louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06606314: Specified Drug-use Surveillance of Fabhalta Capsules
Official title: Specified Drug-use Surveillance of Fabhalta Capsules (Paroxysmal Nocturnal Hemoglobinuria, CLNP023C11401)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Paroxysmal Nocturnal Hemoglobinuria
Keywords: paroxysmal nocturnal hemoglobinuria
PNH
Fabhalta
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-09-23
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who received Fabhalta.

Brief summary: This is a multicenter, single-arm, non-interventional study (NIS) with a central registration system and an all-case surveillance system. The observation period is 48 weeks after the start of treatment with Fabhalta.

Detailed description: The observation period will be 48 weeks after the start of treatment with Fabhalta.

For patients in whom treatment with Fabhalta is discontinued within 48 weeks after the start of the treatment, adverse events occurring by the last day of the treatment + 30 days and concomitant drugs will be monitored and recorded in CRFs.

Eligibility criteria: Inclusion Criteria:

All patients who received Fabhalta.

·

Exclusion Criteria:

Patients receiving Fabhalta for an unapproved indication under the Clinical Trials Act or GCP.

Primary outcomes:
measure: Occurrence status of infections.
timeFrame: 48weeks
Secondary outcomes:
measure: Occurrence status of serious hemolysis after discontinuation of Fabhalta.
timeFrame: 48weeks
measure: Occurrence status of adverse events and adverse drug reactions.
timeFrame: 48weeks
measure: Incidence of breakthrough hemolysis and change of hemolysis-related markers and status of red blood cell transfusion-free.
timeFrame: 48weeks
Other outcomes:
Locations:
city: Okazaki
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Toyota
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Kobe
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Kanoya
country: Japan
facility: Novartis Investigative Site
state: Kagoshima
city: Isehara
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Habikino City
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Shinagawa ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Osaka
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT01171014: Effect of Bifidobacterium Lactis HN019 on Colonic Transit Time and Digestive Symptoms
Official title: A Three-Arm, Placebo Controlled, Double-Blind, Single Center Study to Evaluate the Impact of Probiotic Strain Bifidobacterium Lactis HN019 on Intestinal Well-Being, Colonic Transit Time and Digestive Discomfort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Gastrointestinal Symptoms
Lead sponsor: Fonterra Research Centre
Sponsor class: INDUSTRY
Collaborators: name: Danisco
name: Sprim Advanced Life Sciences
First posted: 2010-07-28
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study was to investigate the dose response effect of Bifidobacterium lactis HN019 supplementation on colonic transit time and gastrointestinal symptoms.


Eligibility criteria: Inclusion Criteria:

* healthy males and females aged 25 to 65 years
* stool type 2-4 on the Bristol Stool Chart
* 1 to 3 bowel movements per week

Exclusion Criteria:

* use of any probiotic product intended to improve gastrointestinal function within the 2 weeks preceding study entry
* major chronic and uncontrolled systemic medical conditions
* severe gastrointestinal conditions known to prolong CTT
* lactose intolerance
* chronic diarrhea
* gastric bypass surgery or lap band insertion for weight loss
* regular laxative use
* pregnant or breast-feeding women

Primary outcomes:
measure: Colonic transit time
timeFrame: 14 days
Secondary outcomes:
measure: Gastrointestinal symptoms
timeFrame: 14 days
Other outcomes:
Locations:
Study officials:
affiliation: Accurate Clinical Research, Houston, TX
name: Philip Waller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00890214: Prostacyclin's Effect on Platelet Responsiveness
Official title: Heparin Versus Prostacyclin in Continuous Hemodiafiltration for Acute Renal Failure: Effects on Platelet Responsiveness in the Systemic Circulation and Across the Filter.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Kidney Failure
Keywords: Anticoagulation
Prostacyclin
Heparin
Renal Replacement Therapy
Kidney failure acute
Platelet aggregation
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2009-04-29
Enrollment: 23
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The researchers investigated the influence of a prostacyclin analogue (PGIA) versus unfractionated heparin (UFH) on ex vivo platelet function, during continuous venovenous hemodiafiltration.

Detailed description: Context and purpose of the study: Prospective, randomized comparison of a PGIA versus UFH as circuit anticoagulant. Platelet responsiveness was assessed from peripheral blood by light-transmittance aggregometry (LTA) induced by collagen and ADP, at baseline, 4 and 24 hrs after treatment onset. Platelet function was also assessed in blood samples collected in the circuit before and after the filter. The Setting was a University Hospital Intensive Care Unit. 23 ICU patients with Acute Renal Failure needing CVVHDF were studied during standard CVVHDF therapy, at random infusion in the extracorporeal circuit of PGIA or UFH.

Eligibility criteria: Inclusion Criteria:

* critically patients ill patients with acute kidney failure (AKI) needing renal replacement therapy

Exclusion Criteria:

* therapy with aspirin or other non-steroidal anti-inflammatory drugs in the previous 7 days
* concomitant treatment with other extracorporeal organ-assist devices any other drug affecting coagulation or platelets

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Policlinico Gemelli
Study officials:
affiliation: Istituto Anestesia e Rianimazione Università Cattolica Policlinico Gemelli
name: Massimo Antonelli, MD
role: STUDY_DIRECTOR
References:
citation: Tsujimoto H, Tsujimoto Y, Nakata Y, Fujii T, Takahashi S, Akazawa M, Kataoka Y. Pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2020 Dec 14;12(12):CD012467. doi: 10.1002/14651858.CD012467.pub3.
Clinical trial NCT02858414: Exploratory Study of Cellular Reservoirs in Blood From HIV Infected Patients
Official title: Exploratory Study of Cellular Reservoirs in Blood From HIV Infected Patients: EURECA (ERANET to Unravel New Roads to Eradication and a Cure for AIDS) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infection
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-08-08
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study evaluates the impact of highly active antiretroviral therapy on the size of the latent viral reservoirs in resting CD4+ T cells and monocytes in HIV positive patients. The activation state of the cells will be assessed, by measuring the activation of Akt, to determine its influence on the size of the viral reservoirs.


Eligibility criteria: Inclusion Criteria:

* HIV infected patients under Highly Active Anti-Retroviral Therapy (HAART) or Naïve from treatment

Exclusion Criteria:

* Age limits
* Pregnancy
* Legal restrictions to consent

Primary outcomes:
measure: Measure of the integrated viral reservoir size
timeFrame: day 1
measure: Measure of the proviral reservoir size
timeFrame: day 1
Secondary outcomes:
measure: Measure of Akt activation
timeFrame: day 1
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hospitalier Régional Universitaire
Study officials:
affiliation: Centre Hospitalier Universitaire de Besancon
name: Georges HERBEIN, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06651814: Treatment Outcome of Supervised Exercise and Home Exercise in Patients with Symptomatic Disc Displacement with Reduction
Official title: Treatment Outcome of Supervised Exercise and Home Exercise in Patients with Symptomatic Disc Displacement with Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Disc Displacement
Lead sponsor: Armed Forces Institute of Dentistry, Pakistan
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the treatment outcome of supervised exercise and home exercise in patients with symptomatic disc displacement with reduction.

Detailed description: This study will help the clinical practitioner to choose better exercise option in patients with symptomatic disc displacement with reduction in order to avoid clicking sound.

Eligibility criteria: Inclusion Criteria:

1. Age: 18-70 years
2. Both genders
3. TMJ clicking sounds fulfilling RDC/TMD for symptomatic disc displacement

   1. Clicking sounds during jaw opening and closing
   2. Interincisor distance ≥ 5mm wider during mouth opening
   3. Clicking suppression with protruded mandible
   4. Clicking presence in at least two of three repetitions
4. NRS score ≥ 4 for TMJ clicking sound severity
5. TMJ clicking sound frequency: once a week or more

Exclusion Criteria:

1. Major psychiatric disorders
2. Ongoing treatments related to symptoms
3. Active rheumatologic disease
4. Malignant disease

Primary outcomes:
measure: clicking sounds frequency
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Armed Forces Institute of Dentistry
state: Punjab
Study officials:
affiliation: Armed Forces Institute of Dentistry, Pakistan
name: Ayesha Younas, BDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04662814: Extracorporeal Shock Wave Therapy for Dysmenorrhea
Official title: the Efficacy of Extracorporeal Shock Wave Therapy for Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Dysmenorrhea
Lead sponsor: MTI University
Sponsor class: OTHER
Collaborators: name: Ghada ebrahim El Refaye -Faculty of Physical Therapy, Cairo University, Egypt
name: Sohier Mahmmoud El Koseiry- Faculty of Physical Therapy, Cairo University, Egypt
First posted: 2020-12-10
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: group A: shockwave therapy and dietary modification group B: dietary modification
Primary purpose: TREATMENT

Brief summary: purpose of this study to investigate the effect of Extracorporeal shock wave therapy on pain and prostaglandin level in patient with primary dysmenorrhea

Detailed description: This randomized controlled trial is to determine the effect of shock wave therapy in the treatment of primary dysmenorrhea.

females are randomly assigned into 2 groups: group A SWT treatment plus dietary modification during PD (n=25） GROUP B:dietary modification only (n=25）;

Participants in group B will receive dietary modification for three successive months

The numerical rating scale (NRS) and prostaglandin blood level will be recorded and evaluated before and after treatment.

Eligibility criteria: Inclusion Criteria:

1. ages ranged between18 - 25 years old.
2. body mass index (BMI) will not exceed 30kg/m2.
3. females will be diagnosed by the physician as primary dysmenorrhea.

Exclusion Criteria:

1. Secondary dysmenorrhea .
2. Mental health problem such as depression and anxiety.
3. Irregular periods

Primary outcomes:
measure: numerical rating scale
timeFrame: 3 months
Secondary outcomes:
measure: prostaglandin
timeFrame: 3months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: MTI
Study officials:
References:
Clinical trial NCT05540314: Robotic Bariatric Database (RBD) Collaborative
Official title: Robotic Bariatric Database (RBD) Collaborative
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Weight Loss
Obesity
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 3. Undergone robotic bariatric surgery between January 2018 and December 2019

Brief summary: With increased prevalence of obesity in the general population over the past 30 years, researchers have been focused on the development of new treatment options to achieve long-lasting weight loss. In 1991, the National Institutes of Health Conference Statement on Gastrointestinal Surgery for Severe Obesity developed a consensus stating that bariatric surgery was the most effective treatment for obesity since it is associated with good long-term results in terms of weight loss, glycemic control and decreased mortality.

To collect and store clinical data related to the treatment outcomes of robotic bariatric surgery in order to develop an evidence base such that physicians can provide the best possible care to patients undergoing surgical weight loss interventions.

Detailed description: With increased prevalence of obesity in the general population over the past 30 years, researchers have been focused on the development of new treatment options to achieve long-lasting weight loss.

Eligibility criteria: Inclusion Criteria:

* \> 18 years of age
* Eligible for or have undergone robotic bariatric surgery per the treating physician
* Undergone robotic bariatric surgery between January 2018 and December 2019

Exclusion Criteria:

* Do not meet the Study Inclusion Criteria l

Primary outcomes:
measure: Date of Birth
timeFrame: January 2018- December2019
measure: Principal Operative Procedure is an Initial Primary Metabolic or Bariatric Procedure
timeFrame: January 2018- December 2019
measure: Patient has a history of metabolic or bariatric surgery
timeFrame: January 2018- December 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Charlton Medical Center
state: Texas
Study officials:
affiliation: Methodist Health System
name: Sachin S . Kukreja, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01454414: Tick-borne Illness and Clothing Study
Official title: Preventing Exposure to Ticks and Tick-borne Illness in Outdoor Workers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tick Bites
Tick-borne Illness
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: North Carolina State University
First posted: 2011-10-19
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The high risk of acquiring tick-borne diseases by outdoor workers is well documented. Workers most at risk include, foresters, park rangers, land surveyors and other outdoor workers have frequent exposure to tick-infested habitats. Many North Carolina state employees with outdoor occupations report multiple tick bites each year, which indicates that existing tick preventive strategies may be ineffective. The principal goal of this study is to assess whether the use of long-lasting permethrin impregnated uniforms can reduce the number of tick bites sustained by North Carolina outdoor workers.


Eligibility criteria: Inclusion Criteria:

* Being over 18 years of age
* Employee of NC Division of Forest Resources, the NC Division of Parks and Recreation, NC Wildlife Resources Commission, or NC County and Local Parks and Recreation who work in Central and Eastern North Carolina
* An average of 10 or more hours of outdoor work per week during tick season
* Self-reported prior work-related tick bites

Exclusion Criteria:

* Pregnancy
* Non-English speaking
* Known allergy to insecticides

Primary outcomes:
measure: Work Related Tick Bites
timeFrame: Weekly for two years
Secondary outcomes:
measure: Seroconversion Against a Tick-borne Illness
timeFrame: Upon enrollment, after the first year, and after the second year
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Gillings School of Global Public Health
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Steven R Meshnick, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vaughn MF, Funkhouser SW, Lin FC, Fine J, Juliano JJ, Apperson CS, Meshnick SR. Long-lasting permethrin impregnated uniforms: A randomized-controlled trial for tick bite prevention. Am J Prev Med. 2014 May;46(5):473-80. doi: 10.1016/j.amepre.2014.01.008.
Clinical trial NCT03306914: Comparing Human Albumin Versus Hydroxyethylstarch in Renal Transplant Recipients
Official title: Plasma Volume Expansion for Optimum Renal Transplant Surgery: Albumin Versus Starch
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia Morbidity
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-10-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this study we try to review the possible effects when using modern hydroxyethylstarch solutions 6 % versus albumin 5% during living donor renal transplantation.


Eligibility criteria: Inclusion Criteria:

* end stage renal disease, for living donor renal transplantation

Exclusion Criteria:

* severe cardiac or hepatic dysfunction, re-transplantation, coagulopathy

Primary outcomes:
measure: Occurrence of complications
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Kasr Al-Ainy Hospiral, Cairo University
name: Ahmed Kareem
role: STUDY_DIRECTOR
References:
Clinical trial NCT05091814: Prevalence of Trismus in Patients With Maxillary Cancer With and Without Radiation Therapy in the Egyptian Population.
Official title: : Post-operative Prevalence of Trismus in Patients With Maxillary Cancer With and Without Radiation Therapy in the Egyptian Population.(a Cross Sectional Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Maxillary Neoplasms
Keywords: surgery , Trismus, Oral
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-10-25
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients with maxillary cancer attending faculty of dentistry ,CU and the national cancer institute.

Brief summary: This study aims at evaluating the prevalence of trismus among maxillary cancer patients in the Egyptian population and the effect of radiotherapy on the occurrence of trismus.

Detailed description: The enrolled participants who meet the eligibility criteria and signed the informed consent of participation in the study will undergo clinical examination to determine the maximum mouth opening after performing surgery only and /or after radiotherapy in case of adjuvant therapy

the maximum mouth opening will be measured in (mm) by using a digital caliper device and will be recorded in the patient sheet,

reading of less than 35mm will be considered trismus while above 35mm or more will be considered normal (NO trismus)

Eligibility criteria: Inclusion Criteria:

* patients with maxillary cancer

Exclusion Criteria:

* patients under 18 yrs .
* patients with TMJ disorders before surgery
* patients on chemotherapy
* - Tumors in other sites( Tongue , buccal mucosa , salivary glands, mandible)

Primary outcomes:
measure: % prevalence
timeFrame: 1 year
Secondary outcomes:
measure: MMO
timeFrame: 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
state: Haram
Study officials:
affiliation: National Cancer Institute (NCI)
name: Gamal Ashour
role: STUDY_DIRECTOR
References:
citation: van der Geer SJ, van Rijn PV, Kamstra JI, Langendijk JA, van der Laan BFAM, Roodenburg JLN, Dijkstra PU. Prevalence and prediction of trismus in patients with head and neck cancer: A cross-sectional study. Head Neck. 2019 Jan;41(1):64-71. doi: 10.1002/hed.25369. Epub 2018 Dec 18.