louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01283399: An Observational Study of Rituximab in Combination With Methotrexate in Participants With Active Rheumatoid Arthritis
Official title: A Non-interventional Multicenter Study of MabThera® (Rituximab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-01-26
Enrollment: 79
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All participants with active refractory RA who were eligible to receive treatment with methotrexate and rituximab in the Investigators' opinion as per the routine clinical practice following inadequate response to a single cycle of anti-TNF therapy.

Brief summary: This observational study will assess the efficacy and safety of combination of rituximab (MabThera) and methotrexate in participants with active refractory rheumatoid arthritis (RA) who have failed to respond to a single course of anti-tumor necrosis factor (TNF) therapy in routine clinical practice. Data will be collected from participants for 12 months after the first dose of rituximab or a minimum of 6 months following a rituximab re-treatment course.


Eligibility criteria: Inclusion Criteria:

* Active rheumatoid arthritis
* Inadequate response to a single TNF inhibitor
* Participants receiving rituximab therapy in accordance with the prescribing information
* Signed data release form within 6 weeks (42 days) of initiating rituximab therapy
* Women of childbearing potential must use effective form of contraception

Exclusion Criteria:

* Contra-indication to receive rituximab according to the local labelling
* Previous treatment with rituximab
* Treatment with any investigational drug within 30 days prior to enrolment

Primary outcomes:
measure: Disease Activity Score Based on 28-joints Count (DAS28)
timeFrame: Up to 5 years
Secondary outcomes:
measure: Reasons for Re-treatment With Rituximab Within 6 Months of the First Treatment
timeFrame: Up to 5 years
measure: Disease Activity Score Based on 28-joints Count (DAS28) 6 Months After the Re-treatment With Rituximab
timeFrame: 6 Months After the Re-treatment With Rituximab (up to 5 years)
measure: Demographics of Participants Eligible to Receive Rituximab
timeFrame: Baseline
measure: Number of Participants With Adverse Events
timeFrame: 5 years
Other outcomes:
Locations:
city: Beirut
country: Lebanon
city: Beirut
country: Lebanon
city: Beirut
country: Lebanon
city: Jbeil
country: Lebanon
city: Tripoli
country: Lebanon
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02921399: Optimal Initiation of Helicobacter Pylori Eradication After Endoscopic Resection for Gastric Neoplasm
Official title: Optimal Initiation of Helicobacter Pylori Eradication After Endoscopic Resection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: H.Pylori Eradication Rate
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2016-10-03
Enrollment: 149
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received proton-pump inhibitor (PPI)-based triple therapy for H. pylori eradication after endoscopic resection for gastric neoplasms. Clinicopathologic characteristics, particularly the timing of triple therapy, were used to compare eradication rates, assigning patients to early- (≤2 weeks),and late-phase (≥8 weeks) eradication groups.

Brief summary: After endoscopic resection (ER) of gastric tumors, eradication of Helicobacter pylori (H. pylori) infection is advised to reduce metachronous recurrence. However, few studies have addressed factors influencing H. pylori eradication rates in the aftermath of ER, and none have focused on the optimal timing of therapy to eradicate H. pylori post-ER.Therefore, the investigators will conduct to evaluate whether differences in timing of eradication therapy after ER of gastric tumors.

Detailed description: Uur previous retrospective study unveiled that administering eradication treatment within 2 weeks post-ESD during the active reparative phase of ESD-induced ulcers yielded a markedly higher success rate compared to treatment post-8 weeks during the scarring phase of ESD-induced ulcers.Therefore, we conducted a multicenter, randomized, prospective study to ascertain whether the optimal timing of eradication post-ESD could influence the eradication success rate.

Eligibility criteria: Inclusion Criteria:

1. patients underwent endoscopic resection of gastric neoplasm
2. patients who diagnosed as H. pylori infection by rapid urease test

Exclusion Criteria:

1. Histories of gastric surgery
2. Histories of prior H. pylori eradication therapy
3. Use of drugs affecting H. pylori positivity (proton pump inhibitor, histamine-2 receptor blocker, or antibiotics) within the preceding 2 weeks

Primary outcomes:
measure: H. pylori eradication rate according to timing of therapeutic regimen after endoscopic resection
timeFrame: The success of H. pylori eradication was determined using a urea breath test conducted 13 weeks ± 5 days after ESD
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital, Yonsei Unversity
Study officials:
References:
Clinical trial NCT01308242: Effects of a Non-Calcium Based Phosphate Binder on FGF23 Levels in Chronic Kidney Disease
Official title: Effects of a Non-Calcium Based Phosphate Binder on FGF23 Levels in Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Chronic Kidney Disease
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: Genzyme, a Sanofi Company
First posted: 2011-03-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Fibroblast Growth Factor 23 (FGF23) is a molecule that has been implicated in the homeostasis of phosphorus. Elevated FGF23 levels are well-documented in patients with Chronic Kidney Disease (CKD) and are inversely correlated with Glomerular Filtration Rate (GFR). FGF23 levels are also predictive of progression of CKD and predict mortality in CKD. Although studies in normal individuals suggest that phosphorus intake is related to FGF23 levels, the effect of dietary and pharmacologic phosphate restriction on FGF23 levels in patients with CKD has never been reported. Our objectives are to determine if phosphate reduction through the use of non-calcium based phosphate binder will decrease serum FGF23 levels. The investigators will also be investigating associations of elevation in FGF 23 levels with commonly encountered co-morbidities in CKD patients such as Coronary Artery Disease, Diabetes Mellitus, and Hypertension.


Eligibility criteria: Inclusion Criteria:

* Adults between ages 18-80 years old, with a GFR less than or equal to 50 ml/min/1.73 m2 as determined by the Modification of Diet in Renal Disease (MDRD) formula will be included.

Exclusion Criteria:

* Patients will be excluded if they have a history of renal transplant or are pregnant. In addition, patients with dysphagia, swallowing disorders, severe GI motility disorders, severe constipation, history of major gastrointestinal surgery and patients taking levothyroxine for hypothyroidism will be excluded.

Primary outcomes:
measure: Effects of a Non-Calcium Based Phosphate Binder on FGF23 Levels in Chronic Kidney Disease
timeFrame: March 2011-June 2012
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
References:
Clinical trial NCT06001242: The Relationship Between Upper Extremity Explosive Power and Trunk Muscles in Volleyball Players
Official title: Voleybolcularda Üst Ekstremite Patlayıcı Güç Ile Gövde Kaslarının Arasındaki İlişkinin İncelenmesi
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ultrasonography
Upper Extremity
Physical Endurance
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 30
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Hacettepe University will be directed from the referred athletes

Brief summary: Volleyball is an interval sport involving consecutive aerobic and anaerobic loads. Strength training based on explosive movements can improve performance in the upper extremities. Strength performance has an important place in this sport. Trunk stabilization is defined as 'proximal stability for distal mobility'. Disorder in any segment of the kinetic chain model will affect the quality of movement in the lower and upper segments.The aim of this study is to examine the relationship between the morphological features of the transversus abdominis, lumbal multifidus (L4-5), internal external oblique muscles, and the anaerobic power of the upper extremity and shoulder girdle functionThis study was designed as a cross-sectional. They will consist of 30 volleyball players between 14-30 years of age. Muscle morphological features of the participants by ultrasound; explosive strength will be evaluated by Medicine Ball Throw test, functional evaluation will be evaluated by Closed Kinetic Chain Upper Extremity Endurance test.


Eligibility criteria: Inclusion Criteria:

* Training for an hour at least 3 days a week for at least 1 year
* Body Mass Index (BMI) below 30 kg/m2
* No concomitant neurological, rheumatological or systemic disease
* Volunteer to participate in the study.

Exclusion Criteria:

* Having any surgery / serious pathology of the spinal column
* Having had an upper extremity injury in the last 6 months that would affect his ability to play volleyball
* Having an injury that requires at least 2 weeks of discontinuation
* Severe musculoskeletal/systemic discomfort during the measurements.

Primary outcomes:
measure: Muscle morphology
timeFrame: 1 day
Secondary outcomes:
measure: Expolsive Power
timeFrame: 1 day
measure: Core stability
timeFrame: 1 day
measure: Upper Extremity Endurance
timeFrame: 1 day
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Aynur Demirel
Study officials:
affiliation: Hacettepe University
name: Aynur Demirel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02779842: Sun Protection Factor - Assay
Official title: Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay on Minimal Persistent Pigment-Darkening Dose(MPPD).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agent
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-05-20
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF
* Signed and dated Informed Consent Form
* Signed and dated HIPAA Form
* An unambiguous MED or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: Minimal Persistent Pigment Darkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02530242: Carbon Monoxide Measurement to Screen for Sickle Cell Disease
Official title: Point-of-Care End-Tidal Carbon Monoxide Measurement to Screen for Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Anemia
Keywords: Sickle Cell Anemia
Lead sponsor: UCSF Benioff Children's Hospital Oakland
Sponsor class: OTHER
Collaborators: name: Capnia, Inc.
First posted: 2015-08-21
Enrollment: 32
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Modify the design of the CoSense device (Model C20112, currently cleared by the FDA for ETCO (end-tidal carbon monoxide) monitoring to improve accuracy and consistency under temperature conditions encountered in countries with high prevalence of SCD (Sickle Cell Disease).

Detailed description: Increase the temperature operating range of ETCO measurements to 5 to 45°C. The signal output-to-CO (carbon monoxide) concentration correlation of the CO sensor is dependent on temperature. The new algorithm will be a different approach because the current algorithm is at the limits of its capability. We will establish the new specifications by determining performance in a bench model under simulated temperature conditions. We will then determine the ability of the modified device to distinguish between SCD and healthy controls. During this initial testing, we will examine the validity of ETCO measurements under regulated room temperature in the hospital setting. We will enroll 20 subjects, 10 each in the SCD arm and control arm to determine the mean and variance of the ETCO values.

Eligibility criteria: Inclusion Criteria:

* Parental / legal guardian consent
* Subject assent for participants ages 7 and above
* Male and female children ages 1-18 years old
* For Hb SS (Homozygous sickle cell anemia) subjects, hemoglobin baseline hemoglobin ≤10 g/dL based upon average hemoglobin value in past year

Exclusion Criteria:

* Subjects must not meet any of the following exclusion criteria to be considered eligible for study enrollment:
* Had a red blood cell transfusion within 8 weeks prior to enrollment
* Currently a primary smoker or was a primary smoker within 4 weeks prior to enrollment
* Exposed to second hand smoke within 24 hours prior to breath sample collections
* Have current upper respiratory infection or symptomatic asthma
* For healthy subjects, known to have the sickle cell trait by electrophoresis or genetic testing

Primary outcomes:
measure: End-Tidal Carbon Monoxide
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital & Research Center at Oakland
name: Ashutosh Lal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lal A, Patterson L, Goldrich A, Marsh A. Point-of-care end-tidal carbon monoxide reflects severity of hemolysis in sickle cell anemia. Pediatr Blood Cancer. 2015 May;62(5):912-4. doi: 10.1002/pbc.25447. Epub 2015 Feb 14.
Clinical trial NCT04904042: Study of Safety and Efficiency of the Use of Neutral Argon Plasma in Cyto-reduction of Miliary Implants in the Peritoneal Surface.
Official title: Phase I/II Study of Efficiency and Single-arm Safety on the Use of Neutral Argon Plasma in Cyto-reduction of Miliary Implants in the Peritoneal Surface.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peritoneal Carcinomatosis
Keywords: Peritoneal carcinomatosis
Cancer
Neutral argon plasma
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
First posted: 2021-05-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Neutral argon plasma vaporization shows little damage to normal tissue and allows a complete removal of tumor tissue, that is, without leaving any cell debris viable tumor.

Our primary objective is to evaluate the effectiveness and safety of neutral argon plasma on peritoneal implants with different dosimetry in vivo and ex vivo.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with peritoneal carcinomatosis (an attempt will be made to cover all histological types of carcinomatosis in similar distribution as 2 patients with carcinomatosis of colonic origin, 2 patients with carcinomatosis of ovarian origin, 2 patients with peritoneal pseudomyxoma, 2 patients with peritoneal mesothelioma and 2 patients with carcinomatosis of gastric origin) with PCI greater than 0 in regions 10-13, and that have been selected as candidates for cytoreductive surgery + HIPEC or for laparoscopy-laparotomy explorer (selection criteria established according to clinical practice usual), and that present peritoneal miliary dissemination consistent with the characteristics of this study for the tissue under examination (implants smaller than 0.25 cm, CC1).
* Signature of specific informed consent for participation in this study and to obtain biological samples.

Exclusion Criteria:

* Patients not suitable for CRS and HIPEC, according to the clinical criteria of the Surgery Unit Oncology and multidisciplinary committee.
* Refusal of the patient to participate in the study.

Primary outcomes:
measure: Pathological evaluation
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
measure: Evaluation of mesentery vascular damage and damage to the intestinal serosa.
timeFrame: During the surgery and through study completion, an average of 1 year.
measure: Morbidity associated with treatment.
timeFrame: 30 days after the intervention
measure: Mortality associated with treatment.
timeFrame: 30 days after the intervention
measure: Global morbidity.
timeFrame: Within the 30 days post-intervention
measure: Global mortality.
timeFrame: Within the 30 days post-intervention
Other outcomes:
Locations:
city: Cordoba
country: Spain
facility: University Hospital Reina Sofia
Study officials:
affiliation: University Hospital Reina Sofia
name: Alvaro Arjona-Sanchez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00094042: Work and Iron Status Evaluation
Official title: Work and Iron Status Evaluation (WISE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: Socioeconomic Factors
Dietary Supplementation
Lead sponsor: National Institute on Aging (NIA)
Sponsor class: NIH
First posted: 2004-10-11
Enrollment: 16000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project seeks to understand how changes in the health of an individual affects the economic and social prosperity of the individual, family and community. The study involves providing iron supplements to a sample of participants in Central Java Indonesia and following those respondents for three years. They are compared with a control group who do not receive the supplement.

Detailed description: The goal of the study is to pin down the causal effect of improvements in health on the economic and social prosperity of individuals and their families. Particular attention will be paid to the dynamics underlying the effect of health on labor outcomes; older adults are more likely to experience transitions in health and economic status and so will be emphasized.

Beginning in 2002, about 4,000 households will be interviewed every four months for about 3 years. The first two waves of the survey will serve as baselines. After the second wave, households will be randomly assigned to one of two groups. Iron supplements will be provided to all members of households assigned to one of those groups. Household members in the 2nd group will receive an identical-looking placebo. Participants will take the supplements (or placebo) on a weekly basis for a year. The study will measure the effect of supplementation on the well-being of individuals and their families.

Data will be collected at the individual, household and community level. Individual level data will cover time allocation including work and participation in community activities, earnings, self-reported and physical health and cognition. All adult household members will be interviewed; questions about children will be answered by a caretaker. Data on wealth and consumption will be collected at the household level. Community resources, services and infrastructure information will be gathered along with detailed price data.

Eligibility criteria: Inclusion Criteria:

* Resident in village in study area in Purworejo District, Central Java, Indonesia

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Purworejo District
country: Indonesia
state: Central Java
Study officials:
affiliation: Department of Economics, UCLA
name: Duncan Thomas
role: PRINCIPAL_INVESTIGATOR
References: