louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00646256: Cognitive Determinants of Psychoeducation and Information in Psychoses
Official title: Psychoeducation in Patients With Schizophrenia: Neuropsychological Performance and Cognitive Training as Determinants of Outcome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Delusional Disorders (ICD-10)
Keywords: schizoaffective
schizotypal
Lead sponsor: German Research Foundation
Sponsor class: OTHER
First posted: 2008-03-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to examine whether the efficacy of psychoeducation in patients with schizophrenia or schizoaffective disorders is dependent on their cognitive performance level and if a preceding cognitive training can enhance the therapeutic effects of psychoeducation

Detailed description: Schizophrenic inpatients are examined shortly after admission with a broad battery of clinical and neurological rating scales and neuropsychological tests. They are then randomized to either standard treatment (including antipsychotic medications, art and occupational therapy, psychotherapy) or to standard treatment plus daily computerbased cognitive training (COGPACK; ten 1-hour sessions over two weeks). After repetition of the broad assessment battery all patients (and some of their family members) take part in a bifocal psychoeducation group program (eight 1-hour sessions over four weeks). Specific pre-post measures are illness knowledge, self and expert ratings of adherence to treatment, insight to the illness, treatment satisfaction. The study also includes a 9-month follow-up, with number of rehospitalizations, days in hospital and psychopathology as the primary outcome measures.

Eligibility criteria: Inclusion Criteria:

* Inpatients
* Informed consent
* German as first language or very good knowledge of German

Exclusion Criteria:

* Mental retardation
* Any serious somatic illness

Primary outcomes:
measure: illness knowledge, adherence to treatment, insight to the illness, satisfaction with treatment. 9-month follow-up: number of rehospitalizations, days in hospital
timeFrame: Baseline, after cognitive training, after psychoeducation, 9-month after end of psychoeducation
Secondary outcomes:
measure: Psychopathological status
measure: Psychosocial rehabilitation
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinik und Poliklinik für Psychiatrie und Psychotherapie, Klinikum rechts der Isar, Technical University of Munich
Study officials:
affiliation: Klinik und Poliklinik für Psychiatrie und Psychotherapie, Klnikum rechts der Isar, Technbical Univesity Munich
name: Thomas Jahn, Prof. Dr. phil. Dipl.-Psych.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pitschel-Walz G, Bauml J, Frobose T, Gsottschneider A, Jahn T. Do individuals with schizophrenia and a borderline intellectual disability benefit from psychoeducational groups? J Intellect Disabil. 2009 Dec;13(4):305-20. doi: 10.1177/1744629509353237.
Clinical trial NCT00030056: GM-CSF in Patients With Pulmonary Alveolar Proteinosis
Official title: Trial of GM-CSF for Alveolar Proteinosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pulmonary Alveolar Proteinosis
Keywords: Sargramostim
Injections, Subcutaneous
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 2002-01-31
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This is a study to determine the efficacy and safety of granulocyte-macrophage colony-stimulating factor (GM-CSF, sargramostim) administered subcutaneously to patients with pulmonary alveolar proteinosis (PAP).

Detailed description: PAP is a rare lung disease characterized by accumulation of surfactant phospholipids and proteins within the lungs. There is no specific pharmacologic therapy for PAP and the current practice of lung lavage under general anesthesia is invasive and has limitations. Although it is unknown if the anti GM-CSF antibody is related to the disease pathogenesis, observations suggest a role for GM-CSF in lung homeostasis as well as in the pathogenesis of PAP.

Patients will receive subcutaneous GM-CSF or placebo once a day and will be followed on an outpatient basis at 2 weeks, and 1, 2, 3, 4, 5 and 6 months after initiation of therapy. Clinical response will determine dosing schedule and will be evaluated by symptom scores, gas exchange data, and chest radiographs.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: Inclusion criteria:

* Diagnosis of primary or idiopathic PAP
* Creatinine no greater than 2 mg/dL
* Bilirubin no greater than 2 mg/dL
* Liver enzymes no greater than 3 times normal
* Women must use an effective method of contraception, be post menopausal, or be surgically sterilized

Exclusion criteria:

* Active respiratory infection
* Active cardiovascular disease (e.g., cardiogenic pulmonary edema)
* Underlying myeloproliferative disorder or leukemia
* Other secondary cause of PAP (e.g., occupational exposure to silica or HIV with PCP)
* At increased risk of side effects from GM-CSF therapy (i.e., rheumatoid arthritis, immune thrombocytopenia, or autoimmune thyroiditis)
* Previous therapy with GM-CSF
* Pregnant or nursing
* Significant renal or liver disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Medical Center
state: Colorado
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: The University of Pennsylvania Medical Center
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01298856: The Effect of Hydrotherapy and Land-based Rehabilitation Program Combined With Ankle Taping in Athletes With Chronic Ankle Instability
Official title: The Effect of Hydrotherapy and Land-based Rehabilitation Program Combined With Ankle Taping on Ankle Functional Ability and Re-injury Rate in Athletes With Chronic Ankle Instability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sports Rehabilitation Program
Hydrotherapy
Ankle Instability
Keywords: hydrotherapy
chronic ankle instability
ankle taping
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
Collaborators: name: Thammasat University
First posted: 2011-02-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: There will be a difference in ankle functional ability between athletes with chronic ankle instability in the intervention group and in the control group.


Eligibility criteria: Inclusion Criteria:

* recurrent ankle sprain in one year
* sustain at least one repeated injury or have the experience of ankle instability feelings or "giving way"
* not undergoing formal or informal rehabilitation for the unstable ankle in the last three months
* have residual symptoms after recurrent sprain of the ankle

Exclusion Criteria:

* have the history of fracture or surgical procedures in the lower extremity
* have the history of neurological disorders affecting the lower extremities vestibular dysfunction or balance disorder
* allergic to the zinc oxide compound in the adhesive tape

Primary outcomes:
measure: To compare the effect of ankle functional ability between the athletes with chronic ankle instability in the intervention group and the control group
timeFrame: 18 months
Secondary outcomes:
measure: To compare the effect of active joint position sense, single limb balance, SF-36 and re-injury rate
timeFrame: 18 months
Other outcomes:
Locations:
city: Khlong Luang
country: Thailand
facility: Thammasat University
state: Pathum Thani
Study officials:
References:
Clinical trial NCT01344356: Stereotactic Body Radiotherapy for Head and Neck Tumors
Official title: Phase IV Trial to Use Stereotactic Body Radiotherapy for Head and Neck Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Squamous Cell Carcinoma of the Head and Neck
Nasopharyngeal Carcinoma
Salivary Gland Cancer
Head and Neck Sarcoma
Paraganglioma of Head and Neck
Chordoma of Head and Neck
Chondrosarcoma of Head and Neck
Angiofibroma of Head and Neck
Keywords: stereotactic radiosurgery
head and neck tumors
squamous cell carcinoma of head and neck
Lead sponsor: Mercy Research
Sponsor class: OTHER
First posted: 2011-04-29
Enrollment: 19
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: This study will evaluate the local control rates as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of benign and malignant head and neck tumors.

Detailed description: This single site, non-randomized, prospective, phase IV study includes 3 patient groups to be treated with SBRT:

* Benign tumors, such as paraganglioma, chordoma, chondrosarcoma, as the sole treatment or to gross residual disease after maximal safe resection
* Malignant tumors, such as nasopharynx cancer and squamous cell carcinoma, after initial external beam radiation (Residual Disease Group)
* Unresectable malignant tumors, such as nasopharynx cancer and squamous cell carcinoma, adenocarcinomas, and sarcomas which are recurrent after prior radiation (Primary RT Group) Data collected will include baseline patient demographics, pathology data, radiation therapy procedure, tumor recurrence data, and toxicities.

Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.

Eligibility criteria: Inclusion Criteria:

* Patient age \> 18 years
* Zubrod performance status of 0-3
* Benign head and neck tumors such as paragangliomas, chordoma, chondrosarcoma
* Malignant head and neck cancers such as invasive squamous cell carcinoma, adenocarcinoma, nasopharyngeal carcinoma, salivary gland cancers, and sarcoma
* Signed study-specific consent form

Exclusion Criteria:

* Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females
* Patients with psychiatric or addictive disorder that would preclude obtaining informed consent

Primary outcomes:
measure: Local Control Rate
timeFrame: 5 years
measure: Local Recurrence
timeFrame: 5 years
measure: Complication Rate
timeFrame: 5 years
Secondary outcomes:
measure: Overall Survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: St. John's Mercy Medical Center
state: Missouri
Study officials:
References:
Clinical trial NCT04635956: Camrelizumab Combined With Chemotherapy for Recurrent or Advanced Cervical Neuroendocrine Carcinomas
Official title: Anti-PD-1 Antibody Camrelizumab Combined With Cisplatin/Paclitaxel/Bevacizumab for Recurrent or Advanced Cervical Neuroendocrine Carcinomas: A Single Arm, Phase II Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chemotherapy
Anti-pd-1 Antibody
Cervical Neuroendocrine Carcinoma
Adverse Drug Event
Recurrent Cervical Carcinoma
Advanced Cervical Carcinoma
Objective Response Rate
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intervention of platinum/etoposide/bevacizumab/camrelizumab
Primary purpose: TREATMENT

Brief summary: Recurrent or advanced cervical neuroendocrine carcinoma (NEC) is refractory to multimodal treatment, even to extensive therapy. Chemotherapy, consisting of platinum and etoposide, remains the main therapy for recurrent or advanced cervical NEC. In addition, bevacizumab has shown progression-free benefits in recurrent or advanced cervical cancer. Case report suggested anti-PD-1 antibody may have antitumor activities in NEC. Based on these evidences, a phase 2, single arm trial is conducted to explore the objective response rate (ORR) of platinum/etoposide/bevacizumab/anti-PD-1 antibody (camrelizumab) for the treatment of recurrent or advanced cervical NEC. This trial is to enroll 20 patients, who would accept 6 courses of platinum/etoposide/bevacizumab/camrelizumab. If the patient achieved complete or partial remission, a total period of 12 months bevacizumab/camrelizumab will be given as maintain therapy. The primary endpoint is ORR. The second endpoints are severe adverse events according to criteria of Common Terminology Criteria for Adverse Events (CTCAE) and iRECIST Guideline, and critical changes of laboratory testing.


Eligibility criteria: Inclusion Criteria:

* Confirmed recurrent or advanced cervical neuroendocrine carcinoma
* Aged 18 years or older
* No immunosuppressive disease
* Signed an approved informed consents
* Performance status of ECOG 0-1

Exclusion Criteria:

* Not meeting all of the inclusion criteria

Primary outcomes:
measure: objective response rate
timeFrame: 1 years
Secondary outcomes:
measure: severe adverse events
timeFrame: 1 year
measure: a composite changes of important laboratory testing
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03922256: Prospective, Observational Clinical Investigation of the Exos Reformable Brace
Official title: Prospective, Observational Clinical Investigation of the Exos® Reformable Brace for Conservatively Managed Distal Radius Fractures: An Evaluation of Time to Union, Satisfaction, and Convenience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distal Radius Fracture
Lead sponsor: Foundation for Orthopaedic Research and Education
Sponsor class: OTHER
Collaborators: name: Encore DJO Global
First posted: 2019-04-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: This single-cohort, consecutive series clinical study.
Primary purpose: TREATMENT

Brief summary: This is a prospective observational single cohort trial quantifying time to radiographic union (primary endpoint) and convenience, satisfaction, pain and resource requirements (secondary) for patients with non-operatively treated distal radius fractures managed with a thermoformable Exos short-arm brace.

Detailed description: The trial will be a prospective trial of a convenience sample of skeletally mature patients with radiographically-confirmed distal radius fractures that can be managed without ORIF. The study population will be defined as all adult patients (\>18 years) with stable, non-displaced distal radius fractures. All patients will be independent in activities of daily living. Patients will be screened as candidates for enrollment into the study and if the patient satisfies the inclusion/exclusion criteria, a clinical research coordinator or the study PI/coPI will explain all essential elements of the clinical trial. If the patient agrees to participate, the study coordinator or PI/coPI will obtain informed consent. The patient will still be followed clinically per the PI/coPI's standard of care.

Eligibility criteria: Inclusion

* Age \> 18 years;
* Unilateral fracture of distal radius without misalignment (dorsal angulation \<10°, axial radial shortening \<5mm), \<2mm intraarticular stepoff;
* Independent in activities of daily living;
* Capable and willing of signing informed consent.

Exclusion

* Children under the age of 18;
* Fracture of the contralateral arm;
* Other fractures of the ipsilateral arm;
* Open fractures;
* Fractures that require reduction.

Primary outcomes:
measure: bony union
timeFrame: 2-12 weeks
Secondary outcomes:
measure: Patient Reported Outcomes
timeFrame: 2-12 weeks
measure: Patient Reported Disability Scale- Quick-DASH
timeFrame: 2-12 weeks
measure: Patient rated Wrist Evaluation
timeFrame: 2-12 weeks
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Florida Orthopaedic Institute
state: Florida
Study officials:
affiliation: Florida Orthopaedic Institute
name: Jason Nydick, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02756156: Low Dose Interscalene and Infraclavicular Block for Humerus Surgery
Official title: Low Dose Interscalene and Infraclavicular Block for Humerus Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Humerus Fracture
Keywords: interscalene
infraclavicular
humerus surgery
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2016-04-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing humerus surgery.

Brief summary: Combining interscalene block with infraclavicular block for humerus surgery provides a unique surgical anaesthesia and postoperative analgesia.

Detailed description: Interscalene block provides effective surgical anaesthesia for shoulder and proximal arm surgery. However, sometimes it can be inadequate for distal arm surgery. Combining infraclavicular block with interscalene block may provide a successful surgical anaesthesia for humerus surgery.

Eligibility criteria: Inclusion Criteria:

* Patients accepting peripheral nerve block technique for humerus surgery
* Unilateral orthopedic humerus surgery
* 18 years of age or older

Exclusion Criteria:

* Patients refused peripheral nerve block
* Non-cooperate patients
* Neuropathy of any etiology in the affected extremity

Primary outcomes:
measure: Success rate of block
timeFrame: 10 min.- 20 min.
Secondary outcomes:
measure: Technique duration
timeFrame: 5 min.
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 24 hours
measure: Complication rate
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02198456: Imaging Control Study, 3D Echo, MR and RHC.
Official title: Prostanoid Therapy in Severe Pulmonary Arterial Hypertension - Imaging Control Study, 3D Echo, MR and RHC.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Arterial Hypertension WHO Group I
Keywords: pulmonary arterial hypertension
Lead sponsor: Elisabethinen Hospital
Sponsor class: OTHER
First posted: 2014-07-23
Enrollment: 12
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: pulmonary arterial hypertension WHO group I

Brief summary: The aim of the study is to intensify the follow up of patients with pulmonary arterial hypertension via modern imaging guided methods in due consideration of the possibilities of three-dimensional echocardiography in order to optimize their specific therapy.

The hypothesis is that the increased use of modern imaging guided tools is essential for the follow up.

Detailed description: It is not possible to perform a magnetic resonance imaging in all patients and as a result echocardiography is not only done at screening but also during the follow up. The imaging technologies made a great progress in the last few years and enable a better assessment of the haemodynamic parameters in our days.

Eligibility criteria: Inclusion Criteria:

* age \>17
* pulmonary arterial hypertension WHO group I who are going to start a therapy with prostanoid
* written informed consent
* Prostanoid naive
* no change of the pulmonary arterial hypertension therapy within 3 weeks of inclusion into the study

Exclusion Criteria:

* pregnancy and lactation period
* Women of childbearing potential who do not use an effective and secure method for birth control
* severe chronic kidney insufficiency (glomerular filtration rate \<30), which will remain for more than 3 months
* liver insufficiency Child C
* life expectancy shorter than the course of the study (for example because of a malignant disease)

Primary outcomes:
measure: right ventricular ejection fracture
timeFrame: month 12 (+/- 7 days)
Secondary outcomes:
measure: right atrial pressure
timeFrame: 12 month (+/- 7 days)
measure: cardiac index (CI)/cardiac output (CO)
timeFrame: 12 months (+/- 7 Days)
measure: pulmonary vascular resistance
timeFrame: 12 months (+/- 7 days)
measure: mean pulmonary capillary wedge pressure
timeFrame: 12 month (+/-7 days)
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Krankenhaus der Elisabethinen Linz GmbH
state: Upper Austria
Study officials:
affiliation: Krankenhaus der Elisabethinen Linz GmbH
name: Regina Steringer-Mascherbauer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01258556: The Impact of Probiotic Bacteria on the Efficacy of Anti-retroviral Therapy and Recurrence of Bacterial Vaginosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Bacterial Vaginosis
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2010-12-13
Enrollment: 150
Sex: FEMALE
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: Purpose of the proposed research is to determine the impact of probiotic yogurt supplemented with Lactobacillus rhamnosus (Fiti) compared to regular yogurt on the well-being of women living with HIV.


Eligibility criteria: Inclusion criteria:

* Confirmed HIV infection;
* Being treated with anti-retroviral medication for \> 6 months.

Exclusion criteria:

* Pregnancy;
* Hypersensitive to fermented milk;
* Intolerant for lactose;
* Complaints of bacterial vaginosis requiring treatment

Primary outcomes:
measure: Vaginal microbiota of HIV patients.
timeFrame: 30 days
Secondary outcomes:
measure: Bacterial vaginosis.
timeFrame: 30 days
Other outcomes:
Locations:
city: Mwanza
country: Tanzania
facility: Sekou-Toure Regional Hospital
Study officials:
affiliation: Sekou-Toure Regional Hospital
name: Nicodemus Butamanya, MD
role: PRINCIPAL_INVESTIGATOR
References: