louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00981565: Mild Carpal Tunnel Syndrome
Official title: Operative Versus Conservative Treatment in Mild Carpal Tunnel Syndrome, Randomized Prospective Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: Carpal tunnel syndrome
CTS
medianus impingement
Lead sponsor: North Karelia Central Hospital
Sponsor class: OTHER
First posted: 2009-09-22
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Carpal tunnel syndrome (CTS) is the most common peripheral nerve entrapment. Diagnosis is based on symptoms, clinical findings and electrophysiological examination. Several conservative and surgical treatment options have been described.

Studies of surgical versus conservative treatment in mild carpal tunnel syndrome have not been done and it is still unclear whether or not surgical treatment is better than conservative treatment.

The aim of this study is to research has surgery better outcome in mild CTS than conservative treatment. Patient satisfactory, clinical and electrophysiologic outcomes, direct and indirect costs will be evaluated.


Eligibility criteria: Inclusion Criteria:

* electrophysiologically proven minimal or mild CTS lasting more than six months will be included in this study

Exclusion Criteria:

* rheumatoid arthritis
* diabetes mellitus
* hypothyreosis
* pregnancy
* wrist trauma or previous surgery
* splinting or corticosteroid injection on the affected side

Primary outcomes:
measure: Change in Symptom Severity Score
timeFrame: 1 year
measure: Pain Visual Analogue Scale (VAS)
timeFrame: 1 year
Secondary outcomes:
measure: Change in electroneuromyography
timeFrame: 1 year
Other outcomes:
Locations:
city: Joensuu
country: Finland
facility: North-Carelia Central Hospital
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Mikkeli
country: Finland
facility: Central Hospital of Mikkeli
Study officials:
References:
Clinical trial NCT00002165: Viracept Expanded Access Program
Official title: Viracept Expanded Access Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Acquired Immunodeficiency Syndrome
HIV Protease Inhibitors
CD4 Lymphocyte Count
Nelfinavir
Anti-HIV Agents
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To make nelfinavir mesylate (Viracept) available for treatment of HIV positive patients who are unable to take the three commercially available protease inhibitors (because of failure, intolerance, or contraindication) and who have a CD4 cell count of \<= 50. To obtain additional information on the safety profile of nelfinavir mesylate (Viracept).

(PER AMENDMENT 1/8/97: People now qualify for the Viracept Program if they are unable to take indinavir and/or ritonavir due to intolerance, contraindication or prior failure.)


Eligibility criteria: Inclusion Criteria

Patients must have:

* HIV infection.
* CD4 T cell count \<= 100 cells/mm3.
* Failed, been intolerant of or had a contraindication to all three commercially available protease inhibitors (saquinavir, indinavir and ritonavir).

(PER AMENDMENT 1/8/97:

* People now qualify for the Viracept Program if they are unable to take indinavir and/or ritonavir due to intolerance, contraindication or prior failure.)

Exclusion Criteria

Prior Medication:

Excluded:

Prior therapy with Viracept.

Required:

* Indinavir.
* Saquinavir.
* Ritonavir.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Agouron Pharmaceuticals Inc
state: California
Study officials:
References:
citation: New protease inhibitor available through expanded access. Posit Aware. 1996 Nov-Dec;7(6):7.
Clinical trial NCT01705665: Histopathology of the Aspirated Thrombus During Acute Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thrombosis
Acute Coronary Syndrome
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-10-12
Enrollment: 100
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: Patients admitted for an acute coronary syndrome who undergo angiography, found to have a coronary thrombosis that is aspirated and which yields thrombus fragments.

Brief summary: This study was initiated on the preliminary premise that a thrombus whose formation was triggered by a thrombogenic substrate, such as within an atherosclerotic plaque (Tissue factor initiated thrombus), may evolve differently than the one evolving at the site of a recently implanted stent (foreign body triggered). Consequently, the thrombus composition of a de novo clot could differ from the other one, extracted during the occurrence of a subacute thrombosis, regarding the number of various cells, the amount of fibrin and platelet aggregates and the relationship among these components. In addition, it seems relevant to evaluate the numbers and the distribution of the local monocytes, once these cells may interact with platelets (via cell -adhesion mechanisms e.g., by CD31 \[PECAM-1\]) and by the extrinsic coagulation pathway (via TF/FVII elaborated by plaque-resident macrophages). Such a distinction, if eventually found, may reveal the mechanisms of thrombosis within coronary arteries, and may have clinical implications.


Eligibility criteria: Inclusion Criteria:

* Patients with acute coronary syndrome who undergo angiography
* Evidence of coronary thrombus
* Undergo aspiration procedure yielding thrombus fragments

Exclusion Criteria:

-

Primary outcomes:
measure: Evaluation of Possible Difference in Composition of Thrombi Aspirated during Acute Myocardial Infarction Precipitated by de novo vs Subacute Thrombosis
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Heart Institute, Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT03105765: Acute and Chronic Pain, Especially Neuropathic Pain, After Thoracotomy and Continuous Application of Ketamine.
Official title: Effects of Prophylactic Administration of Ketamine on Acute and Chronic Pain After Thoracotomy for Lung Cancer, a Double Blind Randomised Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Pain
Chronic Pain
Neuropathic Pain
Keywords: Neuropathic Pain
Chronic Pain
Posterolateral thoracotomy
Lead sponsor: Dr. Horst Schmidt Klinik GmbH
Sponsor class: INDUSTRY
First posted: 2017-04-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Chronic Pain, especially neuropathic pain, are adverse events after posterolateral thoracotomy for lung resection. The continuous application of ketamine may have a prophylactic effect and helps to prevent chronic pain. The investigators record the incidence and severity of acute pain and neuropathic pain during a seven day period after thoracotomy as well as the incidence of chronic pain and neuropathic pain after one and three month period. Parallel Group design, comparing one Group with a continuous application (24 hours) of ketamine against a Placebo Group.


Eligibility criteria: Inclusion Criteria:

* posterolateral thoracotomy for lung parenchyma resection
* informed consent
* ASA (American Society of Anesthesiologists) Status I-III

Exclusion Criteria:

* history of chronic pain
* history of neuropathic pain
* pregnancy or breastfeeding
* participation in another trial
* hypersensitivity for ketamine
* medication with can influence neuropathic pain (gabapentin, clonazepam)
* history of neurological or behavioral illness
* history of alcohol abuse
* history of chemotherapy or radiation
* opioid medication

Primary outcomes:
measure: Change in perioperative opioid consumption
timeFrame: seven days after operation
measure: Change in acute pain
timeFrame: 7 days after Operation
measure: acute neuropathic pain
timeFrame: 7 days after operation
Secondary outcomes:
measure: Change in chronic Pain
timeFrame: one and three month after operation
measure: Chronic Neuropathic pain
timeFrame: one month after operation
measure: Chronic Neuropathic Pain
timeFrame: three month after operation
measure: recovery time
timeFrame: eye opening after stopping anesthesia in minutes
Other outcomes:
Locations:
city: Wiesbaden
country: Germany
facility: Dr. Horst Schmidt Klinik
state: Hessen
Study officials:
References:
Clinical trial NCT01656265: Study of ARQ 197 in Hepatocellular Carcinoma (HCC)
Official title: Phase I Study of ARQ 197 in Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Hepatocellular Carcinoma
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-08-02
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability of ARQ 197 in hepatocellular carcinoma (HCC) patients treated with daily oral ARQ 197, to determine the recommended dose of ARQ 197 in advanced HCC patients.


Eligibility criteria: Inclusion Criteria:

* Confirmed HCC patients who are resistant to, intolerable to, or rejecting a systemic sorafenib therapy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Child-Pugh classification A at the time of registration
* Adequate bone marrow, liver, and renal functions within 14 days prior to registration

Exclusion Criteria:

* Prior therapy with a c-Met inhibitor (including ARQ 197)
* Any systemic anti-tumor treatment or investigational agent within 2 weeks prior to registration. If the treatment/agent was antibody, within 4 weeks
* Local treatment for malignancy within 4 weeks prior to registration
* Major surgical procedure within 4 weeks prior to registration

Primary outcomes:
measure: Number of participants with dose-limiting toxicity (DLT), as a measure of safety and tolerability
timeFrame: DLT observation period will be the first 28 days after the start of ARQ 197 treatment.
Secondary outcomes:
measure: Profiles of Pharmacokinetics
timeFrame: Plasma sample correction at pre-dose 1, 2, 4, 6, 10, 12 and 24 hours on day 1; at pre-dose, 1, 2, 4, 6, 10, 12 hours on day 15; and at pre-dose on day 29.
measure: Antitumor effects according to RECIST 1.1.
timeFrame: Every 6 weeks
Other outcomes:
Locations:
city: Kashiwa-city
country: Japan
state: Chiba
Study officials:
References:
Clinical trial NCT02281565: Attitudes About Blood Donation
Official title: Knowledge, Attitude and Practice About Blood Donation Among Medical Students and Medical Staff
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blood Donation
Keywords: attitudes
blood donation
blood shortage
Lead sponsor: International Institute of Rescue Research and Education
Sponsor class: OTHER
First posted: 2014-11-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical staff: medical doctors, nurses, paramedics Medical students: PhD students, medicine students, nursing and paramedics studies

Brief summary: The study evaluates the knowledge, attitude and practice about blood donation among medical students and medical staff in Poland.

Detailed description: In Poland, the blood gives an average of 31 people per 1.000 inhabitants, while in Western Europe the rate was twice as high.

In the study the investigators are examining how medical students and medical staff feel about the issues of blood donation, especially: blood shortage.

The investigators are planning to focus on the following specific questions:

What is the level of knowledge about blood donation among participants? What are the sociodemographic, sociocultural and socioeconomic characteristics of blood donors and non-blood donors among medical staff and medical students? Evidence on the role of financial and other incentives in eliciting blood donation.

Eligibility criteria: Inclusion Criteria:

* Give voluntary consent to participate in the study

Exclusion Criteria:

* not meet the above criteria

Primary outcomes:
measure: Percentage of participants who approve prosocial motivation to blood donation
timeFrame: 3 months
Secondary outcomes:
measure: Results of the Medical Knowledge Tool (Questionnaire)
timeFrame: 3 months
measure: Results of the Practice Tool (Questionnaire)
timeFrame: 3 months
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: International Institute of Rescue Research and Education
state: Masovia
Study officials:
References:
Clinical trial NCT06684665: Study on the Sociopsychoemotional Mechanism of Dysfunction in Patients With Acute and Chronic Low Back Pain
Official title: Introduction;Epidemiology;Socioeconomic Burden
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Low Back Pain
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consisted of patients who met the requirements of outpatient complaints and healthy people in daily life

Brief summary: Low back pain is defined as pain that extends from the 12th rib to the iliac bone, and its increasing incidence makes it one of the major causes of decreased productivity worldwide. Dysfunction is one of the important complications in patients with chronic low back pain, and related studies have shown that depression, pain catastrophization and other emotions can affect the occurrence and development of dysfunction. So the investigators wanted to study which psychological emotions affect the development of dysfunction in patients with low back pain.


Eligibility criteria: Inclusion Criteria:

1. Age 18-75;
2. Patients with low back pain;
3. Have good communication skills to ensure the collection of scale information

Exclusion Criteria:

1. Suffering from severe mental or psychiatric disorders.;
2. Unwilling to participate in the interview;
3. Patients with pain in other areas

Primary outcomes:
measure: Dysfunction index of patients with acute and chronic low back pain
timeFrame: From enrollment to 2 months later
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: The Second Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References:
Clinical trial NCT02875665: Feasibility Study of the Use of the gekoTM Device for Faecal Incontinence in Older People Living at Home or in Care Homes
Official title: Feasibility Study of the Use of the gekoTM Device for Faecal Incontinence in Older People Living at Home or in Care Homes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fecal Incontinence
Lead sponsor: Firstkind Ltd
Sponsor class: INDUSTRY
First posted: 2016-08-23
Enrollment: 13
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The intervention is the using geko device
Primary purpose: OTHER

Brief summary: This research aims to investigate the feasibility for the treatment of OnPulse(TM) for the treatment of faecal incontinence (FI) (including mixed faecal and urinary incontinence) in older people living at home or in a Care Home. It will determine patient acceptability, tolerability and usability of the T-2 gekoTM device for FI by assessing:

1. device user factors: acceptability of use, ease of device placement, ease of device interface control and understanding of device instructions;
2. tolerability of device: skin tolerability.


Eligibility criteria: Inclusion Criteria:

1. Male or Female
2. Aged 60 and over?
3. Reporting faecal incontinence of any severity
4. Living in own home or a Care Home
5. Able to understand the Patient Information Sheet and willing to sign the written Informed Consent Form.
6. Able and willing to follow the protocol requirements.

Exclusion Criteria:

1. Patients or Carers unable to speak, read or understand English
2. Patients or Carers unable to give informed consent because of lack of capacity
3. Patients with leg conditions (such as a venous ulcer) that would preclude placement of the gekoTM device.
4. Have implantable electronic devices
5. Has sore, infected or inflamed areas, broken skin or skin eruptions for example phlebitis, thrombophlebitis, venous leg ulcers, varicose veins etc. in the region where the device would be fitted.
6. Any cancerous lesions in the lower limb
7. Is pregnant

Primary outcomes:
measure: Reviewing the views of older people with faecal incontinence and their formal and informal carers on using the CE marked gekoTM tibial nerve stimulator device in their place of usual residence with regards to ease of use of the device and tolerability.
timeFrame: 1 week
Secondary outcomes:
measure: Studying the feasibility of older people or their carers applying the device
timeFrame: 1 week
measure: Skin reactions to using the device on the leg of older people measured by clinical examination
timeFrame: 1 week
Other outcomes:
Locations:
city: Brighton
country: United Kingdom
facility: Sussex Community NHS Foundation Trust
state: East Sussex
Study officials:
affiliation: King's College London
name: Christine Norton, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03428165: Transfer of Frozen Embryos in Natural Cycle: Evaluation of Impact of Spontaneous Versus HCG-triggered Ovulation on Pregnancy Rate
Official title: Transfer of Frozen Embryos in NATural Cycle: Evaluation of Impact of Spontaneous Versus HCG-triggered Ovulation on Pregnancy Rate - Bicentric Prospective Open Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: in Vitro Fertilization
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2018-02-09
Enrollment: 103
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of the study is to evaluated whether there is a difference in pregnancy rate when transferring frozen embryos between patietns having spontaneously ovulated versus those triggered to voulate with HCG.


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
* The patient is aged between 18 and 40
* Patient has regular cycles and classified as 'easy' for transfer of a frozen embryo at blastocyste stage (vitrification day 5)

Exclusion Criteria:

* The subject is participating in an 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
* Patient using donated oocytes
* Necessity of pre-implantation diagnosis
* Patients with stage 3 or 4 endometriosis or adenomyosis

Primary outcomes:
measure: Pregnancy rate after transfer of frozen embryos at day 14 between groups
timeFrame: Day 14
Secondary outcomes:
measure: Pregnancy rate at week 12
timeFrame: Week 12
measure: Miscarriage rate within first 12 weeks
timeFrame: Week 12
measure: Live birth
timeFrame: At delivery, maximum week 42
measure: Pregnancy term
timeFrame: At delivery, maximum week 42
measure: Birth weight
timeFrame: At delivery, maximum week 42
measure: Cancellation of transfer due to premature ovulation (progesterone >3ng/ml and/or Luteinizing hormone > 3-fold base level)
timeFrame: Day 0
measure: Number of visits for endometrial preparation until attaining LH peak
timeFrame: Day 0
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU Arnaud de Villeneuve
city: Nîmes
country: France
facility: CHU Nimes
Study officials:
affiliation: CHU Nimes
name: Stéphanie Huberlant
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04875065: Engage Coaching for Latinos
Official title: Healthy Aging Research Program (HARP): Engage Coaching Project for Latinos
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Isolation
Loneliness
Caregiver Burnout
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-05-06
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study asks: "what behavioral strategies are needed to help socially disconnected Hispanic/Latino caregivers with significant barriers to increasing connectedness?" This study uses a mixed methods approach to adapt a brief behavioral intervention-Social Engage psychotherapy-for use with socially disconnected Hispanic/Latino caregivers. This study is a single-arm clinical trial of Social Engage psychotherapy. We propose to enroll 10 participants for up to 8 weekly individual Social Engage psychotherapy sessions, over up to 3 months. Subjects will be aged 40 and older, and be caregivers for a community-dwelling family member with ADRD, living with (or in close proximity to) the family member with dementia, experiencing elevated caregiving distress and social disconnectedness.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 40 yrs;
2. Hispanic/Latino
3. English or Spanish speaking;
4. Caregiver for a community-dwelling family member with ADRD, living with (or in close proximity to) family member with dementia;
5. Endorse elevated caregiving distress as measured by a score of ≥ 11 on the 10-item Perceived Stress Scale (PSS-10) and/or a score of 5 or greater on the Modified Caregiver Strain Index (MCSI);
6. Endorse clinically significant loneliness as measured by a score of ≥ 6 on the UCLA Loneliness Scale: Short Form.
7. Has access to e-mail in order to complete the e-consent module in REDCap which will be used in this study.

Exclusion Criteria:

1. Primary language is not English or Spanish;
2. Recent or current psychosis;
3. Significant cognitive impairment on a cognitive screening measure at the HARP screening assessment;
4. Hearing problems that preclude completion of the intervention.

Primary outcomes:
measure: Change From Baseline in Loneliness at Post Intervention
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Change From Baseline in Social Functioning at Post Intervention
timeFrame: Baseline and 3 months
measure: Change From Baseline in Quality of Life: Social Relationships at Post Intervention
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References: