louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02612974: Clinical Evaluation of Leech Therapy in the Treatment of Knee Osteoarthritis
Official title: Randomized Controlled Clinical Evaluation of Leech Therapy in the Treatment of Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Knee Osteoarthritis
Keywords: Qurse mafasil
leech therapy
Hirudinaria granulosa
Lead sponsor: Hamdard University
Sponsor class: OTHER
First posted: 2015-11-24
Enrollment: 60
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 has been designed to conduct as Randomized comparative clinical study.

Detailed description: Two groups, group B received Qurse Mafasil tablet orally two tablets two times daily for 8 weeks while group A received Leech therapy once weekly for 8 weeks along with Qurse mafasil.

Eligibility criteria: Inclusion Criteria:

* knee osteoarthritis

Exclusion Criteria:

* pregnancy,
* lactation,
* anaemia

Primary outcomes:
measure: KOOS Score
timeFrame: end of 6 weeks
measure: VAS
timeFrame: end of 6 weeks
measure: Active Range of Motion
timeFrame: end of 6 weeks
measure: Knee circumference
timeFrame: end of 6 weeks
measure: 15 m walking time test
timeFrame: end of 6 weeks
Secondary outcomes:
measure: KOOS subscores
timeFrame: end of 6 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00246974: Phase II Gemcitabine + Cisplatin +/- Iressa Bladder CCT
Official title: An Open Randomised Phase II Study Of Gemcitabine Plus Cisplatin +/- Concomitant or Sequential ZD1839 in Patients With Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bladder Cancer
Keywords: bladder cancer
Transitionel cell cancer of the urothelium
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-11-01
Enrollment: 125
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: The primary objective of the study is to assess the activity of ZD1839 250 mg once daily in addition to the standard chemotherapy in patients with advanced or metastatic transitional cell carcinoma of the urothelium by estimating the time to progression.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically-confirmed transitional cell carcinoma of the urothelium
* Locally advanced or metastatic disease
* At least one measurable lesion as defined by RECIST
* Chemotherapy-naiv

Exclusion Criteria:

* Previous chemotherapy or other systemic antitumour therapy
* Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma, cervical cancer in situ or locally limited prostate cancer

Primary outcomes:
measure: Time to progression (TTP)
Secondary outcomes:
measure: 1. Response rate
measure: 2. Overall survival time
measure: 3. Time to treatment failure
measure: 4. Disease control rate
measure: 5. Duration of response
measure: 6. Safety and tolerability
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Research Site
city: Augsburg
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Freiburg
country: Germany
facility: Research Site
city: Halle/ Saale
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Kassel
country: Germany
facility: Research Site
city: Mainz
country: Germany
facility: Research Site
city: Mannheim
country: Germany
facility: Research Site
city: Münster
country: Germany
facility: Research Site
city: Tübingen
country: Germany
facility: Research Site
city: Ulm
country: Germany
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Iressa Medical Science Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06554574: A Phase 1 Single and Multiple Ascending Dose Study of LTG-305 Administered Orally in Healthy Participants
Official title: A Sequential, Randomized, Double-Blind, Placebo-Controlled, Phase 1, Single and Multiple Ascending Dose Study of LTG-305 Administered Orally to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Male and Female Participants 18 to 55 Years of Age
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Latigo Biotherapeutics
Sponsor class: INDUSTRY
First posted: 2024-08-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a sequential, randomized, double-blind, placebo-controlled Phase 1 single (SAD) and multiple (MAD) ascending dose study to evaluate the safety, tolerability, and pharmacokinetics (PK) and Pharmacodynamics of orally administered LTG-305 in healthy male and female participants. The study will also include a randomized, double-blind, placebo-controlled within-participant crossover evaluation of pain tolerance during a cold pressor test in healthy male participants 18-55 years of age.


Eligibility criteria: Inclusion Criteria:

* Male and female participants aged 18 to 55 years, inclusive, at the time of signing the informed consent for SAD and MAD only. For Cold Pressor male participants 18 to 55 years.
* Overtly healthy with no clinically relevant abnormalities based on the medical history, physical examinations, clinical laboratory evaluations, and 12-lead ECG that, in the opinion of the investigator, would affect participant safety.
* Body mass index (BMI) within the range of 18-32 kg/m2 (inclusive).

Exclusion Criteria:

* Clinically significant cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, gastrointestinal, immunological, dermatological, neurological, or psychiatric disease which could interfere with, or the treatment for which might interfere with, the conduct of the study or which would, in the opinion of the investigator, unacceptably increase the participant's risk by participating in the study
* Past or current history or evidence of alcohol abuse and/or dependence on recreational drug use
* Donation of over 500 mL blood ≤ 3 months prior to start of participation
* Participant is under legal custodianship.

Primary outcomes:
measure: To evaluate the safety and tolerability of single and multiple ascending oral doses of LTG-305 in healthy participants.
timeFrame: Up to 7 or 10 days of dosing
measure: To evaluate the pharmacodynamics of LTG-305 in healthy male participants.
timeFrame: 0-24 hrs, 1-12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Christchurch
country: New Zealand
facility: Clinical Research Unit
Study officials:
References:
Clinical trial NCT01606774: A Modernized Approach to Prenatal Care in Low Risk Women
Official title: A Modernized Approach to Prenatal Care in Low Risk Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-eclampsia
Intrauterine Growth Retardation
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-05-28
Enrollment: 4
Sex: FEMALE
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators plan to identify 80 pregnant women at low risk for obstetrical complications and replace 4-5 routine third trimester visits with a structured program of home weight, blood pressure and urine protein monitoring along with regular structured phone interviews and a 28 week ultrasound. The investigators hypothesis is that this protocol is both safe and acceptable.


Eligibility criteria: Inclusion Criteria:

* Age \< 35
* Doesn't live alone
* Current phone number
* Previous pregnancy
* No prior second trimester miscarriage/fetal loss after 13 weeks
* Previous delivery
* If yes, all had uncomplicated antepartum course
* All Deliveries \> 37 weeks
* All birth weight \> 2700 grams
* Maternal BMI between 18.5 and 30
* No chronic medical problems
* No current substance abuse
* Spontaneous conception
* No family history of pre-eclampsia
* Agrees to first trimester aneuploidy screening

Exclusion Criteria:

* Clinically significant abnormalities on routine physical exam or routine laboratory results
* Multiple pregnancy
* Fetal abnormalities detected on either the 11-14 week or the 18 week ultrasound including a nuchal translucency \> 3 mm but not including second trimester markers for aneuploidy or a low lying placenta
* A risk of fetal aneuploidy on first trimester screening \> 1:300 PAPP-A \< 5 %ile or HCG \< 1 %ile (abnormalities of these serum analytes routinely obtained as part of aneuploidy screening are associated with an increased risk of adverse outcome)
* Elevated blood pressure (\> 140/90),
* Cervical length \< 3 cm at the 18 week ultrasound (which is associated with an increased risk for preterm delivery).

Primary outcomes:
measure: Unanticipated pregnancy complications
timeFrame: Gestational age 18-36 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital and Harvard Medical School
name: Allan S Nadel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nicolaides KH. A model for a new pyramid of prenatal care based on the 11 to 13 weeks' assessment. Prenat Diagn. 2011 Jan;31(1):3-6. doi: 10.1002/pd.2685. No abstract available.
Clinical trial NCT01493674: Folic Acid Supplementation in Eating Disorder
Official title: Folic Acid Supplementation for Improving Homocysteine Levels, Cognitive and Depressive Status in Eating Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Eating Disorders
Keywords: folate
homocysteine
cognitive function
eating disorders
depression.
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
Sponsor class: OTHER
First posted: 2011-12-16
Enrollment: 24
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: The aim of this study was to determine the effect of folic acid supplementation on homocysteine levels in a group of patients with eating disorders (ED) with low folate intake. The secondary aims were to evaluate the evolution on cognitive and depressive status after the intervention.

Detailed description: Some authors have identified the presence of increased levels of homocysteine in patients with eating disorders and attempts have been made to find some association between this and the high rates of depression and cognitive function impairment recorded in these patients. It is still not known what causes this increase in homocysteine levels, whether the levels return to normal after the nutritional state is normalised and what strategies must be employed to carry out this normalisation.

Eligibility criteria: Inclusion Criteria:

* Males and females diagnosed with eating disorders (DSM-IV criteria of the American Psychiatric Association, 2000)
* Age \> 18 years
* Low folate intake based on the recommended daily intake in terms of age (Institute of Medicine, 1998)

Exclusion Criteria:

* Patients with contraindications for folic acid supplementation due to hypersensitivity to folic acid or anaemia due to lack of B12
* Patients who routinely used drugs that interfere with folic acid absorption (analgesics, anticonvulsants, hydantoin, carbamazepine, antacids, antibiotics, cholestyramine, methotrexate, pyrimethamine, triamterene, trimethoprim and sulphonamides)
* Patients with vitamin and mineral supplements intake.

Primary outcomes:
measure: Blood variables monitored
timeFrame: after 6 month of intervention
Secondary outcomes:
measure: Evolution on cognitive and depressive status
timeFrame: after 6 month of intervention
measure: Anthropometric parameters
timeFrame: after 6 month of intervention
measure: Dietary parameters
timeFrame: after 6 months of intervention
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: Nutrition Department. La Paz University Hospital. La Paz Health Research Institute.
name: Carmen Gómez Candela, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06073574: CARDIO-TTRansform Magnetic Resonance Imaging (MRI) Sub-study
Official title: The CARDIO-TTRansform Magnetic Resonance Imaging (MRI) Sub-study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)
Keywords: TTR
Amyloidosis
Cardiomyopathy
Lead sponsor: Ionis Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
First posted: 2023-10-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants who were randomized in Study ION-682884-CS2 (NCT04136171) and who signed informed consent for the MRI sub-study will participate in this sub-study.

Brief summary: The main purpose of this study is to measure the amyloid burden, defined as extracellular volume (ECV) assessed by Magnetic Resonance Imaging (MRI) over time in a subset of up to 150 participants enrolled in ION-682884-CS2 (NCT04136171).

Detailed description: This pilot study will determine the efficacy of ION-682284 in reducing the amyloid deposit on the heart tissue compared to placebo.

Eligibility criteria: Inclusion Criteria:

To participate in the ION-682884-CS2MRI sub-study, participants must meet all inclusion criteria of the study protocol ION-682884-CS2 (NCT04136171).

Exclusion Criteria

1. Contraindication or sensitivity to MRI contrast agents
2. Orthopnea of sufficient severity to preclude supine scanning at screening.
3. Weight or body girth exceeds the limits of the cardiac MRI machine specifications.
4. Contraindication to cardiac MRI scanning, as assessed by local MRI safety questionnaire/checklist.

Primary outcomes:
measure: Change in the Percent of ECV in Participants Receiving ION-682884 vs. Placebo According to ION-682884-CS2 Treatment Groups
timeFrame: From Baseline up to Week 140
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Florence
country: Italy
facility: Azienda Ospedaliero - Universitaria Careggi
city: Padova
country: Italy
facility: Azienda Ospedale Università di Padova
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Bellshill
country: United Kingdom
facility: Synexus - Scotland Clinical Research Centre
city: Birmingham
country: United Kingdom
facility: Synexus Midlands Clinical Research Centre
city: Cardiff
country: United Kingdom
facility: Synexus - Wales
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust
city: London
country: United Kingdom
facility: Richmond Pharmacology
city: Manchester
country: United Kingdom
facility: Synexus - Manchester Clinical Research Centre
Study officials:
References:
Clinical trial NCT06203574: Clinical Study of TROP-2 PET/CT for Noninvasive Diagnosis of Solid Tumors
Official title: Clinical Study of TROP-2 PET/CT for Noninvasive Diagnosis of Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Positron-Emission Tomography
Neoplasms
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study will investigate the safety and preliminary diagnostic efficacy of \[68Ga\]Ga-NOTA-T4 or \[18F\]AlF-RESCA-T4 in pancreatic cancer, breast cancer, head and neck cancer, lung cancers and other types of solid tumors. Then, this study will provide a new method for the noninvasive target-specific diagnosis of pancreatic cancer, breast cancer, head and neck cancer, lung cancers and other types of solid tumors. PET imaging of TROP-2 will be integrated to TROP-2-targeted therapies in some of the included patients. Therefore, PET imaging with \[68Ga\]Ga-NOTA-T4 or \[18F\]AlF-RESCA-T4 will help select patients for targeted therapy and monitor treatment responses after the treatment.


Eligibility criteria: Inclusion Criteria:

1. Be between 18 and 65 years of age and of either sex.
2. Patients with colorectal cancer confirmed by puncture or surgical pathology.
3. Written informed consent signed by the subject or legal guardian or caregiver.
4. Willingness and ability to cooperate with all programs of this study.

Exclusion Criteria:

1. Severe hepatic or renal insufficiency;
2. Targeted therapy before radiotherapy or PET/CT scan；
3. Renal function: serum creatinine less than or equal to the upper limit of the normal range;Liver function: bilirubin, AST(SGOT)/ALT(SGPT) less than or equal to the upper limit of the normal range；
4. History of serious surgery in the last month. Those who have participated in other clinical trials during the same period.

Primary outcomes:
measure: evaluate the safety and feasibility of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 PET/CT imaging in patients with solid tumors
timeFrame: 1 hour after injection of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4
measure: evaluate the sensitivity and specificity of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 PET/CT for visualizing TROP-2 expression
timeFrame: 1 hour after injection of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4
measure: evaluate the value of TROP-2 expression determined by [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 PET/CT
timeFrame: 1 hour after injection of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
Study officials:
affiliation: Huashan Hospital
name: Fang Xie, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01032174: Non-Interventional Open Label Prospective Comparative Observational Study Of Evaluation Of Compliance In The Empiric Treatment With Azithromycin SR Versus Amoxiclav 1000 Mg In Adult Patients With Of Acute Bacterial Maxillary Sinusitis
Official title: Non-Interventional Open Label Prospective Comparative Observational Study Of Evaluation Of Compliance In The Empiric Treatment With Azithromycin SR Versus Amoxiclav 1000 Mg In Adult Patients With Of Acute Bacterial Maxillary Sinusitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Maxillary Sinusitis
Keywords: Azithromycin SR Amoxiclav 1000 mg Maxillary Sinusitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-12-15
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Acute Maxillary Sinusitis

Brief summary: The purpose of this study is to compare compliance between patients with Acute Bacterial Sinusitis (ABS) treated with Azithromycin SR 2.0 g single dose orally and those treated with Amoxiclav - 1000 mg twice daily 10 days for the empiric treatment of ABS in outpatient clinic practice.


Eligibility criteria: Inclusion Criteria:

* Male or nor pregnant or lactating female outpatients, 18 years of age or older.
* A clinical diagnosis of acute bacterial uncomplicated maxillary sinusitis as demonstrated by presence of the following signs and symptoms for a minimum duration of 7-10 days:

  1. Facial pain, pressure and/or tightness over one or both maxillary sinuses, and/or pain in one or both maxillary areas that worsens with movement or percussion, and
  2. Presence of one or more of the following signs:

  i.purulent nasal discharge ii.purulent drainage in the posterior pharynx iii.purulent discharge from the maxillary sinus orifice
* A sinus X-ray (Water's view) confirming the clinical diagnosis of maxillary sinusitis. At least one of the following must be documented in one or both maxillary sinuses on radiologic examination:

  1. complete or partial opacification
  2. an air/fluid level

Two or more of the following:

1. fever, as defined by temperature: \>38ºC
2. leukocytosis \[White Blood Cell (WBC) \>10,000/mm3 or \>15% band forms\], ECR;
3. headache,
4. nasal congestion and post nasal drainage.

Exclusion Criteria:

* Known or suspected hypersensitivity or intolerance or contraindications to Azithromycin, Amoxiclav according to LPDs, pregnant or lactating women.

Primary outcomes:
measure: Percentage of Participants With Response of Very Convenient or Somewhat Convenient
timeFrame: Day 11
Secondary outcomes:
measure: Percent Compliance With Prescribed Treatment Regimen
timeFrame: Day 11
measure: Percentage of Participants Who Were 100 Percent Compliant With Prescribed Treatment Regimen
timeFrame: Day 11
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: