louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06927856: The Test-to-PrEP Study
Official title: Test-to-PrEP: A Randomized Hybrid Implementation/Effectiveness Trial of a Social Network Strategy to Increase Equitable Reach of HIV Testing and PrEP Information
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Infections
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2025-04-15
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To compare the effectiveness of two social network strategies (direct distribution and referral-based distribution) in increasing HIV self-testing (HIVST) completion rates among social network contacts of current Pre-Exposure Prophylaxis (PrEP) clients.


Eligibility criteria: Inclusion Criteria - PrEP Clients (Egos):

* Stated willingness to provide informed consent.
* Stated willingness to comply with all study procedures.
* Stated availability for the duration of the study.
* Ability to identify members of their social network who may benefit from receiving an HIVST kit and PrEP information.
* Currently prescribed PrEP by RAPID clinics, including those initiating PrEP on the same day as study enrollment.

Inclusion Criteria for Peers (Alters):

- Provision of electronic informed consent prior to completion of the Quick Response (QR)-linked survey instruments.

Exclusion Criteria for PrEP Clients (Egos):

* Inability or refusal to provide informed consent (e.g., cognitive impairment).
* Unable or unwilling to comply with study procedures per study investigator
* Inability to identify members of their social network who may benefit from receiving an HIVST kit and PrEP information.
* Aged 17 years or younger.

Exclusion Criteria for Peers (Alters):

* Failure to provide electronic informed consent prior to starting QR-linked Alter survey tools.
* Age 17 years or younger.

Primary outcomes:
measure: Number of Alter participants per ego who use the HIV self-test kit
timeFrame: Up to 6 months
measure: Number of Alter participants per ego using an HIV self-test who meet criteria for PrEP
timeFrame: Up to 6 months
Secondary outcomes:
measure: Number of Alters per ego initiating PrEP
timeFrame: Up to 6 months
measure: Alters' self-reported PrEP knowledge as indicated by the Post-Test Survey.
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Susanne Dobleck-Lewis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06385756: Effect of Amobarbital Sodium Combined With Low-dose Propofol on Hemodynamics During Induction and Perioperative Adverse Reactions
Official title: Effect of Amobarbital Sodium Combined With Low-dose Propofol on Hemodynamics During Induction and Perioperative Adverse Reactions in Gynecological Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Amobarbital Sodium
Hemodynamics Instability
Keywords: Anesthesia induction
Perioperative Adverse Reactions
Gynecological Laparoscopic Surgery
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 96
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: At present, there are limited data on perioperative efficacy of barbiturates at home and abroad. The purpose of this clinical trial is to observe the effects of amobarbital sodium combined with low-dose propofol on hemodynamics during induction and perioperative adverse reactions in gynecological laparoscopic surgery patients, and to provide a more reasonable, safe and comfortable anesthesia program for female patients who undergoing laparoscopic surgery.

The main questions it aims to answer are:

* whether the combination of the two results on more stable hemodynamics during induction in gynecological laparoscopic surgery patients;
* whether the incidence of perioperative oxidative stress and inflammation and postoperative nausea and vomiting（ponv） improved after the use of the two combinations of anesthesia induction.

Participants will:

* Induction of anesthesia with the experimental drug or placebo；
* 5 ml of venous blood was retained before, after, and 1 day after surgery for follow-up determination of serum associated factor levels；
* To record their vital signs at any point during the anaesthetic process; Serum serological indexes related to oxidative stress and inflammation were determined. The agitation during the recovery period was recorded. The incidence and severity of ponv were recorded at 2h, 2-6h, and 6-24h postoperatively, and the use of palonosetron was also recorded.


Eligibility criteria: Inclusion Criteria:

* Age 40\~60 years old；
* ASA Class I to II；
* The operation time was 1h\~2h；
* BMI 18\~25；
* Sign informed consent.

Exclusion Criteria:

* Known allergy to narcotic drugs used in this study;
* Severe pulmonary insufficiency;
* Abnormal liver and kidney function；
* History of severe anemia and hematoporphyrin；
* History of asthma;
* Uncontrolled high blood pressure or diabetes;
* Pregnant and lactating women；
* Accompanied by cognitive impairment or inability to communicate.

Primary outcomes:
measure: Mean arterial pressure (MAP) during Induction of anesthesia
timeFrame: Up to 3 hours
Secondary outcomes:
measure: MAP at different time points
timeFrame: Up to 3 hours
measure: Incidence of postoperative nausea and vomiting (ponv)
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05898256: Cadonilimab in the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma
Official title: A Single-arm, Multicenter, Phase II Study Evaluating the Efficacy and Safety of Cadonilimab Plus Chemotherapy for Recurrent or Metastatic Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Nasopharyngeal Carcinoma
Immune Checkpoint Inhibitors
Lead sponsor: Guangxi Medical University
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 20
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: TREATMENT

Brief summary: This study is a single-arm, multicenter clinical study to evaluate the efficacy and safety of Cadonilimab in combination with gemcitabine/cisplatin as a first-line treatment for recurrent or metastatic nasopharyngeal carcinoma.


Eligibility criteria: Inclusion Criteria:

1. The subject must sign the written informed consent form (ICF) voluntarily；
2. Age ≥18 years and ≤65 years；
3. Subjects with histopathological diagnosis of nasopharyngeal carcinoma；
4. Primarily metastatic (stage IVB as defined by AJCC staging system for NPC, eighth edition) or recurrent/metastatic NPC that is not amenable to local regional treatment or curative treatment and at least 6 months after radical treatment；
5. Has not received prior systemic treatment;
6. Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status
7. Subject must have a measurable target lesion based on RECIST v1.1;

Exclusion Criteria:

1. Allergic to monoclonal antibodies, any cadonilimab components, gemcitabine, cisplatin, and other platinum drugs;
2. Prior therapy as follow:

   Anti-PD-1, anti-PD-L1 or anti-CTLA-4; Concurrent medical condition requiring the use of cortisol (\>10mg/day Prednisone or equivalent dose) or other systematic immunosuppressive medications within 14 days before the study treatment（Except：inhalation or topical corticosteroids）.
3. Any active malignancy ≤ 2 years before randomization except for specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)；
4. Female patients who are at pregnancy or lactation.

Primary outcomes:
measure: Objective response rate(ORR)
timeFrame: Up to approximately 2 years
measure: Incidence and severity of adverse events(AEs)
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Up to approximately 2 years
measure: Overall Survival (OS)
timeFrame: Up to approximately 2 years
measure: Disease control rate (DCR)
timeFrame: Up to approximately 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06273956: Explore the Relationship Between Platelet Count and Bleeding Score in ITP
Official title: Assessment of Bleeding Scores in Immune Thrombocytopenia Purpuria
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ITP - Immune Thrombocytopenia
Keywords: bleeding scores
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: adults(≥18 years old) , diagnosed as primary ITP

Brief summary: Assessment of bleeding scores in immune thrombocytopenia purpuria to explore the relationship between platelet count and bleeding score in immune thrombocytopenia purpura (ITP) and compare the clinical practicability of bleeding grading systems with adult patients with ITP.

Detailed description: Immune thrombocytopenia purpura (ITP) is an autoimmune hemorrhagic disease, characterized by a decreased platelet count ( \< 100\*109) and suppressed platelet development . The incidence of ITP increases with age, with an incidence rate of 20-40/ million adults (over 18 years old) /year and higher in the people over 60 years old . The main clinical manifestations were bleeding symptoms, but heterogeneity between manifestations was noted. Severe thrombocytopenia is considered as a risk factor for bleeding in ITP, but patients with moderate or even mild thrombocytopenia can also experience severe bleeding, which seems like a disproportionate performance

. Bleeding is one of the leading causes of death in patients with thrombocytopenia . Bleeding manifestations in ITP with mild mucocutaneous to life-threatening bleeding, and prediction of severe bleeding is instructive to the management of thrombocytopenia.

Bleeding assessment tools, such as ITP Bleeding Assessment Tool (ITP-BAT), ITP Bleeding Scale (IBLS) and Khellaf bleeding score, have been developed and studied in a variety of clinical settings for diagnosis and to evaluate the severity of bleeding.

In this study, investigators retrospectively assessed the relationship between platelet count and bleeding score in patients with ITP and compared the clinical aspects of existing ITP bleeding score systems .

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of primary ITP .

Exclusion Criteria:

* Malignancy disease
* Virus infection:

  * HIV
  * Hepatitis B virus
  * Hepatitis C virus
* Pregnancy.

Primary outcomes:
measure: explore the relationship between platelet count and bleeding assessment systems (ITP Bleeding Assessment Tool (ITP -BAT) and ITP Bleeding Scale (IBLS) in Patients with ITP to measure severity of bleeding
timeFrame: througth study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Aml Sayed Hamed
Study officials:
affiliation: Assiut University
name: Rania Mohammed Mahmoud Hafez, professor
role: STUDY_CHAIR
affiliation: Assiut University
name: Yousreyia Abdel Rahman Ahmed, professor
role: STUDY_CHAIR
References:
Clinical trial NCT06619756: Anomia Treatment Predictors
Official title: Predictors of Phonological-focused Anomia Treatment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anomia (Word-Finding Impairment)
Aphasia
Keywords: anomia treatment
aphasia treatment
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 2
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: The goal of this clinical trial is to identify predictors of response to phonological-focused anomia treatment in people with aphasia. The main question it aims to answer is who responds to which type of anomia treatment. Researchers will compare Phonomotor Treatment and Phonological Components Analysis to see which treatment is more beneficial, and for whom. Participants will engage in both treatments over several months.

Detailed description: Participants will complete screening and characterization testing to determine eligibility for the study. Each treatment will be administered twice a week, for 10-15 sessions. Pre-treatment and post-treatment testing will also occur for each treatment. There will be a period of no treatment in between the first and second treatment blocks.

Eligibility criteria: Inclusion Criteria:

* Chronic aphasia (6+ months)
* Anomia
* Sufficient auditory comprehension to follow task instructions
* Phonologic impairment

Exclusion Criteria:

* Progressive neurological illness or disease, including dementia
* Chronic medical illness that interferes with adherence to testing schedule
* Severe, uncorrected vision or hearing impairment that interferes with task completion
* Moderate-severe apraxia of speech or dysarthria that interferes with task completion

Primary outcomes:
measure: Naming of Trained Words
timeFrame: Pre-treatment and Immediately post-treatment
Secondary outcomes:
measure: Naming of Untrained Words
timeFrame: Pre-treatment and Immediately post-treatment
measure: Standardized Assessment of Phonology in Aphasia (SAPA)
timeFrame: Pre-treatment and Immediately post-treatment
measure: Philadelphia Naming Test
timeFrame: Pre-treatment and Immediately post-treatment
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: UB Audiology and Speech-Language Pathology Clinic
state: New York
Study officials:
affiliation: SUNY at Buffalo
name: Nichol Castro, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05219656: Efficacy of Cyclosporine Rescue Therapy in Acute Ulcerative Colitis.
Official title: Long-term Outcome of Patients With Acute Ulcerative Colitis Treated With Cyclosporine Rescue Therapy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis Acute
Keywords: Cyclosporine A
Rescue therapy
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2022-02-02
Enrollment: 182
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated in Tampere University Hospital with Cyclosporine rescue therapy for acute flare of UC.

Brief summary: The efficacy and safety of Cyclosporine A as rescue therapy for acute severe ulcerative colitis in long-term follow-up.

Detailed description: All UC patients treated with CyA in Tampere University Hospital between 2009 and 2018 were reviewed from patient records and analyzed. Amelioration of UC was defined as clinical response for rescue therapy with no need for colectomy or third-line rescue therapy at the same hospitalization as index flare. Relapse was defined as requiring further Cs treatment, re-hospitalization, biologicals, small molecules, or colectomy later in follow-up. Patients were followed-up from the date of index flare until colectomy, death, or the end of observation period. Adverse events related to treatment were assessed throughout the duration of treatment. Surgical complications were defined by using Clavien-Dindo classification (grade III-V classified as severe complications). The surgical complications in Cyclosporine-treated patients were compared to all patients operated for treatment refractor UC in Tampere University Hospital within the same follow-up period.

Eligibility criteria: Inclusion Criteria:

* Patients admitted to hospital for acute flare of UC and treated with CyA rescue therapy.
* Age 16 or over

Exclusion Criteria:

-

Primary outcomes:
measure: Response
timeFrame: From january 2009 to december 2018
measure: Remission
timeFrame: From january 2009 to december 2018
measure: Adverse events
timeFrame: From january 2009 to december 2018
measure: Surgical complications
timeFrame: From January 2009 to December 2018
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kanta-Häme Central Hospital
name: Heli Eronen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06631456: Effects of Platelet-Rich Plasma and Ozone Therapy in Knee Osteoarthritis
Official title: Effects of Platelet-Rich Plasma and Ozone Therapy on Pain and Quality of Life in Knee Osteoarthritis: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Keywords: knee osteoarthritis
platelet rich plasma
ozone therapy
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 54
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Stage 2-3 gonarthrosis according to KL who apply to our hospital\&#39;s Physical Medicine and Rehabilitation out-patient clinic will be included.

Brief summary: Knee osteoarthritis can frequently occur with advancing age. In cases of pain that persists despite hot/cold applications, drug therapy and exercise, intra-articular injections are considered. In advanced-stage gonarthrosis, steroid injections may respond. However, in mild and moderate knee arthritis, regenerative methods come to the forefront because the joint cartilage is still partially/completely intact. PRP and ozone therapy are frequently applied intra-articular treatments. This study will compare the effects of both injection methods on clinical outcomes.

Detailed description: Knee osteoarthritis is a common arthrosis that can be encountered frequently with increasing life expectancy. In mild-moderate stages, hot/cold applications, drug treatments and exercise applications are usually applied, while in those who do not respond, physical therapy or intra-articular injection treatments are applied. This retrospective study aims to examine the effects of intra-articular Platelet Rich Plasma (PRP) and ozone therapy on pain, functionality and quality of life in patients with Stage 2-3 gonarthrosis according to the Kelgren-Lawrence (KL) Classification.

Eligibility criteria: Inclusion Criteria:

* 30-70 years old, Stage 2-3 gonarthrosis according to KL
* Voluntariness to participate in the study

Exclusion Criteria:

* Cognitive dysfunction
* General medical condition is not suitable for injections and evaluations
* History of knee injections in the last 3 months
* History of previous knee surgery
* Bleeding disorders or those taking medications that may cause bleeding disorders after injections

Primary outcomes:
measure: Pain-Numerical Rating Scale
timeFrame: From enrollment to the end of treatment at 3rd month
Secondary outcomes:
measure: Pain, stiffness and physical function-WOMAC
timeFrame: From enrollment to the end of treatment at 3rd month
measure: Quality of life-SF-12
timeFrame: From enrollment to the end of treatment at 3rd month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Şişli Hamidiye Etfal Training and Research Hospital, İstanbul
Study officials:
affiliation: Şişli Hamidiye Etfal Training and Research Hospital
name: Banu Kuran, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02636556: Chemoradiotherapy for Limited Advanced Unresectable Thymic Epithelial Tumors
Official title: Phase Ⅱ Study of Concurrent Chemoradiotherapy for Limited Advanced Unresectable Thymic Epithelial Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thymoma and Thymic Carcinoma
Keywords: thymoma
thymic carcinoma
chemoradiotherapy
inoperable
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2015-12-21
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intensity modulated radiotherapy with VP-16/Cisplatin
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the feasibility and safety of concurrent chemoradiotherapy for limited advanced unresectable thymoma or thymic carcinoma.

Detailed description: Complete resection is difficult to achieve without damaging the main organs in advanced thymoma or thymic carcinoma. The previous trials have showed that radiotherapy was significantly associated with prolonged OS and chemotherapy is playing an increasing role in treatment of patients with advanced thymoma or thymic carcinoma. However, whether concurrent chemoradiotherapy is safety in advanced thymoma or thymic carcinoma is still unknown. The purpose of this study is to evaluate the feasibility and safety of concurrent chemoradiotherapy for limited advanced unresectable thymoma or thymic carcinoma.

Eligibility criteria: Inclusion Criteria:

1.18\~75 years old; 2.Eastern Cooperative Oncology Group performance status of 0 to 2; 3.Pathologically or cytologically confirmed untreated thymoma or thymic carcinoma; 4.Unresectable, limited adanced disease could be encompassed within a tolerable radiotherapy field; 5.Have adequate bone marrow, hepatic, and renal function; 6.Patients who cannot receive surgery resection; 7.Written informed consent.

Exclusion Criteria:

1. Distant metastases could not be encompassed within a tolerable radiotherapy field;
2. Underwent surgery, radiotherapy or chemotherapy before entering this study ;
3. Have other malignancy history excluding carcinoma in situ of cervix in the previous five years;
4. Active clinical pulmonary infection;
5. Pregnant or nursing.

Primary outcomes:
measure: Objective response rate
timeFrame: 3 months after treatment
Secondary outcomes:
measure: Overall survival
timeFrame: 2 years
measure: Progression free survival
timeFrame: 2 years
measure: Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v4.0
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Kailiang Wu
state: Shanghai
Study officials:
affiliation: Fudan University
name: Kailiang Wu, M.D.,Ph.D
role: PRINCIPAL_INVESTIGATOR
References: