louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06111729: Habit Awareness Device for Treatment of Onychophagia
Official title: Habit Awareness Device for Treatment of Onychophagia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nail Biting
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical trial wants to find out if using a special bracelet that vibrates gently whenever someone with a nail-biting problem bites their nails can help them stop. The investigators are looking at adults who bite their nails a lot. If this bracelet works, it could make nail-biters bite their nails less and have a better life.

The main question the investigators are trying to answer is: "Does the gentle vibration from the bracelet make people bite their nails less?"

The investigators will give participants a bracelet that vibrates when it senses nail-biting for 12 weeks. Participants will need to download an app that connects to the bracelet. This app will help the investigators keep track of how often participants get these vibration signals and see if nail-biting decreases while using the bracelet.


Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with onychophagia
2. Must understand and voluntarily sign an informed consent form
3. Must be aged 18-95 years at the time of consent
4. Must be able to adhere to the study visit schedule and other protocol requirements

Exclusion Criteria:

1. Subject is unable to provide written informed consent for any reason.
2. Subject is sensitive or allergic to any of the elements included in this study.
3. Subject is unable to complete the required pain dairy.
4. Subject is pregnant, planning pregnancy, or nursing.
5. Subject does not have a compatible personal device with either IOS 13.0 or greater or Android version 6.0 or greater.

Primary outcomes:
measure: Mean Change in Nail Biting Behavior as Measured by Number of Patient Reported Vibrations a Day
timeFrame: baseline; 4 weeks; 8 weeks; 12 weeks
Secondary outcomes:
measure: Change in nail length in millimeters
timeFrame: Monthly for 3 months
measure: Change in nail health as measured by Malone-Massler Scale For Nail Biting
timeFrame: baseline; 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Department of Dermatology
state: New York
Study officials:
affiliation: Professor of Clinical Dermatology
name: Shari Lipner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stiede JT, Woods DW, Idnani AK, Pritchard J, Klobe K, Kumar S. Pilot trial of a technology assisted treatment for trichotillomania. J Obsessive Compuls Relat Disord. 2022 Apr;33:100726. doi: 10.1016/j.jocrd.2022.100726. Epub 2022 Apr 29.
Clinical trial NCT00962429: Lipoic Acid to Treat Chronic Inflammatory Demyelinating Polyneuropathy
Official title: Lipoic Acid for Chronic Inflammatory Demyelinating Polyneuropathy-A Randomized, Double-Blind, Placebo Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: CIDP
Chronic Inflammatory Demyelinating Polyneuropathy
Keywords: neuropathy, lipoic acid
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Collins Medical Trust
First posted: 2009-08-20
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to examine if alpha lipoic acid is an effective treatment for chronic inflammatory demyelinating polyneuropathy (CIDP).

Detailed description: Chronic inflammatory demyelinating polyneuropathy (CIDP) is a progressive disease leading to paralysis. CIDP is an immune-mediated disorder resulting from a synergistic interaction of T cell-mediated and B cell-mediated immune responses directed against peripheral nerve antigens. These immune mediated responses in turn increase the production of reactive oxygen intermediate and cause oxidative damage of the peripheral nerve system. Although corticosteroids, plasma exchange, and intravenous immunoglobulin (IVIg) reduce impairment caused by CIDP at least temporarily and can be used as a first-line treatments, they are not ideal for long-term treatment because of serious side effects and cost. Alpha lipoic acid (LA) is an antioxidant that also possesses anti-immune activity. It is effective in treating diabetic neuropathy. It is also promising in treating patients with multiple sclerosis.

Eligibility criteria: Inclusion Criteria:

* diagnosis of CIDP
* on a stable dose of immunotherapy for at least 3 months before enrolling in the study

Exclusion Criteria:

* myelopathy or evidence of central demyelination
* persistent neurological deficits from stroke, CNS trauma, or peripheral neuropathy from other causes (eg, diabetes mellitus, IgM, paraproteinaemia, or uraemic, toxic, or familial neuropathy)
* evidence of systemic disease that might cause neuropathy
* heart diseases (congestive heart failure or arrhythmia)
* pulmonary conditions (asthma or CIPD)
* rheumatoid conditions (such as rheumatoid arthritis)
* renal failure

Primary outcomes:
measure: Muscle Strength
timeFrame: 16 weeks
Secondary outcomes:
measure: Hughes Functional Disability Scale
timeFrame: 16 weeks
measure: Forced Vital Capacity (FVC)
timeFrame: 16 weeks
measure: Motor Nerve Conduction Studies (NCS)
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Jau-Shin Lou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00495729: 15-Day Repeated-Dose Study With SB-649868 And Its Interaction With CYP3A4 Isoenzyme In Healthy Male Subjects.
Official title: A Single-blind, Randomised, Placebo-controlled, 15 Day Repeated-dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SB-649868 and Its Interaction With the CYP3A4 Isoenzyme in Healthy Male Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sleep Initiation and Maintenance Disorders
Keywords: SB-649868,
Simvastatin
Repeated dose,
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-07-03
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Subjects will be screened within 28 days, Simvastatin dose and single SB-649868 dose 10 and 7 days prior to repeat dosing respectively, 15 days SB-649868 repeat dosing with safety and cognition function tests.


Eligibility criteria: Inclusion Criteria:

* Healthy adult male subjects aged between 18 and 65 years of age inclusive.
* Body weight =50 kg and BMI within the range 18.5-29.9 kg/m2 inclusive.
* Healthy as judged by responsible physician. No clinically significant abnormality identified on the medical or laboratory evaluation and 12-lead ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for this age group may be included only if the Investigator and the Medical Monitor considers that the finding will not introduce additional risk factors and will not interfere with the study procedures.
* Subjects will have blood pressure measurements within the normal range for healthy volunteers.

Exclusion Criteria:

* The subject has a positive pre-study urine drug/ alcohol urine screen.
* A positive pre-study Hepatitis B surface antigen, Hepatitis C antibody, or HIV 1/2 result at the screening visit.
* Abuse of alcohol defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units.
* Subject complains of sleep disturbances and/ or is receiving treatment for sleep disorders.

Primary outcomes:
measure: -AE, Lab values and cardiovascular monitoring after the SD and 14 days RD period (15 days)
timeFrame: after the SD and 14 days RD period (15 days)
measure: - SB649868 levels on days -7, 1, 4, 7 and 14 (pre-dose and post-dose)
timeFrame: on days -7, 1, 4, 7 and 14 (pre-dose and post-dose)
measure: - Simvastatine and Beta-idroxy-simvastatine levels on days -10,1,4,7 and 15
timeFrame: on days -10,1,4,7 and 15
Secondary outcomes:
measure: Cognitive functions, sleep profile and appetite assessment on days -7, 7 and 14.
timeFrame: on days -7, 7 and 14.
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01572129: Clopidogrel Reloading in Patients With NSTEACS Undergoing Percutaneous Coronary Intervention on Chronic Clopidogrel Therapy
Official title: Clopidogrel Reloading in Patients With Non-ST Elevation Acute Coronary Syndrome Undergoing PCI on Chronic Clopidogrel Therapy. Results of the ARMYDA RELOAD ACS (Antiplatelet Therapy for Reduction of MYocardial Damage During Angioplasty in Acute Coronary Syndrome) Randomized Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Myocardial Infarction
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2012-04-06
Enrollment: 240
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: PREVENTION

Brief summary: Patients who developed an acute coronary syndrome despite dual antiplatelet therapy with aspirin and clopidogrel may benefit from a further dose of clopidogrel before a percutaneous coronary intervention.

The aim of this study is to evaluate safety and effectiveness of clopidogrel reloading in patients on chronic clopidogrel therapy with acute coronary syndrome undergoing percutaneous coronary intervention.


Eligibility criteria: Inclusion Criteria:

* chronic (\> 10 days) therapy with clopidogrel (75 mg/day)
* non-ST-segment elevation acute coronary syndrome (ACS) requiring early diagnostic angiography

Exclusion Criteria:

* primary percutaneous coronary intervention (PCI) for acute ST-segment elevation acute myocardial infarction
* platelet count \< 70 × 10\^9/L
* high bleeding risk
* coronary bypass grafting in the previous 3 months

Primary outcomes:
measure: Major Adverse Cardiovascular Events
timeFrame: 30 days
Secondary outcomes:
measure: Bleeding Events
timeFrame: 30 days
measure: Grade of platelet residual reactivity
timeFrame: Immediately before PCI (4-6h after randomization), 8h and 24h after PCI
Other outcomes:
Locations:
city: Lecce
country: Italy
facility: Vito Fazzi Hospital
city: Rome
country: Italy
facility: Campus Bio-Medico University
Study officials:
affiliation: Campus Bio-Medico University
name: Giuseppe Patti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Di Sciascio G, Patti G, Pasceri V, Colonna G, Mangiacapra F, Montinaro A; ARMYDA-4 RELOAD Investigators. Clopidogrel reloading in patients undergoing percutaneous coronary intervention on chronic clopidogrel therapy: results of the ARMYDA-4 RELOAD (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty) randomized trial. Eur Heart J. 2010 Jun;31(11):1337-43. doi: 10.1093/eurheartj/ehq081. Epub 2010 Apr 2.
citation: Kastrati A, von Beckerath N, Joost A, Pogatsa-Murray G, Gorchakova O, Schomig A. Loading with 600 mg clopidogrel in patients with coronary artery disease with and without chronic clopidogrel therapy. Circulation. 2004 Oct 5;110(14):1916-9. doi: 10.1161/01.CIR.0000137972.74120.12. Epub 2004 Jul 19.
Clinical trial NCT01251029: Effect of N-acetylcysteine on Renal Functioning of Chronic Kidney Diseases(CKD) Patients After General Anesthesia
Official title: Ability of N-acetylcysteine to Prevent Deterioration in Renal Functioning in CKD Patients Undergoing Major Surgery Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Chronic Kidney Diseases
General Anesthesia
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-12-01
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Acute kidney injury (AKI) is one of the most serious and frequent complication of general anesthesia. Patients suffer from chronic kidney diseases (CKD) predispose to develop AKI. CKD patients often need some surgical interventions that have been done under general anesthesia; they therefore have an increased probability to develop AKI.

N-acetylcysteine (NAC), a thiol compound with antioxidant and vasodilatory properties, reduces oxygen free radical production, decreases pump-related ischemia-reperfusion injury and the levels of pro-inflammatory cytokines. NAC has been reported to protect the kidney from injury induced by contrast media, ischemia, and toxins.

Present study aimed to explore the efficacy of NAC treatment to prevent deterioration in renal functioning in CKD patients undergoing major surgery under general anesthesia.

Study will include about 200 CKD (eGFR (estimated glomerular filtration rate) less than 40) patients that should undergo surgical interventions under general anesthesia and will divide to 3 groups as follows: group 1- about 40 patients which should undergo major vascular surgery; group 2 - about 60 patients that suppose to undergo major orthopedic surgery (revision of total hip, revision of knee); group 3 - about 100 patients undergoing major abdominal surgery. Patients from each group will randomly divide in two sub-groups (A and B). Subgroup A will receive NAC twice (14-16h and 2h) before surgery and 12h after surgery. Subgroup B will receive placebo (saline).

Markers for kidney function such as eGFR, creatinin, urea, electrolytes, cystatin C, NGAL (Neutrophil Gelatinase-Associated Lipocalin), urine albumin will measure before and after surgery in all patients. An additional blood samples for assessment of nitric oxide and cytokine levels will be taken from each patient before and after surgery.


Eligibility criteria: Inclusion Criteria:

* patients suffering from chronic kidney disease that should undergo surgical interventions under general anesthesia

Exclusion Criteria:

* pregnancy
* single kidney
* heart failure (NYHA class III-IV)
* hepatic failure
* mental diseases

Primary outcomes:
measure: parameters of kidney function
Secondary outcomes:
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf Harofeh Medical Center
Study officials:
affiliation: Assaf-Harofeh Medical Center
name: Murat Bahar, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05755529: Effects of Low LH Serum Levels on Ovarian Pick-up Outcome
Official title: Effects of Low LH Serum Levels on Oocyte Retrieval, Fertilization Rate and Embryo Quality During Controlled Ovarian Stimulation: Results From a Prospective Cohort Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility, Female
ART
Keywords: embryo quality
LH levels
Oocyte retrieval
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who received ovarian stimulation with follitropin alfa (Gonal F, Merck Serono, Germany) and ganirelix (Fyremaldel, Sun Pharma, Italy).

Brief summary: Luteinizing hormone (LH) plays a key role for normal follicular development and oocyte maturation in controlled ovarian stimulation. In particular, LH stimulates the proliferation and differentiation of theca cells for the secretion of androgens, which synergistically increase the production of estrogen. This study aimed to investigate the effects of low LH concentrations on oocyte retrieval, fertilization and embryo development in patients undergoing in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI). Patients undergoing IVF/ICSI were prospectively analyzed, subdividing them into three groups according to their age. Serum LH levels were evaluated at day 3, during stimulation (day 10) and before ovulation induction (day 12).


Eligibility criteria: Inclusion Criteria:

age between 18 and 40 years, body mass index 18-29 kg/m 2 , regular menstrual cycles, normal uterine cavity assess by hysteroscopy, normal uterus and ovaries at transvaginal sonography,

Exclusion Criteria:

abnormal cervical cytology, affected by any other endocrinological, metabolic, autoimmune, and gynecological disease.

Primary outcomes:
measure: Oocyte retrieval
timeFrame: immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Clinica del Mediterraneo - Ragusa
name: Jessica Dragotto, Biologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinica del Mediterraneo - Ragusa
name: Giovanni Bracchitta, M.D.
role: STUDY_DIRECTOR
affiliation: University of Palermo
name: Antonio Simone Laganà, M.D., Ph.D.
role: STUDY_CHAIR
affiliation: University of Palermo
name: Andrea Etrusco, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT06296329: Rubber Hand Illusion in Anorexia Nervosa
Official title: Rubber Hand Illusion in Anorexia Nervosa: the Role of Hand Dimensions and Physical Appearance
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anorexia Nervosa
Keywords: bodily illusion
body representation
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
Collaborators: name: University of Turin, Italy
First posted: 2024-03-06
Enrollment: 28
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with anorexia nervosa will be recruited at the beginning of a rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy). Controls will be recruited out of the hospital.

Brief summary: The present research project aims to verify a possible difference in the recalibration of the real hand position (i.e. proprioceptive drift) in relation to the dimensions of the plastic hand in the Rubber Hand Illusion, among a group of female participants with anorexia nervosa compared with a normal weight control group.


Eligibility criteria: Inclusion criteria:

* Right-handed
* diagnosis of Anorexia Nervosa according to the APA criteria

Exclusion criteria:

• concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders.

Primary outcomes:
measure: Proprioceptive drift in centimeters
timeFrame: baseline
Secondary outcomes:
measure: Score at the Embodiment questionnaires
timeFrame: Baseline
Other outcomes:
Locations:
city: Piancavallo
country: Italy
facility: IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe
state: VCO
Study officials:
References:
Clinical trial NCT00985829: Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma
Official title: Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Basal Cell Carcinoma
Keywords: basal cell carcinoma
photodynamic therapy
photo chemotherapy
basal cell epithelioma
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2009-09-28
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of pdt in treatment of bcc and factors that affect response rate.

Detailed description: Background and Aim: Basal cell carcinoma (BCC) is the most common skin cancer .Photodynamic therapy _as a novel , non-invasive therapeutic approach _may be considered a valuable strategy. This study was designed with the aim of the evaluation of efficacy of PDT in treatment of BCC and factors that may affect response rate.

Materials and Methods: This was a clinical trial which was done on 28 BCCs. Patients were treated with ALA-PDT monthly for 1-6 sessions and evaluated for clinical response,cosmetic results and probable side effects.

Eligibility criteria: Inclusion Criteria:

* Histologically proven BCCs

Exclusion Criteria:

* rodent ulcer
* morphea type
* ANA +
* history of photosensitivity or photodermatosis or ingestion of phototoxic drugs during last month
* pregnancy
* breast feeding
* age\< 18
* history of another therapeutic intervention for bcc during last 6 months

Primary outcomes:
measure: Clinical Response to Photodynamic Therapy
timeFrame: immediately after termination of treatment course (with an average of 5 month after initiation of PDT)
Secondary outcomes:
measure: Histologic Resolution of Lesion
timeFrame: immediately after the terminaton of treatment course (with an average of 5 months after initiation of PDT)
Other outcomes:
measure: Cosmetic Result
timeFrame: 1 month after termination of treatment course (with an average of 6 months after initiation of PDT)
measure: Location of Lesion
timeFrame: baseline
measure: BCC Type
timeFrame: baseline
measure: Past Medical History of Radiotherapy
timeFrame: baseline
Locations:
Study officials:
affiliation: Skin Research Center
name: Zohreh Tehranchi-nia, assist.prof.
role: PRINCIPAL_INVESTIGATOR
References: