louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02590250: A Safety and Efficacy Study of BOTOX® (Botulinum Toxin Type A) in Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity or Overactive Bladder in India
Official title: Evaluation of the Safety and Effectiveness of BOTOX® (Botulinum Toxin Type A) in the Treatment of Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity or Overactive Bladder: A Phase IV Non-interventional Post-marketing Surveillance Study in India
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence
Overactive Bladder
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2015-10-29
Enrollment: 250
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 urinary incontinence (due to NDO, eg, as a result of SCI or MS, or due to OAB) who have an inadequate response to or are intolerant of an anticholinergic medication

Brief summary: This is a Post-Marketing Surveillance study in India to evaluate safety and efficacy of BOTOX® (Botulinum Toxin Type A) in the treatment of patients with urinary incontinence due to neurogenic detrusor overactivity or overactive bladder.


Eligibility criteria: Inclusion Criteria:

* Patients with urinary incontinence due to NDO or OAB treated with BOTOX® as per local standard of care in clinical practice.

Exclusion Criteria:

* None

Primary outcomes:
measure: Change from the baseline value of the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
timeFrame: at up to 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Padmanabha Nagar
country: India
facility: NU Hospitals
state: Banglore
city: New Delhi
country: India
facility: Dr. Ram Manohar Lohia Hospital
state: Delhi
city: New Delhi
country: India
facility: Indian Spinal Injuries Centre
state: Delhi
city: Ahmedabad
country: India
facility: Bodyline Hospitals
state: Gujarat
city: Bengaluru
country: India
facility: Fortis Hospitals
state: Karnataka
city: Mumbai
country: India
facility: Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute
state: Maharashtra
city: Pune
country: India
facility: AMAI Charitable Trust's ACE Hospital and Research Centre
state: Maharashtra
city: Pune
country: India
facility: Inamdar Multispeciality Hospital
state: Maharashtra
city: Okhla Road
country: India
facility: Fortis Escorts Heart Institute
state: New Delhi
city: Ludhiana
country: India
facility: Christian Medical College & Hospital
state: Punjab
city: Vellore
country: India
facility: Christian Medical College and Hospital
state: Tamil Nadu
city: Hyderabad
country: India
facility: Global Hospital
state: Telangana
Study officials:
affiliation: Allergan
name: Ahunna Ukah
role: STUDY_DIRECTOR
References:
Clinical trial NCT06321250: A Study of JMKX003948 Tablets in Patients With Renal Cell Carcinoma
Official title: An Open-label, Multicenter Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of JMKX003948 Tablets in Patients With Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Renal Cell Carcinoma Metastatic
Lead sponsor: Jemincare
Sponsor class: INDUSTRY
Collaborators: name: Zhejiang Hangyu Pharmaceutical Co., Ltd.
First posted: 2024-03-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This open-label Phase 1 study will evaluate the safety, tolerability, PK characteristics and preliminarily efficacy of JMKX003948 tablets in patients with renal cell carcinoma.


Eligibility criteria: Inclusion Criteria:

1. Has the ability to understand and willingness to sign a written informed consent form.
2. Male or female from 18 years of age or older.
3. Histologically confirmed locally advanced or metastasis clear cell renal cell carcinoma.
4. Has at least one measurable lesion per RECIST v1.1.
5. Has a life expectancy of ≥ 12 weeks.
6. Adequate organ function.

Exclusion Criteria:

1. Patients with known active CNS metastases and/or cancerous meningitis.
2. Has received any type of systemic anticancer monoclonal antibodies or other immunosuppressants within 4 weeks prior to the first dose. Has received prior chemotherapy, targeted therapy, or other investigational therapy within 2 weeks prior to the first dose.
3. Has failed to recover from a ≥ grade 2 adverse event due to prior anti-tumor therapy.
4. Has impaired heart function,or clinically significant cerebrovascular and cardiovascular disease.
5. Subjects with dysphagia or known drug absorption disorders.
6. Has a history of any other malignancy within 5 years.
7. Has severe oncological complications.
8. Is currently participating in other clinical studies.
9. Subjects with be unsuitable for participation in the trial evaluated by investigator.

Primary outcomes:
measure: Dose Escalation: Number of participants with dose limiting toxicities (DLTs)
timeFrame: Up to 2 months
measure: Dose Escalation: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Up to 2 years
measure: Dose Expansion: Objective Response Rate (ORR)
timeFrame: Up to 1 year
Secondary outcomes:
measure: maximum plasma concentration (Cmax)
timeFrame: Up to 1 month
measure: maximum plasma concentration (Tmax)
timeFrame: Up to 1 month
measure: Duration of Response (DoR)
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Caancer Hospital
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Jun Guo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04554550: Post-operative Cognitive Function Following Pelvic Floor Surgery
Official title: Post-operative Cognitive Function Following Pelvic Floor Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 130
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women aged 60 and older scheduled to undergo surgery for pelvic organ prolapse at the University of Pennsylvania.

Brief summary: The aim of this study is to assess cognitive function before and after surgery for pelvic organ prolapse using sensitive tests of various neurocognitive domains.

Detailed description: Post operative cognitive dysfunction has been well described as a relatively common phenomenon with potentially long-lasting detrimental effects. However, there are currently limited data exploring the effects of gynecologic surgery on cognitive function. The population of patients treated surgically for pelvic floor disorders is typically older, and therefore at higher baseline risk for cognitive dysfunction. Therefore, it is of interest to determine the effects of pelvic floor surgery and anesthesia on this patient population. The investigators plan to conduct a prospective cohort study to assess cognitive function before and after pelvic organ prolapse surgery using sensitive tests of memory and other neurocognitive domains. Participants will be women undergoing surgery for pelvic organ prolapse. All participants will undergo cognitive tests at three time points: at their pre-operative clinic appointment, in the hospital the morning after surgery, and at their post-operative clinic appointment. In addition to the neurocognitive tests, patients will undergo a series of questionnaires regarding physical function, frailty, sleep quality, and incontinence symptoms.

Eligibility criteria: Inclusion Criteria: Women 60 years of age or older who are scheduled to undergo surgery for pelvic organ prolapse.

Exclusion Criteria:

* Women who have a known baseline diagnosis of cognitive dysfunction or central nervous disorder
* A Mini-Mental State Exam (MMSE) score of greater than 24
* Non-english speaking
* Any severe visual or auditory disorder
* Alcoholism or drug dependence

Primary outcomes:
measure: Change in episodic memory neurocognitive test scores
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Uduak Andy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01472250: A Prospective and Observational Cohort Study to Evaluate the Treatment Model and Medical Economics of Advanced Gastric Cancer Chemotherapy in Clinical Practice in China
Official title: A Prospective and Observational Cohort Study to Evaluate the Treatment Model and Medical Economics of Advanced Gastric Cancer Chemotherapy in Clinical Practice in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Gastric Cancer
Keywords: Advanced Gastric Cancer
chemotherapy
quality of life
treatment expense
patients accepted first-line chemotherapy
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2011-11-16
Enrollment: 498
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with advanced gastric cancer

Brief summary: This is a multi-center, prospective and observational clinical study. Eligible patients will accept generalized chemotherapy according to the investigator's assessment. Information related to the treatment, including medication, disease condition, expenses, etc. will be periodically collected. Follow-up at 2-month intervals will be periodically performed to continually collect information about the disease progression, subsequent treatment and survival until death or completion of the study.

Recruited patients will fill out questionnaires about quality of life before initiation of treatment, at Cycle 3 and completion of first-line treatment.


Eligibility criteria: Inclusion Criteria:

1. The patient has histologically confirmed locally-advanced or recurrent and/or metastatic gastric or esophagogastric junction adenocarcinoma, has missed the opportunity of surgical excision, making curative therapy impossible.
2. The informed consent form is signed.
3. A specimen of tumor tissue (puncture biopsy or surgical specimen) is available.
4. ECOG performance status is 0, 1 or 2.
5. The patient's general conditions and functions of important organs allow generalized chemotherapy according to the investigator's judgment
6. The patient is aged≥18

Exclusion Criteria:

1. The patient is known to be allergic to any study drug.
2. The patient is recruited in other clinical study or is planned to participate into other clinical study.
3. The patient has previously accepted chemotherapy against advanced or metastatic diseases (the patient may be recruited if the previous adjuvant therapy/neoadjuvant therapy was completed more than 6 months before inclusion).

Primary outcomes:
measure: chemotherapy regimen
timeFrame: 2 months
Secondary outcomes:
measure: overall survival
timeFrame: 2 months
measure: quality of life
timeFrame: 6 weeks
measure: treatment expense
timeFrame: 2 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lin Shen
state: Beijing
Study officials:
References:
Clinical trial NCT03418350: The Role of Laryngopharyngeal Reflux in IPF
Official title: The Role of Laryngopharyngeal Reflux in IPF
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: IPF
Reflux
Lead sponsor: National Jewish Health
Sponsor class: OTHER
First posted: 2018-02-01
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ILD clinic

Brief summary: The primary objective of this study is to show that the Supraglottic Index (SGI) is an easily-collected index that accurately identifies the presence and severity of laryngopharyngeal reflux (LPF) in idiopathic pulmonary fibrosis (IPF).

Detailed description: The study team hypothesizes the SGI will correlate more strongly with measures of IPF severity (at baseline and over time) than gastroesophageal reflux (GER) data derived from the esophageal detector channels of a pH/impedance probe.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of IPF
* Age 40-95
* Able to read, speak, and understand English
* If subjects are currently taking medication for reflux or GERD, they much be on a stable does for at least 4 weeks prior to consent.

Exclusion Criteria:

* Patients who do not meet all inclusion criteria
* Pregnant females

Primary outcomes:
measure: The supraglottic index (SGI) quantifies laryngopharyngeal reflux (LPF) and is associated with severity of pulmonary fibrosis.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
Study officials:
affiliation: National Jewish Health
name: Matthew Koslow, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03385850: The Th17/Treg Cells and IL-23/IL-17 Axis and Early Enteral Nutrition in Sepsis
Official title: The Roles of Th17/Treg Cells and IL-23/IL-17 Axis in the Mechanisms of Early Enteral Nutrition Improving Immune Function of Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Immune System Disorder
Enteral Feeding
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2017-12-29
Enrollment: 53
Sex: ALL
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: The investigators aim to evaluate the roles of Th17/Treg cells and IL-23/IL-17 axis in the mechanisms of early enteral nutrition (EEN) correcting immune imbalance of sepsis by means of improving the intestinal flora disturbance. The results of this study would lay the foundation for revealing the mechanisms of EEN improving immune imbalance of sepsis and provide a new idea to the early treatment of sepsis


Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of sepsis
2. Within 3 days of sepsis onset before ICU admission
3. No artificial nutrition (enteral or parenteral nutrition) were provided before ICU admission

Exclusion Criteria:

1. Ileus
2. Digestive tract hemorrhage
3. Inflammatory bowel disease
4. Abdominal hypertension (IAP \>25mmHg)
5. Cancer or chronic organ dysfunction (e.g., hepatic or renal dysfunction)
6. Malnutrition or immunodeficiency
7. Long-term use of hormones

Primary outcomes:
measure: 28-d mortality
timeFrame: 28 days
Secondary outcomes:
measure: immune parameters
timeFrame: 7 days
measure: immune parameters
timeFrame: 7 days
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Xiang Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06903650: The Effect of Salpingectomy Operation on Ovarian Reserve
Official title: Evaluation of the Effect of Salpingectomy Operation on Ovarian Reserve With Anti-Mullerian Hormone and Ovarian Doppler Ultrasonography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Insufficiency
Keywords: Salpingectomy
Ovarian Reserve
Anti-Mullerian Hormone
Doppler Ultrasonography
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2025-03-31
Enrollment: 31
Sex: FEMALE
Minimum age (years): 37
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Serum samples will be separated from routine blood samples taken from patients who apply to the outpatient clinic and will undergo salpingectomy within the indication, during perioperative preparation and at the 6th week postoperatively, after patient consent is obtained. This serum sample will be taken into an Eppendorf tube and kept at -40˚C for later AMH levels to be studied. Ovarian artery pulsatility index values measured during the patient's perioperative and postoperative routine ultrasonographic examination and weeks 6 postoperative control will be recorded.

Brief summary: This study aimed to evaluate the effect of salpingectomy operation on ovarian reserve. Ovarian reserve was evaluated by measuring anti-mullerian hormone levels from serum samples taken from the patients before the operation and 6 weeks after the operation. Ovarian doppler flow were evaluated by measuring the ovarian artery pulsatility index with transvaginal ultrasonography preoperatively, postoperative days 2 and postoperative weeks 6 . In our study, it was determined that ovarian functions may be negatively affected in the acute period after salpingectomy operation.


Eligibility criteria: Inclusion Criteria:

1. Women between the ages of 37-45 with continuing menstrual cycles (37 and 45 included)
2. Patients who will undergo uterine surgery for benign reasons or who will undergo salpingectomy only due to hydrosalpinx, ectopic pregnancy, tubo-ovarian abscess
3. Patients who have not had ovarian surgery before
4. Those without menopause and premature ovarian failure
5. Patients who accept the study

Exclusion Criteria:

1. Age younger than 37 or older than 45
2. Those who want to withdraw from the study
3. Those who do not come for follow-up examination
4. Use of drugs that affect ovarian reserve
5. Any surgical procedure performed on the ovaries during the operation
6. No menstrual bleeding in the last year
7. Patients who received radiotherapy and hormonal therapy within 3 months before surgery

Primary outcomes:
measure: right ovarian arter pı
timeFrame: perioperative, postoperative days 2 , postoperative weeks 6
measure: left ovarian arter pı
timeFrame: perioperative, postoperative days 2, postoperative weeks 6
measure: AMH levels
timeFrame: perioperative-postoperative weeks 6
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dokuz Eylul University School of Medicine
Study officials:
References:
Clinical trial NCT01682850: Pulmonary Rehabilitation Before Lung Cancer Resection
Official title: Pulmonary Rehabilitation Before Lung Cancer Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
COPD
Chronic Obstructive Lung Disease
Emphysema
Keywords: COPD
Chronic Obstructive Lung Disease
lung cancer
emphysema
Pulmonary Rehabilitation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-09-11
Enrollment: 27
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study seeks to study the effectiveness of a short mindfulness based pulmonary rehabilitation program prior to a surgical resection in patients with lung cancer and severe Chronic Obstructive Lung Disease (COPD).


Eligibility criteria: Inclusion Criteria:

* Patient is scheduled to undergo a surgery for non small cell lung cancer
* Moderate to severe COPD
* Current or ex smoker of ten or more years

Exclusion Criteria:

* Unable to perform exercise due to active cardiovascular, musculoskeletal or mental problems Poorly motivated to attend the rehabilitation sessions or receive randomization.

Primary outcomes:
measure: Measure of length of hospital stay post surgical resection of lung cancer in patients that underwent a resection for lung cancer.
timeFrame: baseline to release from hospital - approx 10 days
Secondary outcomes:
measure: Measure post-operative complications in patients that under went 10 session of Mindful Pulmonary Rehabilitation prior to lung resection compared to patients who received usual care prior to a lung resection for lung cancer.
timeFrame: Post surgerybaseline to release from hospital - approx 10 days
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: Mayo Clinic
name: Roberto P Benzo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01860950: Effects of Transcranial Direct Current Stimulation on Pain Perception
Official title: Effects of Transcranial Direct Current Stimulation on Pain Perception
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Healthy Adults
Pain Perception
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2013-05-23
Enrollment: 79
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: OTHER

Brief summary: The purpose of this study is to determine whether a new medical technology can temporarily alter pain perception. The new technology is called Transcranial direct current stimulation (tDCS).

Detailed description: Healthy subjects underwent thermal pain tolerance testing pre- and post intervention. The intervention includes either anodal, cathodal, or sham tDCS for 20 minutes during a pain cognitive intervention \[either brief cognitive intervention (BCI) or general pain education\]. The tDCS brand was the Phoresor-II Auto (Model PM850, Iomed, Salt Lake City Utah, USA) and the current was set to 2.0mA. Electrodes were 4x4 cm sponge electrodes soaked in sterile saline. For anodal and cathodal tDCS, One electrode was placed over the left DLPFC (F3 from the EEG 10-20 system) located via the Beam F3 measurement system and the other electrode was attached to the right shoulder. For sham tDCS, the device was turned on for 30 seconds to temporarily mimic tingling and skin sensations of real tDCS and then ramped-down to 0mA for the duration of the 20-minute session.

Eligibility criteria: Inclusion Criteria:

Inclusion Criteria:

* 100 Health Individuals recruited from Charleston ,SC

Exclusion Criteria:

* Can not be pregnant
* No history of Depression, chronic pain, Seizers, suicidal implanted metal devices, history of brain surgery, loss of consciousness.

Primary outcomes:
measure: Pre-Intervention Pain Tolerance
timeFrame: Duration of the study visit, approximately 2 hours
measure: Post-Intervention Pain Tolerance
timeFrame: Duration of the study visit, approximately 2 hours
Secondary outcomes:
measure: Percentage of Participants That Correctly Guessed Condition Assignment
timeFrame: 2 hours
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Jeffrey Borckardt, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: