louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01339429: Simplified Negative Pressure Wound Therapy
Official title: Evaluation of the Performance and Safety of a Simplified Negative Pressure Wound Therapy Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Wounds
Keywords: wound
negative pressure wound therapy
non-powered negative pressure wound therapy
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Center for Integration of Medicine & Innovative Technology
name: Fogarty International Clinical Research Scholarship
First posted: 2011-04-20
Enrollment: 41
Sex: ALL
Minimum age (years): 14
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to implement a simplified Negative Pressure Wound Therapy (sNPWT) device in a low resource setting. The investigators hypothesize that the sNPWT device is at least equivalent to commercially available NPWT devices. Therefore, the specific aims of this study will be to measure: 1. the mechanical properties of the sNPWT device and 2. the adverse events associated with the sNPWT device.


Eligibility criteria: Inclusion Criteria:

* open wound appropriate for NPWT
* wound size greater than 2 cm2 and less than 150 cm2
* adequate adjacent intact skin for application of sNPWT
* adequate contour of wound location for application of sNPWT
* patient is expected to tolerate change of the NPWT dressing with the chosen analgesia and sedation plan by the treating physician
* the patient is expected to remain clinically stable for the duration of the study
* the patient is to remain hospitalized for the duration of the study
* patient or their legal representative is willing and able to sign an IRB-approved informed consent
* patient less than 21 years old is willing to sign an approved assent form if able to sign

Exclusion Criteria:

* exposed blood vessels
* ischemic wound
* wound with necrotic tissue requiring further debridement at the time of enrollment
* infection
* acute osteomyelitis
* malignancy in the wound
* latex or rubber containing product sensitivity

Primary outcomes:
measure: Maintenance of Negative Pressure
timeFrame: 3 days
Secondary outcomes:
measure: Number of Participants With Serious Adverse Events
timeFrame: 3 days
Other outcomes:
Locations:
city: Rwinkwavu
country: Rwanda
facility: Rwinkwavu Hospital
state: Kayonza District
city: Kigali
country: Rwanda
facility: Central University Teaching Hospital in Kigali
Study officials:
affiliation: Brigham and Women's Hospital
name: Robert Riviello, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mody GN, Zurovcik DR, Joharifard S, Kansayisa G, Uwimana G, Baganizi E, Ntakiyiruta G, Mugenzi D, Riviello R. Biomechanical and safety testing of a simplified negative-pressure wound therapy device. Plast Reconstr Surg. 2015 Apr;135(4):1140-1146. doi: 10.1097/PRS.0000000000001101.
Clinical trial NCT05087329: Mindfulness Practice in Pregnancy As an Intervention to Decrease Prenatal Stress During the COVID-19 Pandemic
Official title: Mindfulness Practice in Pregnancy As an Intervention to Decrease Prenatal Stress During the COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prenatal Stress
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to examine whether a simple mindfulness intervention conducted via a virtual platform can reduce stress among pregnant women.


Eligibility criteria: Inclusion Criteria:

1. Women between 16w0d-26w6d gestation with a single gestation who have had a confirmed dating ultrasound

   a. Only women with singleton gestations will be included because multiple gestation pregnancies introduce additional levels of stress and introduce confounding variables for the adverse composite pregnancy outcome that will be measured. As this is a study of pregnant patients, only women are included.
2. English speaking

   a. The mindfulness meditation trainings have been scripted and recorded in English. Thus, to understand the recordings and participate in the courses it is necessary for all participants to speak English.
3. Regular internet access through either phone, tablet or computer. a. Mindfulness meditations are administered via Zoom webinars so internet access is required. A proxy for internet access during recruitment will be confirmed by the inclusion of an email address in the electronic medical record (EMR).

Exclusion Criteria:

1. Multiple gestations. This has been chosen as an exclusion criteria to limit confounding variables for the secondary outcome of composite adverse pregnancy events.
2. Age \< 18

Primary outcomes:
measure: Decrease in Maternal Stress
timeFrame: 6 to 8 weeks
Secondary outcomes:
measure: Composite score of maternal morbidity/pregnancy outcomes
timeFrame: 6 to 8 weeks post-delivery
measure: Change in score on Edinburgh Postnatal Depression Scale
timeFrame: change between score at time of delivery and 6 weeks
Other outcomes:
Locations:
city: Philadephia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT05685329: Determining Patterns In Trial Experiences of Parkinson's Disease Patients
Official title: An In Depth Study Examining Patterns in the Clinical Trial Experiences of Parkinson's Disease Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Parkinson Disease
Keywords: Parkinson's Disease
Parkinson's
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-01-17
Enrollment: 500
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Parkinson's Disease who are actively considering enrolling in an interventional clinical trial for said condition, but have not yet completed enrollment and randomization phases in said clinical trial.

Brief summary: Historically, participation in clinical studies is highly skewed towards particular demographic groups of people.

This study will invite several participants to gather a wide range of information on clinical trial experiences for Parkinson's Disease patients. The aim of the study is to identify the factors that limit the ability of a person to enroll in, as well as complete a clinical trial for treatment of Parkinson's Disease.

The data collected from this study will help improve future outcomes for all Parkinson's Disease patients as well as those in under-represented demographic groups.


Eligibility criteria: Inclusion Criteria:

* Patient plans to participate in an interventional clinical trial for the condition of Parkinson's Disease
* Patient has been diagnosed with a type of Parkinson's Disease
* Patient is at least 50 to 80 years of age
* Patient has access to a home internet connection in order to provide regular updates through the course of the study

Exclusion Criteria:

* Patient has an ECOG score of 4 or higher
* Patient is not able to provide consistent digital updates as per study requirements
* Patient does not complete or agree to terms outlined in the Informed Consent Form

Primary outcomes:
measure: Number of patients who decide to enroll in an Parkinson's Disease clinical trial
timeFrame: 3 months
measure: Rate of patients who remain in Parkinson's Disease clinical trial to trial completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Reich SG, Savitt JM. Parkinson's Disease. Med Clin North Am. 2019 Mar;103(2):337-350. doi: 10.1016/j.mcna.2018.10.014. Epub 2018 Dec 3.
citation: Armstrong MJ, Okun MS. Diagnosis and Treatment of Parkinson Disease: A Review. JAMA. 2020 Feb 11;323(6):548-560. doi: 10.1001/jama.2019.22360.
citation: McFarthing K, Rafaloff G, Baptista M, Mursaleen L, Fuest R, Wyse RK, Stott SRW. Parkinson's Disease Drug Therapies in the Clinical Trial Pipeline: 2022 Update. J Parkinsons Dis. 2022;12(4):1073-1082. doi: 10.3233/JPD-229002.
Clinical trial NCT05336929: Roy Adaptation Model in People With Type 1 Diabetes
Official title: Effect of Roy Adaptation Model on Metabolic Control in Adolescents With Type 1 Diabetes: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Adolescent
Lead sponsor: Balikesir University
Sponsor class: OTHER
Collaborators: name: Uludag University
First posted: 2022-04-20
Enrollment: 60
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study was conducted to determine the effect of Roy adaptation model-based education on disease compliance and metabolic control in adolescents with Type 1 diabetes.

Detailed description: This study was designed as a randomized controlled study. A total of 60 adolescents, training (n=30) and control (n=30) that meet the research criteria were divided by random method. Pre-training data of the groups were collected using the "Sociodemographic Form", "Diabetes Information Evaluation Form" and "Roy Adaptation Model Interview Form" and HbA1c values were recorded. The training group was trained on the Roy Adaptation Model by a month break, in two sessions. After the training, the adolescents in the training group were given a curvature booklet based on the Roy Adaptation model. The control group was not intervened. After the training, the diabetes Information Assessment Form and the Roy Adaptation Model Discussion Form have applied to both groups again and the values of HbA1c were recorded.

Eligibility criteria: Inclusion criteria:

1. Having type 1 diabetes
2. Must be between the ages of 11-18
3. volunteering for research

Exclusion criteria

1. Presence of mental disability
2. To have received training on the content of the study

Primary outcomes:
measure: HbA1c values
timeFrame: 3 month
Secondary outcomes:
measure: Diabetes Knowledge Level
timeFrame: baseline and 2nd month
Other outcomes:
measure: Roy Adaptation Model Interview results
timeFrame: baseline and 2nd month
Locations:
Study officials:
affiliation: sibel.ergun@balikesir.edu.tr
name: sibel ergün, Assoc. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06127329: Efficacy and Safety of BAI Combined With DEB-BACE of EqualSpheres in the Treatment of Advanced NSCLC
Official title: Efficacy and Safety of Bronchial Infusion Chemotherapy Combined With Drug-loaded Microsphere Embolization of EqualSpheres in the Treatment of Advanced Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Carcinoma, Non-Small Cell Lung
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, single-arm, open-label study designed to evaluate the efficacy and safety of bronchial infusion chemotherapy（BAI） combined with drug-loaded microsphere embolization of EqualSpheres in advanced Non-small cell lung cancer (NSCLC). Progression-free survival (PFS) will be evaluated as the primary endpoint.


Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years old, male and female;
2. According to the Guidelines for the Diagnosis and Treatment of Primary Lung Cancer (2022 edition), the patient was diagnosed with NSCLC by imaging and histopathology;
3. TNM stages were III-IV;
4. Newly diagnosed, first-line treatment failure, refusal or inability to perform conventional treatment (surgery, chemoradiotherapy);
5. ECOG PS ≤2;
6. Expected survival \> 3 months;
7. Sign the informed consent voluntarily, and the compliance is good.

Exclusion Criteria:

1. Previously received interventional therapy (iodine particle implantation, ablation, TACE treatment);
2. Combined with extensive and uncontrolled extrapulmonary metastases, such as liver metastasis, bone metastasis, and brain metastasis;
3. Have had or currently having other primary malignant tumors;
4. White blood cell \< 3×109/L, platelet count \< 50×109/L, HGB \< 90 g/L;
5. Hepatic and renal insufficiency (creatinine \> 2 mg/L; AST and/or ALT \> 2 times the normal upper limit);
6. Coagulation dysfunction (INR \> 1.5) or known bleeding disease (except lung cancer combined with hemoptysis), or anticoagulation therapy;
7. Patients with active infection requiring antibiotic treatment;
8. Uncontrolled hypertension, diabetes, and cardiovascular disease with obvious symptoms;
9. contrast agent allergy;
10. Women with pregnancy or lactation.

Primary outcomes:
measure: PFS
timeFrame: up to 3 years
Secondary outcomes:
measure: ORR
timeFrame: up to 3 years
measure: Overall survival (OS)
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Gang Wu
state: Henan
Study officials:
References:
Clinical trial NCT06776029: Fecal Microbiota Transplantation for Radiation-Induced Proctopathy
Official title: A Prospective, Single-Arm Trial of Fecal Microbiota Transplantation for Hemorrhagic Radiation-Induced Rectal Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Radiation Induced Proctitis
Keywords: fecal microbiota transplantation
rectal bleeding
radiation proctitis
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this single-arm trial is to learn if Fecal Microbiota Transplantation (FMT) works to treat hemorrhagic radiation-induced proctopathy. The main questions it aims to answer are:

* Dose FMT alleviate the symptom of severe rectal bleeding?
* Dose FMT improve the endoscopic findings of proctopathy?

Participants will:

* Take fecal microbiota capsules by 8 sessions over a 12-week period.
* Visit the clinic once every 4 weeks for checkups and tests.
* Keep a diary of their symptoms and the number of times they use other supportive care.


Eligibility criteria: Inclusion Criteria:

* Age: 18-75 years old
* At least 3 months since the completion of pelvic radiotherapy
* No evidence of tumor recurrence or metastasis
* Rectal bleeding with grade 2-4 by LENT-SOMA scales
* Colonoscopy indicating rectal congested mucosa or telangiectasia
* Poor response to supportive care, or hemoglobin level less than or equal to 70 g/L in the past 3 months

Exclusion Criteria:

* Acute or chronic infectious diseases
* Serious systemic diseases
* Known allergies to any components of the study medication
* Colonoscopy indicating rectal ulceration (\>1cm2), fistula, stricture, or necrosis
* Late complications related to pelvic radiation injury
* Other hemorrhagic or coagulation disorders
* Previous rectal resection
* Bowel obstruction or perforation that require surgery
* Cognitive or psychological disorder
* Contraindications to FMT administration

Primary outcomes:
measure: Number of participants with mild rectal bleeding (grade 0-1)
timeFrame: At the time of 12 weeks since the start of treatment
Secondary outcomes:
measure: Number of participants with mild rectal bleeding (grade 0-1)
timeFrame: At the time of 24 weeks since the start of treatment
measure: Number of participants with improved colonoscopic findings
timeFrame: At the time of 12 and 24 weeks since the start of treatment
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT04183829: Effects of Prior Induced Termination of Pregnancy on Complications and Pregnancy Outcomes.
Official title: Effects of Prior Induced Termination of Pregnancy on Complications and Pregnancy Outcomes.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Reproductive Health
Lead sponsor: National Research Institute for Family Planning, China
Sponsor class: OTHER_GOV
First posted: 2019-12-03
Enrollment: 20000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women who have induced abortion in early pregnancy (\<12 weeks of gestation)

Brief summary: A prospective multicenter cohort study to evaluate effects of prior induced termination of pregnancy on complications and pregnancy outcomes.

Detailed description: A prospective multicenter cohort study to evaluate effects of prior induced termination of pregnancy on complications and pregnancy outcomes.

Eligibility criteria: Inclusion Criteria:

* women have induced abortion in early pregnancy (\<12 weeks of gestation).
* permanent population and no tendency to move.
* normal language expression and understanding ability, able to understand research content.
* be able and willing to provide written informed consent and effective contact information, and be willing to cooperate with follow-up investigations.

Exclusion Criteria:

* above the age of 40
* with history of adverse pregnancy and childbirth

Primary outcomes:
measure: adverse pregnancy outcomes
timeFrame: 2021.6
Secondary outcomes:
measure: Complications
timeFrame: 2020.6
Other outcomes:
Locations:
city: Zhongshan
country: China
facility: Zhongshan Boai Hospital
state: Guangdong
city: Zhangjiakou
country: China
facility: Zhangjiakou Maternal and Child Health Hospital
state: Hebei
city: Daqing
country: China
facility: Daqing People's Hospital
state: Heilongjiang
city: Changzhou
country: China
facility: Changzhou Maternal and Child Health Hospital
state: Jiangsu
city: Yangzhou
country: China
facility: Yangzhou Maternal and Child Health Hospital
state: Jiangsu
city: Hohhot
country: China
facility: People's Hospital of Inner Mongolia Autonomous Region
state: Mongolia Autonomous
city: Qingdao
country: China
facility: Qingdao Maternal and Child Health Hospital
state: Shandong
city: Zaozhuang
country: China
facility: Zaozhuang Maternal and Child Health Hospital
state: Shandong
city: Taiyuan
country: China
facility: Taiyuan Maternal and Child Health Hospital
state: Shanxi
city: Tanggu
country: China
facility: Tanggu Maternal and Child Health Hospital
state: Tianjin
Study officials:
affiliation: National Research Institute for Family Planning (NRIFP)
name: Pei Kaiyan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00584129: Pre-treatment Exercises Versus Post-treatment Exercises for Dysphagia
Official title: Determining the Efficacy of Pre-treatment Swallowing Therapy as a Means to Improve Dysphagia Quality of Life When Compared to Post-Treatment Therapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Keywords: Cancer
Dysphagia
Radiation
Patients with H&N cancer who will be receiving chemoradiation
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: American Academy of Otolaryngology-Head and Neck Surgery Foundation
First posted: 2008-01-02
Enrollment: 52
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this project is to determine if pre-treatment swallowing exercises can improve post-treatment swallowing function in patients undergoing radiation with or without chemotherapy for advanced squamous cell carcinoma of the head and neck.


Eligibility criteria: Inclusion Criteria:

* Stage III or IV squamous cell cancer of teh pharynx and larynx
* Patients who will be receiving chemoradiation
* Age 19 years of age or older
* Must sign informed consent.

Exclusion Criteria:

* Prior cancer diagnosis
* Metastatic disease
* Cognitive Impairment

Primary outcomes:
measure: To test whether pre-treatment swallowing exercises compared with "usual care" (where exercises are taught post-treatment) improves quality of life in patients undergoing chemoradiation therapy for advanced head and neck cancer.
timeFrame: 8 weeks, 6 months, 12 months post radiation treatment
Secondary outcomes:
measure: To test whether pre-treatment swallowing exercises compared with usual care improves secondary outcome measures related to dysphagia in this patient population.
timeFrame: 8 weeks, 6 mnths and 12 months post radiation.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Division of Otolaryngology
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: William R. Carroll, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01927029: Preterm Delivery Prevention in Twins With Progesterone
Official title: Prevención de Parto Prematuro en Gemelares: Ensayo Aleatorio Con Progesterona Vaginal.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pregnancies
Keywords: twin pregnancy
progesterone
preterm delivery
>14 years
Abscense of cerclage,
TTTS, hemorrage,
history of thrombosis.
cervix >15mm
Lead sponsor: Universidad del Desarrollo
Sponsor class: OTHER
Collaborators: name: Hospital Padre Hurtado
name: Hospital San Borja-Arriaran
First posted: 2013-08-21
Enrollment: 213
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Twin pregnancies have very high preterm delivery rate. Until now, no RCT has proven benefit of progesterone in this population. In contrast, singleton pregnancies are treated with this hormone. The objective is to compare 180mg/day progeterone vaginal gel with 180mg/day with placebo, from 18 weeks to 34 weeks. The sample size was calculated and 213 cases in each group are needed to demonstrate a reduction of preterm delivery \<34weeks from 13% to 7%.


Eligibility criteria: Inclusion Criteria:

* Monochorionic or Dichorionic twin pregnancies
* 18 weeks to 24 weeks at inclusion.

Exclusion Criteria:

* Cerclage before inclusion
* Contractions, rupture of the membranes, cervix dilation,
* Short cervix (15mm or 20mm if there is history of preterm delivery
* Monoamniotic twins, Major malformation, Selective IUGR, TRAP, TTTS.
* Younger than 14 years.

Primary outcomes:
measure: Preterm delivery <34 weeks
timeFrame: 14 months
Secondary outcomes:
measure: Preterm delivery <37 weeks
timeFrame: 14 months
Other outcomes:
measure: Neonatal mortality
timeFrame: 14 months
Locations:
Study officials:
References: