louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00852241: Rejuvenation of the Lower Eyelid Using a Combination of Two Hyaluronic Acid Fillers - a Pilot Study
Official title: Rejuvenation of the Lower Eyelid Using a Combination of Two Hyaluronic Acid Fillers - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infraorbital Hollows
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2009-02-26
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine the efficacy and longevity of the use of Restylane® and Perlane® in combination for the rejuvenation of the infraorbital hollows and to measure patient satisfaction with this treatment

Detailed description: This study will examine the effectiveness of using Restylane® and Perlane® together in the treatment of the hollows in the under eye area. The combination of these treatments for use in the under eye area is considered investigational. An investigational therapy is a therapy that is not approved by the US Food and Drug Administration (FDA). Restylane® and Perlane® has been approved for treatment of moderate to severe facial wrinkles and folds, such as nasolabial folds by the FDA.

Eligibility criteria: Inclusion Criteria:

* Age 18 years and older
* No significant medical illness
* Subjects with the willingness and ability to understand and provide informed consent

Exclusion Criteria:

* Under 18 years of age
* Pregnancy or Lactation
* Subjects who have had previous surgical treatment of the lower eyelid area or previous use of filling agents in the under eye area
* Subjects with a known allergy to the components in Restylane® or Perlane®
* Subjects currently taking blood thinners or who have had chemotherapy or radiation within the last 6 months
* Subjects with liver/kidney disease or compromise or who are immunocompromised
* Subjects with a known susceptibility to keloid formation or hypertrophic scarring
* Subjects with an open, non-healing sore or infection near the site of injections
* Subjects who are unable to understand the protocol or to give informed consent
* Subjects with mental illness

Primary outcomes:
measure: The Primary Objective of This Study is to Determine the Efficacy and Longevity of the Use of Restylane® and Perlane® in Combination for the Rejuvenation of the Infraorbital Hollows and to Measure Patient Satisfaction With This Treatment
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Rebecca Tung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02669641: Complex Imaging Assessment of Steatosis
Official title: Complex Imaging Assessment of Steatosis in Patients Under Treatment With Combination Silimarin, Phyllanthus Niruri and Choline
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Fatty Liver
Keywords: Steatosis, Fatty liver, Steatohepatitis
Lead sponsor: University of Medicine and Pharmacy Craiova
Sponsor class: OTHER
Collaborators: name: Fiterman Pharma SRL
First posted: 2016-02-01
Enrollment: 50
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: The main objective is the assessment of MRI (Magnetic Resonance Imaging) Spectroscopy in patients diagnosed with hepatic steatosis in treatment with combination Silimarin, Phyllanthus Niruri and Choline.

Detailed description: In the study will be included patients with alcoholic and non-alcoholic steatohepatitis evaluated in Research Center of Gastroenterology and Hepatology and Gastroenterology Clinic of University of Medicine and Pharmacy of Craiova. All the patients will undergo MRI and MRI Spectroscopy (3 Tesla) using PHILIPS INGENIA 3T System for exact steatosis quantification. The eligible patients will be treated with combination Silimarin, Phyllanthus Niruri and Choline (Stoptoxin Forte) for 6 months (in conformity Product Characteristics). After the treatment a new IRM Spectroscopy examination will be performed. All the acquired data will be analyzed and published.

Eligibility criteria: Inclusion Criteria:

* steatosis described on abdominal ultrasound

Exclusion Criteria:

* chronic viral hepatitis
* liver cancer
* abusive alcohol consumption

Primary outcomes:
measure: Fat-fraction
timeFrame: 6 months after specific treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Craiova
country: Romania
facility: Research Center in Gastroenterology and Hepatology, University of Medicine and Pharmacy Craiova, Romania
state: Please Select
Study officials:
affiliation: University of Medicine and Pharmacy Craiova
name: Ioana Andreea Gheonea, Lecturer
role: STUDY_DIRECTOR
References:
citation: Kirpich IA, Miller ME, Cave MC, Joshi-Barve S, McClain CJ. Alcoholic Liver Disease: Update on the Role of Dietary Fat. Biomolecules. 2016 Jan 6;6(1):1. doi: 10.3390/biom6010001.
citation: Gheonea DI, Saftoiu A, Ciurea T, Gorunescu F, Iordache S, Popescu GL, Belciug S, Gorunescu M, Sandulescu L. Real-time sono-elastography in the diagnosis of diffuse liver diseases. World J Gastroenterol. 2010 Apr 14;16(14):1720-6. doi: 10.3748/wjg.v16.i14.1720.
citation: Bannas P, Kramer H, Hernando D, Agni R, Cunningham AM, Mandal R, Motosugi U, Sharma SD, Munoz del Rio A, Fernandez L, Reeder SB. Quantitative magnetic resonance imaging of hepatic steatosis: Validation in ex vivo human livers. Hepatology. 2015 Nov;62(5):1444-55. doi: 10.1002/hep.28012. Epub 2015 Sep 28.
Clinical trial NCT01900041: A Study to Evaluate the Superiority, Efficacy and Tolerability of Combination Pantovigar With 2% Minoxidil vs 2% Minoxidil in Women With Female Pattern Hair Loss
Official title: Multicenter, Randomised, Open Label, Comparative Clinical Study to Evaluate the Superiority, Efficacy and Tolerability of Combination Pantovigar With 2% Minoxidil vs 2% Minoxidil in Women With Female Pattern Hair Loss (Including AGA Ludwig's Type 1-2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Female Pattern Hair Loss
Androgenetic Alopecia (AGA)
Ludwig Type 1
Ludwig Type 2
Lead sponsor: Merz Pharmaceuticals GmbH
Sponsor class: INDUSTRY
Collaborators: name: LLC Merz Pharma, Russia
First posted: 2013-07-16
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pantovigar - a high effective product designed primarily for the treatment of diffuse hair loss in women as well as for the treatment of damaged hair, in the combined therapy can be successfully applied in other types of alopecia.

The purpose of this study is to evaluate efficacy and tolerability of combination therapy Pantovigar plus 2% minoxidil vs 2% minoxidil. To collect tolerability data for combined treatment Pantovigar plus 2% Minoxidil course therapy.


Eligibility criteria: Inclusion Criteria:

* Female patient complaint of hair loss and/or hair density reduction for more than 3 months.
* More than 15 % of telogen frontoparietal hair as shown in the phototrichogram.

Exclusion Criteria:

* Symptomatic diffuse alopecia (screening for iron and thyroid function, thyroid stimulating hormon, triiodothyrine, ferritin , total iron-binding capacity)
* Active or history of systemic autoimmune disease, e.g. lupus erythematodes etc.
* Hyperandrogenic alopecia (polycystic ovary syndrome, adrenogenital syndrome, tumors with androgenic activity) (testosterone, prolactin hormone, androstenedione, dehydroepiandrosterone)
* Initiation or termination of hormone therapy within 6 months prior to entering study
* Hormone therapy with androgenic action, e.g. norethisterone etc.
* Pregnancy or lactation within 6 months prior to entering study
* Alopecia areata
* Scarring alopecia
* Treatment with hair promoting agent within 3 months prior to entering study
* Known hair loss after drug intake
* Concomitant use of the drugs causing a hair loss (e.g. aromatase inhibitors, thyreostatics, cytostatics, etc,)

Primary outcomes:
measure: Rate of responders to the treatment
timeFrame: Week 16-20 post baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: State Scientific Center of Dermatology and Cosmetology
city: Moscow
country: Russian Federation
facility: Moscow Scientific Clinical Center of Dermatology and Cosmetology
Study officials:
affiliation: LLC Merz Pharma, Russia
name: Medical Expert
role: STUDY_DIRECTOR
References:
Clinical trial NCT00000241: Flupenthixol Decanoate in Methamphetamine Smoking - 1
Official title: Flupenthixol Decanoate in Methamphetamine Smoking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Substance-Related Disorders
Keywords: methamphetamine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: Friends Research Institute, Inc.
First posted: 1999-09-21
Enrollment: 58
Sex: ALL
Minimum age (years): 22
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of flupenthixol decanoate for treatment of methamphetamine dependence. Also, study will compare flupenthixol with desipramine in blocking methamphetamine self-administration.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Methamphetamine use
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Friends Research Institute
state: California
Study officials:
affiliation: Friends Research Institute, Inc.
name: Frank Gawin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06629441: Effectiveness and Safety of Probiotics in Relieving Anxiety and Depression
Official title: Effectiveness and Safety of Probiotics, BC99 in Relieving Anxiety and Depression in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Depression
Lead sponsor: Wecare Probiotics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-10-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effectiveness and safety of probiotics in relieving anxiety and depression in adults, in comparison with placebo.


Eligibility criteria: Inclusion Criteria:

1. Voluntary, Written, and Signed Informed Consent: Agreeing to participate in the study.
2. Ability to Complete the Study According to Protocol: Able to meet the requirements of the study protocol.
3. Age: 18-65 years old.
4. Depression and Anxiety Scores:

   * Hamilton Depression Rating Scale (HAMD-17) score of 20 or higher, or
   * Hamilton Anxiety Rating Scale (HAMA) score of 14 or higher.
5. No History of Certain Conditions: No history of heart, liver, kidney, nervous system, psychiatric disorders, or metabolic abnormalities.

Exclusion Criteria:

1. Past Diagnosis of Certain Conditions: Individuals with a history of other clearly diagnosed psychiatric disorders, intellectual disabilities, consciousness disorders, complete aphasia, bipolar disorder, treatment-resistant depression, or suicidal thoughts.
2. Pregnant or Breastfeeding Women: Individuals who are pregnant or breastfeeding.
3. Use of Certain Medications: Individuals who have used anti-anxiety, anti-depressant medications, or mood stabilizers within the past month.
4. Allergy History: Individuals with allergic constitutions or a history of drug allergies, or those with severe systemic diseases.
5. Substance Abuse History: Individuals with a history of alcohol or psychoactive substance abuse within the past 3 months.
6. Impact of Medications on Gut Microbiota: Individuals who have used medications affecting gut microbiota (including antibiotics, probiotics, mucosal protectors, traditional Chinese medicine, etc.) continuously for more than 1 week in the month prior to screening.
7. Discontinuation or Addition of Medications: Individuals who have stopped taking the study medication or started taking other medications, making it difficult to assess efficacy or with incomplete data.
8. Use of Similar Products: Individuals who have taken items similar to the study product in the short term, affecting the evaluation of results.
9. Inability to Participate: Research participants who cannot participate in the study due to personal reasons.
10. Other Exclusions: Participants deemed unsuitable for the study by the researchers.

Primary outcomes:
measure: Changes in Anxiety Symptoms
timeFrame: 56 day
Secondary outcomes:
Other outcomes:
Locations:
city: Luoyang
country: China
facility: The 1st Affiliated Hospital of He'nan University of Science and Technology
state: Henan
Study officials:
References:
Clinical trial NCT03544541: Cardiometabolic Risk in Children With Type 1 Diabetes.
Official title: Association Between Metabolic Control and Cardiometabolic Risk in Children With Type 1 Diabetes.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type1 Diabetes Mellitus
Metabolic Complication
Lead sponsor: University of Ljubljana, Faculty of Medicine
Sponsor class: OTHER
First posted: 2018-06-01
Enrollment: 150
Sex: ALL
Minimum age (years): 10
Maximum age (years): 25
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nationwide cohort of children and adolescents with type 1 diabetes

Brief summary: To access the relationship between metabolic control of children and adolescents with type 1 diabetes and cardiometabolic risk through noninvasive imaging modalities to assess the early vasculature changes.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes for more than 0.5 year
* Age ≥ 10 years up to 25 years (inclusive)
* The subject/carer is willing to follow study specific instructions

Exclusion Criteria:

* Youth with maturity-onset diabetes of the young, hybrid, other, or missing type
* Any significant diseases / conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study
* Current use of the following medications: medications that are used to lower blood glucose such as Pramlintide, Metformin and GLP-1 analogs. Beta blockers, glucocorticoids and other medications, which in the judgment of the investigator would be a contraindication to participation in the study (Anticoagulant therapy e.g. Plavix, LMW heparin, Coumadin, Immunosuppressant therapy)

Primary outcomes:
measure: Carotid Intima-Media Thickness
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: UMC-University Children's Hospital
Study officials:
References:
Clinical trial NCT00087841: Self-Hypnotic Relaxation Therapy During Invasive Procedures
Official title: Midcareer Development of Nonpharmacologic Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Uterine Neoplasms
Leiomyoma
Keywords: Hypnosis
Analgesia
Embolization, Therapeutic
Chemoembolization, Therapeutic
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2004-07-16
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
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 determine the effectiveness of self-hypnotic relaxation on mental and physical distress during and after tumor treatment procedures.

Detailed description: Pain relievers and sedatives may have limited effectiveness and serious side effects when given to alleviate distress during minimally invasive surgical procedures. Unabated distress may interfere with the ongoing procedure and may negatively impact future interventions.

Studies have shown that nonpharmacologic analgesia in the form of self-hypnotic relaxation during invasive medical procedures significantly reduces patients' pain, anxiety, drug use, and number of complications. The long-term goal of this study is to determine whether self-hypnotic relaxation therapy can be a safe and practical method for reducing cognitive and physiologic distress associated with invasive procedures.

Participants in this study will be randomly assigned to one of three groups: a standard care group, an empathic control group, and a self-hypnotic relaxation group. The emphatic control group will meet with a clinician who will offer encouragement and support. The group assigned to self-hypnotic relaxation will read a standardized script prior to procedure. Self-report questionnaires will be used to assess pain and anxiety.

Eligibility criteria: Inclusion Criteria:

* Referred for transcatheter embolization for benign uterine fibroid tumor or radiofrequency ablation or chemoembolization for malignant tumors
* Able to hear and understand English

Exclusion Criteria:

* Impaired mental function
* Psychosis
* Severe chronic obstructive pulmonary disease
* Intolerance of midazolam or fentanyl
* Weigh less than 121 lbs
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Elvira Lang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03697941: Percutaneous Plug-based Arteriotomy Closure Device Use in Minimally Invasive Mitral Valve Surgery
Official title: Percutaneous Plug-based Arteriotomy Closure Device Use in Minimally Invasive Mitral Valve Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitral Valve Disease
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2018-10-05
Enrollment: 268
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: Patientes operated with minimally invasive mitral valve surgery between February 2016 and March 2019 at the Karolinska University Hospital in Stockholm, Sweden, with use of either surgical cut-down and arterial puncture under direct vision or percutaneously with planned percutaneous arteriotomy closed using a plug-based arteriotomy closure device.

Brief summary: A single-center prospective study. Patients undergoing minimally invasive mitral valve surgery between February 2016 and December 2018 at the Karolinska University Hospital in Stockholm, Sweden are eligible. Femoral cannulation was performed either with surgical cut-down and arterial puncture under direct vision or percutaneously with planned percutaneous arteriotomy closed using a plug-based arteriotomy closure device (MANTA, Essential Medical Inc., Malvern, Pennsylvania). Data regarding preoperative clinical characteristics and operative details were obtained by medical records review and from the Swedish Web system for Enhancement and Development of Evidence based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART) electronic data collection platform.


Eligibility criteria: Inclusion Criteria:

* Operated with minimally invasive mitral valve surgery between February 2016 and March 2019 at the Karolinska University Hospital in Stockholm, Sweden, with use of either surgical cut-down and arterial puncture under direct vision or percutaneously with planned percutaneous arteriotomy closed using a plug-based arteriotomy closure device.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Major vascular groin-related complication according to the VARC-2 definition criteria
timeFrame: During the first 8 weeks after surgery
Secondary outcomes:
measure: Minor vascular groin-related complication according to the VARC-2 definition criteria
timeFrame: During the first 8 weeks after surgery
measure: Access-site related groin seroma
timeFrame: During the first 8 weeks after surgery
measure: Access-site related groin infection
timeFrame: During the first 8 weeks after surgery
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
References:
citation: Kastengren M, Svenarud P, Kallner G, Settergren M, Franco-Cereceda A, Dalen M. Percutaneous Vascular Closure Device in Minimally Invasive Mitral Valve Surgery. Ann Thorac Surg. 2020 Jul;110(1):85-91. doi: 10.1016/j.athoracsur.2019.10.038. Epub 2019 Nov 30.
Clinical trial NCT02937441: Evaluation of the Cerebral Edema in Children Having Diabetic Ketoacidosis
Official title: Evaluation of the Cerebral Edema With Measurement of Optic Nerve Sheath in Children Having Diabetic Ketoacidosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Edema
Keywords: C10.228.140.187
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 31
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: General

Brief summary: The purpose of this study is to determine cerebral edema with evaluation of measurement of diameter of optic nerve sheath.

Detailed description: The purpose of this study is to determine cerebral edema with evaluation of measurement of diameter of optic nerve sheath. For that, If patients have Fluid treatment shall be started in 4 hours in our or other Emergency Care, they will be included our study. If not, they will be out of our study.

How we measure;

1. First measurement shall be taken in 4 hours.
2. Second measurement shall be taken at 12 hours in mild and 12-18 hours measurement shall be taken for severe diabetic ketoacidosis,
3. Third measurement shall be taken after fluid treatment.
4. Fourth measurement shall be taken at polyclinic control. So, after all measurements will be hand and all data will be analyzed with statistical program. After that all outcome will be discussed and compared with patient at normal conditions at their polyclinic visit.

Eligibility criteria: Inclusion Criteria:

Fluid treatment shall be started in 4 hours in our or other Emergency Care

Exclusion Criteria:

Fluid treatment was started over four hours in other Emergency Care

Primary outcomes:
measure: Optic Nerve Sheath diameters will be measured from 3 mm back of globe.
timeFrame: March 2017
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University
Study officials:
affiliation: Cukurova University
name: Özlem T Kendir, Dr. Fellow
role: PRINCIPAL_INVESTIGATOR
References: