louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04554511: Prognostic Nomogram of Extranodal NK/T-cell Lymphoma
Official title: Prognostic Nomogram of Extranodal NK/T-cell Lymphoma: A Multi-center Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Extranodal NK/T-cell Lymphoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1. Patients diagnosed with ENKTL, between January 1, 2000 and August 31, 2020;
2. Patients older than 18 years.

Brief summary: This study aims to evaluate prognostic factors for overall survival and explore risk progression-free survival in ENKTL, and establish a prognostic predictive nomogram for ENKTL patients.

Detailed description: This is a retrospective cohort study using anonymized information from patients with ENKTL. The following criteria are required: (1) Patients diagnosed with ENKTL between January 1, 2000 and August 31, 2020; (2) Patients older than 18 years. The pathology of initial diagnosis was reviewed by designated pathologists.

Eligibility criteria: Inclusion Criteria:

* Patients newly diagnosed with ENKTL
* Patients diagnosed between January 1, 2000 and August 31, 2020
* Patients older than 18 years

Exclusion Criteria:

* Patients who did not have complete clinical information or immunohistochemistry, or who were lost follow-up immediately after treatment.

Primary outcomes:
measure: Overall survival
timeFrame: 5 year
Secondary outcomes:
measure: Progression-free survival
timeFrame: 5 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Hua Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01957111: Metabolomics of Insomnia-Related Hyperarousal
Official title: Metabolomics of Insomnia-Related Hyperarousal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Insomnia
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2013-10-08
Enrollment: 32
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with primary insomnia (n=15) and matched good sleepers (n=15)

Brief summary: Individuals with insomnia have been shown to have higher overall metabolic rates compared to good sleepers, but it is not known which metabolic processes are involved. The goal of this study is to compare a wide array of metabolic processes in 15 people with insomnia and 15 good sleepers. We hypothesize that there will be distinct metabolic processes that are functioning differently in those with insomnia.


Eligibility criteria: Inclusion Criteria:

Criteria for primary insomnia:

* subjective complaint of difficulty initiating or maintaining sleep, waking up too early or nonrestorative sleep
* daytime consequences as a result of the poor sleep
* duration of at least 1 month
* sleep disturbance is not secondary to a medical or psychiatric condition

Criteria for good sleepers:

-subjective report of consistent good sleep

Exclusion Criteria:

* significant medical or psychiatric illness
* diagnosis of a sleep disorder other than insomnia
* women who have been pregnant or lactating in the past 6 months
* non-fluency in spoken or written English
* Current shift work defined as working during the evening or night shift
* Current use of medications that affect sleep
* BMI \>27

Primary outcomes:
measure: Number of Metabolites Elevated Relative to the Other Group.
timeFrame: 48 hours
Secondary outcomes:
measure: Sleep Efficiency Percentage on Overnight Sleep Study
timeFrame: 1 night
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Philip Gehrman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gehrman P, Sengupta A, Harders E, Ubeydullah E, Pack AI, Weljie A. Altered diurnal states in insomnia reflect peripheral hyperarousal and metabolic desynchrony: a preliminary study. Sleep. 2018 May 1;41(5):zsy043. doi: 10.1093/sleep/zsy043.
Clinical trial NCT00954811: Luteal Supplementation With Rec-LH After GnRH-agonist Triggering in In Vitro (IVF)
Official title: A Phase IV Study on the Effect of Luteal Supplementation With Rec-LH on the Pregnancy Rate After Ovulation Triggering With GnRH-agonist Instead of HCG in IVF Protocol;Proof of Concept
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pregnancy
Pregnancy Loss
Keywords: pregnancy
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
Collaborators: name: Merck Serono International SA
First posted: 2009-08-07
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our aim is to access whether we can achieve equivalent pregnancy rates by the addition of six doses of luteal support with recLH after agonist triggering for IVF cycles in the absence of OHSS.

Detailed description: Whether pregnancy outcome after GnRH-agonist triggering could be improved by adding luteal recLH support plus progesterone, compared to that observed after ovulation triggering with HCG in GnRH antagonist stimulated cycles.

Eligibility criteria: Inclusion Criteria:

* \< 36years,
* single blastocystET,
* FSH \< 12

Exclusion Criteria:

* endometriosis,
* 3 and 4,
* pco,
* frozen sperm

Primary outcomes:
measure: pregnancy occurrence, pregnancy loss
timeFrame: 14 days after OPU
Secondary outcomes:
measure: hormone levels, OHSS, endometrium
timeFrame: 14 days after oocyte pick up
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Centre for Reproductive Medicine, UZ Brussel
state: Jette
Study officials:
affiliation: Professor or OB-GYN
name: Paul Devroey
role: STUDY_CHAIR
References:
Clinical trial NCT01512511: Comparing Nitrous Oxide and Carbon Dioxide for Laparoscopic Cholecystectomy
Official title: Prospective Randomized Trial Comparing Nitrous Oxide and Carbon Dioxide for Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumoperitoneum
Keywords: laparoscopic cholecystectomy
pneumoperitoneum
nitrous oxide
carbon dioxide
Lead sponsor: Ahvaz Jundishapur University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-01-19
Enrollment: 64
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: There is no general agreement about the ideal gas for pneumoperitoneum. CO2, now in common use, has not compared to N2O sufficiently to disclose which one has minimal "physiological" invasiveness characters. Assigned randomly to carbon dioxide or nitrous oxide group, the hemodynamic and respiratory parameters (heart rate, mean arterial blood pressure, end-tidal CO2, minute ventilation, and O2 saturation) before pneumoperitoneum and during it were recorded. Pain, as perceived by patients, is measured 2, 4 and 24 hours after the procedure by visual analogue scale. Vomiting and use of analgesics and antiemetics were recorded and compared.


Eligibility criteria: Inclusion Criteria:

* developed gallstones
* candidates for laparoscopic cholecystectomy
* written informed consent
* ASA Score = 1\&2

Exclusion Criteria:

* signs and complications of gallstones in admission include acute cholecystitis and suppurative cholangitis
* complete Inability to move
* severe physical or mental disorders leading to inability to communicate -Pregnancy and
* cancer

Primary outcomes:
measure: heart rate
timeFrame: At the start of laparoscopic surgery and Immediately after surgery.
Secondary outcomes:
measure: Mean arterial pressure
timeFrame: At the start of laparoscopic surgery and Immediately after surgery.
Other outcomes:
Locations:
city: Ahvaz
country: Iran, Islamic Republic of
facility: Ahvaz jundishapur university of medical sciences; Razi Hospital
state: Khuzestan
Study officials:
affiliation: Ahvaz Jundishapur University of Medical Sciences
name: Mehdi Asgari, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00181311: Investigation of the Incidence of Complications After Vaginal and Abdominal Hysterectomy
Official title: Prospective Investigation of the Incidence of Complications After Vaginal and Abdominal Hysterectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hysterectomy
Keywords: vaginal hysterectomy
abdominal hysterectomy
complications
physical well being
mental well being
Lead sponsor: Maasland Hospital
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The purpose of this study is to evaluate the short and long term complications after an abdominal or vaginal hysterectomy and to detect the prevalence of occult/subclinical haematomas and vaginal cuff abscesses and the postoperative course of these.

The investigators will also evaluate the physical and mental well being after a hysterectomy with a questionnaire and correlate these results with the occurrence of complications.

Detailed description: Hysterectomy is the most common major gynaecological operation performed worldwide.

The overall average rate of hysterectomy in the United States is 5.6 per 1000 women. There are three different procedures to perform a hysterectomy. The surgery can be approached abdominally, vaginally or as a laparoscopically assisted hysterectomy.

This study will contribute to the improvement of knowledge in short and long term complications and especially the prevalence of occult and subclinical haematomas and vaginal abscesses after abdominal or vaginal hysterectomy. The occurrence of short and long term complications will have an influence on the general well being of the patient. We will also evaluate the physical and mental well being of the patient after a hysterectomy.

After statistical analysis of the study outcome parameters, some conclusions can be drawn for the treatment policy after an abdominal or vaginal hysterectomy to reduce the complication rate and improve the general well being of our patients.

Eligibility criteria: Inclusion Criteria:

* Benign indication for undergoing of a hysterectomy
* Written informed consent of the patient

Exclusion Criteria:

* Inability to undergo an operation due to high surgical or anaesthetic risk
* Malignancy as indication for the hysterectomy
* Patients with an enterocele or rectocele and who need prolapse surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sittard
country: Netherlands
facility: Maasland Hospital
state: Limburg
Study officials:
affiliation: Maasland Hospital
name: Erik Jan Sollie, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01779011: Monitoring and Treatment of Extremity Trauma for Mass Casualties in Difficult Contexts
Official title: Suivi et Traitement du Traumatisme Des Membres en Cas d'Afflux Massif de blessés Dans Les Contextes Difficiles
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wounds and Injuries
Traumatic Amputation
Lead sponsor: Alliance for International Medical Action
Sponsor class: OTHER
Collaborators: name: Lille Economie Management UMR CNRS 8157
name: National Research Agency, France
First posted: 2013-01-29
Enrollment: 305
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited by phone from databases issued by:

* A surgical clinic, The Clinique Lambert (Pétion-Ville, Haiti),
* Two non-governmental organizations

  * Handicap International (HI)
  * Bangladesh Rural Advancement Committee (BRAC),
* A local organization l'Union des Jeunes Victimes du Séisme (UJVS)

Brief summary: The prospective cohort study, SuTra2, assesses the functional and socio-economic status of patients who were operated on for a severe limb injury resulting in amputation or limb preservation 1 and 2 years after the 2010 Haiti earthquake.


Eligibility criteria: Inclusion Criteria:

* Patients, with limb injuries due to the earthquake,
* Who underwent limb surgery, which ended up in limb amputation or limb conservation.

Exclusion criteria :

* Limb injury not related to the earthquake
* No surgery for the limb injury

Primary outcomes:
measure: Patient Satisfaction with Musculoskeletal functional recovery
timeFrame: 2 years
Secondary outcomes:
measure: Employment status
timeFrame: 2 years
Other outcomes:
Locations:
city: Port-au-Prince
country: Haiti
facility: ALIMA
Study officials:
affiliation: Alliance for International Medical Action
name: Marie-Christine Delauche, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04129411: Treatment of Papillary Thyroid Carcinoma With Radiofrequency Ablation
Official title: Pilot Study for the Treatment of Papillary Thyroid Carcinoma With Radiofrequency Ablation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Papillary Thyroid Cancer
Papillary Thyroid Microcarcinoma
Keywords: RFA
Radiofrequency
Thyroid Cancer
Ablation techniques
Ultrasonography
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-10-16
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label single interventional series
Primary purpose: TREATMENT

Brief summary: Investigators intend to evaluate the efficiency of Radiofrequency ablation (RFA) therapy to treat papillary thyroid carcinoma.

Detailed description: Investigators plan to identify patients with small papillary thyroid carcinoma and subject such patients to radiofrequency ablation (RFA) therapy.

Following RFA procedure patients will be monitored to study the changes in primary tumor volume, development of lymph node involvement, development of distant metastasis and changes in serum thyroid hormone levels.

Investigators will also assess the stability of these changes (need for repeat therapy) and the safety of the RFA procedure.

Eligibility criteria: Inclusion Criteria:

* Are adults
* Nodule with Papillary thyroid carcinoma meeting the below criteria:

  * Diagnosed by fine needle aspiration (FNA) cytology.
  * Size \< 1.5 cm
  * Non-surgical therapy is considered acceptable by the treating physician
  * Radiology evaluation deems the lesion amenable to RFA therapy with minimal risk of complication

Exclusion Criteria:

* Clinical evidence for a multifocal papillary thyroid malignancy
* Clinical evidence for local or distant metastatic disease
* Pregnancy
* Vocal cord paralysis on contralateral side
* Coagulopathy or patients on anticoagulation therapy
* Patients with prior neck surgery or neck radiation
* Patients with neck anatomy that precludes easy access by RFA
* Patients with comorbidities deemed too high of a risk for general anesthesia
* Treatment with another investigational drug or intervention (within 6 weeks of planned RFA).
* Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.

Primary outcomes:
measure: Changes in Thyroid Nodule Size
timeFrame: 24 months
Secondary outcomes:
measure: Pain Related to RFA Procedure
timeFrame: Up to 24 months
measure: Development of Lymph Node Involvement
timeFrame: 18 months
measure: Development of Distant Metastasis
timeFrame: 18 months
measure: Safety of the RFA Procedure
timeFrame: Up to 24 months
measure: Change in Thyroid Status
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Marius Stan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03081611: RAM Cannula VS Short Nasal Prongs for Delivering NIPPV in Preterm Infants
Official title: RAM Cannula for Delivering Nasal Intermittent Positive Pressure Ventilation (NIPPV) in Preterm Infants: Non Inferiority Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome, Newborn
Noninvasive Ventilation
Infant, Premature
Intubation, Intratracheal
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2017-03-16
Enrollment: 166
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non Inferiority Randomized Control Trial
Primary purpose: TREATMENT

Brief summary: Randomized control trial, Ram cannula VS short nasal prongs for delivering Non Invasive Positive Pressure Ventilation (NIPPV) for preterm infants

Detailed description: Randomized control trial comparing Ram cannula to the regular, more investigated short nasal prongs for delivering Non Invasive Positive Pressure Ventilation (NIPPV) for preterm infants with respiratory distress.

Eligibility criteria: Inclusion Criteria:

* Gestational age 24-33.6
* Physician decision on the need for non invasive ventilation
* parental consent

Exclusion Criteria:

* Pneumothorax before recruitment
* Significant congenital heart disease or chromosomal disorder

Primary outcomes:
measure: intubation
timeFrame: 72 hours
Secondary outcomes:
measure: nasal trauma
timeFrame: during NIPPV procedure
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
affiliation: NICU, Rambam Medical Center, Haifa, Israel
name: Ori Hochwald, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hochwald O, Riskin A, Borenstein-Levin L, Shoris I, Dinur GP, Said W, Jubran H, Littner Y, Haddad J, Mor M, Timstut F, Bader D, Kugelman A. Cannula With Long and Narrow Tubing vs Short Binasal Prongs for Noninvasive Ventilation in Preterm Infants: Noninferiority Randomized Clinical Trial. JAMA Pediatr. 2021 Jan 1;175(1):36-43. doi: 10.1001/jamapediatrics.2020.3579.
Clinical trial NCT01948011: Racecadotril Suspension Linearity Study & Comparative Bioavailability Versus Granules
Official title: Study of the Racecadotril Linearity After Single Administrations of 10, 30 and 60 mg of a New Racecadotril Formulation (Suspension) by Oral Route and Evaluation of the Comparative Bioavailability of This New Formulation Versus the Sachet Formulation (Granules) After a 60 mg Single Oral Administration in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Volunteers
Lead sponsor: Bioprojet
Sponsor class: OTHER
First posted: 2013-09-23
Enrollment: 53
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: To investigate the Racecadotril pharmacokinetic linearity after single oral administration of 10, 30 and 60 mg as a suspension.

To evaluate the comparative bioavailability of the new Racecadotril formulation (suspension) versus the reference sachet formulation (granules)

Detailed description: This is a single center, open-label, single oral dose, 4-period cross-over study to assess the bioequivalence of a new formulation (suspension) in healthy male volunteers.

Eligibility criteria: Inclusion Criteria:

* Healthy male,
* 18 to 45 years old,
* be certified as normal by a comprehensive clinical assessment (detailed medical history and a complete physical examination), arterial blood pressure (BP), heart rate (HR), an ECG and laboratory investigations (haematological, blood chemistry tests, urinalysis), the results of which are within the normal range and/ or judged by the investigator as clinically acceptable for healthy subjects,
* Body Mass Index (BMI) between 18 and 28 kg/m2.

Exclusion Criteria:

* History of cardiovascular, pulmonary gastro-intestinal, hepatic, renal, metabolic, haematological, neurological, psychiatric, systemic, or infectious disease.
* Any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
* Subject has used any drug including OTC products two weeks before the scheduled administration of study drug, except paracetamol (maximum 1g/day).

Primary outcomes:
measure: Bio-equivalence
timeFrame: Total study duration per subject should be 6 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Gières
country: France
facility: Eurofins Optimed
Study officials:
affiliation: Eurofins Optimed
name: Yves Donazzolo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02261311: An Innovation During the Surgical Wait; Evaluation of the Opportunity for Intervention
Official title: An Innovation During the Surgical Wait; Evaluation of the Opportunity for Intervention
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: Breast
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2014-10-10
Enrollment: 200
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with BIRADS 4/5 on initial mammogram.

Brief summary: The investigators will compare the differences in the scores between the baseline questionnaire (at diagnosis) and the second questionnaire (at treatment) in the RADS II patients that enrolled in pre-treatment trials versus those that don't.


Eligibility criteria: Inclusion Criteria:

* \>18 years of age
* Diagnosis of BI-RADS 4 and 5 (highly suspicious for carcinoma) on an initial imaging
* \>2cm area of disease
* Provide informed consent

Exclusion Criteria:

* Previous neo-adjuvant therapy
* Patients with recurrent disease

Primary outcomes:
measure: Quality of life
timeFrame: up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Angel Arnaout, Surgeon
role: PRINCIPAL_INVESTIGATOR
References: