louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06987214: REGEND001 Autologous Basal Layer Stem Cell Transplantation for Bronchiectasis: A Translational Application Study
Official title: REGEND001 Autologous Basal Layer Stem Cell Transplantation for Bronchiectasis: A Translational Application Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Bronchiectasis Adult
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 10
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical trial aims to evaluate the safety and efficacy of REGEND001, an autologous basal layer stem cell transplantation therapy, in patients with chronic structural lung disease (bronchiectasis). The treatment involves harvesting bronchial basal layer stem cells from the patient, expanding them ex vivo, and reintroducing them via bronchoscopic infusion to repair damaged lung tissue.


Eligibility criteria: Inclusion Criteria:

1. Age 25-80 years.
2. Confirmed diagnosis of bronchiectasis.
3. FEV1 ≥35% predicted; DLCO ≥30% and \<80% predicted.

Exclusion Criteria:

1. Pregnancy, lactation, or plans for pregnancy within 1 year.
2. Active malignancy or history of malignancy.
3. Positive serology for HIV, HBV, HCV, or syphilis.

Primary outcomes:
measure: Change in DLCO from baseline.
timeFrame: Baseline, 4 weeks post treatment, 24 weeks post treatment
Secondary outcomes:
measure: Change in FEV1 from baseline
timeFrame: Baseline, 4 weeks post treatment, 24 weeks post treatment
measure: Incidence of adverse events and serious adverse events.
timeFrame: Through study completion, an average of 6 months
measure: Change in HRCT lung imaging scores
timeFrame: Baseline, 4 weeks post treatment, 24 weeks post treatment
measure: Quality of life (QoL) assessment via validated questionnaires
timeFrame: Baseline, 4 weeks post treatment, 24 weeks post treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03764514: Spinal Cord Stimulation in Chemotherapy Induced Neuropathy
Official title: Effectiveness of Spinal Cord Stimulation As Therapy for Chemotherapy-Induced Peripheral Neuropathy: a Pilot Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chemotherapy-induced Peripheral Neuropathy
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary Care Clinic

Brief summary: This is an observational based pilot study evaluating the use of spinal cord stimulators for the treatment of chemotherapy induced peripheral neuropathy will lead to an increase in quality of life and decrease in pain.

Detailed description: Cancer treatment, for many patients, results in painful side effects. As evidence mounts demonstrating the risks associated with long term opioid therapy, non-opioid modalities need to be developed. Spinal cord stimulators are implanted devices that modulate the pain signaling system in the spinal cord. This research hopes to determine if the use of a spinal cord stimulator in patients with chemotherapy induced peripheral neuropathy will lead to an increase in quality of life and decrease in pain.The primary endpoints will be the number of patients who undergo permanent implantation. The endpoints will measure pain with the Brief Pain Inventory Short Form visual analog scale. The sleep quality will be measured using the Pittsburgh Sleep Quality Assessment.

Eligibility criteria: Inclusion Criteria:

• The patient has persistent, severe peripheral neuropathy secondary to chemotherapy

Exclusion Criteria:

• Refusal to undergo a spinal cord stimulator procedure

Primary outcomes:
measure: Permanent Spinal Cord Stimulator Implantation
timeFrame: 2 years
Secondary outcomes:
measure: Subjective Pain Assessment: Brief Pain Inventory-Short Form
timeFrame: 2 years
measure: Subjective Quality of Life Assessment: Pittsburgh Sleep Quality Assessment
timeFrame: 2 years
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Patewood Memorial Hospital
state: South Carolina
Study officials:
affiliation: Prisma Health-Upstate
name: Joshua Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Braun Filho JL, Braun LM. [Spinal cord stimulation in the treatment of refractory painful polineuropathy induced by chemotherapy.]. Rev Bras Anestesiol. 2007 Oct;57(5):533-8. doi: 10.1590/s0034-70942007000500008. Portuguese.
Clinical trial NCT01245114: Tübingen High Altitude Ophthalmology Study
Official title: Tübingen High Altitude Ophthalmology Study (THAO)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Altitude
Hypoxia
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2010-11-22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: healthy volunteers

Brief summary: Tuebingen High Altitude Ophthalmology Study to investigate the effects of high altitude on retinal structure and function as well as anterior chamber in regard to acute mountain sickness.


Eligibility criteria: Inclusion Criteria:

* healthy subjects, non-smokers, physical fitness,

Exclusion Criteria:

* ocular pathologies, ascent above 2000m 2 weeks prior to study and 2 weeks before post-examination

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Eye Hospital, University of Tübingen
state: BW
Study officials:
affiliation: Eye Hospital, University of Tübingen, Germany
name: Florian Gekeler, MD
role: STUDY_DIRECTOR
affiliation: Eye Hospital, University of Tübingen, Germany
name: Gabriel Willmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05717114: Dexmetomedine as an Adjuvant to Bupivacaine in Ultrasound Guided PECS Block
Official title: Efficacy of Different Doses of Dexmetomedine as an Adjuvant to Bupivacaine in Ultrasound Guided PECS Block in Patients Undergoing Modified Radical Mastectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized study
Primary purpose: PREVENTION

Brief summary: Regional anesthesia is an essential component of anesthesia and analgesia. It has many advantages, it decreases pain post operatively, improves patient outcome and allow early recovery and ambulation Post-operative pain following breast surgery results from injured muscles and nerves, management of acute post operative pain is a consistent factor for better outcome and patient satisfaction

Detailed description: All patients will be monitored by standard intraoperative monitoring that includes continuous electrocardiography (ECG), capnography, pulse oximetry, and non invasive blood pressure.

Induction of general anesthesia will be done by propofol 1.5-2 mg/kg and fentanyl 3µg/kg.

Tracheal intubation will be facilitated by administration of rocuronium 0.8 mg/kg. Anesthesia will be maintained with isoflurane 1MAC (Pecs block):the block will be performed with the patients in the supine position.The infraclavicular and axillary regions will be cleaned with antiseptic solution. the in plane technique will be used from proximal and medial to distal and lateral in an oblique manner at dermatome level T2 and T3.The puncture site was infiltrated with 2%lidocaine and once the structures is identified with Ultrasound

Eligibility criteria: Inclusion Criteria:

* adult patients
* aged 18-60years old
* ASA class 1 to 3
* scheduled for elective modified radical mastectomy

Exclusion Criteria:

* patients refusal,
* coagulopathies
* concurrent anticoagulant therapy
* allergy to local anaesthetics
* infection at puncture site

Primary outcomes:
measure: postoperative pain
timeFrame: 48 hours
Secondary outcomes:
measure: Total morphine consumption
timeFrame: 48 hours
Other outcomes:
Locations:
city: Menoufia
country: Egypt
facility: Menoufia
state: المنوفية
Study officials:
affiliation: Menoufia University
name: rabab M habeeb
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06462014: Description of Relugolix Use in Patients With Prostate Cancer Within the VHA
Official title: Description of Relugolix Use in Patients With Prostate Cancer: An Analysis of National Veterans Affairs Health Care Network Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Relugolix
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-06-17
Enrollment: 500
Sex: MALE
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: Men who are part of this study initiated relugolix as part of their usual treatment for PC

Brief summary: The purpose of this real-world study is the learn about the demographics and clinical characteristics of patients with prostate cancer who initiated relugolix

Detailed description: Prostate cancer (PC) is the most common cancer and the second leading cause of cancer death among men in the United States. Androgen deprivation therapy (ADT) such as injectable luteinizing hormone-releasing hormone (LHRH) agonists (e.g., leuprolide) is the standard of care for PC patients. ADT treatment can suppress testosterone level to castrate level and delay the progression of the disease.

Relugolix is a recently approved oral GnRH antagonist. While the introduction of relugolix has offered a unique opportunity for patients with PC, it's vital to understand how it is being used in real-world.

Eligibility criteria: Inclusion Criteria:

* Male with ≥ 1 diagnosis for PC
* Had ≥ 2 prescriptions of relugolix on or after the first observed PC diagnosis.
* Index date: the initiation date of relugolix
* At least 18 years old at the index date

Exclusion Criteria:

* had surgical castration (bilateral orchiectomy) any time before the index date

Primary outcomes:
measure: Characterize patient characteristics initiating relugolix treatment
timeFrame: Up to 1 year prior to initiating relugolix
measure: Characterize clinical characteristics of patients intitiating relugolix treatment
timeFrame: Up to 1 year prior to initiating relugolix
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Pfizer
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04957914: A Study of LY3209590 on Low Blood Sugar in Participants With Type 2 Diabetes Mellitus
Official title: Effects of LY3209590 on Frequency and Severity of Hypoglycaemia Under Conditions of Increased Hypoglycaemic Risk Compared to Insulin Glargine in Participants With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2021-07-12
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to evaluate the effect of study drug known as LY3209590 compared to insulin glargine administered in participants with type 2 diabetes mellitus (T2DM). Side effects and tolerability will be documented. The study will last almost six months and 21 visits for each participant including screening period.


Eligibility criteria: Inclusion Criteria:

* Have been diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 1 year prior to screening
* Body mass index (BMI) of 18.5 to 40.0 kilograms per meter squared (kg/m²)
* Be treated for T2DM with stable dose of metformin, a stable dose of a dipeptidyl peptidase-4 (DPP-4) inhibitor with or without metformin, or a stable dose of a glucagon-like peptide-1 (GLP-1) receptor agonist with or without metformin for at least 3 months prior to screening

Exclusion Criteria:

* Have an abnormality in the 12-lead ECG
* Have a supine blood pressure at screening
* Have alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5x upper limit of normal (ULN)
* Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (except T2DM and controlled thyroid disease), haematological, or neurological disorders
* Are receiving chronic (lasting longer than 14 consecutive days) systemic or inhaled glucocorticoid therapy
* Have an average weekly alcohol intake

Primary outcomes:
measure: Incidence of Documented Hypoglycemia
timeFrame: Baseline through Day 186
Secondary outcomes:
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Profil Institut für Stoffwechselforschung
state: Nordrhein-Westfalen
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06631014: Effect of Early Prosthetic Fitting in Patients With Below Knee Amputation
Official title: Effect of Early Prosthetic Fitting in Patients With Below Knee Amputation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Amputation of Knee
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 50
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: A randomized control trial of 50 patients to identify the effect of early prosthetic fitting and physical rehabilitation. Previous studies show a significant impact of early induction of prosthetic rehabilitation of amputation.

Detailed description: Delayed rehabilitation may cause severe physical complications like joint contracture, muscle strength loss. Along with physical complications delayed in rehabilitation may also significantly affect psychological, economical and quality of daily life. Pakistan is a low income under developed country and major cause of amputation in here is traumatic amputation, that will effect mostly the younger age people. After missing a precious body part if the amputee comes along with such kind of physical and Psychological complications, his/her whole daily life will be effected. There is a keen need of implementation of global rules for physical rehabilitation of amputees and disables including the duration of induction of prosthetic as well as overall physical rehabilitation after surgical and traumatic removal of limbs.

Eligibility criteria: Inclusion Criteria:

* Male and female below-knee amputees due to trauma and diabetes

Exclusion Criteria:

* patients with comorbidities
* old user of prosthesis

Primary outcomes:
measure: World Health Organization Quality of life (WHO QOL)
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Dera Ismāīl Khān
country: Pakistan
facility: Mobility Rehab care, Islamabad Medical Center, Near DHQ D.I.Khan
state: Khyber Pakhtunkhwa
Study officials:
References:
Clinical trial NCT06820814: The Association Between Physical Symptoms and Depression Among Medical Students in Egypt
Official title: The Association Between Physical Symptoms and Depression Among Medical Students in Egypt
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression Anxiety Disorder
Physical Disorders
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 155
Sex: ALL
Minimum age (years): 19
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Medical students enrolled in any medical program in Egypt.

Brief summary: To examine the association between depression and physical symptoms among medical students in Egypt.

Detailed description: The Google Form will be open for one week from the start of the academic term. It is divided into three parts:

Demographic Data - which includes age, academic level, relationship status, and whether the student intends to work while studying.

Patient Health Questionnaire PHQ-9: Assesses symptoms of poor mental health in the two weeks prior to the start of term.

Patient Health Questionnaire PHQ-15: This is a measure of physical symptoms felt in the week prior to the commencement of the academic term.

The questionnaire will be distributed among different medical faculties in Egypt and all students will be required to fill it out. Data analysis will be done through SPSS to explore the relationship between psychological and physical symptoms.

Eligibility criteria: Inclusion Criteria:

* Medical students enrolled in any medical program in Egypt.
* Age range: Typically 19 to 30 years (or based on your study's demographic focus).
* Willingness to participate and provide informed consent.
* Self-reported symptoms of depression: Those who indicate moderate to severe symptoms on screening tools (e.g., PHQ-9).
* Physical symptoms: Those who report experiencing physical symptoms (e.g., headaches, fatigue, gastrointestinal discomfort, etc.) on a checklist.

Exclusion Criteria:

* Non-medical students (students outside of the medical program).
* Students with a history of major medical conditions that may confound the physical symptoms (e.g., chronic diseases like diabetes, hypertension, or neurological disorders).
* Students with a diagnosed psychiatric disorder (e.g., bipolar disorder, schizophrenia, etc.) or those already undergoing psychiatric treatment.
* Non-consenting individuals: Students who decline to participate in the study or do not provide informed consent.
* Incomplete responses: Students who fail to provide adequate or valid responses in the questionnaires.

Primary outcomes:
measure: PATIENT HEALTH QUESTIONNAIRE (PHQ-9)
timeFrame: 1 week
measure: PATIENT HEALTH QUESTIONNAIRE PHYSICAL SYMPTOMS (PHQ-15)
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
state: Giza
Study officials:
References:
Clinical trial NCT01949714: Effect of Chronic Catecholamine Overproduction on Brown Adipose Tissue
Official title: Effect of Chronic Catecholamine Overproduction on Brown Adipose Tissue
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pheochromocytoma
Adrenal Incidentaloma
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2013-09-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with adrenal tumors

Brief summary: * To investigate the effect of catecholamine excess on brown fat.
* To evaluate the effect of brown fat on energy expenditure and lipid and glucose metabolism


Eligibility criteria: Inclusion Criteria:

* 10 patients with pheochromocytoma
* 5 patients with incidentaloma without hormone production
* Age \> 18 years

Exclusion Criteria:

- None

Primary outcomes:
measure: [18F]FDG uptake in brown adipose tissue
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Department of Endocrinology MEA, Aarhus Hospital
state: Please Select
Study officials:
References:
Clinical trial NCT00678314: Patient Controlled Regional Analgesia Following Carpal Tunnel Release: A Double-Blind Study Using Distal Perineural Catheters
Official title: Patient Controlled Regional Analgesia Following Carpal Tunnel Release: A Double-Blind Study Using Distal Perineural Catheters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Carpal Tunnel Syndrome
Keywords: Anesthetics
Local
ropivacaine
Surgery
Hand
carpel tunnel
Carpal tunnel surgery
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2008-05-15
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was done with the primary aim of assessing the efficacy (as calculated by pain intensity difference) of patient controlled regional analgesia (PCRA) technique against oral analgesics, which has been the standard of care at our hospital. Secondary objectives were to analyze the volume and dose of LA that should be given, patient satisfaction and the long-term outcome for patients treated with the PCRA technique.


Eligibility criteria: Inclusion Criteria:

* Patients with clinically established carpel tunnel syndrome
* Surgery performed under local anesthesia

Exclusion Criteria:

* Chronic pain requiring analgesics

Primary outcomes:
measure: This study was done with the primary aim of assessing the efficacy (as calculated by pain intensity difference) of patient controlled regional analgesia (PCRA) technique against oral analgesics, which has been the standard of care at our hospital.
timeFrame: 24 h
Secondary outcomes:
measure: Secondary objectives were to analyze the volume and dose of LA that should be given, patient satisfaction and the long-term outcome for patients treated with the PCRA technique.
timeFrame: Up to 1 yr after surgery
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Örebro University Hospital
Study officials:
affiliation: Institution for Clinical Medicine
name: Kurt Pettersson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: