louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04008056: Impact of Patient Reported Outcomes for Pre-chemotherapy Medical Decision in Day Patients With Digestive Cancer
Official title: Impact of Patient Reported Outcomes for Pre-chemotherapy Medical Decision in Day Patients With Digestive Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Digestive Cancer
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 138
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: Day patients treated by chemotherapy for a digestive tumor in the Oncology Department of Nimes hospital.

Brief summary: The investigators hypothesize that an early assessment of the clinical toxicity of the patient is possible via patient reported outcomes and that this information provides at least the same information level as the clinical examination of the patient made by the doctor. The early decision to prepare chemotherapy medications based on the indirect early collection of clinical information from the patient via a patient reported outcome should help minimize the number of chemotherapy medications destroyed.


Eligibility criteria: Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* Patient is undergoing at least their second chemotherapy regime (outside weekly scheme or protocol with cisplatin requiring hospitalization) for a digestive tumor
* Patient has a Smartphone or access to the internet (via tablet or computer)
* The patient is under consultation as a day patient in the Oncology Department of Nimes hosptial

Exclusion Criteria:

* The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* The patient is pregnant, parturient or breastfeeding
* Patient has already participated in the study
* Patient undergoing first chemotherapy regime

Primary outcomes:
measure: Authorization for preparation of chemotherapy based on clinical information (decision 2)
timeFrame: Day 1
measure: Authorization for preparation of chemotherapy based on patient reported outcome (decision 3)
timeFrame: Day 1
Secondary outcomes:
measure: Cost of unused pouches of prepared chemotherapy according to decisions
timeFrame: Day 1
measure: Authorization for preparation of chemotherapy based on biological results (decision 1)
timeFrame: Day 0
measure: Patient satisfaction with the patient reported outcome questionnaire
timeFrame: Before starting chemotherapy (Up to 72 hours prior to treatment starting)
Other outcomes:
Locations:
city: Nimes
country: France
facility: CHU de Nimes
Study officials:
affiliation: CHU Nimes
name: Mireille Favier
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06550856: SUTURE-CLOSURE OMENTOPEXY VERSUS OMENTOPEXY ALONE IN REPAIR OF PERFORATED PEPTIC ULCER
Official title: SUTURE-CLOSURE OMENTOPEXY VERSUS OMENTOPEXY ALONE IN REPAIR OF PERFORATED PEPTIC ULCER
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Perforated Peptic Ulcer
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study will be conducted to assess whether there is a direct benefit associated with modified-Graham's omentopexy (MGO), above and beyond the benefit associated with Graham's omentopexy (GO) in the treatment of perforated duodenal ulcers. We attempted to answer the question whether primary closure of the perforation in MGO will affect the outcome of surgery. Complication rates will be compared for the two alternative surgical procedures.


Eligibility criteria: Inclusion Criteria:

- All adult patients of both sexes with a clinical diagnosis of perforated peptic ulcer (gastric or duodenal) that are fit to undergo surgery.

Exclusion Criteria:

- 1. Patients with associated bleeding ulcer (additional steps are needed to control bleeding).

2. Patients with associated pathology other than perforated peptic ulcer that needs surgical intervention.

Primary outcomes:
measure: Early postoperative follow up for repair of perforated peptic ulcer
timeFrame: Three days after the operation
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university Hospital
Study officials:
References:
citation: Berne TV, Donovan AJ. Nonoperative treatment of perforated duodenal ulcer. Arch Surg. 1989 Jul;124(7):830-2. doi: 10.1001/archsurg.1989.01410070084017.
citation: Boey J, Choi SK, Poon A, Alagaratnam TT. Risk stratification in perforated duodenal ulcers. A prospective validation of predictive factors. Ann Surg. 1987 Jan;205(1):22-6. doi: 10.1097/00000658-198701000-00005.
citation: Chung KT, Shelat VG. Perforated peptic ulcer - an update. World J Gastrointest Surg. 2017 Jan 27;9(1):1-12. doi: 10.4240/wjgs.v9.i1.1.
Clinical trial NCT04149756: Persistent Weight Maintenance for 6 Months After 3 Months of Active Weight Loss
Official title: An Observation Study on Maintaining Weight for 6 Months After 3 Months of Weight Loss Program
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Weight Reduction
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2019-11-04
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Body mass index (BMI) more than 27kg/m2 with comorbidities or BMI more than 30kg/m2

Brief summary: This study is intended to report changes in the weight and metabolic indicators of the subjects six months after the end of the study for adults with a risk factor of 27 kg/m2 or higher (formerly the research task name\[clinicaltrial.gov;NCT03675191\]).

Detailed description: There was no special intervention after the previous research intervention. After the previous research was completed, we will check the changes in the body composition and metabolic indicators over six months.

Eligibility criteria: Inclusion Criteria:

* Those who have participated in the previous trial (NCT03675191) and have completed the three-month study
* Those who agreed the trial.

Exclusion Criteria:

* Those who have withdrawn the previous trial (NCT03675191)

Primary outcomes:
measure: weight
timeFrame: after 6months
Secondary outcomes:
measure: lipid profile
timeFrame: after 6months
Other outcomes:
Locations:
city: Yongin
country: Korea, Republic of
facility: Yongin Severance hospital
state: Gyeonggi-do
Study officials:
affiliation: Severance Hospital
name: Yu-Jin Kwon, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05857956: A Clinical Trial to Assess the Efficacy of a Plant-based Energy Shot on Focus and ADHD-like Symptoms
Official title: A Clinical Trial to Assess the Efficacy of a Plant-based Energy Shot on Focus and ADHD-like Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Attention Difficulties
Mood
Anxiety
Caffeine
Lead sponsor: Proper Wild, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2023-05-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a virtual, single-arm clinical trial that will last 28 days. Participants will drink 1 bottle of Proper Wild energy shot daily and complete questionnaires at baseline, day 1, day 14, and day 28.

Attention deficit hyperactivity disorder (ADHD)-like symptoms, such as concentration, focus, and attention, will be evaluated at baseline and at each check-in. Likert scale responses will be examined from baseline to each check-in. Participant responses on product feedback will be presented as % scores.


Eligibility criteria: Inclusion Criteria:

* Currently experiencing symptoms associated with ADHD, including:

Impulsiveness. Disorganization and problems prioritizing Poor time management skills Problems focusing on a task Trouble multitasking Excessive activity or restlessness Poor planning

* Age 18-55
* Self-reported issues with focus and/or productivity
* Generally healthy - don't live with any uncontrolled chronic disease

Exclusion Criteria:

* Currently taking prescription medication for ADHD
* Currently supplementing with L-Theanine.
* Known to respond negatively to caffeine (no effect, makes them sleepy or feel unwell)
* People with a high caffeine tolerance defined as regular consumption of \>400mg of caffeine (\>4 coffees) per day.
* Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
* Anyone with known severe allergic reactions.
* Women who are pregnant, breastfeeding, or attempting to become pregnant
* Unwilling to follow the study protocol.

Primary outcomes:
measure: Change in Attention-deficit/hyperactivity disorder (ADHD)-like symptoms. [Time Frame: Baseline to Day 28]
timeFrame: 28 days
Secondary outcomes:
measure: Assess the product as a replacement for coffee or caffeinated beverages. [Time Frame: Baseline to Day 28]
timeFrame: 28 days
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References:
Clinical trial NCT04737356: SIA - Internet-administered CBT for Adolescents With Low Self-esteem
Official title: SIA - Internet-administered CBT for Adolescents With Low Self-esteem
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self Esteem
Keywords: cognitive behavior therapy
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2021-02-03
Enrollment: 52
Sex: ALL
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will investigate a novel CBT based treatment approach for low self-esteem among adolescents.


Eligibility criteria: Inclusion Criteria:

* Low self-esteem, as indicated by rating of \< 20 the Rosenberg Self-Esteem Scale.
* Age between 15 and 19 years old.
* Access to a computer, smartphone, or tablet with internet access.
* Write and speak Swedish.
* In case of use of psychotropical medication, a stable dose for the past three months prior to registration and no planned changes during the treatment.

Exclusion Criteria:

* Other ongoing psychological treatment that affects the treatment received in the study.
* No comorbid severe depressive symptoms and no suicidal plans.
* Ongoing alcohol use disorder, as indicated by Alcohol Use Disorders Identification Test (AUDIT).
* Severe psychiatric comorbidities (e.g. psychosis, anorexia nervosa) that requires specialist care within the regular psychiatric care.

Primary outcomes:
measure: Change in Rosenberg Self-Esteem Scale
timeFrame: Before treatment, after 3 weeks, after 7 weeks and follow-up at 12 months after treatment termination.
Secondary outcomes:
measure: Change in Brunnsviken Brief Quality of Life Questionnaire
timeFrame: Before treatment, after 7 weeks and follow-up at 12 months after treatment termination.
measure: Change in Robson Self-concept Questionnaire
timeFrame: Before treatment, after 7 weeks and follow-up at 12 months after treatment termination.
measure: Change in Self-Compassion Scale Short Format
timeFrame: Before treatment, after 7 weeks and follow-up at 12 months after treatment termination.
measure: Change in Performance based self-esteem Scale
timeFrame: Before treatment, after 7 weeks and follow-up at 12 months after treatment termination.
measure: Change in Patient Health Questionnaire
timeFrame: Before treatment, after 7 weeks and follow-up at 12 months after treatment termination.
measure: Change in Generalised Anxiety Disorder 7-item scale
timeFrame: Before treatment, after 7 weeks and follow-up at 12 months after treatment termination.
measure: Change in Alcohol Use Disorder Identification Test
timeFrame: Before treatment, after 7 weeks and follow-up at 12 months after treatment termination.
measure: Change in Rathus assertiveness schedule - 6
timeFrame: Before treatment, after 7 weeks and follow-up at 12 months after treatment termination.
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Linköping University
Study officials:
affiliation: Linkoeping University
name: Gerhard Andersson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03606356: Sustained onabotulinumtoxinA Therapeutic Benefits in Patients With Chronic Migraine
Official title: Sustained onabotulinumtoxinA Therapeutic Benefits in Patients With Chronic Migraine Over 3 Years of Treatment. A
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine Disorders
Lead sponsor: Corfu Headache Clinic
Sponsor class: OTHER
First posted: 2018-07-30
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Open-label, single-arm, prospective multicentre, clinical study
Primary purpose: PREVENTION

Brief summary: To assess whether there is a sustained benefit and good safety with repeated onabotulinumtoxinA sessions in chronic migraine over more than three years of treatment.

We prospectively enrolled 65 chronic migraine patients, who were classified as responders after three sessions of onabotulinumtoxin A and were eligible to further continue treatment.

Detailed description: Evidence on whether the therapeutic effect and good safety profile of onabotulinumtoxinA (Botox®) in chronic migraine (CM) patients is maintained over long term treatment is still limited. This study aims at assessing whether there is a sustained benefit and good safety with repeated onabotulinumtoxin A sessions in CM over more than three years of treatment.

This study prospectively enrolled 65 CM patients, who were classified as responders after three sessions of onabotulinumtoxinA and were eligible to further continue treatment. Data documenting longitudinal changes from the trimester after the third onabotulinumtoxinA administration (T1) to the trimester after completing two years of treatment (T2) and eventually to the trimester after completing three years of treatment (T3) in (i) mean number of monthly headache days (ii) migraine severity as expressed by the mean number of days with peak headache intensity of \>4/10, and (iii) mean number of days with use of any acute headache medication, were prospectively collected from patients' headache diaries.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with chronic migraine according to IHC-III with or without medication overuse.
* Responders defined as patients that after 3 sessions of treatment with onabutulinum toxin A, having experienced a ≥50% reduction in their average monthly migraine days

Exclusion Criteria:

-

Primary outcomes:
measure: Change in the mean number of monthly headaches
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Vikelis M, Argyriou AA, Dermitzakis EV, Spingos KC, Mitsikostas DD. Onabotulinumtoxin-A treatment in Greek patients with chronic migraine. J Headache Pain. 2016 Dec;17(1):84. doi: 10.1186/s10194-016-0676-z. Epub 2016 Sep 17.
Clinical trial NCT00004656: Nutritional Aspects of Rett Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rett Syndrome
Keywords: Rett syndrome
neurologic and psychiatric disorders
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Baylor College of Medicine
First posted: 2000-02-25
Sex: FEMALE
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Primary purpose: DIAGNOSTIC

Brief summary: OBJECTIVES: I. Determine dietary macronutrient intake in children with Rett syndrome and in healthy controls.

II. Measure sleeping and awake metabolic rates in various positions, i.e., reclining, sitting, and standing, by whole-room indirect calorimetry and isotope dilution.

III. Quantify activity patterns by time-motion studies using 24-hour activity records and 12-hour videotaping.

IV. Correlate 24-hour activity patterns with 24-hour heart rate telemetry and short-term oxygen consumption.

V. Estimate 24-hour fecal and urinary energy losses. VI. Determine body composition by clinical anthropometry, whole-body potassium counting, and total-body electrical conductance.

VII. Calculate apparent energy needs based on measurement of energy intake and expenditure.

Detailed description: PROTOCOL OUTLINE:

All participants undergo extensive nutritional and metabolic assessment with body composition evaluation. Studies include macronutrient intake, body fat, lean muscle mass, metabolic rate, and time-action studies; and 24-hour cardiac telemetry. Rett syndrome girls also receive a hemogram and hand x-ray.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

Patients aged 5 to 18 with Rett syndrome Able to sleep and awaken alone

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Baylor College of Medicine
name: Kathleen J. Motil
role: STUDY_CHAIR
References:
Clinical trial NCT06117956: Helicobacter Pylori in Patients With Chronic Tonsillits Prepared for Tonsillectomy
Official title: Helicobacter Pylori in Patients With Chronic Tonsillits Prepared for Tonsillectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Helicobacter Pylori Infection in Patients With Chronic Tonsillits
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Tonsillar disorders are frequent In both pediatric and adult otolaryngological practice, . Numerous disorders that damage tonsillar tissue necessitate tonsillectomy. Tonsillectomy is typically required for recurrent tonsillitis. (Mani et al., 2019).

According to studies, the mucosa-associated lymphoid tissue (MALT) of the stomach and tonsillar tissue in the Waldeyer's ring are both lymphoid tissues (Ma et al., 2018).

One of the most prevalent and frequent conditions in otorhinolaryngology is chronic tonsillitis, which is mostly brought on by bacterial infection. Chronic tonsillitis attacks can affect not only the tonsillar tissue but also can contribute to the emergence and progression of systemic disorders (Alrayah.,2023).

A gram-negative, urease-producing bacterium called Helicobacter pylori colonizes the mucosa of the digestive tract. It has been linked to gastric malignancies, notably mucosa-associated lymphoid tissue (MALT) lymphoma, as well as gastric ulcers and duodenal ulcers (Kusters et al., 2006).


Eligibility criteria: Inclusion Criteria:

1. Age: 5 to 50 years.
2. Of both sex.
3. Diagnosed with chronic tonsillitis undergoing elective tonsillectomy

Exclusion Criteria:

1. Patients on proton pump inhibitor or antibiotics 2 weeks before surgery .
2. Immune-compromised patients.
3. Patients with obstructive sleep apnea candidates for adenotonsillectomy

Primary outcomes:
measure: positive or negative h pylori infection in tonsillar tissue after tonsillectomy
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university Hospital
Study officials:
References:
Clinical trial NCT03345056: Vitrectomy With Planned Foveal Detachment for Refractory DME With or Without Vitreo-macular Interface Abnormality
Official title: Evaluation of Vitrectomy With Planned Foveal Detachment as Surgical Treatment for Refractory Diabetic Macular Edema With or Without Vitreo-macular Interface Abnormality
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Edema of the Macula
Lead sponsor: Ministry of Health and Population, Egypt
Sponsor class: OTHER_GOV
First posted: 2017-11-17
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the therapeutic efficacy of sub retinal BSS injections in conjunction with conventional vitrectomy for refractory Diabetic macular edema (DME)- resistant to more than one anti-VEGF agent, intravitreal corticosteroids and to previous vitrectomy. Some of enrolled cases had normal vitreo-macular interface (VMI) relationship, while other cases had incomplete vitreoretinal separation with vitreomacular attachment (VMA).


Eligibility criteria: Inclusion Criteria:

* Cases with refractory DME with a central macular thickness (CMT) of more than 300 µm despite undergoing anti-VEGF therapy (5-6 monthly injections of ranibizumab (IVR) or bevacizumab (IVB) with shifting to aflibercept (IVA) for additional 3 injections).

Exclusion Criteria:

* The major exclusion criteria were: (1) presence of apparent retinal pigment epithelium (RPE) atrophy at or near the macula; (2) presence of proliferative diabetic fibrovascular membranes threating or at the macula; (3) presence of diabetic optic atrophy; and (4) presence of neovascular glaucoma.

Primary outcomes:
measure: central macular thickness decrease
timeFrame: 10 months postperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Abdel Hadi AM. Evaluation of Vitrectomy with Planned Foveal Detachment as Surgical Treatment for Refractory Diabetic Macular Edema with or without Vitreomacular Interface Abnormality. J Ophthalmol. 2018 May 7;2018:9246384. doi: 10.1155/2018/9246384. eCollection 2018.
Clinical trial NCT02708056: Sugammadex Given for the Reversal of Rocuronium Induced Neuromuscular Blockade Under Sevoflurane Anesthesia in Infants
Official title: Sugammadex Given for the Reversal of Deep Rocuronium Induced Neuromuscular Blockade Under Sevoflurane Anesthesia in Infants: A Retrospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Brain Cancer
Keywords: Sugammadex
Rocuronium
Infant patients
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2016-03-15
Enrollment: 26
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the efficacy and safety of sugammadex in reversing profound neuromuscular block induced by rocuronium in infant patients


Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 1-12 month,
* ASA physical status 1-3 who underwent elective brain cancer surgery during general anesthesia were included in the study

Exclusion Criteria:

* younger than 1month or older than 12 months.
* hepatic or renal failure
* A history of allergy to study medication

Primary outcomes:
measure: The efficacy of sugammadex were assessed by using Train of four (TOF)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: