first bevacizumab administration, before the second administration, at the time of first MRI evaluation and at progression. Plasma CD146 value will be analyzed by ELISA.

The investigators expect to confirm the correlation between soluble CD146 value in plasma and patient response to bevacizumab.


Eligibility criteria: Inclusion Criteria:

* - Adult patients with recurrent IDHwt glioblastoma
* Relapse after standard first line treatment (radio-chemotherapy)
* Candidate for bevacizumab treatment
* Able to be monitored by MRI
* KPS ≥ 60%
* Written signed consent form

Exclusion Criteria:

* Pregnancy or breast feeding
* Life expectancy less than 3 months
* Bevacizumab in first line treatment
* Other concomitant life-threatening disease
* Under legal protection

Primary outcomes:
measure: correlation between soluble CD146 plasma value and patient response (RANO)
timeFrame: first evaluation (2 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Service de Neuro-oncologie
Study officials:
affiliation: AP-HM
name: Emeline Tabouret
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03788681: Luteal Phase Support With Estradiol In Poor Responders Undergoing In Vitro Fertilization
Official title: Luteal Phase Support With Estradiol In Poor Responders Undergoing In Vitro Fertilization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: ICSI
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-12-27
Enrollment: 170
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The role of progesterone (P) supplementation in the luteal phase of in vitro fertilization (IVF) cycles is well established world-wide , but the influence of the luteal phase estradiol level on implantation is not clearly defined . There is a significant difference in estradiol levels between fertile and infertile cycles of fertile women who underwent donor insemination.


Eligibility criteria: Inclusion Criteria:

* Participants included in this study will have the following criteria : ( 2 of 3 criteria )

  1. advanced maternal age or any other risk factor for POR :

     1. Age ≥35 years
     2. other risk factor of poor responder : ovarian surgery especially in case of endometrioma , chemotherapy, radiotherapy, autoimmune disorders, single ovary, chronic smoking, and unexplained Infertility.
  2. previous poor ovarian response : Number of oocytes at the pickup time 3 or less .
  3. Abnormal ovarian reserve tests :

     1. FSH ≥12 mIu/ml in the early follicular phase .
     2. Estradiol level more than 70 pg/dl in the early follicular phase
     3. Anti-Mullerian hormone (AMH) below 0.5-1.1 ng/ml.
     4. Antral follicle count (AFC) \< 5-7 follicles .

Exclusion Criteria:

1. Age \>35 with good ovarian response .
2. any intra-uterine pathology can affect receptivity , ( for example ; Sub-mucosal fibroid , intra-uterine adhesions ).
3. Severe male factor infertility.
4. Extended endometriosis (stage 3 or more) .
5. All contraindications for estradiol : venous thrombo-embolism , stroke and breast cancer

Primary outcomes:
measure: live birth rate
timeFrame: at least 28 weeks after ET
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AinShams university maternity hospital
state: Abbassya
Study officials:
References:
Clinical trial NCT00931281: Study in Healthy Adults to Evaluate Pharmacokinetics, Safety and Tolerability of ABT-450 With Ritonavir
Official title: A Blinded, Randomized, Nonfasting, Placebo-Controlled Study in Healthy Adults to Evaluate Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Ascending Doses of ABT-450 With Ritonavir
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HCV Infection
Keywords: Multiple Ascending Doses
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2009-07-02
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of multiple doses of an experimental hepatitis C virus (HCV) protease inhibitor with ritonavir in healthy volunteers.

Detailed description: This is a multiple ascending dose, non-fasting, open label, randomized study.

Eligibility criteria: Inclusion Criteria:

* overall healthy subjects
* non-childbearing potential females included

Exclusion Criteria:

* history of significant sensitivity to any drug
* positive test for HAV IgM, HBsAg, anti-HCV Ab or anti-HIV Ab
* history of gastrointestinal issues or procedures
* history of seizures, diabetes or cancer (except basal cell carcinoma)
* clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder
* use of tobacco or nicotine-containing products within the 6-month period prior to study drug administration
* donation or loss of 550mL or more blood volume or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration
* abnormal screening laboratory results that are considered clinically significant by the investigator
* current enrollment in another clinical study
* previous enrollment in this study
* recent (6-month) history of drug/alcohol abuse that could preclude adherence to the protocol
* pregnant or breastfeeding female
* requirement for any OTC and/or prescription medication, vitamins and/or herbal supplements on a regular basis

Primary outcomes:
measure: Pharmacokinetics (blood draws, pre- and post-dose)
timeFrame: 17 days
measure: Safety and Tolerability (ECGs, AEs, vitals, physical exams, routine labs)
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Waukegan
country: United States
facility: Site Reference ID/Investigator# 18161
state: Illinois
Study officials:
affiliation: Abbott
name: Isabelle A Gaultier, M.S., IBMH
role: STUDY_DIRECTOR
References:
Clinical trial NCT03718481: Perceptions of the Annual Review of Competence Progression (ARCP) in Surgical Training in the UK and Ireland
Official title: Perceptions of the Annual Review of Competence Progression (ARCP) in Surgical Training in the UK and Ireland: A Prospective Cross-Sectional Questionnaire Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Education, Medical
Keywords: ARCP
Surgical Training
Assessment
Qualitative
Lead sponsor: University College Hospital Galway
Sponsor class: OTHER
Collaborators: name: The Association of Surgeons in Training
First posted: 2018-10-24
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Surgical Trainees in the UK and Ireland who are members of ASiT

Brief summary: A Prospective Cross Sectional Questionnaire Study was conducted to evaluate surgical trainees' experiences of the ARCP process in order to identify areas for improvement.

Detailed description: Background: Surgical trainees in the UK and Ireland undergo rigorous formative and summative assessments throughout each placement and appraisal at an Annual Review of Competence Progression (ARCP). The ARCP evaluates performance during each training year and determines progression to the next year of training. It is critical that the ARCP is a robust and fair process. The Association of Surgeons in Training (ASiT) sought to evaluate surgical trainees' experiences of the ARCP process in order to identify areas for improvement.

Methods: A Prospective Cross-Sectional Questionnaire Study was conducted An electronic survey was developed and distributed electronically to the trainee membership of ASiT in the UK and Republic of Ireland. A 57 point survey examined the specifics of one ARCP cycle as well as attitudes to the process in general. Quantitative analysis was performed, along with thematic analysis on the free-text comments.

Eligibility criteria: Inclusion Criteria:

* Must be a trainee member of ASiT
* All grades, Deaneries, including less than full-time/academic trainees are eligible for inclusion

Exclusion Criteria:

• Student members are excluded

Primary outcomes:
measure: Experiences of Annual Review of Competence and Progression
timeFrame: Oct 2017-March 2018
Secondary outcomes:
measure: Face to Face
timeFrame: Oct 2017- March 2018
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Association of Surgeons in Training
Study officials:
affiliation: The Association of Surgeons in Training
name: Deirdre Nally, MCH
role: PRINCIPAL_INVESTIGATOR
References: