louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06961188: Clinical Study on Nanocrystalline Megestrol Acetate for Appetite Improvement and Weight Gain in Pre-Cachexia and Cachexia Stages Key Terminology Analysis
Official title: Clinical Study on Nanocrystalline Megestrol Acetate for Appetite Improvement and Weight Gain in First-Line Non-Squamous Non-Small Cell Lung Cancer Patients During Pre-Cachexia and Cachexia Stages.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Metastatic (Stage IV) Non-squamous Non-small Cell Lung Cancer (Nsq-NSCLC) With Driver Gene Negativity
Untreated With Systemic Therapy
Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Wuhan Union Hospital, China
First posted: 2025-05-07
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
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 evaluate the efficacy and safety of nanocrystalline medroxyprogesterone acetate for improving appetite and weight gain patients with non-small cell lung cancer (NSCLC) and cachexia and pre-cachexia. The enrolled patients were those with advanced NSCLC who had not received therapy, negative for driver genes and ineligible for curative treatment, and were planned to receive PD-1 inhibitors in combination with platinum-based chemotherapy.


Eligibility criteria: Inclusion Criteria:

* ≥18 years at the time of enrollment.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
* Life expectancy ≥6 months.
* Histologically or cytologically confirmed metastatic (stage IV) driver gene-negative non-squamous non-small cell lung cancer (NSCLC) that is unresectable and not amenable to curative therapy
* Subjects with no prior systemic chemotherapy for metastatic non-small cell lung cancer (NSCLC).

Exclusion Criteria:

* Presence of any gastrointestinal absorption-impairing conditions (e.g., dysphagia, malabsorption, prior gastrectomy, or uncontrolled vomiting); current use of tube feeding/parenteral nutrition; or existence of anorexia nervosa, psychiatric disorder-induced anorexia, or pain-related feeding intolerance.
* Driver gene-positive NSCLC or histologically/cytologically confirmed squamous cell-dominant NSCLC.
* Patients with Cushing's syndrome, adrenal/pituitary insufficiency; poorly controlled diabetes mellitus.
* Concurrent enrollment in another clinical trial, unless it is an observational/non-interventional study or the follow-up phase of an interventional trial.

Primary outcomes:
measure: Proportion of appetite improvement assessed by A/CS-12 (Anorexia/Cachexia Subscale of Functional Assessment of Anorexia/Cachexia Therapy)
timeFrame: Week 3
measure: Proportion of individuals with weight gain exceeding 5% relative to baseline
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References:
Clinical trial NCT01109888: Administration of Increased Dose of GnRH Antagonist for Coasting for Decreasing the Risk for Ovarian Hyperstimulation Syndrome( OHSS)
Official title: Administration of Increased Dose of GnRH Antagonist for Coasting for Decreasing the Risk for Ovarian During Controlled Ovarian Stimulation(COH) for In Vitro Fertilisation(IVF)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Administration of Increased Dose of GnRH Antagonist for Coasting for Decreasing the Risk for Ovarian Hyperstimulation Syndrome( OHSS)
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-04-23
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT

Brief summary: Coasting is one of the means to reduce the risk of OHSS for patients at risk for severe OHSS. During coasting gonadotrophin administration is withheld until serum E2 levels drop to a range considered safe. Prolonged coasting reduces the chance for implantation and pregnancy. The aim of the study is to explore whether an increased dose of GnRH Antagonist will shorten the coasting period without an adverse effect on cycle outcome.

Detailed description: 30 patients undergoing IVF using a GnRH antagonist protocol that present with a high response to gonadotrophin stimulation, will be randomized into one of two groups: group A - withdrawal of gonadotrophin support and continue a daily dose of 0.25 mg of the GnRH antagonist. group B - withdrawal of gonadotrophin support and continue a double daily dose of 0.5 mg of the GnRH antagonist.

The main outcome measures will be the duration of coasting (days)and the rate of serum E2 drop (%).

Eligibility criteria: Inclusion Criteria:30 women undergoing IVF cycle with GnRH Antagonist protocol under 35 years old.

E2 higher than 3000 pg/ml. -

Exclusion Criteria: 3 or more failed fresh IVF cycles.

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02010788: Evaluation of Safety and Efficacy of Botulinum Toxin Type A (BOTOX®) to Treat Urinary Incontinence Due to Neurogenic Detrusor Overactivity or Overactive Bladder in Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence
Urinary Bladder, Overactive
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-12-13
Enrollment: 523
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 or OAB.

Brief summary: This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and efficacy of botulinum toxin Type A to treat urinary incontinence in patients with neurogenic detrusor overactivity (NDO) or overactive bladder (OAB) not adequately controlled by anticholinergic drugs.


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: Number of Participants with Adverse Events and Adverse Drug Reactions
timeFrame: 4 Months
measure: International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) Total Score
timeFrame: 4 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04640688: Endoscopic Sleeve Gastroplasty / Endoscopic Sleeve Gastroplasty
Official title: Endoscopic Sleeve Gastroplasty / Endoscopic Sleeve Gastroplasty
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2020-11-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who undergo bariatric procedures at Methodist Dallas Medical Center

Brief summary: This will be a prospective, registry study of an investigational procedure for at least 12 standard of care visits up to 1 year after subject consents for study. Subjects will be enrolled between 8/1/2018 and 8/1/2023. Subjects will undergo a clinically indicated endoscopic procedure and subsequent follow up clinic visits as part of their standard medical care.

Disclaimer: To undergo the procedure there is an out of pocket expense for $9000.

Detailed description: All procedures, barring research activities such as consenting and data collection from Electronic Health Record , will be either clinically indicated and/or standard of care. Subject data will be collected and recorded in a registry which will allow for the prospective review and collection of clinical data related to Endoscopic Sleeve Gastroplasty for safety and efficacy assessment.

Study duration: At least 12 standard of care visits up to 1 year for each subject.

Standard of care follow up visits for Endoscopic Sleeve Gastroplasty are usually 2 weeks, 3 months, 6 months and 12 months post procedure with the physician and 8 follow-up visits over the year with a dietitian. No additional research related visits will be requested. All data will be collected from Electronic Health Record.

Disclaimer: To undergo the procedure there is an out of pocket expense for $9000.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Able to comprehend and provided written informed consent
* Willing to comply with the substantial lifelong dietary restrictions required by the procedure
* History of failure with non-surgical weight-loss methods
* Willing to follow protocol requirements, including providing informed consent, routine follow-up schedule, completing laboratory tests, and completing diet counseling
* Women of childbearing potential ( not post-menopausal or surgically sterilized) must agree to use adequate birth control methods

Exclusion Criteria:

* Below 18 years of age
* Prohibitive anesthetic risk

Primary outcomes:
measure: Weight loss
timeFrame: 8/1/2018 and 8/1/2023
Secondary outcomes:
measure: Documentation of safety
timeFrame: 8/1/2018 and 8/1/2023
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Prashant Kedia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00561288: Effects of Acetaminophen on Hurt Feelings
Official title: Effects of Acetaminophen on Hurt Feelings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotional Pain
Keywords: Acetaminophen
Social Psychology
Affect
Interpersonal Rejection
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2007-11-20
Enrollment: 60
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to investigate whether ingestion of acetaminophen reduces the experience of hurt feelings.


Eligibility criteria: Inclusion Criteria:

* University of Toronto undergraduate psychology student

Exclusion Criteria:

* Alcohol consumption (more than 2 drinks per day)
* Intake of enzyme-inducing drugs
* Prolonged fasting/eating disorders/gastroenteritis
* Intake of other over-the-counter or prescription analgesics
* Liver Disorders
* History of abuse treatment

Primary outcomes:
measure: Self-reported daily hurt feelings
timeFrame: 21 days
Secondary outcomes:
measure: Reports of emotional states other than hurt feelings
timeFrame: 21 days
measure: Evaluations of self-worth
timeFrame: 21 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
affiliation: University of Toronto
name: Geoff MacDonald, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kentucky
name: Nathan DeWall, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06404788: Anxiety Level Among Patients With Chronic Low Back Pain
Official title: Anxiety Level Among Polish Patients With Chronic Low Back Pain: a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Anxiety Disorders
Anxiety Disorders and Symptoms
Lower Back Pain
Chronic Pain
Keywords: chronic pain
low back pain
anxiety
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult people with chronic low back pain waiting for consultation or physiotherpay intervention in primary care clinic or physiotherapy clinic.

Brief summary: The goal of this observational cross-sectional study is to learn about the intensity of anxiety symptoms among Polish people suffering from chronic lower back pain. The main question it aims to answer is:

What is the severity of anxiety symptoms among the Polish population of patients suffering from chronic lower back pain?


Eligibility criteria: Inclusion Criteria:

* age minimum 18 years old
* chronic low back pain (duration longer than 3 months)
* native Polish speaker
* people who gave informed consent to participate in the study

Exclusion Criteria:

* trauma/ surgery on the low back within the past one year
* diagnosis of severe mental illness
* pregnant within the past one year

Primary outcomes:
measure: Severity
timeFrame: up to 10 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01984788: Safety and Efficacy of Oral BCX4161 as a Prophylactic Treatment for HAE
Official title: A Phase 2a Double-Blind Placebo-Controlled 2-Period Crossover Study to Evaluate the Safety and Efficacy of BCX4161 as a Prophylactic Treatment to Reduce the Frequency of Attacks in Subjects With Hereditary Angioedema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hereditary Angioedema
Keywords: Oral Prophylaxis
Lead sponsor: BioCryst Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-11-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether BCX4161 given as a daily oral prophylactic treatment is safe and effective in reducing the number of acute attacks in patients with hereditary angioedema.


Eligibility criteria: Key Inclusion Criteria:

* Written informed consent
* Clinical and laboratory diagnosis of Hereditary Angioedema Type I or II
* An average angioedema attack frequency of 1/week
* Acceptable birth control measures

Key Exclusion Criteria:

* Concurrent use of defined treatments for prophylaxis
* Pregnancy or breast-feeding
* Clinically significant medical condition, laboratory abnormality or medical history

Primary outcomes:
measure: Number of acute angioedema attacks
timeFrame: Over 28 days of treatment
Secondary outcomes:
measure: Incidence and severity of adverse events and laboratory abnormalities
timeFrame: Over 28 days of treatment
measure: Number of attack free days
timeFrame: Over 28 days of treatment
measure: Angioedema Quality of Life scores
timeFrame: Over 28 days of treatment
measure: Angioedema activity scores
timeFrame: Over 28 days of treatment
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Dr Marcus Maurer
city: Frankfurt
country: Germany
facility: Dr Emel Aygoren-Pursun
city: Mainz
country: Germany
facility: Dr Petra Staubach
city: Morfelden-Walldorf
country: Germany
facility: Dr Inmaculada Martinez-Saguer
city: Munchen
country: Germany
facility: Dr Murat Bas
city: London
country: United Kingdom
facility: Dr Hilary Longhurst
Study officials:
affiliation: Charite University, Berlin, Germany
name: Marcus Maurer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beard N, Frese M, Smertina E, Mere P, Katelaris C, Mills K. Interventions for the long-term prevention of hereditary angioedema attacks. Cochrane Database Syst Rev. 2022 Nov 3;11(11):CD013403. doi: 10.1002/14651858.CD013403.pub2.
Clinical trial NCT01165788: Social Adaptation in Long Term Survivors of Blood and Marrow Transplantation
Official title: Social Adaptation in Long Term Survivors of Blood and Marrow Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Social Adaptation
Keywords: Blood and Marrow Transplant (BMT)
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2010-07-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be identified from the comprehensive database of the Blood and Marrow Transplant Division of Stanford Hospitals \& Clinics. We will target lymphoma patients who received an autologous BMT as adults (18 years or older). We estimate there are \~580 surviving who are between 2 and 22 years post-BMT.

Brief summary: 1. To explore specific aspects of social adaptation such as social connectedness, occupational outcomes and family relationships in lymphoma patients after autologous blood or marrow transplantation (BMT).
2. To investigate how social adaptation varies with time lapsed since BMT and with the life stage as determined by patient?s age. Understanding both the positive and negative aspects of cancer and cancer therapy leads to opportunities to promote adaptive strategies.


Eligibility criteria: Inclusion Criteria:

1. Lymphoma patients treated with blood and marrow transplantation at Stanford University Medical Center
2. Age \> 18 years at the time of transplant
3. English speaking
4. Willingness to sign a written informed consent document

Primary outcomes:
measure: Specific aspects of social adaptation, such as social connectedness, occupational outcomes and family relationships in lymphoma patients after autologous blood or marrow transplantation (BMT)
timeFrame: 1 year
measure: Social adaptation variation with time lapsed since BMT and with the life stage as determined by patient's age
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Karen Cook
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Kate Tierney
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01528488: Prophylactic EVOZAC® Calming Skin Spray for EGFR-TKIs Associated Rash Eruption in NSCLC
Official title: A Randomized, Double-blind, Prospective Trial of Prophylactic EVOZAC® Calming Skin Spray for EGFR-TKIs Associated Rash Eruption in Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2012-02-08
Enrollment: 118
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The epidermal growth factor receptor (EGFR) has become an important target for cancer therapy, and the small molecular tyrosine kinase inhibitors (EGFR-TKIs) have played an important role in the treatment of non-small cell lung cancer (NSCLC). What accompanies with the encouraging efficacy in NSCLC is the common side effects, of which the most common one is the specific papular and pustular acne-like rash which affects mainly the face, scalp, and upper torso. But till now, no medicament has been proved effective enough to treat or prevent the EGFR-TKIs associated rash. The EVOZAC® Calming Skin Spray has shown acceptable activity at the rash prevention in our preliminary study, so the investigators conduct the randomized, double-blind, controlled trial to evaluate the efficacy and safety of EVOZAC® Calming Skin Spray in prevention of EGFR-TKIs associated rash in NSCLC.

Detailed description: Not suitable: no more information is needed to be described.

Eligibility criteria: Inclusion Criteria:

* Histologically proven NSCLC diagnosis
* Life expectancy over four weeks
* absolute neutrophil count ≥ 2.0X109/L, Pt ≥ 100X109/L, hemoglobin ≥ 90g/l
* With normal hepatic function(AST, ALT \< 2.5 x upper limit of normal , and Total bilirubin ≤ upper limit of normal)
* Suitable for EGFR-TKIs treatment and expectant duration over four weeks
* No specific therapies received within 4 weeks prior to enrollment which may induce similar skin reaction,such as Cetuximab, Sorafenib, Avastin.
* With a pre-existing peripheral neuropathy (National Cancer Institute Common Toxicity Criteria for Adverse Events \[NCI-CTC\] grade ≥ 3)
* No other concomitant therapy referred to the face skin during the study
* Signed and dated informed consent

Exclusion Criteria:

* Performance status ≥ 3(ECOG)
* Pregnant or breast-feeding patients
* The lesion counts can't be evaluated due to concomitant diseases or other conditions
* Not suitable for EGFR-TKIs treatment

Primary outcomes:
measure: Lesion counts in total face at completion of the study period (week 4)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Medical Oncology,Cancer Center of Sun Yat-Sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: li zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04378478: Urological Management of Complications of Penile Constriction Devices:
Official title: Urological Management of Complications of Penile Constriction Devices: French National Retrospective Study and Literature Review
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sexual Dysfunction
Keywords: Penile constriction device
Cockering
Emergency care
Penile strangulation
Urinary dysfunction
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient has complications secondary to ischemia caused by strangulation of the penis and / or scrotum

Brief summary: Wearing a penile ring is justified by international societies of Urology (AFU, EAU, AUA) only for the treatment of erectile dysfunction with vacuum. In this case, it is a constriction rubber band that can only be worn for 30 minutes.

Nowadays, wearing a cockring device for recreational purposes can lead to complications secondary to ischemia caused by strangulation of the penis and/or scrotum.

The variety of devices and materials used (metallic and/or alloys in particular) sometimes makes it difficult to remove them, requiring expensive surgery and dedicated equipment.

There is no official recommendation for the management of these complications.


Eligibility criteria: Inclusion criteria:

* Age ≥ 18 years old
* Peyronie's disease stable for more than 3 months after 12 to 18 months of evolution
* Any patient care for this pathology in public or private healthcare hospitals in France

Exclusion criteria:

- Refusal to participate

Primary outcomes:
measure: To draw up recommendations for the emergency management of these complications thanks to a study of the (few) cases treated in France and a review of the literature
timeFrame: 1 day
Secondary outcomes:
measure: Studying
timeFrame: 1 day
measure: Studying
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Edouard Fortier, MD
role: STUDY_DIRECTOR
References: