louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04259593: Exercise for Elderly Lymphoma Patients
Official title: Exercise Training is a Feasible and Active Complementary Therapy in Adult and Elderly Patients Receiving Anti- Lymphoma Treatments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly Lymphoma Patients
Keywords: Exercise training, Complementary therapy
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This pilot study was designed in a real-life setting to establish the feasibility, the safety and the activity of a supervised and combined Exercise Training (ET) program in adult and elderly lymphoma patients undergoing cancer-treatments.

Detailed description: Eligible patients were assigned to the ET group. All the patients eligible for exercise but not partiticpating to the ET program because of logistical reasons, were considered as the control group. All clinical outcomes were assessed before exercise training (T0), 3 (T1) and 6-months (T2) after the beginning of the exercise.

Eligibility criteria: Inclusion Criteria:

* ≥18-80 years old, histologically conﬁrmed HL or NHL, patients in need of first or subsequent lines of systemic treatment and with a long-life expectancy

Exclusion Criteria:

* Patients were excluded if they had less than 4 months of anti-cancer treatment to be delivered, severe orthopaedic, cardiac, pulmonary, or cognitive impairment, osteolytic lesions with the risk of fracture, cachexia or if they were ≥ 65 years and frail on the basis of comprehensive geriatric assessment

Primary outcomes:
measure: The eligibility rate
timeFrame: 6 months
measure: The recruitment rate
timeFrame: 6 months
measure: The exercise adherence rate
timeFrame: 4 months
measure: The assessment rate
timeFrame: 6 months
measure: Safety of the exercise training
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Sant'Andrea Hospital
Study officials:
affiliation: Sant'Andrea Hospital, Rome, Italy
name: Maria Christina Cox
role: STUDY_CHAIR
References:
citation: Streckmann F, Kneis S, Leifert JA, Baumann FT, Kleber M, Ihorst G, Herich L, Grussinger V, Gollhofer A, Bertz H. Exercise program improves therapy-related side-effects and quality of life in lymphoma patients undergoing therapy. Ann Oncol. 2014 Feb;25(2):493-9. doi: 10.1093/annonc/mdt568.
Clinical trial NCT04202393: Intervention for Comorbid Substance Use and Bipolar Disorders
Official title: RCT to Improve Post-Hospital Treatment Adherence for Comorbid Substance Use and Bipolar Disorders
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Bipolar Disorder
Substance Use Disorders
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2019-12-17
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial aims to evaluate the effectiveness of a novel intervention for patients with co-occurring bipolar and substance use disorders following a psychiatric hospitalization. Half of the participants will receive a specialized psychosocial intervention program, while the other half will receive an enhanced safety monitoring program, both provided in addition to their routine care.


Eligibility criteria: Inclusion:

* Diagnosis of a bipolar-spectrum disorder
* Diagnosis of a substance use disorder
* Taking at least one mood-stabilizing medication

Exclusion:

* Unable to speak and read English
* Younger than age 18

Primary outcomes:
measure: Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C)
timeFrame: 6 months
measure: Clinician-Administered Rating Scale for Mania (CARS-M)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
affiliation: Butler Hospital
name: Brandon Gaudiano, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Butler Hospital
name: Ivan Miller, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00210093: A Pharmacokinetic Evaluation Study in Healthy Volunteers
Official title: A Single-Center, Randomized, Crossover Pharmacokinetic Evaluation of the Effect of Single Doses of Intravenous INS37217, Nasally Inhaled INS37217 and Orally Inhaled INS37217 Solution in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to characterize the pharmacokinetics of INS37217 following intravenous, intranasal, and inhalation administration and to calculate the relative bioavailability of INS37217 when administered via oral or nasal inhalation.


Eligibility criteria: Inclusion Criteria:

* Are current nonsmokers or previous smokers who have not smoked within 6 months and who do not have greater than or equal to a 10 pack-year history of tobacco use
* Are within 20% of their ideal body weight
* Are healthy on the basis of a pre-trial physical examination

Exclusion Criteria:

* History or suspicion of recent alcohol, barbiturate, amphetamine or narcotic abuse or a positive urine drug test at study screening
* History of cardiac arrhythmias, any pathological abnormality on the ECG, bronchospasm, diabetes mellitus, thyrotoxicosis, Parkinsonism, asthma, COPD or cardiovascular disease significant drug allergy
* Subject with a physical obstruction in the nose
* Use of concomitant medication other than hormonal contraceptives and multi-vitamins
* Subjects with a current upper respiratory illness or infection for the 2 weeks prior to screening or any chronic respiratory illness

Primary outcomes:
measure: plasma concentrations of INS37217
Secondary outcomes:
measure: Pilot study - not specified
Other outcomes:
Locations:
Study officials:
name: Amy Schaberg, BSN
role: STUDY_DIRECTOR
References:
Clinical trial NCT05276193: GamReg Sweden - Quality Register for Gambling and Gaming Disorders
Official title: GamReg Sweden - Quality Register for Gambling and Gaming Disorders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gambling Disorder
Gaming Disorder
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2022-03-11
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All included subjects.

Brief summary: This is a quality register for the monitoring of clinical assessment and treatment for gambling disorder and gaming disorder in Swedish health care.

This register is held by Region Skåne, the health care organization of Skåne in southern Sweden, and administered by Register center South, which is associated with health care services in the southern regions of Sweden (the establishment of quality registers in Swedish health care relies upon a national legislation). Quality registers by themselves do not represent formal research projects. However, future research projects can use quality registers, such as the present one, as a data source for future research projects in case they are approved by an ethics authority.

Clinical study variables collected in the register include the following (examples):

* gender, age, occupation, living conditions
* if applicable, types of gambling associated with the treatment needs
* if applicable, type of problematic video gaming
* type of referral to the present treatment contact
* treatment history in psychiatry, social services, enforcement agency
* history of suicidal behavior
* alcohol and drugs problems requiring assessment or treatment
* violence victimization
* type of treatment provided to the patient


Eligibility criteria: Inclusion Criteria:

* All patients assessed and treated at units where treatment of problem gambling or problem gaming is provided

Exclusion Criteria:

* Patients who - in a standardized opt-out procedure (following standard of national regulation for quality registers) - refuse participation in the quality register

Primary outcomes:
measure: Treatment uptake
timeFrame: 1 year
measure: Characteristics of treatment-seeking patients
timeFrame: 1 year
measure: Distribution of treatment methods provided (assessed annually)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Malmö Addiction Center
Study officials:
References:
citation: Hakansson A, Akesson G. GamReg Sweden-Protocol for a systematic cohort data collection for improved clinical knowledge in specialized gambling disorder treatment. Front Psychiatry. 2022 Sep 12;13:894532. doi: 10.3389/fpsyt.2022.894532. eCollection 2022.
Clinical trial NCT05675293: Cervicitis by Iontophoresis
Official title: Effectiveness of Iontophoresis in Managing Uterine Cervicitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: CERVICITIS
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to:

Investigate effect of iontophoresis on managing uterine cervicitis.


Eligibility criteria: Inclusion Criteria:

1. All patients have vaginal discharge.
2. All patients have irregular vaginal bleeding, especially after sexual intercourse.
3. All patients have dyspareunia.
4. All patients have Lower abdominal pain.
5. Group A: 20 women will receive oral medication (antibiotic zesrosin) and hot water with antiseptic.
6. Group B: 20 women will receive medication by iontophoresis (antibiotic ceftriaxone) and hot water with antiseptic.

Exclusion Criteria:

1. Patients with a history of hypersensitivity or adverse reactions associated with the delivered drug in (ceftriaxone).
2. Patients with prior medical histories of cardiac arrhythmias or hypercoagulability should not receive the procedure near cardiac pacemakers and superficial blood vessels.
3. In the vicinity of embedded wires, stapes, orthopedic implants, and areas of skin with lesions and impaired sensation.
4. It either should not be used or used with extreme caution during pregnancy.

Primary outcomes:
measure: Difference in change in Urine Analysis and Cervical swab results in both groups
timeFrame: 7 Days difference between pre and post tests
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05261893: Effects of ELDOA Versus Post Facilitation Stretching Technique in Patients With Knee Osteoarthritis
Official title: Comparative Effects of Elongation Longitudinaux Avec Decoaption Osteo Articulaire and Post Facilitation Stretching Technique in Patients With Knee Osteoarthritis- A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Comparative
Elongation Longitudinaux Avec Decoaption Osteo Articulaire
Post Facilitation Stretching Technique
Knee Osteoarthritis
Randomized Control Trial
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to assess whether Elongation Longitudinaux Avec Decoaption Osteo Articulaire versus post assistance extending strategy have effects on knee torment. and to check its impact on actual capacity.

Detailed description: A randomized controlled trial will be conducted at Safi Teaching Hospital, Faisal Teaching Hospital and Allied Hospital Fsd after the synopsis has been approved. Patients will be enrolled using a simple random sampling technique. Patients with Knee Osteoarthritis will be chosen based on pre-established inclusion and exclusion requirements. Patients will receive Elongation Longitudinaux Avec Decoaption Osteo Articulaire, and post-facilitation stretching techniques. Two tools will be used to find out the comparison of both groups; Numeric Pain Rating Scale; for knee pain and Lower Extremity Functional Scale; to check the ability of the patient to perform the everyday task and for evaluation of functional impairments for patients with a disorder of lower extremities.

The assessment will need to be done at baseline and follow up will be 15 days after treatment. Each patient will be asked to give their informed consent. Statistical Package of Social Sciences Version 20 will be used for data entry and analysis.

Eligibility criteria: Inclusion Criteria:

* It includes both male and female diagnose with knee Osteoarthritis according to history, physical examination and radiological findings and also patient who score more than 3 on Numeric Pain Rating Scale
* Osteoarthritis grade of 3 and lower as determined by using Kallgran and Lawrence Radiographic classification.

Exclusion Criteria:

* If patient is unable to walk or exercise without functional aid and have previous knee surgery.
* Patient with heart condition.

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: 12th Week
measure: Lower Extremity Functional Scale
timeFrame: 12th Week
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Ripah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Kashif
role: STUDY_CHAIR
References:
Clinical trial NCT01221493: EBUS Guided Cryo Biopsy of Solitary Pulmonary Nodules
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Yield of Cryo Biopsy in Lung Cancer
Solitary Pulmonary Nodule
Keywords: solitary pulmonary nodules
transbronchial lung biopsy
endobronchial ultrasound
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2010-10-15
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To proof the feasibility and safety of EBUS guided transbronchial cryo biopsies in peripheral lung lesions

Detailed description: Solitary pulmonary nodule are a diagnostic dilemma. Nowadays not only the basic tissue diagnosis is necessary, molecular signals are state of the art. Therefore more tissue is necessary. With a cryoprobe the amount of tissue is increased compared to the classical forceps biopsy.

Until now, the use of the cryoprobe ism´t show in peripheral lung tissue.

Eligibility criteria: Inclusion Criteria:

* solitary pulmonary nodule \< 4 cm
* no endobronchial lesion
* indication for bronchoscopy

Exclusion Criteria:

* coagulopathy
* pulmonary hypertension
* pregnancy

Primary outcomes:
measure: Safety
timeFrame: 24 h after intervention
Secondary outcomes:
measure: Efficacy
timeFrame: 48 h after intervention
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Department of Pneumology and Critical Care medicine
state: BW
Study officials:
affiliation: Thoraxklinik, Universityof Heidelberg
name: Felix JF Herth, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eberhardt R, Kahn N, Gompelmann D, Schumann M, Heussel CP, Herth FJ. LungPoint--a new approach to peripheral lesions. J Thorac Oncol. 2010 Oct;5(10):1559-63. doi: 10.1097/JTO.0b013e3181e8b308.
citation: Eberhardt R, Gompelmann D, Herth FJ. Electromagnetic navigation in lung cancer: research update. Expert Rev Respir Med. 2009 Oct;3(5):469-73. doi: 10.1586/ers.09.36.
citation: Eberhardt R, Morgan RK, Ernst A, Beyer T, Herth FJ. Comparison of suction catheter versus forceps biopsy for sampling of solitary pulmonary nodules guided by electromagnetic navigational bronchoscopy. Respiration. 2010;79(1):54-60. doi: 10.1159/000232394. Epub 2009 Jul 31.
citation: Eberhardt R, Kahn N, Herth FJ. 'Heat and destroy': bronchoscopic-guided therapy of peripheral lung lesions. Respiration. 2010;79(4):265-73. doi: 10.1159/000284015. Epub 2010 Feb 10.
citation: Schuhmann M, Bostanci K, Bugalho A, Warth A, Schnabel PA, Herth FJ, Eberhardt R. Endobronchial ultrasound-guided cryobiopsies in peripheral pulmonary lesions: a feasibility study. Eur Respir J. 2014 Jan;43(1):233-9. doi: 10.1183/09031936.00011313. Epub 2013 Jul 30.
Clinical trial NCT01126593: Post-Op Rotator Cuff Pain Study With Subacromial Bupivacaine Infusion
Official title: Efficacy of Continuous Subacromial Bupivacaine Infusion for Postoperative Analgesia After Arthroscopic Rotator Cuff Repair.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tear
Lead sponsor: Orlando Health, Inc.
Sponsor class: OTHER
First posted: 2010-05-19
Enrollment: 96
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: SUPPORTIVE_CARE

Brief summary: Subacromial pain catheters have been used with uncertain efficacy for many years after rotator cuff repair to aid in postoperative pain control. Our null hypothesis is that postoperative subacromial continuous infusion bupivacaine catheters will provide no pain control benefits over placebo infusions or no catheter use.

Detailed description: This will be a prospective, randomized, double-blinded placebo controlled study. Randomization will be performed by a random numbers table. Envelopes will be sealed with the accompanying randomization group.Patients will be eligible for inclusion in the study if they have a full-thickness rotator cuff tear that has been deemed reparable by preoperative MRI. They will be included in the study if they are medically stable to undergo the surgery and consent to involvement in the study.

Patients consenting to the study will undergo arthroscopic rotator cuff repair by one of the two senior authors. The surgery will be performed as an outpatient procedure under general anesthesia. The procedure will be performed utilizing the standard techniques of the senior authors. All concomitant pathology found at the time of arthroscopy will be treated in the usual appropriate fashion. At the completion of the rotator cuff repair, patients will be randomly allocated to one of three groups. This will be done by opening a sealed envelope with the randomization allocation. The patients will either be placed into the study group, the placebo group or the control group.

Eligibility criteria: Inclusion Criteria:

* Full thickness rotator cuff tear
* Pre operative MRI
* Patients who are medically stable to undergo the surgery
* Patients who consent to involvement in the study

Exclusion Criteria:

* Prior surgery on the involved shoulder
* Preoperative MRI suggesting that the rotator cuff tear is unrepairable
* Patients with known allergies to oxycodone, bupivacaine or a similar drug
* Workman's compensation patients
* Patients who do not fill out their visual analog scores or their medication diaries.

Primary outcomes:
measure: Pain Scores
timeFrame: O hour, 1, 2, 3, 4, 5, 6, 12 and 72 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Orthopaedic Center
state: Florida
Study officials:
affiliation: Orlando Orthopaedic Center and Orlando Health, Inc.
name: Randy Schwartzberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02192593: Computerized Cognitive-Behavioral Therapy for Auditory Hallucinations
Official title: Randomized Controlled Trial of Computerized Cognitive Behavioral Therapy for Auditory Hallucinations in Persons With Psychosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia, Schizoaffective Disorder
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
First posted: 2014-07-17
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled trial, examining the effects of a computerized, internet-based Cognitive Behavioral Therapy (CBT) Intervention for persons with a schizophrenia spectrum disorder who experience distressing auditory hallucinations (voices). Participants are randomized to one of two conditions: either to receive the 10-session computer-based program on a weekly basis, or to their usual care at their mental health clinic. This study takes place at Cambridge Health Alliance in Cambridge Massachusetts. It is hypothesized that the participants who participate in the CBT program will have significant improvements in the severity of their auditory hallucinations, as well as their associated distress, compared to the participants receiving usual care.


Eligibility criteria: Inclusion Criteria:

* Participants will be on a stable dose of antipsychotic medication for the past 3 months.

  * Schizophrenia-spectrum diagnosis, including schizophrenia, schizoaffective disorder, schizophreniform disorder, and psychosis, not otherwise specified.
  * At least moderate severity on Brief Psychiatric Rating Scale (BPRS) hallucinations item.
  * Naïve to CBTp for Auditory Hallucinations within the past 3 years.
  * No current suicidal ideation or hospitalization within the past month.
  * Reading level of at least 4th grade, as measured by the reading section of the Wide Range Achievement Test (WRAT)
  * Current patient receiving care at Cambridge Health Alliance

Exclusion Criteria:

* Terminal physical illness expected to result in the death of the study participant within one year.

  * Primary diagnosis of dementia or a diagnosis of a psychiatric disorder secondary to a medical condition.
  * Comorbid dementia (severe cognitive impairment) as indicated by a Mini-mental state examination score \<24.
  * Current active substance abuse or dependence with the need for specialized substance abuse services
  * Does not speak English
  * Does not achieve a 4th grade reading level as demonstrated on the Wide Range Achievement Test (WRAT)
  * Has a legal guardian

Primary outcomes:
measure: Brief Psychiatric Rating Scale (BPRS)
timeFrame: Baseline, Post-Treatment, 3-Month Follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Cambridge Health Alliance
state: Massachusetts
Study officials:
affiliation: Boston University
name: Jennifer D Gottlieb, PhD
role: PRINCIPAL_INVESTIGATOR
References: