louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01971099: Effects of Tribulus Terrestris in Women With Hypoactive Sexual Desire Disorder
Official title: Effects of Tribulus Terrestris in Women With Hypoactive Sexual Desire Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypoactive Sexual Desire Disfunction
Keywords: sexual function
hypoactive
desire
androgens
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2013-10-29
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypoactive Sexual Desire Disorder (HSDD) is the most prevalent female sexual dysfunction in society and is strongly linked to the quality of life of women. The androgen hormones decline over age in the premenopausal period, which occurs around 20 years. Tribulus terrestris is a plant native to India, recommended in the treatment of infertility, low libido and impotence. Its main active ingredient is the protodioscin, which has been attributed to an increase in testosterone levels and improved sexual function. The aim of this study is to evaluate the effects of Tribulus Terrestris in premenopausal women with HSDD.


Eligibility criteria: Inclusion Criteria:

* regular menstrual cycle
* with no use of hormonal contraception within the last 3 months
* without any medication, drugs or alcohol.
* Healthy patients without systemic or psychiatric disease

Exclusion Criteria:

* Patients with amenorrhea and/or pregnant.

  * Patients who underwent bilateral oophorectomy.
  * Patient smoker (10 cigarettes per day).
  * Patients with blood pressure \> 160/90 mm Hg.
  * Patient with breast or endometrial carcinoma.
  * Patients with a history of myocardial infarction.
  * Patient with Diabetes.
  * Patient with vaginal bleeding from any source.
  * Patients with hepatic injury.
  * Patients with active thrombophlebitis or thromboembolic disorders recent
  * Patients with interpersonal relationship problems with your relationship or partner
  * Patients with sexual problems from your partner

Primary outcomes:
measure: Sexual Desire
timeFrame: 120 days
Secondary outcomes:
measure: serum levels of prolactin and thyroid-stimulating hormone (TSH)
timeFrame: 120 days
Other outcomes:
measure: serum levels of testosterone and sex hormone-binding globulin (SHBG)
timeFrame: 120 days
Locations:
city: Belo Horizonte
country: Brazil
facility: Hospital das Clinicas - Universidade Federal de Minas Gerais
state: Minas Gerais
Study officials:
affiliation: Federal University of Minas Gerais
name: Selmo Geber, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03655899: Metabolomic Alterations in the Vascular Compartment in Patients With Sepsis
Official title: Metabolomic Alterations in the Vascular Compartment in Patients With Sepsis - an Observational Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Endothelial Dysfunction
Keywords: metabolomics
systems biology
Sepsis
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with sepsis or septic shock

Brief summary: This study will investigate the metabolic alterations of vascular cells caused by sepsis and septic shock

Detailed description: This study will investigate the metabolic alterations of vascular cells caused by sepsis and septic shock in 60 patients

Eligibility criteria: Inclusion Criteria:

* 18 year or older
* Sepsis or Septic shock

Exclusion Criteria:

* Pregnant or breastfeeding
* Hemoglobin ≤ 5.0 mmol/L
* Platelets ≤ 5.0 mia/L
* Consent not obtainable
* Do not resuscitate order

Primary outcomes:
measure: Shock induced endotheliopaty
timeFrame: Up to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
state: Copenhagen NV
Study officials:
affiliation: Rigshospitalet, Dept. of Clinical Immunology
name: Pär Johansson
role: STUDY_DIRECTOR
References:
Clinical trial NCT05270499: Aveir VR Real-World Evidence Post-Approval Study
Official title: Aveir Single-Chamber Leadless Pacemaker Real-World Evidence Post-Approval Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Pacemaker
Arrythmia
Bradycardia
Keywords: bradycardia
sick sinus rhythm
pacemaker
av block
Vasovagal Syncope
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2022-03-08
Enrollment: 2100
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: All patients who had an implant of the Aveir VR device, meet inclusion/exclusion criteria, link to Medicare FFS claims, and survive past 30 days will be included in the analysis

Brief summary: The purpose of this post-approval study is to evaluate the long-term safety of the single-chamber Aveir VR leadless pacemaker using real-world evidence methods.

Detailed description: This is a non-randomized, multi-center study leveraging real-world evidence methods that merge multiple real-world datasets from Abbott and the Center for Medicare Services to assess Aveir VR leadless pacemaker safety in a large patient population. The results from this study will data to fulfill the Condition of Approval requirements for the Aveir VR device from FDA.

Eligibility criteria: Eligibility Criteria:

* Implanted with an Aveir VR leadless pacemaker
* Continuous enrollment in Medicare Part A and Part B for 12 months prior to implant and for 30 days after implant, except in the case of death within the 30-day period
* Ability to link with Medicare fee-for-service data

Primary outcomes:
measure: Number of Subjects Free from Acute Aveir VR System-Related Complications
timeFrame: 30 days
measure: Number of Subjects Free from Chronic Aveir VR System-Related Complications
timeFrame: 10 Years
Secondary outcomes:
measure: Number of Subjects Free from Individual Aveir VR Leadless Pacemaker-Related Complications
timeFrame: 10 Years
measure: Number of Subjects with End of Device Service Events
timeFrame: 10 Years
Other outcomes:
Locations:
city: Sylmar
country: United States
facility: Abbott
state: California
Study officials:
affiliation: Abbott
name: Nicole Harbert
role: STUDY_DIRECTOR
References:
Clinical trial NCT05403099: Effect of Topical Application of Hyaluronic Acid on Stability of Immediate Loading Dental Implant in Posterior Maxilla
Official title: Effect of Topical Application of Hyaluronic Acid on Stability of Immediate Loading Dental Implant in Posterior Maxilla
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Missing Teeth
Keywords: Hyaluronic Acid, dental implant
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Twenty implants were inserted in patients seeking for replacement of missed single or multiple posterior maxillary teeth. Patients were divided randomly into two groups. In the control group, ten implants were placed and immediately loaded. While in the study group, ten implants were coated with hyaluronic acid (HA) immediately before placement and immediately loaded. All patients were clinically evaluated at implant placement time, one, three and six months after loading regarding implant stability. Peri-implant pocket depth and modified sulcus bleeding index were evaluated clinically at six months in all patients. Bone density was evaluated radiographically after three months. All clinical and radiographic data were subjected to statistical analysis.
Primary purpose: OTHER

Brief summary: Effect of Topical Application of Hyaluronic Acid on Stability of Immediate Loading Dental Implant in Posterior Maxilla

Detailed description: Patients were randomly divided into two groups:

Group I (Control group):

Ten implants were placed in posterior maxilla and immediately loaded.

Group II (Study group):

Ten implants were coated with HA before placement in posterior maxilla and immediately loaded.

Eligibility criteria: Inclusion Criteria:

* Highly motivated patients with good oral hygiene.
* Age 18 years or older.
* Adequate alveolar bone volume at the implant site, at least 6mm in width and 15 mm in height.
* Free from any parafunctional habits

Exclusion Criteria:

* Patients suffering from any systemic or local disease that contraindicate implant placement or surgery.
* Pregnancy.
* Smokers.

Primary outcomes:
measure: implant stability
timeFrame: immediately after surgery
measure: implant stability
timeFrame: one month
measure: implant stability
timeFrame: three months
measure: implant stability
timeFrame: six months
measure: bone density
timeFrame: three months
Secondary outcomes:
measure: propping depth
timeFrame: six months
measure: bleeding inex
timeFrame: six months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Merna Elhadidi
Study officials:
References:
Clinical trial NCT05684536: Comparison of Liagure Safety in Thyroidectomy With Conventional Thyroidectomy
Official title: Comparison of Liagure Safety in Thyroidectomy With Conventional Thyroidectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ligature; Hemorrhage
Recurrent Laryngeal Nerve Injuries
Hypocalcemia
Lead sponsor: Imam Mohammad ibn Saud Islamic University
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare intraoperative and postoperative complication rates in thyroidectomy between ligasure and traditional vascular ligation and clipping .

Detailed description: Due to the high vascularity of the thyroid gland and the relatively tiny operative field, rigorous hemostasis is an essential requirement for successful thyroid surgery. Blood vessel ligation and/or ligation are the primary means of attaining hemostasis in thyroidectomy. New technologies have been developed, including a vessel sealing device (ligasure) that seals vessels by fusing the inner layers of the vessel wall with minimal amounts of thermal dispersion burning and tissue friction, thereby minimizing the occurrence of unintentional burns.

yet. It is unclear whether the heat conveyed by a ligature can harm the recurrent laryngeal nerve due to its proximity to the berry ligament.

thromosis of the inferior parathyroidal gland's supplying artery during dissection may result from alternative prospective delineation of the inferior thyroidal artery using ligasure for dissection.

The purpose of this study is to assess the safety and efficacy of ligasure with standard vascular ligation in open thyroid surgery.

Eligibility criteria: Inclusion Criteria:

Patient who will undergo lobectomy , subtotal thyroidectomy , total thyroidectomy at time of study

Any age

-

Exclusion Criteria:

* patient undergoing re-do surgery " completion thyroidectomy "

patient undergoing concomitant procedures as cervical lymphadenectomy or parathyroidectomy

Primary outcomes:
measure: Post-operative complications
timeFrame: Postoperatively from day of surgery until one week post operatively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05541549: A Phase 2 Study Evaluating JCPyV-specific T Cell Therapy for PML
Official title: ASCEND-JC: A Multi-center, Randomized, Double-blind, Phase 2 Study, Evaluating JCPyV-specific T Cell Therapy for the Treatment of PML
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Progressive Multifocal Leukoencephalopathy
Keywords: VST
Virus specific T-Cell
cell therapy
PML
JC virus
Lead sponsor: Cellevolve Bio Inc
Sponsor class: INDUSTRY
First posted: 2022-09-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, double- blinded, Phase 2 trial in patients with PML due to JCPyV.
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blinded, Phase 2 trial in patients with PML due to JCPyV. Patients will receive treatment with a matched virus-specific T-cell product (CE VST01-JC) or placebo, and will then be monitored for response to therapy.

Detailed description: Progressive multifocal leukoencephalopathy (PML) is a demyelinating disease of the central nervous system caused by JC polyomavirus (JCPyV) occurring in immunocompromised patients who face a disease that is usually progressive and often fatal (Padgett 1971; Tan 2010). Annually, it is estimated that 4,000 people develop PML in the United States and Europe combined (NORD 2015).

This is a randomized, double- blinded, Phase 2 trial in patients with PML due to JCPyV. Patients will receive treatment with a matched virus-specific T-cell product (CE VST01-JC) or placebo, and will then be monitored for response to therapy. The study is designed to evaluate whether CE-VST01-JC infusions will slow and ultimately halt neurological progression in patients with PML compared with placebo as evaluated by modified Rankin Score (mRS).

Eligibility criteria: * Male or female subjects aged 18 years or older, with actively progressing PML confirmed by MRI and JCPyV present in CSF or in brain biopsy tissue (diagnosis confirmed according to algorithm diagnostic criteria for PML developed by the American Academy of Neurology).

Primary outcomes:
measure: To evaluate the effect of CE-VST01-JC on time to disease progression, as measured by mRS (modified Rankin Score)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02129036: Ovarian Clear Cell Adenocarcinoma Review
Official title: Retrospective Multi-institutional Survey of Clinical Characteristics in Ovarian Clear Cell Adenocarcinoma Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cysts
Keywords: Ovarian cancer
Clear cell carcinoma
Paclitaxel-platinum
Chemotherapy
response to chemotherapy
survival of clear cell ovarian carcinoma
Prognostic factors
Lead sponsor: Cathay General Hospital
Sponsor class: OTHER
Collaborators: name: National Taiwan University Hospital
First posted: 2014-05-02
Enrollment: 5
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: total 300 patients of ovarian clear cell carcinoma post operation from 8 institution.

Brief summary: Clear cell carcinoma comprises 5-10% of surface epithelial ovarian cancers, and about 30-40% of the patients with clear cell carcinoma are diagnosed in the advanced stage. The investigators studied the response to chemotherapy and survival for either paclitaxel-platinum based chemotherapy or conventional platinum-based chemotherapy among all stages clear cell ovarian carcinoma. Prognostic factors for survival among the patients with pure, advanced, clear cell ovarian carcinoma were also evaluated.

Detailed description: 1. Several authors have reported frequent admixtures of clear cell ovarian carcinoma with serous, mucinous, and endometrioid tumors. However, few papers addressed the difference in response to chemotherapy and survival between patients with pure and mixed-type advanced clear cell carcinoma.
2. Recent trends in the clinical management of advanced ovarian cancer include increased attention to maximal cytoreduction and general acceptance of paclitaxel-platinum-based adjuvant chemotherapy.
3. The introduction of paclitaxel markedly changed the postoperative management of ovarian cancer patients, but the results and value of these newer efforts and therapies applied to clear cell carcinoma are as yet undetermined.
4. Today, paclitaxel-platinum-based chemotherapy is becoming the standard regimen for ovarian cancer worldwide. Previous research suggests a potential benefit of paclitaxel plus carboplatin regimens for stage I clear cell carcinoma. However, few papers specifically addressed the efficacy of paclitaxel-platinum-based chemotherapy for advanced clear cell carcinoma because clear cell carcinoma occurs only rarely in Western countries.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Ovarian clear cell carcinoma

Exclusion Criteria:

* not undergo operation

Primary outcomes:
measure: Overall survival (OS)
timeFrame: Overall survival (up to 6 years)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Gynecologic Cancer Center, Cathay general Hospital
name: Chih-Ming Ho
role: STUDY_DIRECTOR
References:
Clinical trial NCT06948136: Acute Effects of THC in Older Adult
Official title: Acute Effects of THC in Older Adult
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Age-related Cognitive Decline
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2025-04-29
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The primary objective of this study is to determine if increasing age confers greater vulnerability to the acute A) cognitive (e.g., memory, attention, psychomotor function), B) subjective (e.g., anxiogenic and rewarding effects), and C) cardiovascular (heart rate and blood pressure), effects of THC in adults \> 21 years old. The secondary aims of the study are to explore age-related acute effects of THC on electrophysiological indices of information processing (e.g., auditory steady-state response (ASSR), oddball paradigm \[P300\], and resting state cortical noise) and to determine age-related differences in the metabolism of THC. It is hypothesized that increasing age will confer greater vulnerability to THC-induced cognitive impairments, anxiogenic effects, and cardiovascular effects but are less vulnerability to its rewarding effects. Increasing age will confer greater vulnerability to THC-induced deficits in electrophysiological indices of information processing including.


Eligibility criteria: * at least one lifetime use of cannabis and/or THC in the past ten years
* negative urine screen for illicit substance use
* no other illicit substance use during the past three months
* not nicotine dependent (5 cigarettes per day; score of 3 on the Fagerstrom Test for Nicotine Dependence)
* alcohol use ≤ 7 drinks/week in women and 14 in men
* no current or past serious mental illness (e.g., schizophrenia, bipolar and related disorders, etc.) diagnosed with the use of the diagnostic and statistical manual of mental disorders (DSM-5)
* no family history of psychosis
* no history of significant medical or neurological disease per PI discretion
* BMI ≤ 32
* high school education or greater
* no positive pregnancy test and/or lactation
* English speaking

Primary outcomes:
measure: Rey Auditory Verbal Learning Task (RAVLT) total immediate recall
timeFrame: Each test day will be split into two drug administration sessions. The RAVLT will be administered approximately 25 minutes after each drug administration.
Secondary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: -60 minutes, 20 minutes, 60 minutes, 120 minutes, 170 minutes, 210 minutes, 270 minutes, 300 minutes, 360 minutes, 420 minutes after the start of the initial THC/placebo drug infusion.
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: Yale University
name: Deepak C D'Souza, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00873249: Effect of Daily Short Message System (SMS) Reminders on Medication Adherence to Oral Antipsychotics in Patients With Schizophrenia
Official title: Effect of Daily SMS Reminders on Medication Adherence to Oral Antipsychotics in Patients With Schizophrenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: Schizophrenia
Therapeutic adherence
Short message system
Mobile phone
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-04-01
Enrollment: 339
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stabilized outpatients with a diagnosis of schizophrenia

Brief summary: This study is a 6-month, multicenter, randomized study to assess the effect of daily SMS reminders sent during 3 months in the adherence to oral antipsychotic treatment in stabilized outpatients with schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Male or female patients older than 18 years
* With a diagnosis of schizophrenia (DSM-IV TR criteria)
* Stabilized out-patients
* Under oral antipsychotic monotherapy

Exclusion Criteria:

* Administration of a depot antipsychotic drug
* Suicide risk

Primary outcomes:
measure: Morisky Green Questionnaire
timeFrame: baseline, at months 3 and 6
Secondary outcomes:
measure: Clinical Global Impression- Schizophrenia (CGI-SCH)
timeFrame: baseline, at months 3 and 6
measure: Register of Adherence to Treatment (RAT)
timeFrame: baseline, at months 3 and 6
Other outcomes:
Locations:
city: Berga
country: Spain
facility: Research Site
state: Barcelona
city: Sabadell
country: Spain
facility: Research Site
state: Barcelona
city: Santander
country: Spain
facility: Research Site
state: Cantabria
city: Pamplona
country: Spain
facility: Research Site
state: Navarra
city: Calatayud
country: Spain
facility: Research Site
state: Zaragoza
city: Alicante
country: Spain
facility: Research Site
city: Almeria
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Burgos
country: Spain
facility: Research Site
city: Cordoba
country: Spain
facility: Research Site
city: Granada
country: Spain
facility: Research Site
city: Leon
country: Spain
facility: Research Site
city: Lerida
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Malaga
country: Spain
facility: Research Site
city: Murcia
country: Spain
facility: Research Site
city: Oviedo
country: Spain
facility: Research Site
city: Palma Mallorca
country: Spain
facility: Research Site
city: Salamanca
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Tarragona
country: Spain
facility: Research Site
city: Toledo
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Valladolid
country: Spain
facility: Research Site
city: Zamora
country: Spain
facility: Research Site
Study officials:
References: