louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00944177: Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Metformin HCl (1000 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Glucophage®, Bristol-Myers Squibb Company) in Fasted, Healthy, Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Torrent Pharmaceuticals Limited
Sponsor class: INDUSTRY
First posted: 2009-07-23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: * Objective:

  * A Randomized, Two-Way Crossover, Single-Dose, Open-Label Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Metformin HCl (1000 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Glucophage®, Bristol-Myers Squibb Company) in Fasted, Healthy, Adult Subjects.
* Study Design:

  * Randomized,single-dose,2-way crossover.


Eligibility criteria: Inclusion Criteria:

* Subject is at least 18 years old.
* Subject had no clinically significant abnormal lab values at the screening evaluation.
* Subject's drugs of abuse, Hepatitis B, Hepatitis C, and HIV screenings were negative or non-relative.
* Acceptable screening of ECG.
* Female subject's pregnancy test at screening is negative.
* Subject had no evidence of underlying disease at the pre-entry physical examination.
* Subject has given written consent to participate.
* Female subject has not received any injectable or implantable contraceptive for a period of six months preceding this study.
* Agreed to undergo at least a 14-day pre-dose washout.
* Beginning two weeks prior to dosing and throughout the study, female subject of childbearing potential agrees to utilize one of the following methods of contraception:

  1. Condom and topical spermicide
  2. Condom and diaphragm
  3. Intra-uterine device (I.U.D)
  4. Complete abstinence.
* Agree to abstain from consuming caffeine or alcohol for at least 48 hours. prior to study and throughout the blood collection periods.

Exclusion Criteria:

* History of treatment for alcoholism, substance abuse, or drug abuse with in the past 24 months.
* History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other serious illness.
* History of GRD, malabsorption syndrome, colon cancer, or chronic colitis, including Crohn's disease.
* History of treatment for asthma, hypoxemia, dehydration, sepsis, metabolic acidosis and congestive heart failure.
* Subject is pregnant or lactating.
* History of drug hyper sensitivity.
* Subject was treated with any investigational drug during the four weeks prior to initial dosing for the study.
* Subject smokes more then 15 cigarettes per day or uses tobacco products or currently uses nicotine products.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: St, Charles
country: United States
facility: Gateway Medical Research, Inc.
state: Missouri
Study officials:
References:
Clinical trial NCT06903377: Study of ZG005 Combined With Gecacitinib in Patients With Advanced Non-Small Cell Lung Cancer
Official title: A Multicenter, Open-label, Dose-Escalation and Dose-Expansion Phase I/II Study of ZG005 Combined With Gecacitinib in Patients With Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2025-03-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter Phase I/II study for patients with advanced non-small cell lung cancer who have failed PD-1/L1 therapy, aiming to evaluate the safety of ZG005 in combination with Gecacitinib in this population, as well as the preliminary efficacy of this combination regimen.


Eligibility criteria: Inclusion Criteria:

* Fully understand this study and voluntarily sign the ICF.
* Age 18-75 years, no gender restriction.
* Patients with locally advanced or recurrent/metastatic squamous and/or non-squamous non-small cell lung cancer confirmed by histology/cytology, unsuitable for radical therapy.

Exclusion Criteria:

* Medical history, CT scan, or MRI indicates the presence of CNS metastases.
* Other malignancies within 5 years.
* Any other reason deeming the participant unsuitable for the study, as judged by the investigator.

Primary outcomes:
measure: Adverse Event (AE)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
affiliation: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
name: Jason Wu
role: STUDY_CHAIR
References:
Clinical trial NCT04607577: Cross-cultural Adaptation and Validation in Moroccan Arabic Dialect "Darija" of the QoR-15 Postoperative Recovery Quality Score"
Official title: Cross-cultural Adaptation and Validation in Moroccan Arabic Dialect "Darija" of the QoR-15 Postoperative Recovery Quality Score"
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Recovery of Function
Lead sponsor: Moroccan Society of Surgery
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All scheduled anesthesia procedures with a pre-anesthetic consultation, performed at INO, both in the digestive surgery operating room, as well as in gyneco-mammary and outpatient endoscopy, brachytherapy and conventional and interventional adult radiology

Brief summary: The QoR-15 Is a post operative recovery score developed in 2013 from the QoR-40 with an advantage of simplification. The investigators Aim to translate and to validate a such useful score in Arabic adapted for Morocco by a full psychometric evaluation of the Arabic version, by testing its validity, reliability, responsiveness, and clinical acceptability and feasibility, with patients undergoing abdominal, thoracic, gynecological surgery, or digestive endoscopy in the National Institute of Oncology of Rabat, affiliated to Mohammed V University in Rabat, Morocco.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Agreement in writing for the use of the data

Exclusion Criteria:

* Patients who expressed their refusal to participate in the study
* Patients unable to express their non-opposition to participating in the study
* Patients operated on for surgery for which it was highly probable that it would not be possible for them to answer the questionnaire postoperatively (first 24 hours)
* Patients who do not master the Arabic language, neither read nor spoken

Primary outcomes:
measure: Postoperative Quality of Recovery 15 in Moroccan Arabic scale (QoR-15 MA) functional recovery score at recovery from anesthesia
timeFrame: One Hour after recovery from anesthesia
measure: The differential between the QoR-15MA score preoperatively and postoperatively
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Rabat
country: Morocco
facility: National Institute of Oncology of Rabat
Study officials:
affiliation: Mohammed V University in Rabat
name: Abdelilah Ghannam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05113277: Development and Evaluation of a Tonic Immobility Focused Psychoeducational Intervention
Official title: Development and Evaluation of a Tonic Immobility Focused Psychoeducational Intervention - Randomized Controlled Trial (RCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Tonic Immobility Response
Keywords: Psychoeducation
Online Intervention
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2021-11-09
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to complete 1 of 2 interventions - active or control.
Primary purpose: TREATMENT

Brief summary: A randomized controlled trial is planned to evaluate a brief, web-based intervention intended to educate about tonic immobility (TI) within a sample of those who experienced TI in the context of a traumatic event.

Detailed description: A randomized controlled trial is planned to evaluate a brief, web-based intervention intended to educate about tonic immobility (TI) within a sample of those who experienced TI in the context of a traumatic event. The investigators expect that this intervention will lead to improvement in posttraumatic guilt, shame, and PTSD symptoms as compared to an active control condition.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Endorsed prior TI experience (TIQ items A \& B)
* Elevated posttraumatic stress symptoms (PCL-5; Blevins et al., 2015)

Exclusion Criteria:

Inability to consent or complete the intervention including:

* Cognitive impairment
* Uncorrected visual or auditory impairment
* Unmedicated severe mental illness
* Imminent risk of harm to self or others

Primary outcomes:
measure: Posttraumatic Stress Disorder Symptoms
timeFrame: up to 1 month
measure: Guilt
timeFrame: post-intervention, on Day 1
measure: Shame
timeFrame: post-intervention, on Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Anxiety and Behavioral Health Clinic
state: Florida
Study officials:
affiliation: Florida State University
name: Norman B Schmidt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00127387: Enbrel Versus Placebo With Radiation Therapy to Combat Fatigue and Cachexia
Official title: A Prospective, Randomized Pilot Study of Enbrel VS Placebo in Patients Receiving Radiation Therapy to Combat Fatigue and Cachexia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Lung Cancer
Prostate Cancer
Neoplasm Metastasis
Bone Cancer
Keywords: Bone metastasis
Radiation therapy
Lung cancer
Prostate cancer
Advanced lung cancer receiving radiation therapy
Advanced prostate cancer receiving radiation therapy
Any cancer with bone mets receiving radiation therapy
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: Sanchez Cancer Center
First posted: 2005-08-05
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Patients who receive radiation therapy often have fatigue or a decrease in feeling well causing a "wasting" away. For patients with advanced disease of lung cancer, prostate cancer, or cancer that has spread to the bone, it is hoped that this drug may decrease this. If patients feel better during treatments they can complete the therapy without any breaks in treatment. For treatment to be most effective, it should be given in the amount needed, on a particular schedule.

Detailed description: Subjects will be placed in a group to receive either the drug enbrel, or a placebo. The radiation therapy treatments are as they would be given if the person was not on a research study. The selection of the group a patient is in is done by random, like flipping a coin. The doctor is not able to influence which group anyone is selected for. As is done routinely, radiation therapy is given Monday through Friday for about 4 to 6 weeks.The injections of enbrel or placebo are given two times a week. The enbrel or placebo is given as an injection directly under the skin with a small needle.

Eligibility criteria: Inclusion Criteria:

* Advanced lung, prostate, or bony metastasis for cancer
* Performance status (PS) of 3 or less
* Good lab test results with albumin of at least 2.5
* Radiation therapy of at least 4000Gy in 4 weeks

Exclusion Criteria:

* Poor PS
* Planned radiation therapy for less than 4 weeks or 4000Gy
* Limited disease

Primary outcomes:
measure: Determine if the subjects who received the enbrel study drug had a better quality of life than the subjects who received placebo
Secondary outcomes:
measure: Safety profile for enbrel taken by this group of individuals
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: U Texas Health Science Center San Antonio
name: Charles R Thomas, Jr, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00361387: Use of Focalin for Fatigue in Sarcoidosis
Official title: Randomized, Double-Blind, Placebo-Controlled Study of Dexmethylphenidate Hydrochloride, (d-MPH) in the Treatment of Fatigue in Sarcoidosis Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sarcoidosis
Keywords: Sarcoidosis
Sarcoid
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2006-08-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Patients diagnosed with chronic sarcoidosis with fatigue for more than 6 months. Sarcoidosis and its treatment can greatly affect your quality of life. Many patients suffer from fatigue (feeling tired), lack of focus and concentration, in ability to organize their daily activities, and memory loss. These commonly reported symptoms often get in the way of everyday life.

Detailed description: This is to be a double blind, randomized trial with cross over of 12 patients with chronic sarcoidosis on stable systemic therapy. Patients will be screened for fatigue using a modified SNAP and Facit-F scores. Patients will be in the study for 20 weeks. Objective of study: To determine the effect of dexmethylphenidate hydrochloride, (d-MPH)(Focalin) on fatigue in Sarcoidosis. The is a common complaint in sarcoidosis, related to the chronic inflammatory nature of the disease. It may also related to therapy for the disease.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of sarcoidosis using standard criteria
* Disease for more than one year
* Complain of fatigue which has been present for more than six months.
* Over 18 years of age

Exclusion Criteria:

* Pregnancy
* Change in therapy for sarcoidosis in prior three months
* history of ventricular arrythmias
* Patients with a history of anxiety disorder, glaucoma, motor ties or a family history of Tourette's syndrome.
* Patients who are currently receiving or have received monoamine oxidase inhibitors within 14 days prior to study entry.

Primary outcomes:
measure: Improvement of fatigue.
timeFrame: 30 weeks
Secondary outcomes:
measure: Improvement of pulmonary status
timeFrame: 30 weeks
measure: Safety of treatment
timeFrame: 30 weeks
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
Study officials:
affiliation: Unversity of Cincinnati
name: Robert P Baughman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lower EE, Harman S, Baughman RP. Double-blind, randomized trial of dexmethylphenidate hydrochloride for the treatment of sarcoidosis-associated fatigue. Chest. 2008 May;133(5):1189-95. doi: 10.1378/chest.07-2952. Epub 2008 Feb 8.
Clinical trial NCT02668887: Employment and Quality of Life in Patients With Malignant Melanoma
Official title: A Prospective Cohort Study on Employment and Quality of Life in Patients With Malignant Melanoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Melanoma of Skin
Quality of Life
Work Ability
Lead sponsor: Fachklinik Hornheide an der Universität Münster
Sponsor class: OTHER
Collaborators: name: Universität Münster
name: Deutsche Rentenversicherung
First posted: 2016-01-29
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with malignant melanoma

Brief summary: Within the first year after diagnosis, data on employment and quality of life will be collected and evaluated in patients with malignant melanoma


Eligibility criteria: Inclusion Criteria:

* first diagnosis of malignant melanoma stage 0 to stage IIIC within the last 6 weeks
* written informed consent

Exclusion Criteria:

* diagnosis of malignant melanoma stage IV
* inability to follow the protocol

Primary outcomes:
measure: Quality of life questionnaire
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Münster
country: Germany
facility: Fachklinik Hornheide
Study officials:
affiliation: Fachklinik Hornheide
name: Hans-Joachim Schulze, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04634487: Polish Registry of Takotsubo Syndrome
Official title: Polish Registry of Takotsubo Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Takotsubo Syndrome
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2020-11-18
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients hospitalised with takotsubo syndrome in Poland

Brief summary: Polish registry of takotsubo syndrome


Eligibility criteria: Inclusion Criteria:

all patients with takotsubo syndrome

Exclusion Criteria:

-

Primary outcomes:
measure: Number of participants with in-hospital complications and mortality
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Number of participants with complications with echocardiography
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical University of Warsaw
Study officials:
References:
Clinical trial NCT02755987: Expanded Access to ANG1005 for Individual Patients
Official title: Expanded Access to ANG1005 for an Individual Patient With Recurrent WHO Grade III Anaplastic Astrocytoma; Expanded Access to ANG1005 for an Individual Patient With Recurrent WHO Grade III Anaplastic Oligodendroglioma; Expanded Access to ANG1005 for an Individual Breast Cancer Patient With Recurrent Brain Metastases and Leptomeningeal Carcinomatosis.
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Anaplastic Astrocytoma
Anaplastic Oligodendroglioma
Breast Cancer With Recurrent Brain Metastases
Leptomeningeal Carcinomatosis
Lead sponsor: Angiochem Inc
Sponsor class: INDUSTRY
First posted: 2016-04-29
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This is an expanded access study with ANG1005 treatment for two individual patients from Protocol ANG1005-CLN-03 with WHO Grade III Anaplastic Astrocytoma and WHO Grade III Anaplastic Oligodendroglioma and one individual patient from Protocol ANG1005-CLN-04 with Recurrent Brain Metastases and Leptomeningeal Carcinomatosis.


Eligibility criteria: Inclusion Criteria:

1. Neurologically stable
2. Karnofsky performance status (KPS) ≥ 80
3. Adequate laboratory results

Exclusion Criteria:

1. Radiotherapy within 3 months.
2. Evidence of significant intracranial hemorrhage
3. NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0 Grade ≥ 2 neuropathy
4. Inadequate bone marrow reserve
5. Any evidence of severe or uncontrolled disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: UC Irvine Health
state: California
city: San Antonio
country: United States
facility: Univeristy of Texas Health Science Center in San Antonio
state: Texas
Study officials:
References:
Clinical trial NCT02020187: Aerobic Training in Patients With Congenital Myopathies
Official title: Aerobic Training in Patients With Congenital Myopathies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Myopathy
Keywords: Congenital myopathy
Exercise
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2013-12-24
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Congenital myopathies are clinical and genetic heterogeneous disorders characterized by skeletal muscle weakness. Most patients experience muscle weakness and fatigue throughout their life. However, progression of symptoms is rare. There are no specific treatments for congenital myopathies. Training has been shown to benefit several other muscle diseases with weakness, but the defect in congenital myopathies involves contractile proteins of the sarcomere, why the effect of training is uncertain in these conditions. The investigators will therefore investigate the effect cycle-ergometer training for 30 minutes, three times weakly, for ten weeks in 15 patients with congenital myopathy. Another 5-10 congenital myopathy patients, who do not train, will serve as controls for the trained patients. The study starts and ends with a test day, where efficacy based on VO2max, performance in functional tests and a questionnaire will be assessed.

Detailed description: 10 weeks of cycle-ergometer training at home. Intensity at 70% of maximal VO2,max.

Eligibility criteria: Inclusion Criteria:

* Danish patients with gene verified congenital myopathy

Exclusion Criteria:

* Patients who are to week to train at a cycle-ergometer for 10 weeks
* Patients who have other health issues, which can disturb the interpretation of the efficacy

Primary outcomes:
measure: Efficacy based on VO2,max
timeFrame: 10 weeks
Secondary outcomes:
measure: Level of Creatine Kinase
timeFrame: 10 weeks
measure: Intensity in maximal Watt
timeFrame: 10 weeks
measure: 6 minute walk test
timeFrame: 10 weeks
measure: SF-36 questionnaire
timeFrame: 10 weeks
measure: A timed five-repetitions-sit-to-stand-test
timeFrame: 10 weeks
measure: A timed 14-step-stair-test
timeFrame: 10 weeks
measure: Dynamometry
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Neuromuscular Research Unit
Study officials:
affiliation: Rigshospitalet, Denmark
name: Gitte H Pedersen, Bsc Medicine
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hedermann G, Vissing CR, Heje K, Preisler N, Witting N, Vissing J. Aerobic Training in Patients with Congenital Myopathy. PLoS One. 2016 Jan 11;11(1):e0146036. doi: 10.1371/journal.pone.0146036. eCollection 2016.