louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06621992: Skills to Enhance Positivity in Young Adults
Official title: Skills to Enhance Positivity in Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Positive Affect
Mindfulness
Gratitude
Savoring
Depression
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to test the feasibility and acceptability of a positive affect intervention for suicide in a population of young adults. Skills to Enhance Positivity (STEP) has been demonstrated to be feasible and acceptable among adolescents when delivered individually. The current study aims to test feasibility and acceptability in a group setting of young adults. The specific aims of STEP also seek to establish whether participants who received STEP report a significant increase in attention towards positive affect compared to those receiving Treatment As Usual (TAU). They also seek to explore whether participants who received STEP will report a significant decrease in suicidal ideation and depression compared to those receiving TAU. The final aim is to explore whether an increase in attention to positive affect regardless of condition is a potential mechanism of change for reductions in suicidal ideation and depression. Participants will be randomized into STEP or TAU groups, they will complete baseline and follow-up assessments after a period of 3-months. Participants enrolled in STEP will receive in-person group sessions focusing on psychoeducation of positive affect as well as skills in mindfulness, gratitude and savoring designed to promote positive affect. After completing the group sessions they will also receive text messages for one month, where they will receive prompts to practice skills they learned in the group setting.


Eligibility criteria: Inclusion Criteria:

* Participants must have a recent history of depression and are English-speaking
* Participants also must have a cell phone with text-messaging capabilities

Exclusion Criteria:

* Participants who have acute psychotic disorders or cognitive deficits that would preclude full understanding of the protocol, intervention and assessment materials

Primary outcomes:
measure: Feasibility and Acceptability of a group intervention
timeFrame: Will be assessed at follow-up at 3-months
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
References:
Clinical trial NCT01308892: Cardiovascular Health Effects of Flavanol Rich Chocolate
Official title: Cardiovascular Health Effects of Flavanol Rich Chocolate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endothelial Dysfunction
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: Top Institute Food and Nutrition
First posted: 2011-03-04
Enrollment: 44
Sex: MALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: In the CHOC study the investigators will examine the effect of chocolate flavanols on vascular function, inflammation, oxidative stress and markers of endothelial function. The effects of both acute consumption and prolonged consumption will be studied. The secondary objectives are to investigate if daily intake of chocolate flavanols for 4 weeks will improve the response to a high fat/high energy challenge.


Eligibility criteria: Inclusion Criteria:

* Male
* 45-70 years old
* BMI between 25 and 32 kg/m2

Exclusion Criteria:

* Urine glucose concentrations outside normal ranges (\> 0,25 g/l)
* Fasting blood glucose \< 7.0 mmol/L)
* Systolic Bp \> 160 mmHg or diastolic Bp \> 100 mmHg
* Blood Hb values below 8.4 mmol/L
* Allergic to cow milk, dairy products or chocolate
* Vegetarian
* Tobacco smoker
* Diagnosed with any long-term medical condition (e.g., diabetes, hemophilia, cardiovascular disease, anemia, gastrointestinal disease, renal failure)

Primary outcomes:
measure: Blood pressure
timeFrame: 0, 4wk
measure: FMD
timeFrame: 0, 4wk
measure: PWA
timeFrame: 0, 4wk
Secondary outcomes:
measure: leukocyte count and activation
timeFrame: 0, 4wk
measure: PBMC gene expression
timeFrame: 0, 4wk
measure: Markers of inflammation and ED
timeFrame: 0, 4wk
measure: Blood pressure
timeFrame: 0 and 2h
measure: FMD
timeFrame: 0 and 2hrs
measure: PWA
timeFrame: 0 and 2 hrs
measure: Leukocyte count and activation
timeFrame: 0 and 2 hrs
measure: PBMC gene expression
timeFrame: 0 and 2 hrs
measure: markers of inflammation and ED
timeFrame: 0 and 2hrs
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen universiteit division of human
state: Gelderland
Study officials:
affiliation: Chair Department of human nutrition NMG group
name: Michael Müller, Prof.Dr
role: STUDY_CHAIR
References:
Clinical trial NCT00220246: Clinical and Molecular Characterization of Familial Microsatellite Stable Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Neoplasms
Keywords: Hereditary colorectal cancer
Microsatellite instability
Chromosomal instability
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 130
Sex: ALL
Maximum age (years): 51
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: Two major genetic pathways leading to colorectal carcinoma can well be distinguished; the 'suppressor pathway', which is characterized by inactivation of tumor-suppressor genes and the 'mutator pathway', which is characterized by microsatellite instability. The purpose of this study is to explore a third putative pathway; microsatellite and chromosome stable colorectal cancer where an alternative cancer-causative mechanism might play a role.

Detailed description: Patients with familial colorectal cancer will be characterized with respect to family history, medical history and demographic characteristics. The histopathology of the tumors will be reviewed. Tumor specimens will be analysed on molecular defects.

Eligibility criteria: Inclusion Criteria:

- Colorectal cancer before the age of 51 years

Microsatellite stable tumor

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University
Study officials:
affiliation: Department of Human Genetics, Radboud University Nijmegen Medical Center
name: Nicoline Hoogerbrugge, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chan TL, Curtis LC, Leung SY, Farrington SM, Ho JW, Chan AS, Lam PW, Tse CW, Dunlop MG, Wyllie AH, Yuen ST. Early-onset colorectal cancer with stable microsatellite DNA and near-diploid chromosomes. Oncogene. 2001 Aug 9;20(35):4871-6. doi: 10.1038/sj.onc.1204653.
citation: Hawkins NJ, Tomlinson I, Meagher A, Ward RL. Microsatellite-stable diploid carcinoma: a biologically distinct and aggressive subset of sporadic colorectal cancer. Br J Cancer. 2001 Jan;84(2):232-6. doi: 10.1054/bjoc.2000.1554.
citation: Georgiades IB, Curtis LJ, Morris RM, Bird CC, Wyllie AH. Heterogeneity studies identify a subset of sporadic colorectal cancers without evidence for chromosomal or microsatellite instability. Oncogene. 1999 Dec 23;18(56):7933-40. doi: 10.1038/sj.onc.1203368.
Clinical trial NCT04576546: Inositols and FSH in IVF
Official title: Use of Inositols Within IVF Protocols to Reduce Gonadotropin Administration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amount of FSH Units During Ovarian Stimulation Protocols
Lead sponsor: Lo.Li.Pharma s.r.l
Sponsor class: INDUSTRY
First posted: 2020-10-06
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Ovarian hyperstimulation syndrome (OHSS), although quite uncommon, represents the most serious complication of ovulation induction during in-vitro fertilization (IVF) protocols. The syndrome is triggered by exaggerated ovarian response to gonadotropins, which eventually leads to pathological manifestations that range from mild symptoms, such as abdominal discomfort, to life-threatening complications in the most severe cases. Prevention is paramount during fertilization programs and requires assessment of risk factors and close monitoring of risk markers. Clinicians quite generally consider unusually elevated estrogen levels as both indicator for OHSS and one possible etiological factor. In this scenario, myo-inositol (MYO) treatment proved to reduce the amount of FSH units and the duration of the stimulation protocol, decreasing the risk of OHSS onset. On the other hand, inconclusive evidence is available about the effect of D-chiro-inositol (DCI) supplementation within assisted reproductive treatments. The aim of the proposed pilot study is to assess the effect of DCI supplementation on the doses of FSH used in IVF-ET protocols, also with respect to MYO treatment.


Eligibility criteria: Inclusion Criteria:

* Women undergoing IVF-ET procedure
* HOMA-IR index \< 2.0
* AMH in the range 1.0 - 2.0 ng/ml

Exclusion Criteria:

* History of cancelled IVF cycles
* BMI \< 20 kg/m2 or ≥ 30 kg/m2
* Diagnosis of PCOS
* Thyroid diseases
* Presence of co-morbidities

Primary outcomes:
measure: FSH units/retrieved oocyte
timeFrame: 1 day (single time-point at ovulation)
Secondary outcomes:
measure: Total FSH (IU)
timeFrame: 1 day (single time-point at ovulation)
measure: Duration of the stimulation
timeFrame: 1 day (single time-point at ovulation)
measure: number of viable oocytes
timeFrame: 1 day (single time-point at oocyte pick-up)
measure: oocyte quality
timeFrame: 1 day (single time-point at oocyte pick-up)
measure: embryo quality
timeFrame: 1 day (single time-point at embryo transfer)
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Clinica Alma Res
Study officials:
References:
Clinical trial NCT06067646: Optimizing Counceling on Feeding Options of Babies From Mothers Living With HIV
Official title: From Guidelines to Clinical Care: What is Needed for Optimizing Counceling on Feeding Options of Babies From Mothers Living With HIV?
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hiv
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Semi structured interviews will be performed to determine attitudes and experiences of people living with HIV and health care providers on counseling on feeding options of babies from mothers living with HIV in order to optimize counseling in the future


Eligibility criteria: Inclusion Criteria:

* Health care provider involved in care for people living with HIV in Duth HIV treatment facility or
* Person living with HIV + age 18-45 + prior pregnancy/desire to have children

Exclusion Criteria:

* Insufficient command of Dutch or English language (oral)

Primary outcomes:
measure: Experiences and attitudes on subject
timeFrame: Explore during semistructured interview during 1 to 2 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Radboud University Medical Center
name: Angela Colbers
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01104246: Dose Titration Investigation of the Pharmacokinetics of Testosterone Transdermal Systems in Hypogonadal Men
Official title: An Open Label, Dose-Titration Investigation of the Pharmacokinetics, Metabolism and Safety of Testosterone Transdermal Systems in Hypogonadal Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypogonadism
Keywords: Hypogonadism
Testosterone
Hormone replacement therapy
Lead sponsor: Watson Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-04-15
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will evaluate the pharmacokinetics of testosterone transdermal systems at steady-state in hypogonadal men.

Detailed description: Subjects will receive testosterone for 4 weeks. Based on a single morning testosterone measurement performed at the end of Week 1, the dosage can be titrated up or down to the next dose level to maintain testosterone levels in the normal range. At the end of 4 weeks of treatment, a pharmacokinetic profile for total testosterone and metabolites will be obtained.

Eligibility criteria: Inclusion Criteria:

* Males in good general health, 18 years of age or older.
* Have a previously documented testosterone deficiency.
* Willing and able to comply with the requirements of the protocol.

Exclusion Criteria:

* Have a history of intolerance to Androderm or other testosterone products.
* Prostate specific antigen (PSA) level ≥ 4.0 ng/mL
* Prostate cancer or severe benign prostatic hypertrophy (BPH)
* Have significant abnormalities in the physical examination at screening.
* Have current dermatological disease, skin damage or blemishes.
* Have participated in an investigational drug study within 30 days prior to screening.

Primary outcomes:
measure: Time-average (Cavg) Steady State Testosterone Concentration Over 24 Hours
timeFrame: Day 28/29
Secondary outcomes:
Other outcomes:
Locations:
city: Miramar
country: United States
facility: Watson investigational site
state: Florida
city: Omaha
country: United States
facility: Watson investigational site
state: Nebraska
city: San Antonio
country: United States
facility: Watson investigational site
state: Texas
Study officials:
affiliation: Watson Laboratories
name: Keshava Kumar, PhD, MHSA
role: STUDY_DIRECTOR
References:
Clinical trial NCT03340246: Delayed or Immediate Local Treatment of Veins
Official title: Delayed or Immediate Local Treatment of Varicose Veins
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Varicose Veins Leg
Keywords: Varicose veins, phlebectomy
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2017-11-13
Enrollment: 140
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Varicose veins affect a majority of adult patients and cause a decreased quality of life. In recent years, standard practice has been to perform thermoablation and local phlebectomies in the same procedure. There is conflicting data on the long-term outcome of the local varicose veins; there seems to be a need for more re-interventions if the local varicosities are not treated immediately. On the other hand, the prolonged combined procedure increases procedural pain and bleeding, as well as the risk for complications from deep vein thrombosis/pulmonary embolism.

This trial aims to evaluate the need for immediate treatment of local varicosities and the potential sufficiency of main trunk treatment.


Eligibility criteria: Inclusion Criteria:

* Ultrasound verified insufficiency of great saphenous vein (GSV)
* GSV diameter 5-10 mm
* C2-C4 varicosities
* Most proximal insufficient branch in the distal thigh
* Written and signed informed consent

Exclusion Criteria:

* Peripheral arterial disease
* Body mass index \>40
* Lymphoedema
* Known allergy to sclerosant
* Any known coagulopathy or history of deep vein thrombosis
* Severe illness
* Pregnancy

Primary outcomes:
measure: Need for sclerotherapy
timeFrame: 3 months
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 3 months
measure: Occlusion rate of great saphenous vein
timeFrame: 36 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Karoliina Halmesmäki, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital
name: Maarit Venermo, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04473846: Propofol-fentanyl-ketamine (PFK) Combination Versus General Anesthesia Using Propofol and Fentanyl in Patients Undergoing Endoscopic Procedures.
Official title: The Use of Propofol-fentanyl-ketamine (PFK) Combination Versus General Anesthesia Using Propofol and Fentanyl in Patients Undergoing Endoscopic Procedures: a Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Keywords: Anesthesia
Endoscopy
Colonoscopy
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2020-07-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Conscious sedation provides adequate control of pain and anxiety for the majority of routine endoscopic procedures as well as adequate amnesia. Sedation practices vary widely, with some colonoscopists advocating sedation only for the most difficult cases of colonoscopy, while others prefer using deep sedation or general anaesthesia for colonoscopy. However, many physicians are still using moderate sedation for the majority of patients.

The use of propofol, a short acting anesthetic agent, for conscious sedation provides a considerably more rapid onset of action and shorter recovery time, for which it is believed to be a safe drug of choice for patients undergoing endoscopic procedures. Although propofol cannot be used as a single agent for moderate sedation, it can be effectively titrated to moderate sedation after administration of small doses of narcotics and sedatives.

The aim of this study is to compare between general anesthesia and deep sedation using propofol-fentanyl-ketamine (PFK) preparation in terms of perioperative vital signs, intraoperative awareness, post-operative pain scores, and the use of analgesia postoperatively.


Eligibility criteria: Inclusion Criteria:

* patients who were admitted for endoscopic and colonoscopic procedures.
* ASA (American Society of Anaesthesiologists physical status) score from 1 to 3.

Exclusion Criteria:

* patient refusal.
* urgent and emergency cases, which were not elective procedures.
* Surgeries that were expected to take a long duration (more than 1.5 hour).

Primary outcomes:
measure: Transient decrease in oxygen saturation
timeFrame: 1 hour
measure: Blood pressure stability
timeFrame: 1 hour
measure: Recovery time
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Jordan University Hospital
Study officials:
References:
Clinical trial NCT00372346: Safety and Efficacy Study of Transplantation of EPCs to Treat Idiopathic Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Idiopathic Pulmonary Arterial Hypertension
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2006-09-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Experimental data suggest that transplantation of endothelial progenitor cells (EPCs) attenuates monocrotaline-induced pulmonary hypertension in rats and dogs. In addition, clinical studies suggest that autogolous progenitor cells transplantation is feasible and safe in patients with ischemic disease. This study will investigate the feasibility, safety, and initial clinical outcome of intravenous infusion of autologous EPCs in patients with idiopathic pulmonary arterial hypertension.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of idiopathic pulmonary arterial hypertension

  1. in New York Heart Association (NYHA) functional class II to III
  2. a mean pulmonary artery pressure more than 30 mmHg on right heart catheterization
  3. the ability to walk ≥50 m during a standardized 6-minute walk test

Exclusion Criteria:

* Pulmonary hypertension as a result of heart disease, pulmonary disease, sleep-associated disorders, chronic thromboembolic disease, autoimmune or collagen vascular disease, HIV infection, liver disease, NYHA functional class IV, major bleeding requiring blood transfusion, diabetes, renal dysfunction, and evidence for malignant diseases were excluded

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Department of Cardiology, the First Affiliated Hospital, College of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: First Affiliated Hospital of Zhejiang University
name: junzhu chen, MD
role: STUDY_CHAIR
References:
citation: Takahashi M, Nakamura T, Toba T, Kajiwara N, Kato H, Shimizu Y. Transplantation of endothelial progenitor cells into the lung to alleviate pulmonary hypertension in dogs. Tissue Eng. 2004 May-Jun;10(5-6):771-9. doi: 10.1089/1076327041348563.