louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03750240: Metabolic Sodium MRI to Assess Early Response of Breast Cancer to Neoadjuvant Chemotherapy
Official title: Metabolic Sodium MRI to Assess Early Response of Breast Cancer to Neoadjuvant Chemotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Triple Negative Breast Cancer
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2018-11-21
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Neoadjuvant chemotherapy (NACT) is administered to treat invasive breast cancer before surgery. It offers the opportunity to evaluate tumor response to treatment in aggressive disease, and guide additional therapies for patients with inadequate response, if detected early. Investigators propose to develop a sodium breast MRI technique that will allow to assess the early metabolic response of breast cancer to NACT, occurring before late structural changes can be detected with standard MRI.

This study will scan 12 patients using 1H/23Na MRI at 7 T and DCE MRI with triple-negative breast cancer undergoing AC-T therapy (2 months of Adriamycin + Cyclophosphamide, then 3 months of Taxol): at baseline (pre-NACT); after the first AC cycle (2 weeks); after AC treatment (2 months); after complete NACT (5 months, pre-surgery).


Eligibility criteria: Inclusion Criteria:

* Women with no sign of breast cancer as controls
* Non-pregnant and non-lactating
* Ability to understand and willingness to sign a written consent

Exclusion Criteria:

* Contra-indications to MRI (i.e., ferromagnetic prostheses, metallic surgical implants that are not compatible with an MRI machine, claustrophobia etc.)
* Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.
* Pregnant or lactating women, women using hormonal treatment in the 6 months prior to the study.
* Women with history of breast disease, previous breast surgery, or breast implants.
* Patients with a currently active second malignancy other than non-melanoma skin cancers. Patients are not considered to have a currently active malignancy if they have completed therapy and are free of disease for 3 years.
* Psychiatric illness or other conditions and circumstances which could prevent the patient from being compliant with the protocol.

Primary outcomes:
measure: Change in Tumor Size
timeFrame: Baseline, 2 Years
Secondary outcomes:
measure: Total Sodium Concentration (TSC)
timeFrame: Baseline
measure: Intracellular Sodium Concentration (CIC)
timeFrame: Baseline
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Guillaume Madelin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03540940: PEEP During Induction of Anesthesia in Small Children
Official title: The Effect of Positive End-expiratory Pressure During Induction of General Anesthesia on Atelectasis Formation and Non-hypoxic Apnea Time in Small Children: a Randomized Controlled Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Anesthesia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Positive end-expiratory pressure (PEEP) applied during induction of anesthesia prevents atelectasis formation and increases the duration of nonhypoxic apnea in obese and nonobese patients. PEEP also prevents atelectasis formation in pediatric patients. Because pediatric patients arterial desaturation during induction of anesthesia develops rapidly, we studied the clinical benefit of PEEP applied during anesthesia induction.


Eligibility criteria: Inclusion Criteria:

* pediatric patients undergoing general anesthesia using endotracheal intubation

Exclusion Criteria:

* previous history of lung disease
* anticipated difficulty in airway management

Primary outcomes:
measure: Duration of Apnea
timeFrame: from the start of apnea until SpO2 reached 95%, maximum 5 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hee-Soo Kim
state: Soul-t'ukpyolsi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hee-Soo Kim, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim EH, Lee JH, Jang YE, Ji SH, Cho SA, Kim JT, Kim HS. Effect of positive end-expiratory pressure during anaesthesia induction on non-hypoxic apnoea time in infants: A randomised controlled trial. Eur J Anaesthesiol. 2021 Oct 1;38(10):1012-1018. doi: 10.1097/EJA.0000000000001400.
Clinical trial NCT01529840: Somatropin Effect on Linear Growth and Final Height in Subjects With Noonan Syndrome
Official title: Norditropin Treatment in Subjects With Noonan Syndrome. Effects on Linear Growth and Final Height - Data Collection and Follow-up Visit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Genetic Disorder
Noonan Syndrome
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-02-09
Enrollment: 24
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: This trial is conducted in Europe. The aim of this trial is to evaluate the effect of somatropin (Norditropin®) on final height in children with Noonan syndrome having being treated for up to 10 years with somatropin (Norditropin®) for the attainment of an optimal final height in the original trial S/GHD/004/NOO.


Eligibility criteria: Inclusion Criteria:

* Participation in the original S/GHD/004/NOO trial or following the protocol for S/GHD/004/NOO without being randomised in the trial

Primary outcomes:
measure: Change in height SDS (Standard Deviation Score) from start of treatment to final height (referenced to normal population)
Secondary outcomes:
measure: Final height SDS
measure: Change in height SDS from start of treatment to final height (referenced to Noonan population)
measure: Height velocity
measure: Change in height velocity
measure: Sitting height
measure: Number and proportion of subjects with final height SDS above -2 SDS
measure: Adverse events
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Osio D, Dahlgren J, Wikland KA, Westphal O. Improved final height with long-term growth hormone treatment in Noonan syndrome. Acta Paediatr. 2005 Sep;94(9):1232-7. doi: 10.1111/j.1651-2227.2005.tb02081.x.
Clinical trial NCT01122940: Bioequivalence Study Of Phenytoin Suspension Versus Epamin® In 34 Healthy Volunteers.
Official title: Bioequivalence Study Of 10ml Dose Of Phenytoin 0.75g/100ml Suspension Made By Laboratorios Pfizer, S.A. De C.V. Versus Epamin® 0.75g/100ml Made By McNeil LA LLC, Study In 34 Healthy Volunteers Under Fasting Conditions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioequivalence
Phenytoin
Epamin
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-05-13
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Mexican healthy volunteers will receive the current form of the drug (under the name of Epamin) as well as Pfizer's compound (Phenytoin). Bioequivalence will be tested.

Detailed description: Bioequivalence

Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive
* A Body Mass Index (BMI) of 18 to 26.9 kg/m2 or ± 10% variation of the ideal weight; and a total body weight \>50 kg (110 lbs)
* An informed consent document signed and dated by the subject or a legally acceptable representative.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
* Any condition possibly affecting drug absorption (eg, gastrectomy)
* A positive urine drug screen.

Primary outcomes:
measure: To prove the bioequivalence of Phenytoin versus Epamin by measuring; Area under the curve (AUC), Maximum Concentration (Cmax), Time maximum concentration (tmax), Constant of elimination (ke), Elimination half life (t1/2)
timeFrame: April 2010 - May 2010
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: Distrito Federal
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04775940: Use of Perforated Barrier Membranes and IPRF Nano- Micro Sticky Bone
Official title: The Use of Perforated Barrier Membranes and IPRF Nano- Micro Sticky Bone in Horizontal Alveolar Ridge Augmentation - Controlled Clinical and Histomorphometric Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Augmentation
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparing amount of horizontal bone gain 4 months after alveolar ridge augmentation using IPRF Nano- micro Sticky Bone with perforated collagen membrane versus occlusive barrier membrane by :

1. clinical and Radiographic analysis .
2. Histomorphometric analysis .


Eligibility criteria: Inclusion Criteria:

1. Healthy adult patients.
2. Both sex, males and females. 3-Age from 20 - 40 years old. 4-All patients will be free from any systemic diseases as evidenced by Burkett's oral medicine health history questionnaire.

5-Remaining alveolar bone ≥ 8mm vertically and ≤ 4 mm horizontally. 6-Gingival biotype 1-2mm thickness.

Exclusion Criteria:

1. Smokers.
2. Pregnant and breast feeding females.
3. Mentally retarded Patients.
4. Presence of hematologic disease.
5. Previous radiation, chemotherapy, or immunosuppressive treatments.
6. Diabetes mellitus, metabolic bone disease, ongoing treatment with bisphosphonates drugs, or pregnancy.
7. Anticoagulant drugs, Endocarditis risk factors, renal and hepatic failure

Primary outcomes:
measure: Horizontal alveolar bone width in mm
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT05077540: Oxytocin Versus, Sublingual Misoprostol in the Secondary Prevention of Postpartum Hemorrhage After Vaginal Delivery
Official title: The Effect of Oxytocin Versus, Sublingual Misoprostol in the Secondary Prevention of Postpartum Hemorrhage After Vaginal Delivery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Labor Complication
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2021-10-14
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double-blinded a randomized controlled trial
Primary purpose: PREVENTION

Brief summary: Researchers sought to see how oxytocin versus, sublingual misoprostol affected estimated and measured blood loss during vaginal delivery in women who had blood loss \>300 ml .

Detailed description: The greatest cause of maternal mortality globally is postpartum hemorrhage (PPH), which is defined as a blood loss of 500 mL or more after birth. All women giving birth should be given a preventive uterotonic drug, according to the World Health Organization (WHO).

Despite the use of a uterotonic drug as a preventative measure, PPH remains a frequent complication, accounting for one-quarter of all maternal fatalities worldwide. When prophylaxis fails and PPH develops, it is advised that uterotonic medicines be used as first-line therapy. However, it's unclear whether the uterotonic drug is better for treating PPH as first-line therapy.

Eligibility criteria: Inclusion Criteria:

* vaginal birth in women who had blood loss \>300 ml

Exclusion Criteria:

* \<37 weeks of pregnancy,
* genital tract injuries,
* coagulation deficit,
* hypertension, preeclampsia,
* cardiac, renal, or hepatic disease,
* epilepsy,

Primary outcomes:
measure: measured excessive bleeding blood loss ≥ 300 mills after PPH treatment
timeFrame: 24 hours
Secondary outcomes:
measure: change in hemoglobin
timeFrame: 12 hours
measure: need for additional interventions
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06446440: Lap Adhesiolysis in Intestinal Obstruction
Official title: Comperative Study Between Laparoscopic Adhesiolysis Vs Open Adhesiolysis in Adhesive Intestinal Obstruction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adhesions Bowel
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 40
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: Any case of intestinal obstruction and failed medical treatment and for surgery either open or laparoscopic adhesiolysis

Brief summary: Comparison between the results of laparotomy and laparoscopy in adhesive intestinal obstruction and introduce the use of laparoscopy to the emergency setting in Asyut University Hospital.

Detailed description: Adhesive Intestinal obstruction is one of the most common complications after any abdominal surgery.

Adhesions account for 75% of causes of intestinal obstruction. laparoscopic adhesiolysis recently increase in frequency over open adhesiolysis but there is no definit evidence of its superiority. In term of length of hospital stay and morbidity.

adhesive bowel obstruction mainly managed by conservative treatment but some refractory cases needs surgical intervention In this study we will evaluate feasibility and efficacy of using laparoscop in adhesiolysis over open approach .

Eligibility criteria: Inclusion Criteria:

* any male or female above 18 years has adhesive Intestinal obstruction
* patient fulfilled the criteria to participate but operated before time of study if adequate data available
* patient in which conservative management is failed

Exclusion Criteria:

* othe casues of intestinal obstruction (other than adhsions)
* shocked patient
* cardiovascular diseases
* coagulopathy
* liver cirrhosis
* intracranial diseases

Primary outcomes:
measure: Recurrence rate
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
References:
Clinical trial NCT05912140: Assessment of Trunk Aesthetics: Development of a New Tool
Official title: TRACE2: Development of a New Tool for the Evaluation of the Trunk Aesthetics in Patients with Scoliosis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Adolescent Idiopathic Scoliosis
Lead sponsor: Istituto Scientifico Italiano Colonna Vertebrale
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 600
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescent with a diagnosis of scoliosis

Brief summary: Scoliosis is a three-dimensional deformity of the spine and the trunk. TRACE (Trunk Aesthetic Clinical Evaluation) is an aesthetics assessment tool for patients with scoliosis. It has been validated with Rasch analysis is easily usable in daily clinical practice. Despite this tool being more sensitive in detecting changes in aesthetics during treatment compared to other existing ones, its reliability is still low, probably due to the small number of elements that make up the rating scale.

This study aims to develop a new version of the TRACE tool by adding new items. The development of TRACE2 in a Rasch environment will ensure greater sensitivity and specificity of the scale assessment.


Eligibility criteria: Inclusion Criteria:

* diagnosis of scoliosis
* age between 10 and 17 years old
* scoliosis \>10° Cobb
* humps \> 5° ATR

Exclusion Criteria:

* History of spinal surgery
* positive neurological assessment

Primary outcomes:
measure: TRACE2
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: ISICO
state: Mi
Study officials:
affiliation: Istituto Scientifico Italiano Colonna Vertebrale
name: Stefano Negrini, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02413840: Evaluation, Psychological Intervention and Follow-up Study of Anxiety and Depression in Stable COPD Patients
Official title: Evaluation, Psychological Intervention and Follow-up Study of Anxiety and Depression in Stable Chronic Obstructive Pulmonary Disease Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD
Anxiety
Depression
Keywords: COPD
Baduanjin qigong
depression
anxiety
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2015-04-10
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study expect to investigate psychological intervention (Baduanjin qigong) in COPD patients combined with anxiety and/or depression.

Detailed description: Anxiety and depression is one of the most common complications of COPD patients.This research use psychological questionnaires to evaluate the stage of COPD patients with anxiety and/or depression(asymptomatic, subclinical，clinical). The subclinical type will divided into the treatment group of Baduanjin qigong，and the control group. Two groups are all receive the same psychological counseling, the treatment group also receive further treatment of Baduanjin qigong under the guidance of medical staff. The treatment along for 1 year. Two groups were followed up for 2 years, dynamically observe the stage of anxiety and depression,the number of exacerbations,lung function,etc.

Eligibility criteria: Inclusion Criteria:

* Diagnosed of COPD
* In stable phase
* FEV1%predicted \<80.

Exclusion Criteria:

* Cancer
* Severe cerebrovascular disease
* Severe arrhythmia,cardiac insufficiency
* Alzheimer's disease
* Mental illness
* Severe liver disfunction
* Severe renal disfunction
* Physical activity disable.

Primary outcomes:
measure: stage of anxiety and depression ((Hospital Anxiety and Depression Scale)
timeFrame: one year
Secondary outcomes:
measure: the number of acute exacerbations
timeFrame: one year
measure: lung function (pulmonary function test(20 minutes after inhaled 400ug albuterol),the forced expiratory volume in 1 second(FEV1)will be detected)
timeFrame: one year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing institute of respiratory diseases
Study officials:
affiliation: Capital Medical University
name: Ting Yang
role: STUDY_CHAIR
References:
Clinical trial NCT04412967: Nurse-led Placement of Peripheral Venous Catheters in Overweight Patients Using Standard or Dynamic Ultrasound-guided Technique
Official title: A Randomized, Controlled Comparison of Nurse-led Placement of Peripheral Venous Catheters in Overweight Patients Using Standard or Dynamic Ultrasound-guided Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Emergencies
Keywords: Nurse led
Ultrasound
Emergency department
Overweight
Obesity
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 89
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: Overweight and obesity may be associated with difficult intravenous access leading to longer procedure time and more placement attempts of peripheral venous catheters (PVC). Dynamic ultrasound-guided short-axis needle tip navigation (DUST) may facilitate the procedure.

This was a prospective, randomized, non-blinded study to compare time and placement attempts for nurse-led standard (ST) and ultrasound guided PVC placement in 90 emergency patients with a BMI ≥25kg/m2.

Consenting patients were randomized at a 1:1 ratio to receive PVC by either ST or DUST.

Application time was defined as the time from applying stasis to visible blood in the PVC flash-chamber.

No difference in time was found (medians: ST 42 s; DUST 53.5 s, P = 0.535). There were on average 17 % less placement attempts in the DUST-group (median 1 attempt; Q1 = 1 Q3 = 1) compared to the ST-group (median 1 attempt; Q1 = 1 Q3 = 1.5), (p = 0.031). Patients reported no differences in perceived pain (p = 0.955) or perceived satisfaction (p = 0.342). Pain and subcutaneous infiltrations were the only side-effects reported (ST-group 6, DUST-group 5).

DUST does not decrease time to functional PVC but reduces the number of PVC placement attempts in patients with BMI ≥25 kg/m2.


Eligibility criteria: Inclusion Criteria:

* REETS prioritization level of "Orange", "Yellow", "Green" or "Blue"
* 18 years old
* BMI ≥25 Kg/m2
* Need of PVC according to Emergency department guidelines
* Able to give written informed consent

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Life threatening patient status (REETS prioritization level of "Red")
* Immunosuppression
* Pregnant or lactating women
* Blood infections
* Puncture zone skin damaged (burns, eczema, infection)

Primary outcomes:
measure: Time to application
timeFrame: 1 hour
measure: Number of cannulation attempts
timeFrame: 1 hour
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 1 hour
measure: Perceived Pain
timeFrame: 1 hour
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: University Hospital Linköping
state: Östergötland
Study officials:
affiliation: Linkoeping University
name: Daniel Wilhelms, Phd
role: PRINCIPAL_INVESTIGATOR
References: