louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06591182: Effects of Social Determinants of Health on IV Iron Treatments
Official title: Impacts of Social Determinants of Health for Patients Seeking Intravenous Iron Treatments At a Large Community Hospital Adult Infusion Center
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Social Determinants of Health (SDOH)
Keywords: Iron
social determinants of health
intravenous iron
patient compliance
Lead sponsor: BayCare Health System
Sponsor class: OTHER
Collaborators: name: University of South Florida
First posted: 2024-09-19
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients attending an appointment for an IV iron infusion at the community hospital infusion clinic on the same day they are being asked to participate in the survey; 18 years of age or older; those who speak English or Spanish.

Brief summary: This study investigates how social determinants of health (SDOH) like income, employment, transportation, food, and housing affect patients' ability to receive IV iron treatments. It aims to understand how these factors influence patients' healthcare behaviors, particularly their attendance at IV iron appointments.


Eligibility criteria: Inclusion Criteria:

* Patients receiving one of the following IV iron products: Ferric Carboxymaltose, Ferric Derisomaltose, Ferumoxytol, Iron Sucrose, or Iron Dextran
* Patients 18 years of age or older
* Patients who speak English or Spanish

Exclusion Criteria:

* Patients receiving an alternative IV iron product: Sodium ferric gluconate
* Patients under 18 years of age
* Patients who do not speak English or Spanish

Primary outcomes:
measure: Association between SDOH and patient compliance
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Patient Perceptions of IV Iron
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Tampa
country: United States
facility: St. Josephs Hospital Adult Infusion Center
state: Florida
Study officials:
affiliation: BayCare Health System
name: Les Louden, PharmD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of South Florida
name: Janelle Applequist, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06702982: Virtual Support, Real Impact: Effectiveness of Tele-nursing in Alleviating Chemotherapy Symptoms Among Cancer Patients
Official title: Virtual Support, Real Impact: the Effectiveness of Tele-nursing in Alleviating Chemotherapy Symptoms Among Cancer Patients; a Quasi-experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Chemotherapy Effect
Quality of Life (QOL)
Keywords: chemotherpay
tele-nursing
quality of life
Lead sponsor: Helwan University
Sponsor class: OTHER
First posted: 2024-11-25
Enrollment: 74
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This quasi-experimental study evaluated a tele-nursing educational program's impact on improving the quality of life and managing chemotherapy-related symptoms in 74 adult cancer patients at Mansoura University Hospital in Egypt. Delivered via Telegram, the program involved weekly educational sessions, aiming to enhance symptom management and quality of life.

Detailed description: The study aimed to assess the effectiveness of a tele-nursing educational program in managing chemotherapy-related and cancer-related symptoms and improving the quality of life among adult cancer patients. Conducted at the Oncology Center at Mansoura University Hospital in Egypt, the study recruited 74 participants who completed structured interviews detailing their demographics, medical history, symptom severity (using the MDASI-A tool), and quality of life (using the QOL-ACD tool). The intervention, delivered via a Telegram group, included weekly educational sessions focused on managing chemotherapy symptoms. The sessions featured educational content and feedback, with outcomes measured through changes in symptom severity and quality of life scores before and after the intervention. This approach highlighted the program's potential to enhance patients' overall well-being and symptom management.

Eligibility criteria: Inclusion Criteria:

* • Diagnosed with cancer and receiving treatment at an outpatient chemotherapy center

  * Age from 20 less than 60 years.
  * Accept to participate in the study.
  * Had smart phones linked with internet
  * Educated and able to use Zoom and Telegram applications

Exclusion Criteria:

* • Having active, serious physical disease

  * Patients with mental disease.

Primary outcomes:
measure: cancer-related and treatment-related symptoms
timeFrame: 3 months
Secondary outcomes:
measure: Quality of life for Cancer Patients
timeFrame: 3 months
Other outcomes:
Locations:
city: Mansura
country: Egypt
facility: Mansura university
state: Dakhalia
Study officials:
affiliation: Faculty of Nursing
name: Alaa El Din M Abd Elaleem, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03187782: Pulse Diagnoses in Patients While Dysmenorrhea is Attacking
Official title: The Effect of Acupuncture Treatment of Acupoint San Yin Jiao on the Pulse Diagnoses in Patients While Dysmenorrhea is Attacking
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dysmenorrhea
Lead sponsor: Taipei Hospital, Taiwan
Sponsor class: OTHER
First posted: 2017-06-15
Enrollment: 15
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 55
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fifteen patients suffering from dysmenorrhea who visited the traditional Chinese medicine outpatient department were recruited voluntarily in this study.

All subjects live in the greater Taipei area.

Brief summary: The mechanism led to the dysmenorrhea can be understood more clearly and one may have a better idea to treat the disease in the future.

Detailed description: Background: Pulse diagnosis of the dysmenorrhea patients before and after acupuncture treatment on the acupoint San Yin Jiao (SP6) were performed so that the mechanism led to the pain can be understood more clearly and one may have a better idea to treat the disease in the future.

Methods: Fifteen women participated in the study voluntarily. They have first to fill in the form of Visual Analogue Scale (VAS) for pain. Then the pulse of the subjects were measured by ANSWatch before and after acupuncture. All meridians can be assessed by analyzing the pulse spectra through Fast Fourier Transform (FFT) of the original pulse data. The significant change of amplitude in certain harmonics which corresponds to a specific meridian after acupuncture treatment can be selected out.

Eligibility criteria: Inclusion Criteria:

* The inclusion criteria of the subjects were the presence of pain during menstruation or three days before it. It needed to recheck if the menstrual cycle appeared within three days after recruiting if dysmenorrhea attacked before menstruation.

Exclusion Criteria:

* The exclusion criterion was that subjects did not take pain killers in the 12 hours before measurement.

Primary outcomes:
measure: Patients' radial artery pulses. Change is being assessed.
timeFrame: Measure subjects' radial artery pulses before and after acupuncture in 10 minutes respectively.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Taipei Hospital
name: Chen-Kai Liao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02587182: Effects of Dry Needling in Patients With Sleep Bruxism and Temporomandibular Disorders: a Prospective Case Series
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain
Lead sponsor: CEU San Pablo University
Sponsor class: OTHER
First posted: 2015-10-27
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the present study was to assess the effectiveness of deep dry needling in the masseter and temporalis MTrPs on pain, pressure pain threshold (PPT), range of motion and disability in patients with sleep bruxism and myofascial temporomandibular disorders.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of myofascial temporomandibular disorders
* Diagnosis of myofascial trigger point
* Diagnosis of sleep bruxism

Exclusion Criteria:

* insurmountable fear of needles
* any systematic joint or muscle disease
* bleeding disorders or
* prior physical therapy treatment

Primary outcomes:
measure: Pain: visual analog scale, ranging from 0mm (no pain) to 100mm (worst imaginable pain).
timeFrame: 1 week
measure: Pressure pain sensitivity: mechanical pressure algometer.
timeFrame: 1 week
measure: Range of motion: distance between the upper and lower central dental incisors was measured with a millimeter ruler.
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Blasco-Bonora PM, Martin-Pintado-Zugasti A. Effects of myofascial trigger point dry needling in patients with sleep bruxism and temporomandibular disorders: a prospective case series. Acupunct Med. 2017 Mar;35(1):69-74. doi: 10.1136/acupmed-2016-011102. Epub 2016 Oct 3.
Clinical trial NCT05172882: Efficacy of Transversalis Fascia Plane Block Versus Wound Infiltration in Varicoselectomy Surgery
Official title: Comparison of the Efficacy of Transversalis Fascia Plane Block and Wound Infiltration in Varicoselectomy Surgery; Randomised, Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Transversalis Fascia Plane Block
Wound Infiltration
Varicoselectomy
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2021-12-29
Enrollment: 60
Sex: MALE
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: Before surgery, patients will be divided into 2 groups as transversalis fascia plane block will be applied and skin infiltration will be applied. Post-operative analgesic procedures will be applied to patients receiving general anesthesia. Postoperative analgesic consumption and pain scores of the patients will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Patients over the age of 18 who will undergo Varicocele operation
* ASA I-II

Exclusion Criteria:

* Patients with allergic reaction to anesthesia and analgesia drugs to be used
* Patients who did not want to voluntarily participate in the study
* Severe systemic disease (kidney, liver, pulmonary, endocrine)
* Substance abuse history
* Chronic pain history
* Psychiatric problems and communication difficulties
* History of hematological problem
* Patients with severe hemodynamic instability due to infection, heavy bleeding

Primary outcomes:
measure: Pain Scores (0 (low)-10 (high))
timeFrame: 1st hour
measure: Pain Scores (0 (low)-10 (high))
timeFrame: 2nd hour
measure: Pain Scores (0 (low)-10 (high))
timeFrame: 4th hour
measure: Pain Scores (0 (low)-10 (high))
timeFrame: 8th hour
measure: Pain Scores (0 (low)-10 (high))
timeFrame: 12th hour
measure: Pain Scores (0 (low)-10 (high))
timeFrame: 24th hour
Secondary outcomes:
measure: Rescue analgesic consumption
timeFrame: Any time on postsurgical first 24 hour.
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Erkan Cem ÇELİK
Study officials:
References:
Clinical trial NCT00184782: Evaluation of Metabolic Activity of Liver Metastases by FDG-PET Scanning
Official title: Exploratory Study on FDG-PET Scanning in Evaluating the Metabolic Activity of Liver Metastases Before and After Resection of the Primary Tumor in Patients With a Colorectal Malignancy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Neoplasms
Keywords: colorectal cancer
liver metastases
metabolic activity
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the effect of primary tumor resection on the metabolic activity of metastases in patients with a colorectal primary tumor and synchronous liver metastases by positron emission tomography (PET) with 2-deoxy-2-fluoro\[18F\]-D-glucose (FDG-PET) scanning.

Detailed description: The goal of this study is to evaluate the activity of liver metastases before and after resection of the primary tumor. Non-invasive assessment of tumor metabolism is possible in vivo by means of positron emission tomography (PET)-scanning. Therefore, FDG-PET scan offers a suitable approach to determine the influence of removal of a primary colorectal tumor on metabolic activity of the liver metastases. The FDG uptake in the liver metastases is quantified by calculating standardised uptake values (SUVs).

Eligibility criteria: Inclusion Criteria:

* Colorectal cancer and synchronous liver metastases

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Increase in metabolic activity of liver metastases after resection of the primary tumor compared to the activity of metastases in patients without primary tumor resection
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Theo Ruers, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04606082: Human Chorionic Gonadotropin Versus Granulocyte Colony Stimulating Factor in Increasing Pregnancy Rate in ICSI
Official title: Intra Uterine Injection of Human Chorionic Gonadotropin Versus Granulocyte Colony Stimulating Factor at Ovum Pick up Day Significantly Increase Implantation Rate and Pregnancy Rate in Intra Cytoplasmic Sperm Injection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fertility Disorders
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2020-10-28
Enrollment: 200
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Intrauterine Granulocyte colony stimulating factor (GCSF) was compared with intrauterine Human Chorionic Gonadotropin (HCG) in increasing clinical pregnancy rate as a primary outcome and ultrasound imaging of gestational sac as a secondary outcome.

Detailed description: Two hundred females with history of recurrent implantation failure and undergoing Intracytoplasmic Sprem injection (ICSI) were randomized into two groups; the first group (100 patients) received intrauterine Granulocyte colony stimulating factor (GCSF) and the second group (100) received intrauterine Human Chorionic Gonadotropin (HCG) at ovum pick up day. The clinical pregnancy rate was evaluated as a primary outcome after 14 days and ultrasound imaging of gestational sac was evaluated as a secondary outcome after 6 weeks.

Eligibility criteria: Inclusion Criteria:

* Females suffering from recurrent implantation failure and undergoing ICSI

Exclusion Criteria:

* presence of comorbidity as diabetes, hypertension, heart diseases, or endocrine disorders

Primary outcomes:
measure: clinical pregnancy rate
timeFrame: after 14 days from positive pregnancy test
Secondary outcomes:
measure: Gestational sac imaging
timeFrame: 6 weeks of pregnancy
Other outcomes:
Locations:
Study officials:
affiliation: Assistant professor of obstetrics and gynecology faculty of medicine Alazhar university Cairo
name: Elsayed Eldesouky
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00296582: Gastric Motor Function Measurement in Dyspepsia and Normal Subjects
Official title: Simultaneous Gastric Motor Function Measurement in Dyspepsia And Normal Subjects Ingesting a Solid-Liquid Meal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyspepsia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2006-02-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is being done to measure the functions of the stomach after eating a meal and to develop a new method that will simultaneously measure both gastric emptying and the relaxation of the stomach after a meal using nuclear medicine testing. This would make the testing more convenient for patients and will also offer better understanding of these two gastric functions.


Eligibility criteria: Inclusion criteria:

Dyspeptic Subjects:

* Recurrent episodes of upper abdominal pain or discomfort including early satiety, fullness, bloating, or nausea for at least 3 months in the prior year.
* A baseline impaired satiety test (maximum tolerated volume 25% of normal or 1000cc).
* No evidence on esophagogastroduodenoscopy of erosions, peptic ulcer, pyloric obstruction, esophagitis or malignancy in the prior 3 years.

All Subjects:

* No history suggestive of small bowel obstruction.

Exclusion criteria

* No structural or metabolic diseases/conditions that affect the gastrointestinal system.
* Unable to stop medications 48 hours prior to the study that:

  * Alter GI transit including laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics, tricyclic antidepressants, SSRI and newer antidepressants.
  * Analgesic drugs including opiates, NSAID, COX 2 inhibitors
  * Systemic antifungal drugs
  * Carbamazepine, glucocorticoids, phenobarbital, phenytoin, rifampin, but also grapefruit juice.
  * Benzodiazepines NOTE: Low stable doses of thyroid replacement, estrogen replacement, low dose aspirin for cardioprotection and birth control pills or depot injections are permissible.
* Female subjects who are pregnant or breast feeding.
* Significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric, or other disease that interfere with the objectives of the study.
* Subjects who have participated in another clinical study within the past 30 days.
* Previous gastric or intestinal surgery (except appendectomy , cholecystectomy or hysterectomy).

Primary outcomes:
measure: Fasting and postprandial gastric volumes (Gastric accommodation)
Secondary outcomes:
measure: T1/2 of gastric emptying of solid
measure: Maximum tolerated volume
measure: Individual postprandial symptom scores
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: H. Jae Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01639482: Neuroimaging Studies of the Treatment of Bipolar Depression With Citalopram
Official title: Neuroimaging Studies of the Treatment of Bipolar Depression With Citalopram
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Depression
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-07-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Bipolar Depression

Brief summary: Regional metabolic changes associated with response to 6 weeks of citalopram treatment, using 18-Fluorodeoxyglucose Positron Emission Tomography imaging, will be characterized (FDG PET).

Detailed description: Regional metabolic changes associated with response to 6 weeks of citalopram treatment, using 18-Fluorodeoxyglucose Positron Emission Tomography imaging, will be characterized (FDG PET). The following hypothesis will be tested: Antidepressant response or remission in depressed BPD patients will be associated with changes in cortical (prefrontal, parietal, premotor) and paralimbic (hippocampus, anterior cingulate, subgenual cingulate, posterior cingulate, and anterior insula) regions, consistent with SRI antidepressant response in unipolar depressed patients.

Eligibility criteria: Inclusion Criteria:

* Current age 18-64 years; DSM-IV diagnosis of BPD, type-I, or type-II; Enrolled in the Citalopram Study at Tufts Medical Center

Exclusion Criteria:

* Current pregnancy, or inability to utilize contraception, The presence of any metallic implants, History of claustrophobia

Primary outcomes:
measure: rCMRglu
timeFrame: pre and post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Massachusetts General Hospital - East
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Darin D Dougherty, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03883282: Influence of Participation in Randomized Controlled Trials on adheRence to Medicines' Intake and regUlar viSits to the docTor
Official title: Influence of Participation in Randomized Controlled Trials on Cardiovascular Patient's Adherence to Medicines' Intake and regUlar viSits to the docTor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adherence, Patient
Keywords: patient adherence, randomized clinical trials
Lead sponsor: National Medical Research Center for Therapy and Preventive Medicine
Sponsor class: OTHER_GOV
First posted: 2019-03-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients will be taken from the outpatient register PROFILE

Brief summary: A prospective non-interventional single-center study aimed to evaluate the influence of participation in international randomized controlled trials (RCT) of cardiovascular patients on their compliance and adherence to medicines' intake and regular visits to the doctor in comparison with those patients, who had never participated in RCT within the outpatient registry PROFILE (prospective, observational study).


Eligibility criteria: Inclusion criterion for study group

• All patients of the outpatient register PROFILE who participated in the international randomized clinical trials from 2011 to 2018, (n≈100).

Inclusion criterion for control group

• Patients of the outpatient register PROFILE, who from 2011 to 2018 were observed in the research center for preventive medicine and never participated in international randomized clinical trials (n≈100).

Exclusion criteria for both groups

* Patients whose life status is defined as "dead"
* Patients who refused to participate in our study

Primary outcomes:
measure: Assessment of motives of enrollment in a trial and patient's attitude to RCT based on elaborated questionnaires for both groups
timeFrame: on enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: National Research Center for Preventive Medicine
Study officials:
References: