louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01093079: Laparoscopic Versus Open Partial Nephrectomy - Surgical and Oncological Outcomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tumor
Nephrectomy
Laparoscopy
Keywords: Renal tumor, RCC, Partial nephrectomy, Laparoscopy
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2010-03-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to partial nephrectomy due to renal lesion , suspected to be a tumor

Brief summary: Partial Nephrectomy is the standard care for small (\<4 cm) renal tumors. Despite the expanding use of laparoscopic approach, debate exist regarding the short and long term outcomes compared to the open approach. Our goal is to perform a prospective randomized trial to compare these methods


Eligibility criteria: Inclusion Criteria:

* patients referred to partial nephrectomy

Exclusion Criteria:

* Contra-indication for laparocopic surgery
* Complexed , large tumors, single kidney, chronic renal failure

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Rabin medical center
Study officials:
References:
Clinical trial NCT01589679: Contracture Reduction Following Bunionectomy: a Longitudinal, Controlled Trial
Official title: Contracture Reduction Following Bunionectomy: a Longitudinal, Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hallux Limitus
Lead sponsor: Dynasplint Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2012-05-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To determine the efficacy of Metatarsal Dynasplint Sytem (MTP) in reducing contracture of hallux limitus secondary to Bunionectomy, in a longitudinal, controlled trial.


Eligibility criteria: Inclusion Criteria:

* Diagnosis 1st MTJ Contracture following Bunionectomy

Exclusion Criteria:

* Current treatment with Botulinium Toxin-A (Botox), lower extremity
* Current treatment Fluoroquinolones (antibiotic medication)
* Current use of muscle relaxant medications
* Fibromyalgia
* Stroke, CVA, Brain Injury, Spinal Cord Injury, or any neural pathology causing plasticity or hypertonicity
* Treatment with electrical stimulation assisting ambulation (i.e Bioness, WalkAide, Parastep, etc.)

Primary outcomes:
measure: A Repeated Measures Analysis of Variance (ANOVA)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Henderson
country: United States
facility: Brown Hand Center and Achilles Foot & Ankle Specialist
state: Nevada
city: Houston
country: United States
facility: Advanced Diagnostic Foot and Ankle Specialist of Cy-Fair
state: Texas
Study officials:
References:
Clinical trial NCT06780579: Expanded Access for Bulevirtide
Official title: Expanded Access Treatment Protocol for Bulevirtide
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Chronic Hepatitis Delta Virus Infection
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2025-01-17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The goal of this study is to provide access to bulevirtide (BLV (GS-4438), Hepcludex®) to eligible participants with chronic hepatitis delta virus infection (CHD).


Eligibility criteria: Key Inclusion Criteria:

* Diagnosed with CHD as confirmed by medical records.
* Compensated liver disease with liver cirrhosis (defined by biopsy, Fibroscan, or clinically by the treating physician) and Child-Pugh score ≤ 6.
* Positive HDV RNA test within 6 months of initial EAP request (only applicable to patients who have not received treatment with BLV).

Key Exclusion Criteria:

* Coinfection with hepatitis C virus (HCV) (HCV viremia defined by polymerase chain reaction (PCR)) or uncontrolled HIV infection (CD4 \< 500 cells/mm\^3 and detectable HIV RNA).
* Current or previous (within last 3 months from screening) decompensated liver disease, including coagulopathy, hepatic encephalopathy, and esophageal varices hemorrhage.
* Significant medical diseases or conditions, that might decrease the benefit-risk ratio of participating in this program to an unacceptable level, as determined by the treating physician.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05545579: Comparative Effects of Circuit Training and Trunk Stabilization Technique in Basketball Players
Official title: Comparative Effects of Circuit Training and Trunk Stabilization Techniques on Speed, Power and Dynamic Balance in Basketball Players
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Basketball Players
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-09-19
Enrollment: 24
Sex: MALE
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the sports world, physical training is the most important factor because physical training increases the efficiency and the effectiveness of the sports. The players performance depends on various factors, but the main factor of players performance is physical training. Training contributes tremendously towards the achievement of such aims of this area in sports. The circuit training is a non-stop, high intensity, basketball specific workout. It increases overall speed and quickness, explosive power, upper and lower body strength, vertical jump and, most of all, the athlete's conditioning.

Detailed description: This study will be a randomized control trial and will be conducted in National stadium and Ravians Basketball club Lahore. The study will be completed within the time duration of six months. Non-probability convenience sampling technique will be used to collect the data. The sample size of total 24 athletes will be taken in this study. The participants will be divided into two groups i-e, one group will receive circuit training and other group will receive trunk stabilization exercises.

Circuit training consisted of 6 exercises, divided in 2 blocks (1st block contains ½ squats, bench press and pushups and 2nd block contains burpees, squat thrust and lunges) of 3 minutes. The stabilization exercise group will repeat 6 exercises (Balance Ball with Pocket Knife, Reverse Crunch, Russian Return, Shuttle, Leg Lift, and Back extension) for 6 weeks. Lane agility drill, Sprint test, Vertical jump test, Star excursion test will used to evaluate outcomes

Eligibility criteria: Inclusion Criteria:

* Males
* Age between 16-30 years
* No pain complaint
* Recreational activity
* Participate voluntarily
* Players have spent at least one year in sports

Exclusion Criteria:

* Higher BMI
* joint, meniscus, or ligament damage
* lower extremity surgical history
* persistent knee instability
* cardiac/musculoskeletal/vestibular/neurological issues

Primary outcomes:
measure: Agility test
timeFrame: 4 week
measure: Vertical jump test
timeFrame: 4 week
measure: Star excursion balance test
timeFrame: 4 week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Pakistan sports board
state: Punjab
Study officials:
affiliation: Riphah International University
name: Amna Shahid, t-DPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05680779: Neuromodulation in Chronic Ankle Instability
Official title: Ultrasound-guided Percutaneous Neuromodulation in Patiens With Chronic Ankle Instability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Sprains
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ankle sprain is a common injury. Around 712,000 sprains occur every day in the world. It is estimated that they account for 45% of sports injuries, being the second part of the body that is most frequently injured in sports. Of the patients who suffer this injury, around 70% will develop chronic ankle instability, a situation that can cause residual pain, recurrent sprains, a feeling of lack of stability and decreased physical activity.

Two entities can be included in chronic ankle instability: mechanical instability, which involves movement of the joint beyond its physiological limit, and functional instability, which includes proprioceptive dysfunction, impaired neuromuscular control, postural control, and strength deficits.

Currently, the conservative treatment of these patients consists of neuromuscular training through the use of dynamic balance platforms, taping, joint mobilization, dry needling, and the use of plantar supports, balance training being the one that has shown the best result.

Ultrasound-guided percutaneous neuromodulation (PNM) is a recently used technique in the field of invasive physiotherapy that consists of applying a square wave biphasic electrical current through an acupuncture needle-like electrode that is place in close proximity to the nerve with ultrasound guidance. The aim of this study is to evaluate the effectiveness of PNM in ankle instability.


Eligibility criteria: Inclusion Criteria:

* Ankle instability

Exclusion Criteria:

* Subjects taking NSAIDs, analgesics or muscle relaxants
* Epilepsy
* Belonephobia or allergy to metals

Primary outcomes:
measure: Cumberland ankle instability tool
timeFrame: Change from Baseline up to three months
Secondary outcomes:
measure: Byodex Balance System (BBS)
timeFrame: Change from Baseline up to 5 minutes
measure: Electromyography muscle (EMG)
timeFrame: Change from Baseline up to 5 minutes
measure: stiffness tissue
timeFrame: Change from Baseline up to 5 minutes
Other outcomes:
Locations:
city: Alcalá de Henares
country: Spain
facility: Physioterapy and Pain center research
state: Madrid
Study officials:
affiliation: Alcala University
name: Daniel Pecos-Martin, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01797679: Study of Cartilage Relaxometry and Physical Activity in Osteoarthritis
Official title: Efficacy of Strength and Aerobic Exercise on the Articular Cartilage of Patients With Mild and Moderate Knee Osteoarthritis Measured by T2 and T1 Rho MR Imaging - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Osteoarthritis
Keywords: Osteoarthritis,Articular Cartilage, Relaxometry, Morphometry, MRI, T2 mapping, T1 rho
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
name: Oslo University Hospital
name: Hjelp24
name: South-Eastern Norway Regional Health Authority
First posted: 2013-02-22
Enrollment: 0
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study is the radiological component of an earlier registered trial under the title: Efficacy of Exercise on Physical Function and Cartilage Health in Patients With Knee Osteoarthritis. The main purpose in this component of the study is to evaluate the efficacy of aerobic exercise and strength training on the T2 and T1 rho relaxation times of the articular cartilage. It has been proven that exercise can improve function and reduce the need for analgesics in patients with osteoarthritis. With this study, we wish to investigate if different kinds of exercise can cause measurable improvements in T2 and T1 rho relaxation times of the articular cartilage, and also if this improvements are transient or permanent.


Eligibility criteria: Inclusion Criteria:

* Women and men aged 45-65 years
* Clinical knee OA according to the American College of Rheumatology Clinical Criteria 17
* Kellgren and Lawrence radiographic OA grade 2 and 3 (mild to moderate radiographic OA)

Exclusion Criteria:

* Severe knee OA according to the Kellgren and Lawrence classification (grade 4)
* Other known major musculoskeletal impairments in the lower extremities or the back or prostheses in any joint of the lower extremities
* Known coronary heart diseases or cancer
* Body mass index \> 35
* Scheduled for surgery in any joint
* Known mental or psychologic diseases
* Known drug abuse
* Persons who already perform sports related moderate physical activity more than two times a week
* Contraindications for magnetic resonance imaging (specific point list at Diagnostic Imaging Division, Akershus University Hospital)
* Not speaking Norwegian

Primary outcomes:
measure: Qualitative Cartilage Morphology Assessment
timeFrame: One year
Secondary outcomes:
measure: Semiquantitative Cartilage Assessment
timeFrame: One year
Other outcomes:
Locations:
city: Lorenskog
country: Norway
facility: Akershus University Hospital
Study officials:
References:
Clinical trial NCT04994379: Investigating the Effects of Intensity of Transcranial Direct Current Stimulation on Subjective Appetite
Official title: Investigating the Effect of the Intensity of Primary Motor Cortex Cathodal TDCS on Appetite; a Double-blind Sham-controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy
Keywords: Perceived appetite
tDCS
Submental muscle
M1
Lead sponsor: University of Messina
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly allocated to one of the three groups of active 1 mA, active 1.5 mA, or the sham group.
Primary purpose: BASIC_SCIENCE

Brief summary: This is a randomized double-blind sham controlled systematic investigation to understand the importance of the brain region that controls the tongue and the submental muscle region on perceived appetite. The results of this study can have clinical implications for a phenomenon called hyperphagia.

Detailed description: After explaning all the procedure and the scientific aims of the project to participants and completing the informed consent form, each participant will be randomly asked to take part in the experiment while fasting for at least 6 hours or completely sated, to enable an investigation of the role of the basic level of hunger on the effects of brain stimulation on subjective appetite. Different intensities of stimulation (1 mA, 1.5 mA, and sham) will be used in three separate groups, to which participants will be randomly assigned, in a double-blind manner.

Eligibility criteria: Inclusion Criteria:

* Normal weight, based on the Body Mass Index (BMI)
* Males and females between 18 and 35

Exclusion Criteria:

* Use of psychoactive drugs
* Presence of metal implants in the brain, skull, scalp or neck
* Use of pacemaker
* Neurological or psychiatric pathologies
* History of severe head injury
* Pregnancy
* Clinical obesity based on BMI

Primary outcomes:
measure: Change in the subjective rating of appetite
timeFrame: Baseline measurement in the begninning of the experiment before stimulation versus post stimulation, exactly after the stimulation protocol has finished (with an approximate time interval of 1 hour)
Secondary outcomes:
measure: Change in excitability of the submental muscle region in primary motor cortex
timeFrame: Baseline measurement in the begninning of the experiment before stimulation versus post stimulation, exactly after the stimulation protocol has finished (with an approximate time interval of 1 hour)
Other outcomes:
Locations:
city: Messina
country: Italy
facility: University of Messina
state: Sicily
Study officials:
affiliation: University of Messina
name: Carmelo Mario Vicario, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02833779: Trial to Compare the Effectiveness of Group Versus Individual Therapy on Alternate Days in Patients With Subacromial Impingement Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mobility
Lead sponsor: Basque Health Service
Sponsor class: OTHER_GOV
First posted: 2016-07-14
Enrollment: 89
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pathology of the rotator cuff and subacromial bursa is considered to be the principal cause of pain and symptoms arising from the shoulder. Physiotherapy specialists often disagree about which type of exercise is most appropriate. Manual Physiotherapy combined with guided exercise is a commonly applied clinical treatment, but no proof of its effectiveness has been shown. Clinical trials comparing results of treating subacromial syndrome of the shoulder with guided self-treatment and conventional physiotherapy yielded a slightly higher improvement, basically because patients suffered from chronic tendinitis and the treatment period lasted only two weeks. That is the reason why the investigators propose a long-term follow-up study and a more complete assessment of effectiveness of the exercise prescribed to improved this pathology.

Objectives:

* Assessment of effectiveness of two different types of treatment of subacromial syndrome of the shoulder.
* Comparison of effectiveness of both treatments in order to select that one yielding better results as the one to be applied as a routine practice.

Patients will be assigned one of the following treatments:

* Group 1: patients will be taught exercises in groups of six people, on a daily basis for twelve sessions.
* Group 2: patients will be taught the same exercise as Group 1, individually, and will receive manual therapy consisting of muscular and joint re-centering.

A modified version of the Constant scale will be used to assess mobility and pain shoulder.


Eligibility criteria: Inclusion Criteria:

* History of shoulder pain defined as at least 2 positive results in subacromial impingement tests.
* Self-perceived pain reported by the patient under clinical examination of the shoulder.
* A minimum of 90º mobility in flexion.

Exclusion Criteria:

* Luxation, a history of surgery, or evidence the current shoulder pain or other symptoms under cervical examination or other shoulder bone disease, except for acromioclavicular joint arthrosis.
* Patients were receiving other physiotherapy or rehabilitation treatments.
* Patients had been treated for SIS (subacromial impingement syndrome) with injection of anti-inflammatory or analgesic drugs in the last month.

Primary outcomes:
measure: The assessment of pain with a visual analogue scale.
timeFrame: Six Months
measure: The mobility (joint range of motion) with a goniometer.
timeFrame: Six Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04076579: Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma
Official title: Phase II Multi-Center Trial of Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Sarcoma
Sarcoma Metastatic
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
Collaborators: name: Janssen Scientific Affairs, LLC
name: AstraZeneca
First posted: 2019-09-03
Enrollment: 29
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This phase II trial studies how well trabectedin and olaparib work in treating patients with sarcoma that cannot be removed by surgery or has spread to other places in the body. Drugs used in chemotherapy, such as trabectedin, work in different ways to stop the growth of tumor cells, either by killing cells, stopping them from dividing or stopping them from spreading. Olaparib may stop the growth of tumor cells by blocking pathways responsible for repairing damaged cells. Giving trabectedin and olaparib may shrink or stop the tumor from growing.


Eligibility criteria: Key Inclusion Criteria

* Age ≥ 16 years
* Advanced unresectable or metastatic sarcoma

  * Cohort 1: Leiomyosarcoma (LMS)/Liposarcoma (LPS)
  * Cohort 2: Other sarcoma histologies (excluding gastrointestinal stromal tumors)
* Received at least 1 prior standard chemotherapy. For cohort 1 patients, this must have included a prior anthracycline.
* Measurable disease by RECIST 1.1
* Adequate hematologic, renal, hepatic function
* Adequate creatine phosphokinase
* ECOG performance status ≤ 1
* Left ventricular ejection fraction (LVEF) \>= institutional lower limit of normal (LLN)
* Women of childbearing potential and men must agree to use adequate contraception from signing informed consent to at least 6 months (females) and 5 months (men) after study drug treatment

Key Exclusion Criteria

* Prior therapy with PARP inhibitor, including olaparib
* Prior therapy with trabectedin
* Additional active malignancy or treatment for alternative cancer (excluding non-melanoma skin cancer) requiring treatment within the past two years
* Pregnant or breastfeeding women
* Known hypersensitivity to trabectedin or olaparib
* Other exclusions per protocol

Primary outcomes:
measure: Overall Response Rate
timeFrame: Up to 2 years
Secondary outcomes:
measure: Progression Free Survival
timeFrame: At 6 months
measure: Progression Free Survival
timeFrame: At approximately 2 years after enrollment
measure: Overall Survival
timeFrame: At approximately 2 years after enrollment
measure: Incidence of Adverse Events
timeFrame: Up to 30 days after end of treatment
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Rogel Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Rashmi Chugh, M.D.
role: PRINCIPAL_INVESTIGATOR
References: