louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04192201: A Real-world Study for Patients With Multiple Pulmonary Ground-glass Nodules
Official title: A Real-world Study for Patients With Multiple Pulmonary Ground-glass Nodules
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Pulmonary Nodules
Keywords: Multiple Pulmonary Nodules
Lung Neoplasms
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were diagnosed with multiple GGNs by chest CT scan in a hospital.

Brief summary: The purpose of this study is to actively monitor patients with multiple pulmonary Ground-glass Nodules (GGNs), in order to provide evidence for multiple GGNs treatment.

Detailed description: Multiple pulmonary GGNs are very commonly identified particularly as increasing numbers of CT scans are performed as part of routine lung cancer screening. At the same time, the ideal solution for these cases continues to be debated. This aim of this study is to learn more about the effects of multiple factors on outcome of multiple pulmonary GGNs, such as patients' clinical characteristics, CT features and different pathological types. Furthermore, the optimal timing of surgery and the effect of different surgical choices on the prognosis of patients with multiple GGNs will be investigated.

Eligibility criteria: Inclusion Criteria:

1. Age greater than 18 years
2. Have two or more GGNs on CT imaging
3. Diameter of GGNs \> 5mm and ≤ 3cm
4. GGNs must be greater than half ground glass

Exclusion Criteria:

1. patients who have a history of lung cancer
2. patients who have undergone chemotherapy, radiotherapy or targeted therapy before surgery
3. pregnant women

Primary outcomes:
measure: 5-year overall survival [Time Frame: From date of the recruitment, assessed up to 60 months]
timeFrame: October 31, 2024
Secondary outcomes:
measure: 5-year Progression-Free-Survival [Time Frame: From date of the recruitment, assessed up to 60 months]
timeFrame: October 31, 2024
measure: Recurrence-free survival [Time Frame: From date of the recruitment, assessed up to 60 months]
timeFrame: October 31, 2024
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
References:
Clinical trial NCT00214201: Campath-1H Induction to Allow Discontinuation of Calcineurin Inhibitors After Renal Transplantation
Official title: Campath-1H Induction to Allow Discontinuation of Calcineurin Inhibitors After Renal Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Renal Transplant
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 40
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: The purpose of this study is to determine whether Campath-1H induction therapy and the associated lymphocyte depletion will permit long-term, rejection free renal allograft function in the absence of maintenance calcineurin inhibitor (CI) therapy.


Eligibility criteria: Inclusion Criteria:

* received a renal transplant, induction with Campath-1H, and at least 2 months of calcineurin inhibitor therapy, CellCept, and prednisone.

Exclusion Criteria:

* Recipients of HLA-identical living-donor renal transplants;
* PRA value \>20% within 30 days of transplant;
* GFR \<40ml/min;
* multi-organ transplant;

Primary outcomes:
measure: Number of Participants With Biopsy Proven Rejection
timeFrame: 3 years
Secondary outcomes:
measure: Serum Creatinine at 36 Months (End of Study)
timeFrame: 36 months +/- 60 days
Other outcomes:
measure: WBC
timeFrame: 36 months +/- 60 days
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Stuart Knechtle, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06485401: To Compare the Safety and PK/ PD Characteristics of ADC189 Between Hepatic Impairment and Normal Hepatic Function Subjects
Official title: An Phase I, Open-label, Multi-center, Parallel, Single Oral Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of ADC189 in Subjects With Hepatic Impairment (Child-Pugh A and B) Compared With Subjects With Normal Hepatic Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza Type A
Influenza Type B
Lead sponsor: Jiaxing AnDiCon Biotech Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2024-07-03
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the pharmacokinetics, pharmacodynamics, safety, and tolerability of ADC189 in subjects with hepatic impairment compared with subjects with normal hepatic function.

Detailed description: The evaluation of ADC189/ADC189-I07 in mild hepatic insufficiency (Child-Pugh A), moderate hepatic insufficiency (Child-Pugh B) the pharmacokinetic characteristics in subjects, compared with normal liver function subjects, which matched by sex, age, and BMI, in order to provide a scientific basis for a reasonable dosage in patients with liver dysfunction.

Eligibility criteria: Inclusion Criteria:

* 1) The subjects fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent, and can complete the entire trial process according to the requirements of the trial.
* 2) Age 18-75 years old (including the boundary value), both male and female.
* 3) The body weight of male subjects was ≥50 kg, the body weight of female subjects was ≥45 kg, and the body mass index (BMI) was within the range of 18.0\~30.0 kg/m².

Exclusion Criteria:

* 1) Known allergic history to test drug components, or allergic constitution, or history of allergic diseases.
* 2) Have malignant tumors, or have a history of malignant tumors within 5 years prior to screening.
* 3) Patients with severe infection, trauma, gastrointestinal surgery or other major surgical operations within 4 weeks before screening.
* 4) eGFR (CKD-EPI Cr) \<60mL/min/1.73m2.

Primary outcomes:
measure: Cmax of ADC189/ADC189-I07
timeFrame: 15 days
measure: AUClast of ADC189/ADC189-I07
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
Study officials:
References:
Clinical trial NCT05883501: Effect of Self-affirmation Versus Back Massage on Psychological Distress and Fear of Birth Among Primigravid Women in Third Trimester
Official title: Effect of Self-affirmation Versus Back Massage on Psychological Distress and Fear of Birth Among Primigravid Women in Third Trimester
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Self-affirmation, Back Massage
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Based on the literature review, care must be emphasized on aspects of self-strengthening or self-affirmation to reduce stress and fear and equip women with the ability to manage stress and fear due to negative thoughts. Accordingly, the present study aimed to investigate and compare the effects of self-affirmation versus back massage on psychological distress and fear of birth among primigravid women in third trimester.


Eligibility criteria: Inclusion Criteria:

* • Pregnant women aged 20-35 years.

  * Primigravida women.
  * Read \&write.
  * During third trimester of pregnancy.
  * Free from any medical, obstetric, gynecological and other psychological risk factors and /or conditions
  * With normal course of pregnancy.
  * Attend regular antenatal care visits.
  * With intact back skin and free from burn, wound or any scar, injury, inflammation and allergy.

Primary outcomes:
measure: Psychological Distress
timeFrame: 2 months
measure: Fear of childbirth
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Nursing
Study officials:
References:
Clinical trial NCT04058301: Text-Enabled Ascertainment and Community Linkage for Health
Official title: Text-Enabled Ascertainment and Community Linkage for Health
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Emergency Medicine
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2019-08-15
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this study is to pilot test a novel tool for health related social needs screening and linkage to community resources in the ED by randomizing participants to standard handout v. handout + text message with resource information.


Eligibility criteria: Inclusion Criteria:

* 51 ZIP codes included in our database of community resources ("catchment area")
* \>=18 years old
* plan for discharge home
* speak either English or Spanish
* live within the catchment area for the study
* have a cellphone with text messaging capabilities
* ability to respond to text messages from the study team.

Exclusion Criteria:

* Patients who are intoxicated
* on a Section 12
* lack capacity to consent will be excluded.

Primary outcomes:
measure: Satisfaction: Likert scale
timeFrame: 3-5 days
Secondary outcomes:
measure: Resource use
timeFrame: 3-5 days
measure: Health status
timeFrame: 3-5 days
Other outcomes:
measure: ED utilization
timeFrame: 30 days
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT00252369: Treatment of Perianal Crohn's Disease, Combining Medical and Surgical Treatment.
Official title: Instillation of Fibrin Glue After Induction of Local Conditions Using Infliximab, in the Treatment of Perianal Crohn's Disease.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Crohn's Disease
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2005-11-11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is aimed to assess the hypothesis that instillation of fibrin glue with the induction of local conditions using Infliximab, may be useful in the treatment of perianal Crohn's disease.

Detailed description: Patients with perianal fistulae of Crohn's disease will be prospectively enrolled and receive 3 doses of Infliximab. If reduction of fistula associated discharge of at least 50% will be recorded, commercially available fibrin glue will be instilled into the fistula tract using standard surgical techniques. The patients will be followed for 6 months for fistula healing and complications.

Eligibility criteria: Inclusion Criteria:

* Perianal fistula of Crohn's dis

Exclusion Criteria:

* More then 2 fistulae perianal sepsis known contraindication to infliximab or glue

Primary outcomes:
measure: Fistula healing
Secondary outcomes:
measure: Quality of life
measure: Complications
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
city: Zrifin
country: Israel
facility: Assaf Harofe Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Oded Zmora, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01987869: Hiperemezis and Serotonin Elevated Serum Serotonin Levels in Hyperemesis
Official title: Relationship Between Elevated Serum Serotonin Levels in Symptomatic Patients With Hyperemezis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nausea
Vomiting
Markedly Reduced Food Intake
Severe Dehydration
Keywords: hiperemesis gravidarum,vomiting,serotonin levels,ketonuria
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2013-11-19
Enrollment: 90
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant women between six and fourteen weeks

Brief summary: Serotonin excretion was investigated in the nausea and vomiting associated with hiperemezis gravid arum.

Detailed description: The occurrence of severe nausea and vomiting of early pregnancy (hiperemezis gravid arum) is estimated between 0.3% to 1% of all pregnancies. Although hiperemezis gravid arum has been recognized for a long time, its pathophysiologic mechanisms are still poorly understood. Many theories have been advocated, but to date none of these have been convincing.

It has been demonstrated that the nausea and vomiting associated with increased in serotonin liberation. This has provided a rationale for the treatment of these symptoms with specific serotonin antagonists.

The aim of this trial was to investigate the possible relationship between hiperemezis gravid arum and serotonin liberation.

Eligibility criteria: Inclusion Criteria:

* 6-14 week pregnant women
* nausea
* protracted vomiting
* inability to tolerate food intake accompanied by obvious dehydration
* severe enough to justify hospitalisation
* at least 2+ ketonuria on dipstick urinanalysis.

Exclusion Criteria:

* with metabolic disorders such as diabet, thyroid

Primary outcomes:
measure: serum serotonin levels in hiperemezis gravidarum
timeFrame: 6-14week pregnancy
Secondary outcomes:
measure: ıs there any assosiation between serotonin levels and severity of symptoms in pregnant women with hiperemezis
timeFrame: 6-14week pregnancy
Other outcomes:
measure: ıs there any assosiation between other serum parameters includes estrogen,progesterone and serum beta hcg
timeFrame: 6-14week pregnancy
Locations:
city: Istanbul
country: Turkey
facility: Bakirkoy Dr Sadi Konuk Training and Research Hospital
Study officials:
affiliation: Bakırkoy Dr. Sadi Konuk Training and Research Hospital
name: hüseyin cengiz, md
role: STUDY_CHAIR
References:
Clinical trial NCT00590369: Negative Pressure Wound Therapy: Are All Systems Alike?
Official title: Negative Pressure Wound Therapy: Are All Systems Alike?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Wounds
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Smith & Nephew, Inc.
First posted: 2008-01-10
Enrollment: 11
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: Hypotheses: (1)Wound healing during hospital stay will be equal between systems, (2)RNs will perceive the Versatile One (EZCare) system as easier to use, (3)Costs related to dressing changes will be less with Versatile one (EZCare), (4)Hospital length of stay will be equal or shorter with the Versatile One (EzCare) system, (5) Nursing time using Versatile One (EZCare) will be less than or equal to VAC system, (6) Patients will report less pain during dressing changes with Versatile One (EZCare).

Detailed description: This is a prospective, 2 group, randomized, comparative study (sample:50; 25 in each group) that will investigate whether differences can be found in selected outcomes related to wound care, using Versatile One (EZCare)versus KCI VAC negative pressure/vacuum systems. Only wounds which currently meet criteria for such device use,and for which a physician's order has been written for the device, will be included in this study.

Eligibility criteria: Inclusion Criteria:

* Hospitalized adults requiring negative pressure dressings.

Exclusion Criteria:

* Comatose
* Mentally obtunded
* Documented chronic psychiatric illness or any documented dementia significant enough to notably impair cognitive function
* Presence of Manufacturer's contraindications
* Malignancy in wound
* Untreated osteomyelitis
* Unexplored fistula
* Necrotic tissue
* Exposed blood vessels or organs
* Untreated malnutrition.

Primary outcomes:
measure: 5 Measures of Wound Healing: Length, Width, Depth, Undermining, Tunneling
timeFrame: first dressing change; typically within 48 hours
Secondary outcomes:
measure: Ease of Performing Dressing Change
timeFrame: during hospital stay; generally 6 days
measure: Ease of Providing Nursing Care
timeFrame: during hospital stay; generally 6 days
measure: Cost of Wound Care
timeFrame: during hospital stay; generally 6 days
measure: Nursing Time
timeFrame: hospital stay; generally 6 days
measure: Patient Reported Pain
timeFrame: at first dressing change; generally 48 hours
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Nancy M Albert, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06692569: The Effect of Modified Constraint Induced Movement Therapy on Upper Extremity Function in Stroke Rehabilitation
Official title: The Effect of Modified Constraint Induced Movement Therapy on Upper Extremity Function in Stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Hemiplegia
Chronic Stroke Patients
Keywords: stroke
hemiplegia
constraint induced movement therapy
modified constraint induced movement therapy
trunk restrain
upper extremity motor function
Lead sponsor: University of Jazan
Sponsor class: OTHER_GOV
Collaborators: name: Majmaah University
First posted: 2024-11-18
Enrollment: 34
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the effect of Modified Constraint-Induced Movement Therapy and trunk restraint contrasted with conventional physical therapy treatment on improving upper extremity function, balance, and quality of life among chronic hemiplegic patients.

* To find out the effectiveness of conventional physical therapy treatment on improving upper extremity function, balance, and quality of life among chronic hemiplegic patients.
* To find out the effectiveness of modified constraint induced movement therapy (mCIMT) and trunk restraint along with conventional physical therapy treatment on improving upper extremity function, balance, and quality of life among chronic hemiplegic patients.
* To find out the effectiveness of modified constraint induced movement therapy (mCIMT) and trunk restraint combined with conventional physical therapy treatment versus conventional physical therapy treatment alone on improving upper extremity function, balance, and quality of life among chronic hemiplegic patients.


Eligibility criteria: Inclusion Criteria:

* Right or left-sided chronic hemiplegic patients.
* Onset of stroke More than six months.
* Age between 45 to 65 years of both genders.
* Mini-Mental State Examination - Scored more than 24/30.
* Modified Ashworth Scale for spasticity 1 or 1+.
* Have at least 20° wrist active extension and at least 10° of metacarpophalangeal active extension of the paretic upper extremity.
* Have at least grade 2/5 of muscle power on upper extremity especially in wrist extensors.
* Have normal visual perception.
* With no other neurological disorders.

Exclusion Criteria:

* Unable to follow visual and oral commands.
* Unilateral neglect.
* Severe cognitive, or language deficits.

Primary outcomes:
measure: Wolf Motor Function Test
timeFrame: Week 0 and week 6
measure: Berg Balance Scale
timeFrame: week 0 and week 6
measure: Stroke Specific Quality of Life Scale
timeFrame: week 0 and week 6
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Majmaah Rehabilitation center
Study officials:
affiliation: University of Jazan
name: Karthick BALASUBRAMANIAN, MPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06656468: Outcome of Patients Undergoing Leadless Pacemaker Implantaton
Official title: Outcome of Patients Undergoing Leadless Pacemaker Implantaton
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Bradyarrhythmias
Keywords: Bradyarrhythmias
leadless pacemaker
complications
Lead sponsor: Azienda Ospedaliera Cardinale G. Panico
Sponsor class: OTHER
First posted: 2024-10-24
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with indication for leadless pacemaker implantation for symptomatic bradyarrhythmias according to current Guidelines on cardiac pacing.

Brief summary: Observational study aimed to evaluate the rate and of complications related to lealdless pacemaker implantation.

Detailed description: Observational, multicenter study enrolling consecutive patients undergoing leadless pacemaker implantation. Procedure details, intraprocedural complications, and n-hospital outcomes will be recorded.

Eligibility criteria: Inclusion Criteria:

* patients with indication for leadless pacemaker implantation according to current Guidelines on cardiac pacing.

Exclusion Criteria:

* inability to sign informed consent

Primary outcomes:
measure: Acute complications
timeFrame: From date of implantation until the date of first documented complication, assessed up to 30 days.
Secondary outcomes:
measure: Long-term complications
timeFrame: From 31th day from implantation until the date of first documented complication, assessed up to 6 months.
Other outcomes:
Locations:
city: Tricase
country: Italy
facility: Azienda Ospedaliera "Card. G. Panico"
Study officials:
References:
citation: Palmisano P, Facchin D, Ziacchi M, Nigro G, Nicosia A, Bongiorni MG, Tomasi L, Rossi A, De Filippo P, Sgarito G, Verlato R, Di Silvestro M, Iacopino S. Rate and nature of complications with leadless transcatheter pacemakers compared with transvenous pacemakers: results from an Italian multicentre large population analysis. Europace. 2023 Feb 8;25(1):112-120. doi: 10.1093/europace/euac112.