louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00907322: A Phase 1 Trial To Assess The Safety And Pharmacokinetics Of Single, Ascending, Oral Doses Of Dimebon In Healthy Adults
Official title: A Phase 1, Investigator- And Subject-Blind (Sponsor-Open), Randomized, Crossover, Placebo-Controlled Trial To Assess The Safety, Tolerability, And Pharmacokinetics Of Single, Ascending, Oral Doses Of Dimebon [PF-01913539] In Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: oral, single ascending doses; CYP2D6 metabolizer status; healthy subjects; safety, tolerability, pharmacokinetics
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Medivation, Inc.
First posted: 2009-05-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of Dimebon following single ascending doses. A formal single ascending dose study of this nature has not been performed to date in the Dimebon development program.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
* Subjects who display the CYP2D6 extensive, intermediate, ultra-rapid, or poor metabolizer statuses.

Exclusion Criteria:

* A known history of hypersensitivity or previous intolerance to Dimebon or other antihistamines.
* Subjects with any previous history of seizures, convulsions, epilepsy, or significant head injury.
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

Primary outcomes:
measure: Physical/neurological examination findings, clinical safety laboratory assessments, 12-lead ECGs, vital sign measurements, and adverse event monitoring.
timeFrame: July 2009
measure: Pharmacokinetic parameters: Cmax, Tmax, AUClast, AUCinf, half-life, CL/F and Vz/F.
timeFrame: July 2009
Secondary outcomes:
measure: Pharmacodynamics: results of a Drug Effect Questionnaire
timeFrame: once each arm
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01075022: Effect of a Single Colecalciferol Dose on Insulin Resistance
Official title: Effect of a Single Colecalciferol Dose on Insulin Resistance: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insulin Resistance
Glucose Intolerance
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2010-02-24
Enrollment: 136
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: A Prospective Double-Blinded, Placebo Controlled, Randomized Trial comparing a single dose of Vitamin D (Colecalciferol) 300.00UI to placebo on patients with insulin resistance. Primary Outcome: Blood glucose and homeostasis model assessment for insulin resistance (HOMA-R) after 90 days. Study hypothesis: Vitamin D treatment may improve insulin resistance and decrease glucose level, since there is an association between hypovitaminosis D and increased insulin resistance.


Eligibility criteria: Inclusion Criteria:

* Fasten Blood Glucose \> 100 mg/dL and \< 126 mg/dL
* Age \> 18 years

Exclusion Criteria:

* Diabetes Mellitus
* Use of metformin
* Vitamin D Use
* Hypercalcemia
* Chronic Hepatitis
* HIV

Primary outcomes:
measure: Blood Glucose Level
timeFrame: Baseline and day 90
Secondary outcomes:
measure: Blood Calcium Level
timeFrame: Baseline and day 90
measure: HOMA-R
timeFrame: Baseline and day 90
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Tania Furlanetto, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05506722: Using of Testes Shocker in Improving the Spermatogenesis and Sperms Activity
Official title: The Using of the Testes' Shocker in Improving the Sperms' Activity and the Spermatogenesis Process Among Infertile Men
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility, Male
Infertility Unexplained
Infertility Due to Complete Spermatogenic Arrest
Oligospermia
Asthenozoospermia
Necrospermia
Keywords: Infertility
Testes shocker
Electric shocks
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2022-08-18
Enrollment: 250
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blinded two groups, one is the treated group and the other is the placebo group.
Primary purpose: TREATMENT

Brief summary: Infertility was reported in approximately 15% of all heterozygous couples, with male factor accounting for nearly half the cases. This typically occurs due to low sperm production, sperm dysfunction, and sperm delivery obstruction. Etiology of male infertility can be attributed to many factors including acute or chronic illness, accidents, and lifestyle choices.

Detailed description: This study demonstrated that using a painless, convenient at-home device could significantly improve sperm motility and count. This device can be utilized to tackle (for unexplained infertility) the significant issue of infertility in a cost-effective, safe and efficacious.

Eligibility criteria: Inclusion Criteria:

* Infertile male with oligosperma, necrospermia, asthenozoospermia or hypospermia. Must not taking any drugs or medications for infertility and has nit any congenital diseases in the genital tracts or chronic diseases.

Exclusion Criteria:

* Have congenial genital tract disease, has a chrome disease, has other than the above mentioned causes for infertility or taking medications that can affect the fertility.

Primary outcomes:
measure: Semen analysis
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nasiriyah
country: Iraq
facility: Al-Dar medical Center
state: Thi Qar
Study officials:
affiliation: University of Baghdad, College of Medicine
name: Hashim Talib T Hashim, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04912622: RPE Characterisation With Transscleral Optical Phase Imaging in Retinal Disorders
Official title: Cross Sectional Study: in Vivo Morphometric Characterisation of Human Retinal Pigment Epithelium With Transscleral Optical Phase Imaging in Photoreceptor/ Retinal Pigment Epithelium/ Bruch's Membrane/ Choriocapillaris Complex Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinal Disease
Eye Disease
Lead sponsor: Luzerner Kantonsspital
Sponsor class: OTHER
First posted: 2021-06-03
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control group: 110 individuals with healthy retina Patient group: 95 individuals with diseased retina Exclusion: age \< 18y, pregnancy, epilepsy, no informed consent
Primary purpose: DIAGNOSTIC

Brief summary: Accumulating evidence suggest that the functional unit of photoreceptor/ retinal pigment epithelium (RPE)/Bruch's membrane/choriocapillaris plays a key role in pathophysiologic processes of a wide range of medical retinal disorders of the eye. Little is known about in vivo morphometric characteristics of human RPE cells as in vivo observation of these cells was so far technically challenging and hence nearly impossible to implement in a clinical setting. Transscleral optical phase imaging is a novel in-vivo microscopy technique allowing human RPE imaging on a cellular level with the potential of clinical application in a multimodal retinal imaging approach for diagnostic purpose in medical retina patients.


Eligibility criteria: Inclusion Criteria:

* Informed Consent as documented by signature (Appendix Informed Consent Form)
* Patients with a medical retinal disease involving the retinal pigment epithelium (age related macular degeneration, diabetic retinopathy, retinal vascular occlusive disease, central serous chorioretinopathy, tapetoretinal degeneration)
* Participants with healthy eyes for the control group

Exclusion Criteria:

* Inability to follow the procedures of the study due to language problems, psychological disorders, dementia etc. of the participant
* Aged \< 18 years.
* Pregnancy
* Epilepsy

Primary outcomes:
measure: RPE morphology
timeFrame: 12 months
Secondary outcomes:
measure: averaged RPE cell area [um2] Averaged number of neighbors of RPE cells [unitless] Averaged RPE spacing [um] Averaged RPE pigmentation parameter [unitless]
timeFrame: 12 months
Other outcomes:
Locations:
city: Lucerne
country: Switzerland
facility: Kantonsspital Luzern
Study officials:
References:
Clinical trial NCT06720922: MRgLITT for TLE: A PROBE Trial
Official title: Magnetic Resonance-guided Laser Interstitial Thermal Therapy for Temporal Lobe Epilepsy: A Prospective, Randomized, Open Blinded, End-point Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Temporal Lobe Epilepsy (TLE)
Keywords: Magnetic Resonance-guided Laser Interstitial Thermal Therapy
Open Surgery
Temporal Lobe Epilepsy
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 240
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: How does magnetic resonance-guided laser interstitial thermal therapy (MRgLITT) impact clinical prognosis in temporal lobe epilepsy (TLE)?

Detailed description: 1. Compare the clinical prognosis between magnetic resonance-guided laser interstitial thermal therapy (MRgLITT) and traditional open surgery (OS) on patients with temporal lobe epilepsy (TLE).
2. Explore the factors associated with seizure outcomes.

Eligibility criteria: Inclusion Criteria:

* Drug-resistant epilepsy.
* Temporal lobe epilepsy.
* Participants approved.

Exclusion Criteria:

* Individuals with significant medical comorbidities or conditions that pose an excessive risk for surgery, such as severe cardiovascular disease, respiratory disorders, or uncontrolled systemic infections.
* Brain surgery history.

Primary outcomes:
measure: Seizure freedom rate
timeFrame: 6-month, 1-year after surgery
Secondary outcomes:
measure: Seizure frequency
timeFrame: 6-month, 1-year after surgery
measure: Seizure severity
timeFrame: 6-month, 1-year after surgery
measure: Cognitive function evaluation
timeFrame: 6-month, 1-year after surgery
measure: Memory function evaluation
timeFrame: 6-month, 1-year after surgery
measure: Quality of life for epilepsy patients
timeFrame: 6-month, 1-year after surgery
measure: Adverse events
timeFrame: within 7 days, 6-month, 1-year after surgery
measure: Severe adverse events
timeFrame: within 7 days, 6-month, 1-year after surgery
measure: Length of hospital stay
timeFrame: after surgery
measure: Rate of antiepileptic drug reduction or withdrawn
timeFrame: 1-year after surgery
measure: Rate of reoperations
timeFrame: 1-year after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
References:
citation: Mo J, Guo Z, Wang X, Zhang J, Hu W, Shao X, Sang L, Zheng Z, Zhang C, Zhang K. Magnetic resonance-guided laser interstitial thermal therapy vs. open surgery for drug-resistant mesial temporal lobe epilepsy: a propensity score matched retrospective cohort study. Int J Surg. 2024 Jan 1;110(1):306-314. doi: 10.1097/JS9.0000000000000811.
Clinical trial NCT05748522: Functional Movement Analysis (FMS) of Diaphragmatic Breathing-Immediate Effect on Shoulder Mobility
Official title: Functional Movement Analysis (FMS) of Diaphragmatic Breathing-Immediate Effect on Shoulder Mobility- Randomized Controlled, Single-Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Diaphragm Issues
Keywords: Diaphragmatic Breathing
Functional Movement Analysis (FMS)
Shoulder Mobility
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The diaphragm is defined as a thin, smooth muscle that separates the thoracic and abdominal cavities. The shoulder and diaphragm muscle have a clear relationship through innervation and myofascial tissue connection. Fascia is often neglected medically, rehabilitatively, or performance as the underlying cause of problems. Bones, organs, and muscles appear to float in the fascial web, a continuous three-dimensional system of connective tissue. Plastic and viscoelastic properties, which can change tension and shape under the influence of manual techniques and movement retraining, ensure that the structural changes are reversible. Functional Movement Analysis (FMS) is a screening system that aims to predict the risk of injury and functional deficiencies. FMS consists of 7 basic motion component tests. It is scored on a scale of zero to three and creates a composite score whose sum ranges from 0 to 21 points. One of the 7 motion models evaluated is shoulder mobility. According to the results of this study, people who perform activities that require shoulder mobility will be guided as to whether the use of diaphragmatic breathing will be effective for preparation, rehabilitation or performance improvement. The aim of the study was to observe whether shoulder mobility increased in healthy individuals taught diaphragm breathing compared to the control group.


Eligibility criteria: Inclusion Criteria:

* Volunteer to participate in the study
* Individuals between the ages of 18-30

Exclusion Criteria:

* Have a musculoskeletal injury/operation involving the shoulder area in the last 6 months
* Using drugs that can affect the respiratory system
* Have received aerobic exercise training in the last 6 weeks

Primary outcomes:
measure: Shoulder Mobility Measurement
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
state: Etlik
Study officials:
References:
Clinical trial NCT03017222: Therapeutic Efficacy of Ramosetron for Treatment of Established PONV After Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Mass
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-01-11
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients who had at least two risk factors of PONV (Postoperative nausea and vomiting) and underwent laparoscopic surgeries under general anesthesia were assessed for eligibility. Patients who developed PONV within the first 2 hours after anesthesia received intravenously, in a randomized double-blind manner, ondansetron 4 mg or ramosetron 0.3 mg. Patients were then observed for 24 hours after drug administration. The incidence of nausea and vomiting, severity of nausea, requirements for rescue antiemetic and adverse effects at 0-2 and 2-24 hours after drug administration were evaluated. The primary endpoint was the rate of patients exhibiting complete response, defined as no emesis and no further rescue antiemetic medication for 24 hours after drug administration.


Eligibility criteria: Inclusion Criteria:

* age 19-65 years
* patients undergoing elective laparoscopic surgery under inhalational anesthesia
* duration of surgery between 30 min to 4 h
* ASA (American Society of Anesthesiologists) physical status I or II, and patients who had at least two of these risk factors
* female gender, history of motion sickness (MS) or PONV, nonsmoking, and the use of postoperative opioids.

Exclusion Criteria:

* patients with history of being allergic to 5-HT3 receptor antagonist
* patients with history of anticancer chemotherapy
* chronic opioids use, alcohol abuse, or drug abuse
* patients who took antiemetic medication within 24 h before surgery, steroids within 24 h before surgery or 24 h after surgery
* presence of renal (serum Cr \> 1.6 mg/dl)
* hepatic(liver enzymes more than 2 times normal value) insufficiency
* patients converted to open laparotomy
* patient who are pregnant or breast-feeding
* patient with borderline QTc(corrected QT interval) prolongation (\> 430 ms for male, \>450 ms for female)
* patient not able to understand the scoring of pain or express the degree of PONV.

Primary outcomes:
measure: ratio of complete response
timeFrame: 24 hours after administration of study drug
Secondary outcomes:
measure: incidence of nausea and vomiting
timeFrame: 24 hours after administration of study drug
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01151722: Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Diabetic Vitreous Hemorrhage
Official title: Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Diabetic Vitreous Hemorrhage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Recurrent
Hemorrhage
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2010-06-28
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postoperative vitreous hemorrhage is a common complication after vitrectomy for proliferative diabetic retinopathy. There have been efforts to lower the incidence of postoperative vitreous hemorrhage such as preoperative bevacizumab injection. Bevacizumab (Avastin) is a potent inhibitor of angiogenesis and has been shown to decrease retinal and iris neovascularization in proliferative diabetic retinopathy. Recently there have been reports showing that preoperative bevacizumab injection could reduce intraoperative bleeding from abnormal vessels and could make surgery easier and more successful. Our hypothesis is that intraoperative bevacizumab injection could reduce postoperative vitreous hemorrhage by inhibiting the vessel formation after surgery.

We started the prospective randomized comparative study to determine the effect of pre and intra-operative bevacizumab injection on postoperative vitreous hemorrhage after diabetic vitrectomy in comparison to vitrectomy without any adjuvant drug.


Eligibility criteria: Inclusion Criteria:

* patients undergoing first vitrectomy for vitreous hemorrhage secondary to proliferative diabetic retinopathy

Exclusion Criteria:

* follow-up period of less than 3 months
* not first vitrectomy
* abnormal blood coagulation
* uncontrolled hypertension

Primary outcomes:
measure: Vitreous hemorrhage recurrence
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clínicas de Ribeirão Preto - University of São Paulo
state: Sao Paulo
Study officials:
References:
Clinical trial NCT05254522: Fever of Unknown Orgin Registry in Internal Medicine Unit and Infectious Disease Units
Official title: Fever of Unknown Orgin Registry in Internal Medicine Unit and Infectious Disease Units
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fever of Unknown Origin
Lead sponsor: Fadoi Foundation, Italy
Sponsor class: OTHER
First posted: 2022-02-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients (in- or out-patients) with classical FUO hospitalised in Internal Medicine Dept. and in Infectious Diseases Dept.

Brief summary: This registry has the aim to collect epidemiological and clinical data of classical FUO cases in Italian Internal medicine Dept. and in Italian Infection diseases Dept.

Detailed description: In particular this registry intends to record clinical data observed, diagnostic methods used and the clinical evolution of classical FUO cases

Eligibility criteria: Inclusion Criteria:

* • fever (temperature \> 38.3° C) found in several occasions of a duration exceeding 3, unable to make a diagnosis after a period of 3 days of hospitalization or after 3 out-patients visits in Internal Medicine Dept. or Infection Diseases Dept.

  * signed informed consent

Exclusion Criteria:

* • immunocompromised patients

  * patients in treatment with steroidi (prednisone \> 0,5 mg/Kg/die per \> 4 weeks), anti-TNF, ciclofosfamide, tacrolimus, everolimus, sirolimus, azatioprina, ciclosporina, micofenolato, metotrexate
  * neutropenic patients with less than 500 neutrofili/µL
  * HIV positive patients
  * nocosomial fever.

Primary outcomes:
measure: To describe FUO cases collected
timeFrame: 6 moths
Secondary outcomes:
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: ASUI di Trieste
Study officials:
affiliation: FADOI FOUNDATION
name: ANDREA FONTANELLA
role: STUDY_DIRECTOR
References: