louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00283595: Effect of Growth Hormone on Bone Metabolism in Anorexia Nervosa
Official title: Effect of Supraphysiological rhGH on Bone Metabolism in Patients With Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anorexia Nervosa
Osteopenia
Osteoporosis
Eating Disorders
Keywords: Anorexia Nervosa
Eating disorder
Bone
Growth hormone
Osteopenia
Osteoporosis
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2006-01-30
Enrollment: 21
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Decreased bone strength is a serious medical problem present in many women with Anorexia Nervosa, or disordered eating. Women with weaker bones are more likely to suffer broken bones than women with normal bone strength.

We are investigating whether a hormone that is naturally produced by the human body, called growth hormone, can help strengthen the bones of women with this type of disordered eating.

Detailed description: * Twelve week study
* Eight visits, six of which can be conducted at your home physician's office
* Two bone density scans
* Hormonal and nutritional evaluations

Eligibility criteria: Inclusion Criteria:

* women between 14 to 45 years with anorexia nervosa

Exclusion Criteria:

* pregnancy
* previous history of malignancy.
* oral contraceptive pills or other hormones within last 8 - 12 weeks
* medications known to affect bone within last 12 weeks
* fracture within last 6 months

Primary outcomes:
measure: Bone Metabolism
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: IGF-1 Level
timeFrame: Baseline, 12 Weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusettes General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Anne Klibanski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04652895: Sleep Quality, Heart Rate Variability and Anxiety Following Brain Injury
Official title: Sleep Quality, Heart Rate Variability and Anxiety Following Brain Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Anxiety
Keywords: heart rate variability
sleep
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 14
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: moderate to severe traumatic brain injury inpatients in acute rehabilitation hospital

Brief summary: The investigators predict that decreased heart rate variability and poor sleep quality will be significantly correlated with higher self-reported anxiety following brain injury.

Detailed description: Acute rehabilitation inpatients with moderate-to-severe brain injury will wear biosensors that track total sleep time and heart-rate variability for up to 1 week. During this time the participants will also complete surveys regarding symptoms of anxiety. The investigators hypothesize that decreased heart rate variability and poor sleep quality will be significantly correlated with higher self-reported anxiety following brain injury.

Eligibility criteria: Inclusion Criteria:

* traumatic brain injury
* injury within past 6 months
* medically stable
* able to communicate

Exclusion Criteria:

* on medication: beta-blocker
* adverse skin reaction to biosensor adhesive
* non-English speaking
* pregnant women
* prisoners

Primary outcomes:
measure: anxiety
timeFrame: 48 hours
Secondary outcomes:
measure: heart rate variability
timeFrame: 48 hours
measure: sleep
timeFrame: 48 hours
measure: post-traumatic stress disorder (PTSD)
timeFrame: 48 hours
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan Ability Lab
state: Illinois
Study officials:
References:
Clinical trial NCT01463995: Prognosis in Neurological Intensive Care Unit Patients (proNICU Cohort)
Official title: Prognosis in Neurological Intensive Care Unit Patients (proNICU Cohort)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurological Diseases
Keywords: severe neurological diseases
neurological intensive care unit
prediction
long-term outcome
biomarkers
prediction of long-term outcome
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: NeuroCure Clinical Research Center, Charite, Berlin
First posted: 2011-11-02
Enrollment: 46
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 with severe neurological diseases treated on a neurological intensive care unit

Brief summary: This study examines the prognostic properties of immune parameters, clinical scores, electrophysiological tests (eeg, ssep, emg, eng) and functional imaging for the prediction of functional outcome one year after treatment on a neurological intensive care unit.


Eligibility criteria: Inclusion Criteria:

* severe neurological disease making treatment on a neurological intensive care unit necessary
* age ≥ 18
* consent by the patient or the legal representative

Exclusion Criteria:

* participation in an interventional trial

Primary outcomes:
measure: Predictive properties of immune parameters (IL6, IL10, mHLA-DR) for functional outcome one year after symptom onset
timeFrame: one year after symptom onset
Secondary outcomes:
measure: To evaluate of the predictive properties of clinical scores for functional outcome one year after symptom onset
timeFrame: one year after symptom onset
measure: To evaluate of the predictive properties of electrophysiological measurements one year after symptom onset
timeFrame: one year after symptom onset
measure: To evaluate of the predictive properties of conventional (DTI) and functional imaging (resting state) one year after symptom onset
timeFrame: one year after symptom onset
measure: Transcriptome analyses
timeFrame: one year after symptom onset
measure: Predictive properties of immune parameters in the cerebrovascular fluid for functional outcome one year after symptom onset
timeFrame: one year after symptom onset
measure: Quality of life and occurence of depression in patients one year after symptom onset
timeFrame: one year after symptom onset
measure: Quality of life and the occurence of depression and burnout syndrome in relatives
timeFrame: one year after symptom onset
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite University (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)
Study officials:
affiliation: Charite University Berlin (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)
name: Andreas Meisel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04052295: Clinical and Sonographic Diaphragm Evaluation Post-plication
Official title: Clinical and Sonographic Evaluation of the Diaphragm After Plication in Adults With Unilateral Eventration: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diaphragmatic Plication
Unilateral Diaphragmatic Paralysis
Diaphragm Ultrasonography
Keywords: Diaphragmatic eventration
Diaphragm
Dyspnea
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2019-08-09
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: symptomatic unilateral diaphragmatic paralysis patients who underwent surgical diaphragmatic plication presented during a period from January 2015 to January 2020.

Brief summary: Objectives: We aim to clarify the role of diaphragm ultrasonography (DUS) in evaluating the outcome of surgical diaphragmatic plication (SDP) in adults with symptomatic unilateral diaphragmatic paralysis (UDP).


Eligibility criteria: Inclusion Criteria:

- Symptomatic unilateral diaphragmatic paralysis.

Exclusion Criteria:

* Children
* Morbid obesity
* Certain neuromuscular disorders
* Previous thoracic surgical intervention on the affected
* Recurrent eventration

Primary outcomes:
measure: Radiological examination for diagnosis of diaphragmatic paralysis and the changes post surgical diaphragmatic plication for the management of unilateral diaphragmatic paralysis.
timeFrame: Chest sonography was done before operation; and follow up at one week and 6 months, through study completion, an average of 1 year .
measure: Respiratory functions test for evaluation of the changes post surgical diaphragmatic plication for the management of unilateral diaphragmatic paralysis.
timeFrame: Spirometry was done before operation; and follow up at one week and 6 months postoperatively, through study completion, an average of 1 year .
measure: Radiological examination for diagnosis of diaphragmatic paralysis and the changes post surgical diaphragmatic plication for the management of unilateral diaphragmatic paralysis.
timeFrame: Chest X-ray was done before operation; and follow up at one week and 6 months postoperatively, through study completion, an average of 1 year.
Secondary outcomes:
measure: Evaluation of the efficacy of surgical diaphragmatic plication and its effect on improving patients' symptoms.
timeFrame: the data were collected preoperatively as a baseline; one week and 6 months postoperatively.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01261195: Establishment of Vascular Permeability Model for Research Purpose by Human Umbilical Vascular Endothelial Cells
Official title: Establishment of Vascular Permeability Model for Research Purpose by Human
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy People
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2010-12-16
Enrollment: 60
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy pregnant women

Brief summary: HUVEC primary cells for researches about the relation between plasma leakage and infections.

Detailed description: This study is going to collect HUVEC primary cells to set up an in vitro model for researches about the relation between plasma leakage and infections.

Eligibility criteria: Inclusion Criteria:

* healthy pregnant women
* would like to join this study

Exclusion Criteria:

* venereal disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
affiliation: KMUH Tropical Medicine Center
name: Jih-Jin Tsai, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00699595: Hormonal Effects on Pain Perception
Official title: Hormonal Effects on Pain Perception
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Progesterone Levels
Pregnancy Associated Analgesia
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2008-06-18
Enrollment: 50
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy term pregnant women

Brief summary: To investigate if labor pain is affected by mother's hormone levels.

The hormonal effects of pregnancy are well documented. Although differences in pain sensitivity between women and men are partly attributable to social conditioning and to psychosocial factors, many laboratory studies of humans have described sex differences in sensitivity to noxious stimuli, suggesting that biological mechanisms underlie such differences. Some animal studies have suggested that sensitivity to pain decreases during pregnancy because of the progressive activation of endogenous pain inhibitory systems. This effect may be mediated by pregnancy-associated hormones, in particular progesterone.


Eligibility criteria: Inclusion Criteria:

* healthy pregnant women at term (\>37GA)

Exclusion Criteria:

* chronic pain
* regular analgesic medication
* severe cardiopulmonary problems
* very difficult intravenous access
* advanced labor
* precipitous delivery

Primary outcomes:
measure: Change in heat pain threshold and tolerance
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Michael Froelich, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00547495: Study the Safety and Effectiveness of Tadalafil in Men With Problems Getting or Maintaining an Erection When Taken Prior to Desiring an Erection
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Tadalafil Administered "On Demand" to Patients With Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Impotence
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: ICOS Corporation
First posted: 2007-10-22
Enrollment: 343
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to determine how safe and effective tadalafil is for Japanese men taking it when they need to get and keep an erection.


Eligibility criteria: Inclusion Criteria:

* 3 months history of erectile dysfunction (ED)
* Anticipate a monogamous relationship with a female sexual partner
* Be able to make minimum required sexual intercourse attempts
* Abstain from using any other ED treatment

Exclusion Criteria:

* Other primary sexual disorders
* History of radical prostatectomy or other pelvic surgery that affected being able to have an erection
* History of penile implant or clinically significant penile deformity.
* Nitrate use
* Certain heart problems

Primary outcomes:
measure: Effectiveness measured by IIEF score of questions 1-5 and 15 plus the percentages of positive responses to questions 2 and 3 in SEP diary
timeFrame: 12 weeks
Secondary outcomes:
measure: Change from baseline to endpoint of various questions from the IIEF and SEP diary
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Sapporo
country: Japan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon- Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Hokkaido
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04616495: Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases
Official title: Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Metastatic Liver Cancer
Liver Metastases
Lead sponsor: Hospital Universitario La Fe
Sponsor class: OTHER
First posted: 2020-11-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort of patients detected in oncological units where they have been treated for colorectal cancer (stage IV with liver only unresectable metastases)

Brief summary: Multicentric prospective and observational study to assess the 5-year overall survival in a cohort of patients with unresectable liver-only colorectal metastases, well controlled by chemotherapy prior to liver transplantation.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 and ≤ years
* Good performance status, ECOG 0 or 1
* Resected adenocarcinoma in colon or rectum (R0 resection)
* Unresectable liver metastases
* No extrahepatic disease
* Normal blood tests
* Response to ≤ 2 lines of chemotherapy (RECIST criteria)
* ≥ 1 year period since diagnosis of colorectal cancer to enrolment in liver transplant waiting list
* Signed informed consent

Exclusion Criteria:

* Body mass index ≥ 30
* Positive HIV or HCV
* Pregnancy at the time of inclusion
* BRAF mutated status
* Deterioration of general condition (10% weight loss in the prior 6 months)
* Other malignancy with disease free survival \< 5 years
* Concomitant or prior extrahepatic metastases (histologically or radiologically proved), even if surgically resected.
* Palliative resection of primary colorectal adenocarcinoma
* Liver metastases size \> 5 cm (in the last imaging technique)
* CEA \> 80 ng/ml (at time of enrolment in waiting list)
* No neoadjuvant chemotherapy treatment
* General contraindication to liver transplantation

Primary outcomes:
measure: five year overall survival (OS)
timeFrame: 5 years
Secondary outcomes:
measure: one year disease free survival (DFS)
timeFrame: 1 year
measure: three year disease free survival (DFS)
timeFrame: 3 years
measure: five year disease free survival (DFS)
timeFrame: 5 years
measure: Quality of life using EORTC questionnaires: QLQ-C30
timeFrame: 1 year
measure: Quality of life using EORTC questionnaires: QLQ-C30
timeFrame: 3 years
measure: Quality of life using EORTC questionnaires: QLQ-C30
timeFrame: 5 years
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Eva M Montalvá
Study officials:
References:
Clinical trial NCT05460195: Sintilimab Combined With Anlotinib for Perioperative Non-small Cell Lung Cancer Based on MRD Evaluation
Official title: Sintilimab Combined With Anlotinib for Perioperative Non-small Cell Lung Cancer Based on MRD Evaluation: a Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Minimal Residual Disease
Immunotherapy
Anti-angiogenesis
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2022-07-15
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the efficacy of sintilimab combined with anlotinib for perioperative non-small cell lung cancer. To explore the clearance effect of sintilimab combined with anlotinib for postoperative adjuvant therapy based on evaluating minimal residual disease.

Detailed description: Patients with resectable non-small cell lung cancer (NSCLC) have a high postoperative recurrence rate. Perioperative treatment, which can improve the resection rate and clear the minimal residual disease, is the main mean of preventing recurrence, including preoperative neoadjuvant and postoperative adjuvant therapies. In recent years, immunotherapy can significantly improve the pathological remission rate and prolong the survival as a perioperative treatment. In addition to single-agent or combined chemotherapy, the exploration of immunotherapy with other therapeutic strategies is still lacking.

In 2018, we originally designed sintilimab combined with anlotinib in the first-line treatment of advanced NSCLC.

This clinical study plans to: ① apply the "de-chemotherapy" model to the perioperative phase of early NSCLC, ② explore sintilimab combined with anlotinib in preoperative neoadjuvant and postoperative adjuvant therapies, ③ explore clearance effect of sintilimab combined with anlotinib for postoperative adjuvant therapy based on evaluating minimal residual disease (MRD), in order to improve the efficacy of perioperative NSCLC and prolong survival.

Eligibility criteria: Inclusion Criteria:

* Histologically or cyologically confirmed stage II-IIIa NSCLC patients;
* NSCLC patients with negative driver gene: EGFR wild-type, no ALK fusion mutation, no ROS1 fusion mutation;
* ECOG PS: 0\~1;
* Pulmonary function index meets the surgical criteria;
* No previous systemic anti-tumor treatment.

Exclusion Criteria:

* Patients with central cavitary squamous cell carcinoma or investigator-assessed bleeding symptoms or bleeding tendency were excluded.

Primary outcomes:
measure: Major pathologic response (MPR)
timeFrame: 2 months
Secondary outcomes:
measure: Complete pathologic response (CPR)
timeFrame: 2 months
measure: Event free survival (EFS)
timeFrame: 16 months
measure: Overall survival (OS)
timeFrame: 32 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
Study officials:
affiliation: Shanghai Chest Hospital
name: Tianqing Chu Chu
role: PRINCIPAL_INVESTIGATOR
References: