louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03888456: Effects of OMT on ANS: a Thermography Study
Official title: Effects of Osteopathic Manipulative Treatment on Autonomic Nervous System: a Thermography Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autonomic Nervous System Imbalance
Healthy
Lead sponsor: Come Collaboration
Sponsor class: OTHER
Collaborators: name: Università degli Studi 'G. d'Annunzio' Chieti e Pescara
name: Chinesis IFOP
First posted: 2019-03-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: randomised placebo controlled crossover study
Primary purpose: BASIC_SCIENCE

Brief summary: the study will investigate the effect of a specific type of touch intervention on the activity of autonomic nervous system measured using thermography


Eligibility criteria: Inclusion Criteria:

* adults above 18y and below 35y
* without any congenital, genetical and chronic disease
* without any symptomatology

Exclusion Criteria:

* congenital, genetical and chronic disease
* neurological, cardiovascular, psychiatric disease
* acute pain
* paediatric patients
* adults over 35 years old

Primary outcomes:
measure: temperature
timeFrame: 1 week
Secondary outcomes:
measure: skin conductance
timeFrame: 1 week
measure: heart rate variability
timeFrame: 1 week
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: University of Chieti
Study officials:
affiliation: Come Collaboration
name: Francesco Cerritelli
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cerritelli F, Cardone D, Pirino A, Merla A, Scoppa F. Does Osteopathic Manipulative Treatment Induce Autonomic Changes in Healthy Participants? A Thermal Imaging Study. Front Neurosci. 2020 Aug 18;14:887. doi: 10.3389/fnins.2020.00887. eCollection 2020.
Clinical trial NCT05881356: Discovering Factors in the Clinical Study Journey of Patients With OCD
Official title: Understanding the Patient Perspective: An Observational Study on Experiences of OCD Clinical Trial Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: OCD
Obsessive-Compulsive Disorder
Keywords: OCD
Obsessive-Compulsive Disorder
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-31
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with OCD who are actively considering involvement in an observational clinical trial, but have not yet completed enrollment and registration.

Brief summary: This research aims to collect comprehensive data on the clinical trial experience of OCD patients. Its goal is to identify the factors that limit patients' ability to join or complete a trial successfully. Clinical trial participation often favors specific demographic groups, and limited research exists on the impact of trial attributes on participation. Therefore, this study aims to analyze data from various demographic groups and identify any recurring trends that could provide valuable insights for future OCD patients.


Eligibility criteria: Inclusion Criteria:

* Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed.
* Participant has a diagnosis of OCD.
* Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.

Exclusion Criteria:

* Pregnant or lactating woman
* Enrolled in another research study
* Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial

Primary outcomes:
measure: Rate of participants who decide to enroll in a OCD clinical study.
timeFrame: 3 months
measure: Number of OCD patients who remain in clinical trial until completion.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Hirschtritt ME, Bloch MH, Mathews CA. Obsessive-Compulsive Disorder: Advances in Diagnosis and Treatment. JAMA. 2017 Apr 4;317(13):1358-1367. doi: 10.1001/jama.2017.2200.
citation: Albert U, Marazziti D, Di Salvo G, Solia F, Rosso G, Maina G. A Systematic Review of Evidence-based Treatment Strategies for Obsessive- compulsive Disorder Resistant to first-line Pharmacotherapy. Curr Med Chem. 2018;25(41):5647-5661. doi: 10.2174/0929867325666171222163645.
citation: Bidlack JM, Lockshin RA. Evolution of LDH isozymes during programmed cell death. Comp Biochem Physiol B. 1976;55(2):161-6. doi: 10.1016/0305-0491(76)90223-6. No abstract available.
Clinical trial NCT00280956: Open Label Natalizumab Safety Extension Study for Subjects With Crohn's Disease
Official title: A Phase III, Multicenter, Open-Label, Long-Term Study of the Safety, Tolerability, and Efficacy of Intravenous Antegren™ (Natalizumab) in Crohn's Disease Subjects Who Have Previously Participated in Antegren Crohn's Disease Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Crohn's Disease
Lead sponsor: Biogen
Sponsor class: INDUSTRY
Collaborators: name: Elan Pharmaceuticals
First posted: 2006-01-24
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The primary objective of this study is to evaluate the long-term tolerability and safety of natalizumab when administered a dose of 300 mg intravenously (IV) to subjects with Crohn's Disease who have previously participated in studies CD251, CD301, CD303, CD306, or CD307.


Eligibility criteria: * Male and Female Subjects 18 years and older with Crohn's Disease who have participated in studies CD251, CD301, CD303, CD306, or CD307 per protocol

Primary outcomes:
measure: To evaluate the safety of natalizumab by the number and proportion of subjects with adverse events, and by assessing clinical laboratory parameters and vital signs.
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Performed only at CD251, CD301, CD303, CD306, and CD307 sites globally. No general public enrollment. The study is managed from the office of Elan Pharmaceuticals, Inc. in
state: California
Study officials:
References:
Clinical trial NCT06500156: Metabolic Cluster Analysis in Septic Shock Patients
Official title: Metabolic Cluster Analysis in Septic Shock Patients Undergoing Hemodynamic Resuscitation. A Multicenter Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Septic Shock
Keywords: septic shock
hemodynamic resuscitation
cardiovascular monitoring
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2024-07-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Septic shock patients within the first 24 hours of ICU admission, and selected by the attending physician for performing a fluid challenge (FC) due to suspected tissue hypoperfusion.

Brief summary: Observational study including septic shock patients within 24 hours of ICU admission, monitored with a cardiac output estimation system, with ongoing resuscitation. Hemodynamic and metabolic parameters before and after a fluid challenge (FC) will be measured.


Eligibility criteria: Inclusion Criteria:

- Septic shock patients within the first 24 hours of ICU admission, and selected by the attending physician for performing a fluid challenge (FC) due to suspected tissue hypoperfusion (elevated lactate and/or ScvO2 \< 70%).

Exclusion Criteria:

* Age under 18 years old
* Uncontrolled hemodynamic instability, defined as the need for significant changes in vasopressor support (\> 10% from baseline dose) within the 15-minute period prior to, and/or during the administration of fluids.
* Patients receiving continuous renal replacement therapies, since the CO values obtained from the thermodilution techniques might be potentially affected.

Primary outcomes:
measure: VO2-response
timeFrame: 30 minutes
Secondary outcomes:
measure: Organ failure
timeFrame: 4 days
measure: Mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Hospital Universitari Parc Taulí
state: Barcelona
Study officials:
References:
Clinical trial NCT06790056: Efficacy of Endoscopic Band Ligation (DEBL) for Duodenal Neuroendocrine Neoplasms(dNENs)
Official title: Efficacy of Endoscopic Band Ligation (DEBL) for Duodenal Neuroendocrine Neoplasms(dNENs) : A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Duodenal Neuroendocrine Tumor
Keywords: lesion size,
tumour
binding
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2025-01-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 50 patients over 1-year duration .

Brief summary: Primary objective To evaluate the therapeutic efficacy (clinical success) of dEBL at 3 months

2b. Secondary objective

To evaluate adverse events, technical success and recurrence on follow-up

50 patients over 1-year duration based on our previous study of Prospective data (2023-2024)

Detailed description: We will collect your basic demographics details like age, Sex, date of admission, Endoscopy (is a test to look inside your body) details of Site, size, number of lesion.

By EUS (Endoscopic ultrasound (EUS) combines two techniques - endoscopy and ultrasound - to help doctors see, evaluate and diagnose conditions in and near the gastrointestinal (GI) tract) details of layer of Duodenum involved, site/size/number of lesions.

We will collect your details of Duodenal endoscopic band ligation procedure to check feasibility, technical success.

You are requested to come for follow up for 3 months for endoscopy prodecure.

Eligibility criteria: Inclusion Criteria:

* Patients age \>18 years
* Size of lesion less than 15mm
* Site of lesion- duodenum (d1-d4)
* No of lesions- ≤6

Exclusion Criteria:

* Age less than 18 years
* Non-duodenal lesion
* Local or distant metastasis
* Lumen occluding lesions
* Uncorrectable coagulopathy
* Not willing for consent

Primary outcomes:
measure: Therapeutic efficacy (clinical success) of dEBL at 3 months and 1 year
timeFrame: One year
Secondary outcomes:
measure: Adverse events and recurrence on follow up
timeFrame: One year
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Hardik Rughwani
state: Telangana
Study officials:
affiliation: AIG HOSPITALS
name: Hardik Rughwani
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004356: Study of Homocysteine Metabolism in Homocystinuria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Homocystinuria
Keywords: homocystinuria
inborn errors of metabolism
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: University of California, San Diego
First posted: 1999-10-19
Enrollment: 60
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: OBJECTIVES: I. Determine basal and postmethionine plasma homocysteine in patients with premature vascular disease, cystathionine beta-synthase (CBS) or methylenetitrahydrofolate reductase (MTHFR) deficiency, and in obligate heterozygotes for CBS or MTHFR.

II. Determine whole-body homocysteine metabolic rates with isotopically-labeled methionine.

Detailed description: PROTOCOL OUTLINE: This is a two-part study of homocysteine metabolism. Age-matched normal controls are entered in both parts of the study.

In first part of the study, participants are given oral methionine; baseline and postmethionine studies include amino acid quantitation, analysis of rapidly deproteinized plasma, and total plasma homocysteine.

In the second part of the study, participants (men and postmenopausal women only) undergo methionine tracer studies.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Known or suspected homocystinuria Cystathionine beta-synthase-deficient homocystinuria Obligate heterozygotes for cystathionine beta-synthase deficiency Premature vascular disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Diego
name: Bruce Barshop
role: STUDY_CHAIR
References:
citation: Page T, Barshop BA, Yu A, et al.: Treatment of Lesch-Nyhan syndrome with AICAR. In: Sahota A, Tayor M, eds.: Purine and Pyrimidine Metabolism in Man VIII. Plenum Press, New York, NY: 1995, pp 353-356.
Clinical trial NCT04648956: Arabic Version of the ICOAP Questionnaire
Official title: Cross-cultural Adaptation and Psychometric Properties of the Arabic Version of the Intermittent and Constant Osteoarthritis Pain Questionnaire
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Hip Osteoarthritis
Keywords: ICOAP questionnaire
Arabic
Cross-Cultural adaptation
Lead sponsor: Prince Sultan Military College of Health Sciences
Sponsor class: OTHER
Collaborators: name: King Fahd Military Medical Complex
First posted: 2020-12-02
Enrollment: 99
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Knee/Hip osteoarthritis patients recruited from the local community receiving physical therapy rehabilitation.

Brief summary: A study to translate and cross-culturally adapt the Intermittent and Constant Osteoarthritis Pain (ICOAP) measurement tool into the Arabic language, and assess its psychometric properties.


Eligibility criteria: Inclusion Criteria:

* Eligible participants must meet the knee and hip osteoarthritis (OA) diagnostic criteria according to the American College of Rheumatology (ACR).

Exclusion Criteria:

1. rheumatoid arthritis
2. serious pathological conditions (inflammatory arthritis and malignancy)
3. total or partial arthroplasty of the affected joint
4. individuals who cannot read and understand documents written in the Arabic language.

Primary outcomes:
measure: Content Validity
timeFrame: 1 day
measure: Construct Validity
timeFrame: 1 day
measure: Internal Consistency
timeFrame: 48-72 hours
measure: Test-retest Reliability
timeFrame: 48-72 hours
Secondary outcomes:
measure: Responsiveness
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Dhahran
country: Saudi Arabia
facility: Prince Sultan Military College of Health Sciences
state: Eastern Province
Study officials:
affiliation: Prince Sultan Military College of Health Sciences
name: Ahmed Farrag, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04573556: A Study to Evaluate the Safety of DAYVIGO (Lemborexant) Tablets in Participants With Insomnia.
Official title: Multicenter, Post-marketing Observational (Non-interventional) Study to Evaluate the Safety of DAYVIGO Tablet in Patients With Insomnia.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Initiation and Maintenance Disorders
Keywords: E2006
Lemborexant
Insomnia
Non-interventional
Dayvigo
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2020-10-05
Enrollment: 550
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 300 participants with insomnia

Brief summary: The purpose of the study is to evaluate the incidence of somnolence, parasomnia, narcoleptic symptoms, and suicidal ideation/suicidal behavior after administration of lemborexant (DAYVIGO) in daily practice.


Eligibility criteria: Inclusion Criteria:

1. Participants who are treated with lemborexant
2. Participants who provide consent for participation in the study
3. Participants who were registered in EDC by 14 days after DAYVIGO treatment initiation

Exclusion Criteria:

1. Participants who were enrolled in this study before obtaining informed consent of this study
2. Participants who were participating in a clinical trial at the time of this study

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs) and Adverse Drug Reactions (ADRs)
timeFrame: Up to 24 Weeks
Secondary outcomes:
measure: Number of Participants With Response to Treatment
timeFrame: Up to 24 Weeks
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Eisai trial site 1
city: Osaka
country: Japan
facility: Eisai trial site 2
city: Tokyo
country: Japan
facility: Eisai trial site 3
Study officials:
References:
Clinical trial NCT06142656: Efficacy of Vildagliptin Versus Metformin in Poly Cystic Ovary Syndrome
Official title: Efficacy of Vildagliptin Versus Metformin in Poly Cystic Ovary Syndrome: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Poly Cystic Ovary Syndrome
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2023-11-21
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Polycystic ovary syndrome (PCOS) is an endocrine disorder that affects approximately 10-20% of women of reproductive age, Management strategies for PCOS include lifestyle modifications such as diet and physical activity that are the first-line approach to treatment; however, they are reported to be minimally effective in reducing weight or treating PCOS-related symptoms.Pharmacological options are also available; however, they are not explicitly approved for PCOS treatment as they have been primarily used to treat other conditions such as T2DM


Eligibility criteria: Inclusion Criteria:

-Women diagnosed with PCOS according to Rotterdam 2003 criteria National Institute of Health criteria.

Exclusion Criteria:

* Patients with history of diabetes mellitus (Type 1 or 2).
* Patients with liver or renal dysfunction; inflammatory diseases; autoimmune disease; cancer, acute cardiovascular event within last three months
* Known hypersensitivity or contraindications to use dipeptidyl peptidase-4 (DPP-4) inhibitors
* Eating disorders (anorexia, bulimia) or gastrointestinal disorders

Primary outcomes:
measure: Concentration of luteinizing hormone (LH)
timeFrame: at baseline and after 3 months
measure: Concentration of Follicle-stimulating hormone
timeFrame: at baseline and after 3 months
measure: Concentration of Free androgen index
timeFrame: at baseline and after 3 months
measure: Concentration of total testosterone
timeFrame: at baseline and after 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: October 6 university hospital
Study officials:
affiliation: october 6 university hospital
name: ahmed hussein, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03722056: Laparoscopic Management of Gastrointestinal Stromal Tumor of Stomach
Official title: Gastrointestinal Stromal Tumor of Stomach: Feasibility of Laparoscopic Resection in Large Lesions and Its Long Term Outcomes- A Case Series
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric GIST
Submucosal Tumor of Stomach
Keywords: Gastric GISTs
Submucosal tumours
Benign gastric lesions
Laparoscopic wedge resection
Lead sponsor: GEM Hospital & Research Center
Sponsor class: OTHER
First posted: 2018-10-26
Enrollment: 42
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: all patients with suspected Gastric GIST with size more than 2 cm

Brief summary: Gastric GISTs are rare neoplasms that require excision for cure. Although the feasibility of laparoscopic resection of gastric GIST less than 2cms has been established, the feasibility, safety and long-term efficacy of these techniques for larger lesions are unclear. Investigators hypothesized that laparoscopic resection of gastric GISTs even for larger lesions is feasible \& results in low perioperative morbidity and an effective long-term control of the disease.

Detailed description: Open surgical resection was the standard of treatment until two decades ago, but with advent laparoscopy and experienced gained over the years, the safety \& feasibility of laparoscopic resections of gastric GISTs has been proven but for tumors less than 2 cm. However, with gain of experience and skill in laparoscopic surgery, many surgeons have reported a safety \& feasibility excision of tumors greater than 5 cm. Our current study demonstrates the oncologic safety of the laparoscopic approach even with tumour size range up to 12cm, with efficacy and recurrence rates similar or superior to historical open surgical controls, however, it requires considerable expertise for safe manipulation of the tumour. All these resections were accomplished with minimal morbidity, no perioperative mortality, and short post-operative stay and comparable long term oncological outcomes.

Eligibility criteria: Inclusion Criteria:

* Gastric GIST\>2cm size

Exclusion Criteria:

* Metastatic GIST, not fit for GA

Primary outcomes:
measure: rates of intraoperative tumour rupture
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Gem Hospital & research Centre
name: sandeep sabnis, DNB SGE
role: STUDY_DIRECTOR
References:
citation: Keung EZ, Raut CP. Management of Gastrointestinal Stromal Tumors. Surg Clin North Am. 2017 Apr;97(2):437-452. doi: 10.1016/j.suc.2016.12.001.
citation: Park JJ. Long-Term Outcomes after Endoscopic Treatment of Gastric Gastrointestinal Stromal Tumor. Clin Endosc. 2016 May;49(3):232-4. doi: 10.5946/ce.2016.052. Epub 2016 May 19.