louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01327118: Prostaglandin F2alpha in a Human Headache Model
Official title: Headache Inducing Characteristics and Possible Changes in Cerebral Blood Flow After Administration of Prostaglandin F2alpha
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2011-04-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The hypothesis of this study is that PGF2alpha does not induce headache or dilatation of brain vessels.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Primary Headache
* Headache on the day of the investigation
* Hypertension
* Hypotension
* Pregnant/nursing
* Daily intake of medication (except oral contraceptives)
* Cardiovascular or central nervous system (CNS) disease
* Drug/alcohol abuse
* Psychiatric disease

Primary outcomes:
measure: Headache score on a 10-point verbal rating scale (VRS) 0 indicated no headache; 1 indicated a different sensation, pounding or throbbing, but not necessarily painful; 5 indicated moderate headache and 10 indicated worst imaginable headache
timeFrame: 24 h.
Secondary outcomes:
measure: Blood flow velocity in the middle cerebral artery (VMCA) measured by a Transcranial Doppler (TCD) ultrasonography (2MHz)
timeFrame: in-hospital 2 h.
measure: diameter of superficial temporal artery and radial artery measured by a high resolution ultrasound scanner, C-scan
timeFrame: in-hospital 2 h.
measure: mean arterial blood pressure (MAP), heart rate (HR), end-tidal partial pressure of pCO2 (PetCO2), transcutaneous arterial oxygen saturation (SAT) measured by ProPac Encore®
timeFrame: in-hospital 2 h.
measure: electrocardiography (ECG)
timeFrame: in-hospital 2 h.
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish Headache Center
Study officials:
affiliation: Danish Headache Center
name: Troels Wienecke, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04006418: A Registered Cohort Study on Spastic Paraplegia
Official title: A Registered Cohort Study on Spastic Paraplegia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spastic Paraplegia
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed in hosipital and their's family

Brief summary: The aim of this study is to determine the clinical spectrum and natural progression of Hereditary Spastic Paraplegias(HSP) and related disorders in a prospective multicenter natural history study, to assess the clinical, genetic and epigenetic features of patients with Spastic Paraplegias to optimize clinicalmanagement..


Eligibility criteria: Inclusion Criteria:

* Patients with the clinical diagnosis of spastic paraplegia
* Clinical diagnosis of patients with spastic paraplegia
* Unrelated healthy controls

Exclusion Criteria:

* Decline to participate.
* There are serious interferences with individual participation and adherence to the research protocol, including but not limited to neurological, psychological, and/or medical conditions.

Primary outcomes:
measure: Spastic Paraplegia Rating Scale (SPRS)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: First Affiliated Hospital Fujian Medical University
Study officials:
References:
citation: Qiu YS, Zeng YH, Yuan RY, Ye ZX, Bi J, Lin XH, Chen YJ, Wang MW, Liu Y, Yao SB, Chen YK, Jiang JY, Lin Y, Lin X, Wang N, Fu Y, Chen WJ. Chinese patients with hereditary spastic paraplegias (HSPs): a protocol for a hospital-based cohort study. BMJ Open. 2022 Jan 11;12(1):e054011. doi: 10.1136/bmjopen-2021-054011.
citation: Lin Q, Liu Y, Ye Z, Hu J, Cai W, Weng Q, Chen WJ, Wang N, Cao D, Lin Y, Fu Y. Potential markers for sample size estimations in hereditary spastic paraplegia type 5. Orphanet J Rare Dis. 2021 Sep 19;16(1):391. doi: 10.1186/s13023-021-02014-w.
Clinical trial NCT02406118: Phase II Clinical Trial for the Evaluation of the Efficacy of Transanal TME
Official title: Phase II Clinical Trial for the Evaluation of the Efficacy of Transanal Total Mesorectal Excision
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Cancer
Keywords: transanal TME quality
CRM
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2015-04-02
Enrollment: 49
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
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 evaluation of the safety and the efficacy of transanal total mesorectal excision.

Detailed description: Subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. Transanal visualization will be using endoscopy. At the end of the procedure, the rectum will be removed though the anus or ileostomy formation site, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.

Eligibility criteria: Inclusion Criteria:

1. age: 20-80 years
2. biopsy-proven adenocarcinoma of the rectum
3. clinical staging (c or yc): T0-3, N0-2, M0
4. Rectal cancer located 3-12 cm from the anal verge
5. ECOG performance status: 2 or less
6. BMI: less than 30

Exclusion Criteria:

1. Synchronous colon cancer or other malignancy
2. Obstructing rectal cancer
3. Pregnant or breast-feeding
4. Receiving any other study agents
5. Fecal incontinence
6. History of prior colorectal cancer or inflammatory bowel disease
7. Tumor size: more than 7cm in long diameter
8. CRM: mesorectal fascia involvement or less than 1 mm on MRI

Primary outcomes:
measure: TME quality & circumferential resection margin (CRM)
timeFrame: the day of trananal TME
Secondary outcomes:
measure: 30-day postoperative complications
timeFrame: 1 month after surgery
measure: Number of harvested Lymph Nodes
timeFrame: the day of surgery
Other outcomes:
measure: 2-year local recurrence free survival
timeFrame: 2 years after surgery
measure: 5-year overall survival
timeFrame: 5 years after surgery
Locations:
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
Study officials:
affiliation: NCC,Korea
name: Dae Kyung Sohn
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park SC, Sohn DK, Kim MJ, Chang HJ, Han KS, Hyun JH, Joo J, Oh JH. Phase II Clinical Trial to Evaluate the Efficacy of Transanal Endoscopic Total Mesorectal Excision for Rectal Cancer. Dis Colon Rectum. 2018 May;61(5):554-560. doi: 10.1097/DCR.0000000000001058.
Clinical trial NCT06199518: Minimally Invasive Techniques for Treating Large Proximal Ureteral Stones
Official title: Comparison of Laparoscopic Ureterolithotomy, Retrograde Flexible Ureteroscopy, and Mini- Percutaneous Antegrade Ureteroscopic Lithotripsy for the Management of Large Proximal Ureteral Stones (1.5-2 cm): A Prospective Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endourology
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 105
Sex: ALL
Minimum age (years): 26
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: a prospective comparative study designed to compare the outcomes of transperitoneal Laparoscopic ureterolithotomy (T-LUL), mini-percutaneous antegrade ureteroscopy (A-URS) and retrograde ureteroscopy (R-URS) in treating patients with LPUS (15-20 mm). the following parameters were assessed and compared (demographic data and stones characteristics, Stone free rate and complications)

Detailed description: we aimed in the current study to comprehensively evaluate and to compare the outcome of transperitoneal laparoscopic ureterolithtomy, retrograde ureteroscopy and mini-percutaneous antegrade ureteroscopy for management of large proximal ureteric stone (15 -20 mm) with regards to; operative time, stone free rate, success rate, hospital stay and complications.

A total of 105 participants were enrolled in the trial between April 2021 and June 2023 to accomplish this. Inclusion criteria for this study included patients who had a single proximal Ureteral stone (between the pelvi ureteric junction and the upper border of the sacroiliac joint) measuring 15-20 mm in diameter.

Patients were randomly allocated to receive either TPLU, RURS, or Minin-perc Antegrade URS, with a 1:1:1 allocation ratio. After providing informed permission, the patients were randomly assigned to one of three groups: Group I (35 patients treated with TPLU), Group II (35 patients treated with RURS), and Group III (35 patients not treated with either TPLU or RURS) (Included 35 patients who were treated by Mini-perc Antegrade URS)

Eligibility criteria: Inclusion Criteria:

* Adults patients
* large proximal ureteral stones(1.5-2 cm)

Exclusion Criteria:

* larger stones
* multiple stones
* bleeding tendency
* active UTI
* distal stricture

Primary outcomes:
measure: stone free rate (SFR)
timeFrame: immediate (initial SFR ) and 1 -month later (final SFR)
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Urolgy Departement, Faculty of Medicine, Tanta University
state: Outside U.S./Canada
Study officials:
References:
Clinical trial NCT03777618: Volumetric Study of the Buttocks After Flap Augmentation in Buttocks Lifting
Official title: Retrospective Study of Volumetric Gluteal Region by Parasacral Perforator Flaps in Circuferential Body Lift
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Weight Loss
Keywords: plastic and reconstructive surgery
gluteal ptosis
platipygia
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-12-17
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients after massiv weight loss who come in toulouse or montpellier hospital to take care of slimming effects

Brief summary: The development of bariatric surgery, its effectiveness and the reduction of complications are at the origin of massive weight loss, the corollary of which has been a clear increase in the demands of treatment of sequelae of weight loss.


Eligibility criteria: Inclusion criteria:

* 12 months minimum delay with bariatric surgery
* female, BMI\<30kg/m2
* Age greater than or equal to 18 years
* Stable weight for more than 6 months
* lack of volume in gluetal region
* agree with clinical trial

Exclusion criteria:

* Patient under tutorship or curatorship
* Pregnancy or breastfeeding
* hemoglobinemia\< 12g/dL
* Albuminemia\<3,5g/dL
* active smoking more than 1 month before surgery

Primary outcomes:
measure: evaluate gluteal volume
timeFrame: 1 day
Secondary outcomes:
measure: Surgical complication
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Farid BEKARA, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02185118: Effects of Subanesthetic Isoflurane/Sevoflurane in 60% Oxygen on Clinical In-vitro Experimental Sepsis
Official title: In-vitro Experimental Study About Effects of Subanesthetic Isoflurane/Sevoflurane in 60% Oxygen on Clinical In-vitro Sepsis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sepsis
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2014-07-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Sepsis is a major cause of death in intensive care units. Despite the investigators improved understanding, which has reduced the risk of dying with sepsis, the number of people who die each year continues to increase due to an overall increase in the number of cases.In our previous study, the investigators have showed that 100% oxygen or 0.5 minimum alveolar concentration (MAC) isoflurane/sevoflurane in 60% oxygen protect mouse macrophage cell line against in-vitro sepsis induced by lipopolysaccharide (LPS).

In this study, the investigator hypothesized that treatment of 100% oxygen or 0.5 MAC isoflurane/sevoflurane in 60% oxygen protected against clinical in-vitro models of sepsis induced by LPS or plasma from septic patients.

Detailed description: 100% oxygen or 0.5 MAC isoflurane/sevoflurane in 60% oxygen would inhibit increases of tumor necrosis factor (TNF)-alpha, interleukin-1beta, interleukin-6 in the cell culture supernatant after stimulation of LPS or plasma from septic patients, and also inhibit the nuclear location of nuclear factor-kappa B p65 subunit.

Eligibility criteria: Inclusion Criteria:

* Human PBMCs were only isolated from the adult patients without sepsis/SIRS/infectious diseases.
* The plasma for induction of clinical in-vitro sepsis, was only isolated from adult patients with sepsis.

Exclusion Criteria:

* Patients who had been selected for other clinical trials in the 3 months before.

Primary outcomes:
measure: Subcellular location of Nuclear Factor-KAPPA B p65 subunit
timeFrame: within 10 hours after the intervention
Secondary outcomes:
measure: tumor necrosis factor-alpha
timeFrame: within 10 hours after the intervention
measure: interleukin- 1 beta
timeFrame: within 10 hours after the intervention
measure: interleukin 6
timeFrame: within 10 hours after the intervention
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of Anesthesiology, Xijing Hospital, Fourth Military Medical University,
state: Shaanxi
Study officials:
affiliation: Air Force Military Medical University, China
name: Lichao Hou, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04653818: HCV Related Hepatocellular Carcinoma Recurrence After Directly Acting Antivirals: A Randomized Controlled Trial
Official title: Does Directly Acting Antivirals Usage Affect HCV Related Hepatocellular Carcinoma Recurrence After Percutaneous Ablation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatocellular Carcinoma
Hepatitis C
Neoplasm Recurrence
Treatment Complication
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-12-04
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Data regarding hepatocellular carcinoma (HCC) recurrence after directly acting antivirals (DAAs) given for hepatitis C virus treatment are contradictory. Surprisingly, some studies reported that DAAs are accompanied with higher HCC recurrence. But, other studies showed no rise or even decrease in HCC recurrence. Most of these studies were retrospective and some were non-randomized prospective studies. Here investigators aim to perform a randomized controlled trial to study this issue.


Eligibility criteria: Inclusion Criteria:

* Child-Pugh A and B subjects with hepatitis C related \< 5 cm single or up to 3 hepatocellular carcinomas without any vascular or extrahepatic involvement

Exclusion Criteria:

* Those with positive HBsAg, history of alcohol consumption, patients with other known causes of chronic liver disease, patients who have received previous DAAs for HCV and patients who have received previous locoregional treatment for HCC will be excluded.

Primary outcomes:
measure: HCC recurrence
timeFrame: 1 year after HCC ablation procedure
Secondary outcomes:
measure: changes in Child-Pugh scores over time
timeFrame: 1 year from HCC ablation procedure
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University, Faculty of Medicine
Study officials:
affiliation: Lecturer of Internal Medicine and Hepatology, Faculty of Medicine, Alexandria University
name: Ahmed Kamal, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01431118: Iron Metabolism in Dragon Boat Athletes
Official title: Iron Metabolism in Dragon Boat Athletes - An Analysis of Changes in Blood Count Parameters Under Sport-specific Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anaemia
Keywords: iron metabolism
hepcidin
dragon boating
sport-specific stress
iron
anaemia
sport
Lead sponsor: University of Giessen
Sponsor class: OTHER
Collaborators: name: MVZ für Laboratoriumsmedizin Koblenz
name: Deutscher Drachenboot Verband e.V.
First posted: 2011-09-09
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is:

* To investigate the effect of sport-specific stress in the iron metabolism of dragon boat athletes
* To investigate the effects of sport-specific stress in the activity of pro-hepcidin and hepcidin

Detailed description: This investigation evaluates the effects of sport-specific stress in iron metabolism of dragon boat athletes. Recent studies showed a significant increase in hepcidin activity under exercise (Röcker L. et al.(2005): Iron regulatory protein hepcidin is increased in female athletes after a marathon. European Journal of Applied Physiology, S. 95, 569-571)which possibly influences the iron metabolism.

In particular in this investigation the activity of pro-hepcidin and hepcidin under sport-specific stress is analysed. Therefore elite dragonboat athletes will be included to this study. Every athlete is tested once. At one exercise day from every athlete the iron metabolism especially the change of hepcidin, prohepcidin and iron before and after a specific dragonboat intervention is analysed.

Eligibility criteria: Inclusion Criteria:

* athletes performing dragon boat sport

Exclusion Criteria:

* acute clinically significant intercurrent diseases

Primary outcomes:
measure: change from Baseline in prohepcidin after performing dragonboating
timeFrame: pre and post exercise intervention at the same day
Secondary outcomes:
measure: haematocrit
timeFrame: pre and post exercise intervention at the same day
measure: value of reticulocytes
timeFrame: pre exercise
measure: value of hypochromic erythrocytes
timeFrame: pre exercise
measure: change from Baseline in serum iron after performing dragonboating
timeFrame: pre and post exercise intervention at the same day
measure: value of transferrin
timeFrame: pre exercise
measure: value of transferrin saturation
timeFrame: pre exercise
measure: value of ferritin
timeFrame: pre exercise
measure: change from Baseline in hepcidin after performing dragonboating
timeFrame: pre and post exercise intervention at the same day
Other outcomes:
Locations:
Study officials:
affiliation: Department of sportsmedicine- University Giessen
name: Andree Hillebrecht, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01526018: The Bottle Study: Infant Weight Gain During Use of Novel Versus Typical Infant Feeding Bottles
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Infant Feeding Behavior
Keywords: Intake
Formula feeding
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2012-02-03
Enrollment: 5
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Bottle-fed infants aged 1-6 months

Brief summary: The purpose of this study is to pilot test whether a novel infant feeding bottle changes how much formula an infant drinks and how quickly he/she drinks it, as compared to meals provided in a standard bottle. Exclusively formula-fed infants and their caregiver will be provided with the novel feeding bottle and caregivers will be asked to acclimate their infant to this bottle during the next several weeks. Once acclimated, infants will undergo two weighed, timed, and videotaped test meals on two separate days; one with the novel bottle and one with their standard bottle, in random order. It is hypothesized that when the novel bottle is used, infants bottle will consume smaller meals and will have a longer meal duration, as compared to when a standard bottle is used.


Eligibility criteria: Inclusion Criteria:

* healthy, exclusively formula-fed infants aged 1-6 months at enrollment;
* parent must be at least 19 years of age, able to understand written and verbal English, and provide daytime care for the infant at least 4 days per week.

Exclusion Criteria:

* born \< 37 weeks;
* birth weight \< 2500g or \> 4000g;
* current weight \< 10th percentile for age;
* hospitalization \> 72 hours following birth or any hospital admission since birth;
* any health issue that could interfere with feeding and/or growth;
* use of complementary foods;
* inability or unwillingness to comply with study-related procedures.

Primary outcomes:
measure: Food intake
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References: