louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06966661: Peer-Supported E-Health Intervention for College Student Weight Management and Mental Health
Official title: Peer-Supported E-Health Intervention for College Student Weight Management and Mental Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression - Major Depressive Disorder
Psychological Well Being
Obesity Prevention
Lead sponsor: Jinan University Guangzhou
Sponsor class: OTHER
Collaborators: name: Guangzhou Sport University
First posted: 2025-05-13
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will test whether adding peer support and online education can help college students manage their weight and improve their mood: we plan to enroll 300 full-time university students and randomly assign them to one of three six-month groups (monthly in-person health talks and weekly emailed tips alone; those activities plus biweekly peer-mentor meetings and an online chat group; or those activities plus a custom app delivering weekly lessons, monthly expert live Q\&A, and self-tracking tools). We will measure weight, body mass index (BMI), and scores on standard questionnaires for depression (PHQ-9), anxiety (GAD-7) and life satisfaction (SWLS) at baseline, three months and six months to compare the effectiveness of each approach. By identifying which combination of face-to-face support and digital tools produces the greatest improvements, we aim to inform low-cost, scalable programs to help students maintain a healthy weight and emotional well-being.


Eligibility criteria: Inclusion Criteria:

* Full-time undergraduate students aged 18-25 years
* Baseline BMI ≥ 24.0 kg/m²
* Able to provide informed consent
* Owns a smartphone or computer with internet access
* Willing to attend monthly lectures and complete online modules

Exclusion Criteria:

* Current participation in another weight-management or psychological intervention program
* Diagnosis of an eating disorder, severe psychiatric illness, or medical condition affecting weight (e.g., hyperthyroidism)
* Pregnant or planning pregnancy during the study period
* Any physical limitation precluding participation in light-to-moderate physical activity
* Inability to communicate in the language of intervention materials

Primary outcomes:
measure: Change in Body Weight
timeFrame: Baseline and Month 6 (6 months)
Secondary outcomes:
measure: Change in Depression Severity (PHQ-9)
timeFrame: Baseline and Month 6 (6 months)
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: School of Physical Education, Jinan University
state: New Territories
Study officials:
References:
Clinical trial NCT05406661: Registry of Local Recurrences After Breast-conserving Surgery
Official title: Registry of Local Recurrences After Breast-conserving Surgery in Portugal and Spain
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer Recurrent
Keywords: Breast cancer treatment
Local recurrences
Breast-conserving surgery
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Centro Hospitalar Universitário São João, EPE
First posted: 2022-06-06
Enrollment: 3000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with local recurrence after breast-conserving surgery

Brief summary: The ReLoCC project is a prospective, multicenter, clinical study to register cases of local recurrence after breast-conserving surgery, in centers dedicated to the treatment of breast cancer, in Portugal and Spain.

The comparison of the results obtained will allow the optimization of the treatment, making it increasingly personalized.


Eligibility criteria: Inclusion Criteria:

1. Female patients
2. Age \> 18 years
3. Patients who have previously undergone breast-conserving surgery as part of the treatment of invasive or non-invasive (in situ) breast cancer

   1. and adjuvant breast RT: total (WBI) or partial (PBI)
   2. without adjuvant radiotherapy to the breast
4. Recent histological diagnosis of homolateral, invasive or non-invasive (in situ) breast carcinoma

Exclusion Criteria:

1. Male
2. Age \< 18 years
3. Stage 4 at diagnosis
4. Patients operated outside the participating Centers and for whom it is not possible to obtain complete information regarding the primary treatment
5. History of other primary invasive malignant tumor (except non-melanoma skin carcinomas)
6. Patients already treated for another local recurrence of breast carcinoma
7. Absence of clinical follow-up and records in clinical process

Primary outcomes:
measure: Determine prevalence of local recorrence of breast cancer after conserving surgery in Portugal and Spain
timeFrame: 2 years
measure: Follow-up of recurrences up to 5 years after treatment of first recurrence
timeFrame: 5 years
Secondary outcomes:
measure: Identification of risk factors for local recurrence
timeFrame: On inclusion time (2 years)
measure: Identification of predictive and response factors
timeFrame: On inclusion time (2 years)
measure: Determination of surgical morbidity of relapse treatment in follow up
timeFrame: From date of treatment until 30 days after treatment
measure: Assessment of patient quality of life
timeFrame: First and second year after treatment
Other outcomes:
Locations:
Study officials:
affiliation: Centro de Mama - Centro Hospitalar Universitário de São João
name: José Luis Fougo, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06280261: The Struggle That Is Phenylketonuria : What Do The Patients and Caregivers Suffer From
Official title: The Struggle That Is Phenylketonuria : What Do The Patients and Caregivers Suffer From
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychological Well-Being
Caregiver Burden
Life Stress
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 156
Sex: ALL
Minimum age (years): 6
Maximum age (years): 35
Standard ages: CHILD
ADULT
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study was carried out at Hacettepe University, İhsan Doğramacı Children's Hospital, Department of Metabolism, between January 2020 and June 2020. It was planned to include patients who were followed up with the diagnosis of phenylketonuria with diet or Sapropterin hydrochloride therapy, who didn't have BH4 metabolism disorder or any other health problem. Pregnant patients were also excluded

Brief summary: Objective: To assess the stress levels and life hardships of phenylketonuria patients and their parents.

Detailed description: Study Design: Between January 2020 - June 2020, a total of 156 phenylketonuria patients and their parents who arrived for their regular examinations were included. Parents were asked to fill the parenting stress index, Zarit burden scale and the strengths and difficulties questionnaire and children over the age of eleven were asked to fill the Rosenberg self-esteem scale, the stait-trait anxiety inventory and strengths and difficulties questionnaire.

Eligibility criteria: Inclusion Criteria:

* Phenylketonuria patients

Exclusion Criteria:

* BH4 metabolism disorde
* Other chronic illness
* Pregnancy

Primary outcomes:
measure: Rosenberg Self-Esteem Scale
timeFrame: 12 minutes
measure: Stait trait anxiety inventory
timeFrame: 45 minutes
measure: Strenghts and difficulties questionnaire
timeFrame: 30 minutes
measure: Zarit burden scale
timeFrame: 25 minutes
measure: Parenting stress index
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Sihhiye
Study officials:
affiliation: Hacettepe University
name: Serap Sivri, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT02640261: Observational Prospective Study of the Success of Single Embryo Transfer Implantation Related to Level of Follicular Fluid Cytokines Expression in Low Responders Infertile Patients Treated With r-hLH add-on Therapy in a Second Controlled Ovarian Stimulation Cycle.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Female Infertility
Keywords: r-hLH
Cytokines
Follicular Fluid
Lead sponsor: Centro di Procreazione Assistita Demetra
Sponsor class: OTHER
First posted: 2015-12-28
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normogonadotropic Infertile Women that failed the first IVFcycle and require r-hLh add on therapy as per Demetra clinical standard procedures

Brief summary: The objective of our observational prospective study will be to compare, for women treated for infertility and included in a ICSI program, the implantation rate and delivery rate obtained after the transfer of a single blastocyst , chosen in a group of patients on the basis of the embryo morphology and in the other group on the basis of both embryo morphology and follicular fluid cytokines content.

100 IVF infertile patients , aged 32-39 years, with normal ovarian reserve, previously stimulated for their first cycle with standard short protocol (GnRH-Ant) and r-FSH alone, who have had a low ovarian response, Fort \< 50% ( FORT Criteria, 2012; FORT= PFCX100/AFC), will be treated for the second cycle with standard short protocol (GnRH-Ant) and r-FSH plus r-LH , according to the standard established by our clinical practice.

Patients will be part of one of the following groups:

Group 1: single embryo transfer on day 5, according to standard embryo morphological criteria Group 2: single embryo transfer on day 5, chosen on the basis of both embryo morphological criteria and levels of cytokines measured in the individual FF.


Eligibility criteria: Inclusion Criteria:

* women age from \< 38 years
* normal body mass index (BMI ) from 18 to 26
* parameters for ovarian reserve in the normal range (day 3 FSH levels \< 10 mUI/ml ; day 3 E2 levels \< 80 pg/ml; anti-mullerian hormone (AMH) levels \> 1.5 ng/ml ; AFC (antral follicular count) \> 6 )

Exclusion Criteria:

* polycystic ovary syndrome (PCOS)
* ovarian surgery
* pelvic endometriosis
* POR according to ESHRE criteria

Primary outcomes:
measure: Implantation rate
timeFrame: 2 years
Secondary outcomes:
measure: Delivery Rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Florence
country: Italy
facility: DEMETRA
Study officials:
affiliation: Clinica Center DEMETRA
name: Elisabetta Chelo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01129661: Safety, Tolerability and Pharmacokinetics of CSL112 in Healthy Volunteers
Official title: An Adaptive, Phase I, Single-Centre, Randomised, Double-blind, Placebo-controlled Single Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics, of Intravenous CSL112 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: CSL Limited
Sponsor class: INDUSTRY
First posted: 2010-05-25
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and tolerability of escalating doses of CSL112 after single intravenous infusions in healthy volunteers and to measure the pharmacokinetics of CSL112 after single intravenous infusions in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy males and females aged 18 years to less than 55 years
* Body weigh 45 kg or greater

Exclusion Criteria:

* Evidence of a clinically significant medical condition, disorder or disease
* Evidence of clinically relevant abnormal laboratory test result
* Evidence of history of alcohol or substance abuse

Primary outcomes:
measure: Safety and tolerability as measured by the frequency of drug-related clinical adverse events.
timeFrame: Up to 14 days after infusion of CSL112
measure: Safety and tolerability as measured by liver function tests.
timeFrame: Up to 14 days after infusion of CSL112
Secondary outcomes:
measure: Pharmacokinetics of lipoprotein.
timeFrame: Up to 10 days after infusion of CSL112
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: CMAX
state: South Australia
Study officials:
References:
citation: Zheng B, Duffy D, Tricoci P, Kastrissios H, Pfister M, Wright SD, Gille A, Tortorici MA. Pharmacometric analyses to characterize the effect of CSL112 on apolipoprotein A-I and cholesterol efflux capacity in acute myocardial infarction patients. Br J Clin Pharmacol. 2021 Jun;87(6):2558-2571. doi: 10.1111/bcp.14666. Epub 2020 Dec 23.
Clinical trial NCT05697861: Long-Term Follow-Up (LTFU) of Subjects Dosed With NTLA-2001
Official title: Long-Term Follow-Up of Subjects Treated With NTLA-2001
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Transthyretin-Related (ATTR) Familial Amyloid Polyneuropathy
Transthyretin-Related (ATTR) Familial Amyloid Cardiomyopathy
Wild-Type Transthyretin Cardiac Amyloidosis
Lead sponsor: Intellia Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-01-26
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participating sites in an Intellia-sponsored clinical study of NTLA-2001.

Brief summary: This is a follow-up study of subjects who received NTLA-2001 in a previous clinical trial as an observational evaluation of the long-term effects of the investigational therapy.


Eligibility criteria: Inclusion Criteria:

1. A subject has completed or discontinued from an Intellia-sponsored clinical study in which a complete or partial dose of NTLA-2001 was received.
2. A subject has provided informed consent for the LTFU study.

Exclusion Criteria:

None

Primary outcomes:
measure: Incidence of Treatment-related SAEs and Protocol-specified AESIs
timeFrame: up to 15 years
Secondary outcomes:
measure: PD biomarkers for ATTR including serum TTR and serum prealbumin
timeFrame: up to 15 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Clinical Trial Site
city: Auckland
country: New Zealand
facility: Clinical Trial Site
city: Umea
country: Sweden
facility: Clinical Trial Site
city: London
country: United Kingdom
facility: Clinical Trial Site
Study officials:
References:
Clinical trial NCT06615661: A Real-World Evidence Study of Goniotomy With the C-REX™ Instrument in Patients With Primary Open Angle Glaucoma
Official title: An Observational Real-World Evidence Study of Ab-Interno Goniotomy Performed Using the C-Rex Instrument in Patients With Primary Open Angle Glaucoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Open Angle Glaucoma (POAG)
Keywords: Ocular Hypertension
Eye Diseases
Glaucoma
Goniotomy
Lead sponsor: Iantrek, Inc.
Sponsor class: INDUSTRY
First posted: 2024-09-26
Enrollment: 200
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible participants who underwent IOP-lowering surgical procedures using the C-Rex Instrument to perform ab-interno goniotomy

Brief summary: This study enrolls adults with primary open angle glaucoma (POAG) who underwent goniotomy intraocular pressure (IOP)-lowering surgery with the C-Rex Instrument. Patients are consented prior to surgery and followed for 12 months postoperatively. Data regarding IOP, use of glaucoma medications, and any device-related complications are collected during the study time period.

Detailed description: This a multicenter, observational real-world evidence study of eligible adults with primary open angle glaucoma (POAG) in whom ab-interno goniotomy surgery with the C-Rex Instrument was performed.

Data is collected from the preoperative visit(s) that directly preceded the surgery, the surgical procedure, and post-surgical visits through 12 months postoperatively.

Specific data collected includes C-Rex Instrument goniotomy surgical details, preoperative and postoperative IOP and use of ocular hypotensive medications, and device-related safety events.

Eligibility criteria: Inclusion Criteria:

* Primary open angle glaucoma
* Goniotomy surgery performed using the C-Rex Instrument

Exclusion Criteria:

* History of intraocular surgery within 8 weeks prior to C-Rex surgery
* Preoperative IOP higher than 33 mmHg
* Presence of a glaucoma type other than POAG
* Presence of clinically significant intraocular pathology other than cataract or glaucoma

Primary outcomes:
measure: Percent of eyes with intraocular pressure (IOP)reduction ≥20%in comparison with baseline.
timeFrame: 12 month postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Omni Eye Services
state: Georgia
city: Crossville
country: United States
facility: CIRCLE Site 04
state: Tennessee
Study officials:
References:
Clinical trial NCT04427761: A Study of the Life Changes Experienced by Patients With Pancreatic Cancer
Official title: Health-Illness Transition Experiences Among Patients With Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pancreatic Cancer
Keywords: Quality of Life
Health-Illness Transition
20-038
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Hunter College School of Nursing
First posted: 2020-06-11
Enrollment: 55
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: Medical oncology clinic

Brief summary: The purpose of this study is to better understand what types of transitions people with pancreatic cancer face when they receive chemotherapy. Again, this study defines transition as a change in a life situation or a status that causes a change in a person's identity, role, behavior, or personal relationships. Examples of transitions include changes in sleeping habits, anxiety, employment, relationship with a higher power, and treatment goals.


Eligibility criteria: Inclusion Criteria:

* adult patients 18 years of age and older
* primary language listed as English in electronic medical record
* biopsy proven diagnosis of pancreatic cancer
* within three months after initiating a chemotherapy regimen at the Rockefeller Outpatient Pavilion at MSKCC (patient may have previously received chemotherapy at an outside institution or may have received previous chemotherapy regimens at MSKCC).

Exclusion Criteria:

* previous history of cancer within the past five years, except for non-melanoma skin cancer, ductal carcinoma in situ breast cancer, and thyroid cancer.

Primary outcomes:
measure: Extent of the change experienced by patients with pancreatic cancer
timeFrame: 4 to 6 weeks after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jessica Goldberg, RN, MSN, AGPCNP-BC, ACHPN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04258761: A Safety and Tolerability Study of 10XB-101 Injections in Adult Subjects With Extra Fat Under the Chin ("Double Chin")
Official title: A Multi-Center, Open Label, Single Ascending Dose Safety and Tolerability Study of Subcutaneously Administered 10XB-101 in Adult Subjects With Excessive Submental Fat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Submental Fat
Lead sponsor: 10xBio, LLC
Sponsor class: INDUSTRY
First posted: 2020-02-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Multi-center, open label, single ascending dose comparison.
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to find out more about an investigational drug, 10XB-101, for people with fat under their chin which they would like to remove. The Sponsor of this study thinks there may be a chance this drug could be used to dissolve, or "melt" this fat away.

Detailed description: About 15 subjects with excessive submental fat (SMF) will be enrolled across 2 sites in the United States.

Eligibility criteria: Inclusion Criteria:

* Subject is a male or non-pregnant female 18-65 years of age
* Signed informed consent
* Subject has a score of 2 or 3 on the Clinician Submental Fat Scale (CSFS) at Visit 2/Baseline
* Subject is in good general health

Exclusion Criteria:

* Loose skin or prominent platysmal bands in the neck or chin area
* Recent treatment with anticoagulants
* Presence of clinically significant health problems

Primary outcomes:
measure: Adverse Events
timeFrame: 24 weeks
measure: Local Skin Reactions (LSR)
timeFrame: 24 weeks
Secondary outcomes:
measure: Clinician Submental Fat Scale (CSFS)
timeFrame: 24 weeks
measure: Patient Submental Fat Scale (PSFS)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Site 01
state: California
Study officials:
affiliation: 10xBio, LLC
name: John Dobak, MD
role: STUDY_DIRECTOR
References: