louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00034515: A Study in Adult and Pediatric Patients With Cystic Fibrosis
Official title: Ph 1b/2a Study to Assess Levels of INS37217 and Placebo Treatment With Maximum Tolerated Dose Administered by Inhalation Via the Pari LC Star Nebulizer in Adult and Pediatric CF Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cystic Fibrosis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2002-04-30
Enrollment: 63
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this ascending dose group study is to assess the safety, tolerability, and effects of multiple dose levels of INS37217 and placebo followed by five days twice daily treatment with maximum tolerated dose administered by inhalation via the Pari LC Star nebulizer in adult and pediatric patients with cystic fibrosis


Eligibility criteria: Inclusion Criteria:

* FEV1 40-70% (adults)
* FEV1 \>/=50% (pediatrics)
* oxygen saturation \>90%
* clinically stable
* willing to stay overnight

Exclusion Criteria:

* abnormal renal or liver function
* receiving corticosteroids exceeding 10mg/day or 20 mg every other day
* received intravenous or aerosolized antibiotics 1 week prior to dosing

Primary outcomes:
measure: assess safety and tolerability
Secondary outcomes:
measure: assess effects of INS37217 on sputum weight and symptoms
Other outcomes:
Locations:
Study officials:
name: Amy Schaberg, BSN
role: STUDY_DIRECTOR
References:
citation: Deterding R, Retsch-Bogart G, Milgram L, Gibson R, Daines C, Zeitlin PL, Milla C, Marshall B, Lavange L, Engels J, Mathews D, Gorden J, Schaberg A, Williams J, Ramsey B; Cystic Fibrosis Foundation Therapeutics Development Network. Safety and tolerability of denufosol tetrasodium inhalation solution, a novel P2Y2 receptor agonist: results of a phase 1/phase 2 multicenter study in mild to moderate cystic fibrosis. Pediatr Pulmonol. 2005 Apr;39(4):339-48. doi: 10.1002/ppul.20192.
Clinical trial NCT00223015: Investigation of the Steady State Pharmacokinetics of Tacrolimus, Mycophenolate Mofetil and Fluvastatin After Renal Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Transplantation
Keywords: renal transplantation
pharmacokinetics
Fluvastatin
Mycophenolat mofetil
tacrolimus
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Steady state pharmacokinetics of tacrolimus, mycophenolat mofetil and fluvastatin in renal transplant patients are investigated to look for potential interaction between these drugs.

All patient enrolled in this PKI-Study had no changes in the therapy before or because of the study. Only patients without changes more than 4 weeks were included


Eligibility criteria: Inclusion Criteria:

* renal transplant patients (18 - 65 years, inclusive)
* cadaver and living renal transplants(1. Ntx, 2. Ntx)
* Immunsuppression: Tacrolimus with or without Mycophenolat Mofetil und and fluvastatin Fluvastatin for a minimum of three months
* writen informt consent by the patient

Exclusion Criteria:

* contraindications for statins
* pregnancy or lactating
* elevated liver or muscle encymes (\> 2x up to normal values: AST, ALT, bilirubine, CPK)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Schleswig-Holstein, campus Kiel Department odf Nephrology
name: Lutz Renders, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02202915: CBT for Pediatric OCD: Community Training Pilot
Official title: CBT for Pediatric OCD: Community Training Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive Compulsive Disorder
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2014-07-29
Enrollment: 46
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study examines a training program for clinicians who work in mental health clinics that serve children with OCD. We will provide clinician training in conducting exposure-based treatments for children with OCD. The purpose of the project is to test the use of a new tool to enhance training in exposure-based treatments for clinicians. Therapists will receive training and oversight from the researchers regarding the treatment procedures and use of the new tool. All children enrolled in the study will receive treatment by clinicians who are participating in this study. Therapists and youth will be recruited separately for the study and will be assigned to work together.


Eligibility criteria: Inclusion Criteria:

* Obsessive Compulsive Disorder is primary diagnosis

Exclusion Criteria:

* Diagnosis of Psychosis, Pervasive Developmental Disorder, or Mental Retardation

Primary outcomes:
measure: Observed therapist behaviors
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: East Providence
country: United States
facility: Bradley Hospital
state: Rhode Island
Study officials:
References:
Clinical trial NCT06880315: LLM-Generated Coaching Prompts
Official title: Enhancing Physical Activity with LLM-Generated Coaching Prompts: a My Heart Counts Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Exercise
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This pilot study aims to evaluate whether personalized coaching prompts generated by a large language model (LLM) can effectively increase physical activity levels among participants. The study will involve 50 participants who will receive daily text messages, either personalized by the LLM or generic, over a 14-day period. Participants will share their HealthKit data for analysis. The findings will inform the development of future versions of the My Heart Counts application, enhancing user engagement and health outcomes.


Eligibility criteria: Inclusion Criteria:

* Age: Participants must be 18 years or older.
* Health Status: Participants must be healthy enough to engage in physical activity.
* Language Proficiency: Participants must be able to read, understand, and consent in English or Spanish (dependent on which is being studied).
* Device Ownership: Participants must possess an iPhone and an Apple Watch.
* Data Sharing: Participants must be willing to share their HealthKit data via secure upload.

Exclusion Criteria:

* Age: Participants under the age of 18.
* Health Status: Participants who are not healthy enough to engage in physical activity.
* Language Proficiency: Participants who cannot read, understand, or consent in English or Spanish.
* Device Ownership: Participants who do not have both an iPhone and an Apple Watch.
* Data Sharing: Participants unwilling to share their HealthKit data via secure upload.

Primary outcomes:
measure: Physical Activity Levels
timeFrame: 14 days from enrollment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06598215: Hybrid Duckett vs Modified Duckett Urethroplasty for Proximal Hypospadias
Official title: Hybrid Duckett Urethroplasty Versus Modified Single Stage Duckett Uteothroplasty for Management of Proximal Hypospadias: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Proximal Hypospadias
Modified Duckett Urethroplasty
Keywords: proximal hypospadias
staged repair
Duckett urethroplasty
urethrocutaneous fistula
chodree
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 43
Sex: MALE
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: proximal hypospadias presents a serious anomaly for both infants and their care givers. a variety of techniques were described through decades. None of them is completely curable. hundred of modifications were adopted to the original techniques. during the current study, we will do hybrid Duckett urethroplasty which is a staged procedure and compare it to modified Duckett urethroplasty which is a single stage procedure.

Detailed description: two groups of infants diagnosed with proximal hypospadias will be allocated in two groups. group A will include cases of who will be operated upon using hybrid Duckett urethroplasty. group B will include patients who will be operated upon using modified duckett urethroplasty.

recruitment in either group will be done using sealed envelop method. in group A patient will have a double face Duckett tube which will be transferred to the ventral of the penis. the tube will be secured in place however, no proximal anastomosis with the meatus. the anastomosis will be scheduled six months later. In group B patients a double face Duckett tube will be transferred to the ventral aspect of the penis with completion of the anastomosis with the proximal meatus at the same session. the primary out come will be completion of the procedure and restoration of the urethral continuity. secondary out come will the cosmetic appearance

Eligibility criteria: Inclusion Criteria:

* all infants and children with proximal hypospadias

Exclusion Criteria:

* disorders of sex developments
* previous penile surgery
* circumcised children
* crippled penis
* refusal of the plan of the management by the care givers

Primary outcomes:
measure: repair of proximal hypospadias without fistula
timeFrame: six months post operative
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
state: Elgharbeya
Study officials:
References:
Clinical trial NCT00273715: Study of Sutures Versus Staples for Skin Closure After Surgical Procedures of Hip
Official title: A Comparative Randomized Efficacy Study of Sutures Versus Staples in Hip Surgical Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Surgery
Keywords: Comparative
Randomized
Suture
Staples, surgical
Skin
Surgical procedures, operative
Orthopedics
Joint, hip
Surgical procedures of Hip, Operative
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2006-01-09
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Skin closure either by sutures or staples is required after any surgical procedure of the hip.

The purpose of this study is to compare the amount of drainage between patients who have had either staples or sutures placed for skin closure.

Detailed description: Skin closure either by sutures or staples is required after any surgical procedure of the hip.

The purpose of this study is to compare the amount of drainage between patients who have had either staples or sutures placed for skin closure.

Eligibility criteria: Inclusion Criteria:

* The patient must be 18 years of age or greater
* The patient must need an operative procedure of hip

Exclusion Criteria:

* Patients who are unable to undergo surgery.
* Patients who have a history of clotting or bleeding abnormalities.
* Patients who have arthroscopic hip surgery.
* Patients who have infections.

Primary outcomes:
measure: Amount of drainage from skin closure site
timeFrame: up to 5 days following surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center
state: Kentucky
Study officials:
affiliation: University of Kentucky Department of Orthopaedic Surgery
name: Jeffrey Selby, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03129815: Effectiveness of the Routine Use of Extubation Protocol on the Incidence of Occurrence of Failures Number of Extubation in Pediatric Resuscitation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Insufficiency
Keywords: extubation
pediatric resuscitation
reintubation
failures of extubation.
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 70
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children hospitalized in pediatric intensive care, under 18 years, intubated, ventilated for more than 2 hours and for which planning extubation or intubated children for whom an unplanned extubation just happened.

Brief summary: The failure of extubation in pediatric resuscitation is most often described as the need for reintubation within 48 hours after extubation. The failure rate of extubation in pediatric intensive care varies in the literature there is between 4 and 22% failures. These failures result in increased mortality, morbidity with a use of larger tracheostomy, a prolonged residence time. The extubation is codified in adult resuscitation and tends to be increasingly in pediatric resuscitation. In the pediatric intensive care unit of Hautepierre, a extubation protocol already exists for some time, and was prepared to go. the current literature data. It allows the harmonization of practices in service (previously left to the discretion of each doctor).

The investigators are looking to see if the protocol used systematically in the service enables a reduction in the incidence of occurrence of failures of extubation.


Eligibility criteria: Inclusion Criteria:

* Children hospitalized in pediatric intensive care, under 18 years, intubated, ventilated for more than 2 hours and for which planning extubation or intubated children for whom an unplanned extubation just happened.
* Children whose holding parental authority are not opposed to the use of clinical data from their child for research purposes.

Exclusion Criteria:

* Refusal to participate in the study

Primary outcomes:
measure: Failure of extubation
timeFrame: need for a new intubation within the first 48 hours after extubation
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Reanimation Pediatrique Specialisee - S. Continue
state: F
Study officials:
References:
Clinical trial NCT05720715: Clinical Outcomes of Cyclosporine Eye Drops in Management of Herpetic Keratitis
Official title: Evaluation of the Safety and Efficacy of Cyclosporine A 0.05% Eye Drops in Management of Non- Necrotizing Herpetic Stromal Keratitis; a Prospective Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Outcomes of Cyclosporine Eye Drops in Herpetic Keratitis
Lead sponsor: Farwaniya Hospital
Sponsor class: OTHER_GOV
First posted: 2023-02-09
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: To compare the additive effect of topical cyclosporine A 0.05% eye drops to prednisolone eye drops, with topical prednisolone acetate 1% eye drops alone in treatment of herpetic stromal keratitis.

Methods: Patients diagnosed with herpetic stromal keratitis are randomly divided into 2 groups; Group A: receive cyclosporine eye drops together with prednisolone eye drops.

Group B: receive topical prednisolone with placebo eye drops (tear replacement).

The 2 groups receive systemic acyclovir therapeutic dose 400 mg five times daily, which then tapered to twice daily prophylactic dose after one month of treatment. Follow up for patients is scheduled as a weekly visit for a duration of 2 months.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with herpetic stromal keratitis

Exclusion Criteria:

* associated ocular diseases, DM, renal disease, pregnancy, breast feeding.

Primary outcomes:
measure: duration of ttt
timeFrame: 3 months
Secondary outcomes:
measure: improvement in visual acuity
timeFrame: 3 months
Other outcomes:
Locations:
city: Al Farwānīyah
country: Kuwait
facility: Farwanyia Hospital
state: Farwanyia
Study officials:
affiliation: Farwaniya Hospital
name: Salah Al-rasheedy, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03790215: Dydrogesterone in the Treatment of Endometrial Polyps
Official title: Prospective One-arm Cohort Study of Dydrogesterone in the Treatment of Endometrial Polyps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Endometrial Polyp
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2018-12-31
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is intended to observe the therapeutic effect of dydrogesterone on endometrial polyps and provide a reference for clinical treatment.

Detailed description: Endometrial polyps are a common female endometrial lesion.The long-term unrestrained exposure of estrogen to local tissue is one of the causes of polyp formation.Studies suggested that the progesterone can accelerate the regression rate of endometrial polyps due to its antiestrogenic effects.Based on this, investigators intended to observe the therapeutic effect of dydrogesterone on endometrial polyps and provide a reference for clinical treatment.

Eligibility criteria: Inclusion Criteria:

1. women of childbearing age from 20 to 50 years old
2. with or without menstrual changes:

   1. menostaxis (longer than 7 days)
   2. shortened menstrual cycles(less than 23 days)
   3. menorrhagia(more than twice as much as usual)
   4. abnormal vaginal bleeding(non-menstrual vaginal bleeding)
3. with following signs of vaginal ultrasound in the follicular phase (day 1 to day 10 of a menstrual cycle):

   1. typical signs with a suspect of EP: (median/high) echo with a regular contour within the uterine lumen;
   2. atypical signs with a suspect of EP: punctate cystic areas within the endometrium and the endometrial thickness \>1cm;

Exclusion Criteria:

1. no menses within half a year;
2. surgery or drug treatment of endometrial lesions in the past half year;
3. with current intrauterine device;
4. combined with other acute gynecological inflammation;
5. with clinically suspected malignant tumors;
6. long-term use of oral contraceptives;
7. with abnormal liver and kidney function;
8. with benign or malignant breast tumors;
9. with any systemic malignant tumor or a history of tumors;
10. participants who are pregnant.

Primary outcomes:
measure: Regression rate of endometrial polyps
timeFrame: three months after the starting of treatment
measure: Relapse rate of endometrial polyps
timeFrame: six months after the starting of treatment
Secondary outcomes:
measure: Side effects
timeFrame: three months after the starting of treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
References:
Clinical trial NCT03798015: Neurologic Outcome After Mitral Valve Surgery
Official title: Neurologic Outcome After Mitral Valve Surgery
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Mitral Valve Reconstruction
Keywords: mitral valve surgery
mitral valve stenosis
mitral valve insufficiency
minimal invasive mitral valve surgery
neurological outcome
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-01-09
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing a surgical mitral valve reconstruction or replacement at the University Hospital Basel from 2009 until today

Brief summary: Reconstructive mitral valve surgery is increasingly done by minimal- invasive anterolateral thoracotomy technique in contrast to surgical approach by sternotomy. The minimal invasive approach is favourable regarding surgical trauma, length of hospital stay and amount of blood loss.

This study is to investigate the neurological outcome after minimal- invasive mitral valve surgery compared to open mitral valve surgery by sternotomy.

Pre-, intra- and postsurgical data from mitral valve surgery derived from the Basel mitral valve registry (collected from 2009 until now) will be analyzed.


Eligibility criteria: Inclusion Criteria:

* surgery for mitral valve (reconstruction or replacement) (maybe combined with surgery for tricuspid valve and/ or surgery for atrial septal defects and/or patent foramen ovale)

Exclusion Criteria:

* other surgical interventions then the surgical interventions mentioned in the inclusion criteria
* pre- existing neurological deficit; neurologic limitation in daily life
* emergency surgery

Primary outcomes:
measure: occurence of stroke (yes/ no) subsequent to mitral valve surgery
timeFrame: post surgical from day of surgery until day of discharge from hospital (approx. 2 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Herzchirurgie University Hospital Basel
Study officials:
affiliation: Klinik für Herzchirurgie, Universitätsspital Basel
name: Martin Grapow, Prof. Dr. MD
role: PRINCIPAL_INVESTIGATOR
References: